327 Amendments of Dagmar ROTH-BEHRENDT
Amendment 87 #
2013/2061(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Underlines the potential of apps for mobile devices for patients, especially for those with chronic diseases and encourage the development of helpful apps for health only with medically verified content;
Amendment 88 #
2013/2061(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Urges the Commission to come forward with an "mHealth action plan", which should include guidelines on market surveillance of mHealth apps in order to ensure data protection and the reliability of the provided health information, as well as to guarantee that these apps are developed under appropriate medical scrutiny;
Amendment 25 #
2013/0222(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Rapporteurs rely for their assessment on the scientific evaluation and resources of national marketing authorisation bodies, whilst it is the responsibility of the Agency to coordinate the existing scientific resources put at its disposal by the Member States. In view of that and to ensure adequate resources for the scientific assessments relating to the Union-wide pharmacovigilance procedures, the Agency should remunerate the scientific assessment services provided by the rapporteurs appointed by Member States as members of the Pharmacovigilance Risk Assessment Committee referred to in Article 56(1)(aa) of Regulation (EC) No 726/2004 or, where relevant, by rapporteurs in the coordination group referred to in Article 27 of Directive 2001/83/EC. The level of remuneration for the work carried out by those rapporteurs should be based on average estimHowever, in order to ensure that activities linked to Union-wide pharmacovigilance procedures are only connected with the need to ensure patient safety, the rapporteur of a referral should not be the Member State which asked for that referral. Concerning the level of remuneration for the work carried out by rapporteurs and co-rapporteurs, the payment should be based on clear and transparent invoices, which provide a precise indications of the workload involvednumber of working hours spent on each assessment by the rapporteur and the co- rapporteur(s) and of the related costs, and should be taken into account in setting the level of the fees for Union-wide pharmacovigilance procedures.
Amendment 30 #
2013/0222(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Generic medicinal products, mMedicinal products authorised under the provisions relating to well-established medicinal use, authorised homeopathic medicinal products and authorised herbal medicinal products should be subject to a reduced annual flat fee as those products generally have a well-established safety profile. However, in cases where these products are part of any of the Union-wide pharmacovigilance procedures, the full fee should be charged in view of the work involved. As the legislation on pharmacovigilance encourages the conduct of joint post authorisation safety studies, marketing authorisation holders should share the applicable fee in case a joint study is submitted.
Amendment 32 #
2013/0222(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) In order to avoid disproportionate administrative workload for the Agency, reductions and exemptions provided for in this Regulation should apply on the basis of a declaration of the marketing authorisation holder that claims to be entitled to the reduction or the exemption, and whose accuracy could be verified by the Agency. The submission of incorrect information should therefore be discouragstrongly prevented through an increase of the applicable amount of the fee.
Amendment 52 #
2013/0222(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. The Agency shall levy a fee for the assessment carried out in the context of a procedure initiated as a result of the evaluation of pharmacovigilance data under Articles 107i to 107k of Directive 2001/83/EC, under. Costs arising from procedures referred to in the second subparagraph of Article 31(1) thereof or underof Directive 2001/83/EC, or in Article 20(8) of Regulation (EC) No 726/2004 shall include a participation of the referring Member State.
Amendment 58 #
2013/0222(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. A reduced annual flat fee, as laid down in Part IV of the Annex, shall apply in respect of medicinal products referred to in Article 10(1) and Article 10a of Directive 2001/83/EC and in respect of authorised homeopathic medicinal products and authorised herbal medicinal products, as defined respectively in Article 1(5) and Article 1(30) of Directive 2001/83/EC.
Amendment 63 #
2013/0222(COD)
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The Agency may request, at any time, evidence that the conditions for a reduction of fees or for an exemption from fees are fulfilled. In that case, the marketing authorisation holder claiming or having claimed to be entitled to a reduction or an exemption under this Regulation, shall submit to the Agency the information necessary to demonstrate compliance with the relevant conditions, in order for the latter to be able to verify that these conditions are fulfilled.
Amendment 65 #
2013/0222(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Where a marketing authorisation holder claiming or having claimed to be entitled to a reduction of or an exemption from fees under this Regulation fails to demonstrate that it is entitled to such a reduction or exemption, the amount of the fee laid down in the Annex shall be increased by 120% and the Agency shall levy the resulting full applicable amount or, as appropriate, the balance to the resulting full applicable amount.
Amendment 71 #
2013/0222(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point f
Article 9 – paragraph 1 – subparagraph 1 – point f
(f) where the Member State has appointed a member of the Pharmacovigilance Risk Assessment Committee who acts as rapporteur for the referrals referred to in Article 6. In that case, Member State(s) which triggered the referral shall provide all necessary data on signals, but shall not be chosen as rapporteur or co-rapporteur for that referral.
Amendment 73 #
2013/0222(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2
Article 9 – paragraph 1 – subparagraph 2
Where the Pharmacovigilance Risk Assessment Committee or the coordination group decides to appoint a co-rapporteur, the remuneration shall be divided between the rapporteur and the co-rapporteur. , on the basis of clear and transparent invoices, which provide a precise indication of the number of working hours spent on each part of the assessment by the rapporteur and co- rapporteurs, and of the related costs. This amount of working hours shall be presented in an understandable, justified and provable way.
Amendment 74 #
2013/0222(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The remuneration provided for in paragraph 1 shall be paid only after the final assessment report for a recommendation which is intended for adoption by the Pharmacovigilance Risk Assessment Committee has been made available to the Agency. This report shall be submitted in a fully and workable version translated into the working language of the Agency.
Amendment 76 #
2013/0222(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. If the purpose of the payment cannot be established, the Agency shall set a deadline by which the marketing authorisation holder shall and notify itied in writing of the purpose of the payment. If the Agency does not receive a notification of the purpose of the payment before expiry of the deadlineto the Agency within 30 days, the payment shall be considered invalid and the amount concerned shall be refunded to the marketing authorisation holder.
Amendment 87 #
2013/0222(COD)
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2a. The annual flat fee referred to in Article 7 and Part IV of the Annex shall only enter into force six months after the date when Eudravigilance is declared by the Agency as fully functioning, in application of Article 24(2) third subparagraph of Regulation EC No 726/2004.
Amendment 93 #
2013/0222(COD)
Proposal for a regulation
Annex – part I – paragraph 4
Annex – part I – paragraph 4
4. Where reductions and exemptions apply, the remuneration of the rapporteur shall be adapted proportionally. Where the Agency subsequently collects the full applicable amount including the 120 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 97 #
2013/0222(COD)
Proposal for a regulation
Annex – part II – paragraph 4
Annex – part II – paragraph 4
4. Where reductions and exemptions apply, the remuneration of the rapporteur shall be adapted proportionally. Where the Agency subsequently collects the full applicable amount including the 120 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 105 #
2013/0222(COD)
Proposal for a regulation
Annex – part III – paragraph 3 – subparagraph 3
Annex – part III – paragraph 3 – subparagraph 3
Where reductions and exemptions apply, the remuneration of the rapporteur shall be adapted proportionally. Where the Agency subsequently collects the full applicable amount including the 120 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 111 #
2013/0222(COD)
Proposal for a regulation
Annex – part IV – paragraph 3
Annex – part IV – paragraph 3
3. Holders of marketing authorisations for medicinal products referred to in Article 7(5) shall pay 850 % of the amount applicable to the chargeable units corresponding to those products.
Amendment 784 #
2013/0140(COD)
Proposal for a regulation
Article 79 – paragraph 1 – point a
Article 79 – paragraph 1 – point a
Amendment 824 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) the use of resources collected through such fees, including the number of controls performed and, where appropriate, the number of unsatisfactory findings within the field of responsibility of the authority. Regional overviews should be produced;
Amendment 227 #
2013/0136(COD)
Proposal for a regulation
Recital 155
Recital 155
(155) The rules laid down in the legislative acts referred to in recital 154 are to be replaced by this Regulation and by subsequent Commission acts to be adopted pursuant to this Regulation. Accordingly, those legislative acts should be repealed. Howev, except very recent and still under negotiation ones. In order, to ensure legal clarity and avoid a legal vacuum, the repeal should only take effect when the relevant delegated and implementing acts are adopted pursuant to this Regulation. It is therefore necessary to provide the Commission with the empowerment to determine the dates when the repeal of those legislative acts should take effect.
Amendment 228 #
2013/0136(COD)
Proposal for a regulation
Recital 158
Recital 158
(158) In order to ensure legal certainty as regards the application of rules for identification and registration of animals, disease control measures for certain zoonoses and non-commercial movements of pet animals, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the date on which Regulations (EC) No 1760/2000, (EU) No XXX/XXX [Ex-998/2003] and (EC) No 21/2004 and Directives 92/66/EEC, 2000/75/EC, 2001/89/EC, 2002/60/EC, 2003/85/EC, 2005/94/EC and 2008/71/EC cease to apply.
Amendment 389 #
2013/0136(COD)
Proposal for a regulation
Article 258 – paragraph 2 – subparagraph 1 – indent 1
Article 258 – paragraph 2 – subparagraph 1 – indent 1
Amendment 390 #
2013/0136(COD)
Proposal for a regulation
Article 258 – paragraph 2 – subparagraph 1 – indent 19
Article 258 – paragraph 2 – subparagraph 1 – indent 19
Amendment 392 #
2013/0136(COD)
Proposal for a regulation
Article 259 – title
Article 259 – title
Transitional measures related to the repeal of Regulation (EC) No 1760/2000, Regulation (EC) No 21/2004 and Directive 2008/71/EC
Amendment 393 #
2013/0136(COD)
Proposal for a regulation
Article 259 – paragraph 1
Article 259 – paragraph 1
1. Notwithstanding Article 258(2) of this Regulation, Regulations (EC) No 1760/2000, and (EC) No 21/2004 and Directive 2008/71/EC shall continue to apply until the date to be determined in a delegated act adopted in accordance with paragraph 2 of this Article.
Amendment 397 #
2013/0136(COD)
Proposal for a regulation
Annex III – point 1
Annex III – point 1
Amendment 398 #
2013/0136(COD)
Proposal for a regulation
Annex III – point 18
Annex III – point 18
Amendment 27 #
2012/2092(BUD)
Draft opinion
Section 1 – paragraph 15 a (new)
Section 1 – paragraph 15 a (new)
15a. Recalls that the implementation and monitoring of the different policies and programmes requires highly qualified and multilingual staff committed to the European project and drawn on the widest possible geographical balance; stresses that an insufficient allocation of financial resources to meet staff requirements may jeopardize the success of these policies and programmes to the detriment of the Union and the Member States.
Amendment 78 #
2012/0267(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In order to ensure consistent classification across all Member States, it should be the responsibility of the Member StatesCommission to decide on a case-by-case basis whether or not a product or groups of products falls within the scope of this Regulation. If necessary, the Commission may decide, on a case-by- case basis, whether or not a product falls and within the definition of an in vitro diagnostic medical device or of an accessory to an in vitro diagnostic medical device.
Amendment 79 #
2012/0267(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) A multidisciplinary advisory committee of experts and representatives of stakeholder and civil society organisations should be set up in accordance with the conditions and modalities defined in Article 78a of Regulation (EU) [Ref. of future Regulation on medical devices] in order to provide scientific advice to the Commission, the Medical Device Coordination Group (MDCG) and Member States on issues of in vitro diagnostic medical technology, classification and other aspects of implementation of this Regulation as necessary.
Amendment 87 #
2012/0267(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) Transparency and better informationadequate access to information, appropriately presented for the intended user, are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 88 #
2012/0267(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) One key aspect is the creation of a central database that should integrate different electronic systems, with the UDI as an integral part of it, to collate and process information regarding in vitro diagnostic medical devices on the market and the relevant economic operators, marketing authorisations, certificates, interventional clinical performance studies and other clinical performance studies involving risks for the subjects of the studies, vigilance and market surveillance. The objectives of the database are to enhance overall transparency, via better access to information for the public and healthcare professionals, to streamline and facilitate the flow of information between economic operators, the Agency, notified bodies or sponsors and Member States as well as between Member States among themselves and with the Commission, to avoid multiple reporting requirements and to enhance the coordination between Member States. Within an internal market, this can be ensured effectively only at Union level and the Commission should therefore further develop and manage the European databank on medical devices (Eudamed) by further developing the databank set up by Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for Medical Devices.
Amendment 90 #
2012/0267(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) Eudamed’s electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public and healthcare professionals to be adequately informed about devices on the Union market. Adequate levels of access for the public and healthcare professionals to those parts of Eudamed’s electronic systems which provide key information on in vitro diagnostic medical devices that may pose a risk to public health and safety is essential. Where such access is limited, it should be possible, upon a reasoned request, to disclose existing information for in vitro diagnostic medical devices, unless the limitation of access is justified on grounds of confidentiality. The electronic system on clinical performance studies should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities.
Amendment 92 #
2012/0267(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) For high-risk in vitro diagnostic medical devices, manufacturers should summarise the main safety and performance aspects of the device and the outcomeprovide the national authority or the Agency, as relevant, involved in the marketing authorisation procedure, with a full report ofn the clinical evaluation in a document thasafety and clinical performance aspects of that device. A summary of that report should be publicly available via Eudamed.
Amendment 93 #
2012/0267(COD)
Proposal for a regulation
Recital 35
Recital 35
Amendment 96 #
2012/0267(COD)
Proposal for a regulation
Recital 35 a (new)
Recital 35 a (new)
(35a) The conformity assessment procedure should not be applicable for class D in vitro diagnostic medical devices. A swift centralized marketing authorization procedure should be introduced for innovative class D devices. A swift decentralized marketing authorization procedure should be introduced for all other class D devices, with the possibility for manufacturers of those types of devices to rather apply to the centralized marketing authorization procedure.
Amendment 98 #
2012/0267(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) The conformity assessment procedure for class A in vitro diagnostic medical devices should be carried out, as a general rule, under the sole responsibility of the manufacturers, since such devices pose a low risk to patients. For in vitro diagnostic medical devices in classes B, C and D,C the involvement of a notified body should be compulsory to the appropriate degree. For in vitro diagnostic medical devices in class D, the involvement of the Agency or of the Member States should be compulsory.
Amendment 100 #
2012/0267(COD)
Proposal for a regulation
Recital 44 a (new)
Recital 44 a (new)
(44a) An interventional clinical performance studies or any other clinical performance study should only start after being granted a positive evaluation by an independent ethics committee. Member States should take the necessary measures to establish Ethics Committees where such committees do not exist.
Amendment 101 #
2012/0267(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Sponsors of interventional clinical performance studies and other clinical performance studies involving risks for the subjects to be conducted in more than one Member State should be given the possibility to submit a single application in order to reduce administrative burden. In order to allow for resource-sharing and to ensure consistency regarding the assessment of the health and safety related aspects of the device for performance evaluation and of the scientific design of the clinical performance study to be conducted in several Member Stats, such single application should facilitate the coordination between the Member States under the direction of a coordinating Member State. The coordinated assessment should not include the assessment of intrinsically national, local and ethical aspects of a clinical performance study, including informed consent. Each Member State should retain the ultimate responsibility for deciding whether the clinical performance study may be conducted on its territory.
Amendment 103 #
2012/0267(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Member States should take all necessary measures to raise awareness among healthcare professionals, users and patients about the importance of reporting suspected serious incidents. Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats. TIn order to minimise the recurrence of such incidents, the national competent authorities should inform manufacturers and sharereport the information with their peersvia the respective electronic system in Eudamed when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 104 #
2012/0267(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) The Member States shall levy fees for the designation and monitoring of notified bodies to ensure sustainability of the monitoring of those bodies by Member States and to establish a level playing field for notified bodies. These fees should be comparable across Member States and should be made public.
Amendment 105 #
2012/0267(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) Whilst this Regulation should not affect the right of the Member States to levy fees for activities at national level, Member States should inform the Commission and the other Member States before they adopt the comparable level and structure of the fees to ensure transparency.
Amendment 106 #
2012/0267(COD)
Proposal for a regulation
Recital 54 a (new)
Recital 54 a (new)
(54a) Member States should adopt regulations on standard fees for notified bodies, which should be comparable across Member States. The Commission should provide guidelines to facilitate the comparability of those fees. Member States should transmit their list of standard fees to the Commission and ensure that the notified bodies registered on their territory make the lists of standard fees for their conformity assessment activities publicly available.
Amendment 107 #
2012/0267(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) An expert committee, the Medical Device Coordination Group (MDCG), composed of persons designated by the Member States, based on their role and expertise in the field of medical devices and in vitro diagnostic medical devices, should be established in accordance with the conditions and modalities defined in Article 78 of Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) [Ref. of future Regulation on medical devices] on medical devices, to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of this Regulation.
Amendment 135 #
2012/0267(COD)
Proposal for a regulation
Chapter 2 – title
Chapter 2 – title
Chapter II Chapter VI Making available of devices, obligations of economic operators, CE marking, free movement
Amendment 184 #
2012/0267(COD)
Proposal for a regulation
Chapter 3 – title
Chapter 3 – title
Chapter III Chapter VII Identification and traceability of devices, registration of devices and of economic operators, summary of safety and performance, European databank on medical devices
Amendment 196 #
2012/0267(COD)
Proposal for a regulation
Article 26 – paragraph 6 – subparagraph 1
Article 26 – paragraph 6 – subparagraph 1
The national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel at its disposal for the proper performance of its tasks"in house" for the proper performance of its tasks. Compliance with that requirement shall be assessed in the peer-review referred to in paragraph 8. In particular, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.5. of Annex VI. Similarly, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer’s quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.6. of Annex VI.
Amendment 197 #
2012/0267(COD)
Proposal for a regulation
Article 26 – paragraph 6 – subparagraph 2
Article 26 – paragraph 6 – subparagraph 2
Without prejudice to Article 31(3), where a national authority is responsible for the designation of notified bodies in the field of products other than in vitro diagnostic medical devices, the competent authority for in vitro diagnostic medical devices shall be consulted on all aspects specifically related to such devices.
Amendment 199 #
2012/0267(COD)
Proposal for a regulation
Article 26 – paragraph 7
Article 26 – paragraph 7
7. Member States shall provide the Commission and the other Member States with all information they request on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto.
Amendment 201 #
2012/0267(COD)
Proposal for a regulation
Article 26 – paragraph 8 – subparagraph 2
Article 26 – paragraph 8 – subparagraph 2
The Member States shall draw up the annual plan for the peer-review, ensuring an appropriate rotation in respect of reviewing and reviewed authorities, and submit it to the Commission. The Commission mayshall participate in the review. The outcome of the peer-review shall be communicated to all Member States and to the Commission and a summary of the outcome shall be made publicly available.
Amendment 202 #
2012/0267(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. Minimum requirements to be met by notified bodies are set out in Annex VIIn this respect, permanent "in house" administrative, technical and scientific personnel, with pharmacological, medical and technical knowledge is crucial. Minimum requirements to be met by notified bodies are set out in Annex VI. In particular, in accordance with point 1.2. of Annex VI, the notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities and avoid conflict of interests.
Amendment 203 #
2012/0267(COD)
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Where a nNotified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements sehall have permanent "in house" competent personnel and expertise, both in technical fields linked with the assessment of the performance of the devices, and in the medical field. They shall have the capacity to evaluate "in house" the quality of subcontractors. Subcontracting shall be awarded to public entities. Contracts can also be awarded to external experts for the assessment outf in Annex VI and shall infnovative medical devices orm the national authority responsible for notified bodies accordinglyechnologies where clinical expertise is limited.
Amendment 204 #
2012/0267(COD)
Proposal for a regulation
Article 28 – paragraph 1 a (new)
Article 28 – paragraph 1 a (new)
1a. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in Annex VI and shall inform the national authority responsible for notified bodies accordingly.
Amendment 205 #
2012/0267(COD)
Proposal for a regulation
Article 28 – paragraph 2 a (new)
Article 28 – paragraph 2 a (new)
2a. Notified bodies shall make publicly available the list of subcontractors or subsidiaries, as well as the specific tasks for which they are responsible.
Amendment 206 #
2012/0267(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Conformity assessment activities may be subcontracted or carried out by a subsidiary only with the explicit agreement of the legal or natural person that applied for conformity assessment.
Amendment 207 #
2012/0267(COD)
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. Notified bodies shall keep at the disposal ofAt least once a year, notified bodies shall submit to the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
Amendment 212 #
2012/0267(COD)
Proposal for a regulation
Article 30 – paragraph 4 – subparagraph 2
Article 30 – paragraph 4 – subparagraph 2
Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified in the assessment report of the national authority responsible. The national authority shall set out in the assessment report the measures it will take to ensure compliance of that applicant conformity assessment body with the requirements set out in Annex VI.
Amendment 214 #
2012/0267(COD)
Proposal for a regulation
Article 30 – paragraph 6
Article 30 – paragraph 6
6. The joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which t. The relevant national authority shall duly take into consideration for its decision on the designation of the notified bodybase its decision on the designation of the notified body on this recommendation by the MDCG. In case where its decision differs from that recommendation, the national authority shall provide the MDCG with all necessary justifications.
Amendment 215 #
2012/0267(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Member States mayshall notify only conformity assessment bodies which satisfy the requirements set out in Annex VI.
Amendment 216 #
2012/0267(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
Amendment 218 #
2012/0267(COD)
Proposal for a regulation
Article 31 – paragraph 8
Article 31 – paragraph 8
8. When a Member State or the Commission raises objections in accordance with paragraph 7, the effect of the notification shall be immediately suspended. In this case, the Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 28 days after the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion.
Amendment 220 #
2012/0267(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. The Commission shall make easily accessible to the public the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Amendment 221 #
2012/0267(COD)
Proposal for a regulation
Article 33 – paragraph 1 – subparagraph 2
Article 33 – paragraph 1 – subparagraph 2
Notified bodies shall, without delay, and at least within 15 days, inform the national authority responsible for notified bodies of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Annex VI or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated.
Amendment 222 #
2012/0267(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Notified bodies shall respond without delay, and at least within 15 days, to requests relating to conformity assessments they have carried out, submitted by their or another Member State’s authority or by the Commission. The national authority responsible for notified bodies of the Member State in which the body is established shall enforce requests submitted by authorities of any other Member State or by the Commission unless. Where there is a legitimate reason for not doing so in which case both sides may consult the MDCG. The notified body or their national authority responsible for notified bodies may request that any information transmitted to the authorities of another Member State or to the Commission shall be treated as confidential, the notified bodies shall explain these reasons and shall consult the MDCG, which shall then issue a recommendation. The national authority responsible for notified bodies shall comply with the MDCG’s recommendation.
Amendment 225 #
2012/0267(COD)
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 2
Article 34 – paragraph 2 – subparagraph 2
The national authority responsible for notified bodies shall immediately and at least within 10 days, inform the Commission and the other Member States of any suspension, restriction or withdrawal of a notification.
Amendment 226 #
2012/0267(COD)
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to the notification have an impact on the certificates issued by the notified body and, within three months after having notified the changes to the notification, shall submit a report on its findings to the Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shall instruct the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, and at the latest 30 days after the publication of the report, any certificates which were unduly issued. If the notified body fails to do so within the determined period of time, or has ceased its activity, the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued.
Amendment 227 #
2012/0267(COD)
Proposal for a regulation
Article 34 – paragraph 5 – subparagraph 2
Article 34 – paragraph 5 – subparagraph 2
The authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately and at least within 10 days, inform the Commission, the other Member States and the other notified bodies thereof.
Amendment 230 #
2012/0267(COD)
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – paragraph 1
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of the coordination group of notified bodies referred to in Article 39 of Regulation [Ref. of future Regulation on medical devices]. This group shall meet on a regular basis and at least twice a year.
Amendment 234 #
2012/0267(COD)
Proposal for a regulation
Article 38 – title
Article 38 – title
Fees for the activities of national authorities
Amendment 235 #
2012/0267(COD)
Proposal for a regulation
Article 38 – paragraph 1
Article 38 – paragraph 1
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. These fees shall be comparable across Member States and the level of the fees shall be made public.
Amendment 236 #
2012/0267(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 setting out the structure and the comparable level of the fees referred to in paragraph 1, taking into account the objectives of protection of human health and safety, support of innovation and, cost- effectiveness and the need to create a level-playing field across Member States. Particular attention shall be paid to the interests of notified bodies that received a certificate delivered by the national accreditation body as referred to in Article 29(2) and notified bodies that are small and medium-sized enterprises as defined by the Commission Recommendation 2003/361/EC.
Amendment 237 #
2012/0267(COD)
Proposal for a regulation
Article 38 a (new)
Article 38 a (new)
Article 38a Transparency on fees charged by notified bodies for conformity assessment activities 1. Member States shall adopt regulations on standard fees for notified bodies. 2. Fees shall be comparable across Member States. The Commission shall provide guidelines to facilitate comparability of those fees within 24 months from the date of entry into force of this Regulation. 3. Member States shall transmit their list of standard fees to the Commission. 4. The national authority shall ensure that the notified bodies make the lists of standard fees for the conformity assessment activities publicly available.
Amendment 240 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – title
Chapter 5 – title
Classifichapter V Chapter III Marketing authorisation and conformity assessment
Amendment 241 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – section 1 – title
Chapter 5 – section 1 – title
Amendment 242 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – section 1 a – Article 39 a (new)
Chapter 5 – section 1 a – Article 39 a (new)
Section 1a – Marketing authorisation Article 39 a (new) General principles regarding the marketing authorisation 1. None of the innovative class D devices may be placed on the market within the Union unless a Union marketing authorisation has been granted through the centralised procedure referred to in Article 39c, and in accordance with the provisions of this Regulation. 2. None of the non-innovative class D devices may be placed on the market of a Member State unless a national marketing authorisation has been granted by the competent authority of that Member State through the decentralised procedure referred to in Article 39d, and in accordance with the provisions of this Regulation. 3. By way of derogation from paragraph 2, the manufacturer may decide to apply for a marketing authorisation under the centralised procedure for the devices included in paragraph 2. 4. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to amend the list set out in paragraph 1, in the light of technical progress. 5. Devices referred to in paragraphs 1 and 2, and which are already on the Union market at the date of entry into force of this Regulation, shall be required to have a marketing authorisation, in accordance with the procedures set out in this Section, as from the expiry date of the validity of their certificate. 6. A marketing authorisation granted under this Section shall be valid for five years. The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the Agency. 7. All applications for marketing authorisation and granted marketing authorisations under the provisions of Articles 39c, 39d, 39e and 39f as well as the information referred to in Article 39b shall be entered either by the Commission or the Member States, as relevant, in the electronic system referred to in Article 39b(1), without delay and at the latest 15 days after receipt. Before commencing the review of an application for a medical device, the Committee for the Authorisation of Medical Devices, as referred to in Article 41c, or the competent authority of the relevant Member State shall verify that no other application has been introduced for the same medical device.
Amendment 243 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 b (new)
Chapter 5 – Section 1 a – Article 39 b (new)
Amendment 244 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 c (new)
Chapter 5 – Section 1 a – Article 39 c (new)
Amendment 245 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 d (new)
Chapter 5 – Section 1 a – Article 39 d (new)
Amendment 246 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 e (new)
Chapter 5 – Section 1 a – Article 39 e (new)
Amendment 247 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 f (new)
Chapter 5 – Section 1 a – Article 39 f (new)
Amendment 248 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 g (new)
Chapter 5 – Section 1 a – Article 39 g (new)
Amendment 249 #
2012/0267(COD)
Proposal for a regulation
Chapter 5 – Section 1 a – Article 39 h (new)
Chapter 5 – Section 1 a – Article 39 h (new)
Amendment 257 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 1
Article 40 – paragraph 2 – subparagraph 1
Manufacturers of devices classified as class D, other than devices for performance evaluation, shall be subject to a conformity assessmentmarketing authorisation based on full quality assurance, design dossier examination and batch verification, as specified in Annex VIII. Alternatively, the manufacturer may choose to apply a conformity assessmentmarketing authorisation based on type examination as specified in Annex IX, coupled with a conformity assessmentmarketing authorisation based on production quality assurance including batch verification, as specified in Annex X.
Amendment 258 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessmentCommittee for the Authorisation of In Vitro Diagnostic Medical Device referred to in Article 39c, or the national authority, shall request that reference laboratory to verify compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent, as specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX.
Amendment 261 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1
Article 40 – paragraph 3 – subparagraph 1
Amendment 263 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1
Article 40 – paragraph 4 – subparagraph 1
Amendment 264 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 5 – subparagraph 1
Article 40 – paragraph 5 – subparagraph 1
Amendment 265 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 6
Article 40 – paragraph 6
6. Manufacturers may choose to apply a marketing authorisation or a conformity assessment procedure applicable to devices of a higher class than the device in question.
Amendment 266 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 9 – subparagraph 1 – indent 3
Article 40 – paragraph 9 – subparagraph 1 – indent 3
Amendment 267 #
2012/0267(COD)
Proposal for a regulation
Article 41 – title
Article 41 – title
Involvement of notified bodies in the conformity assessment procedure
Amendment 268 #
2012/0267(COD)
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. Where a manufacturer applies to a notified body located in a Member State other than the one where it is registered, the manufacturer shall inform its national authority responsible for the notified bodies of the application. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity.
Amendment 271 #
Amendment 275 #
2012/0267(COD)
Proposal for a regulation
Article 44 – paragraph 1 – introductory part
Article 44 – paragraph 1 – introductory part
1. In cases wWhere a manufacturer decides to terminates his contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, tit shall inform its national authority responsible for the notified bodies of this change. The modalities of the change of notified body shall be clearly defined in an agreement between the manufacturer, the outgoing notified body and the incoming notified body. This agreement shall address at least the following aspects:
Amendment 277 #
2012/0267(COD)
Proposal for a regulation
Chapter 6 – title
Chapter 6 – title
Chapter VI Chapter V Clinical evidence Clinical evidence
Amendment 278 #
2012/0267(COD)
Proposal for a regulation
Article 48 – paragraph 1 – point b
Article 48 – paragraph 1 – point b
(b) to verify that devices achieve the intended benefits to the patient as specified by the manufacturere clinical safety and efficacy of the device, including the intended benefits to the patient, when used for the intended purpose, in the target population and in accordance with the instructions of use;
Amendment 279 #
2012/0267(COD)
Proposal for a regulation
Article 48 – paragraph 4
Article 48 – paragraph 4
4. All clinical performance studies shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in such clinical performance studies are protected, in accordance with Article 48 a (3), and that the clinical data generated in the clinical performance study are going to be reliable and robust.
Amendment 280 #
2012/0267(COD)
Proposal for a regulation
Article 48 a (new)
Article 48 a (new)
Article 48 a Involvement of Ethics Committee 1. Authorisation to conduct a clinical performance study may only be granted if an independent ethics committee has previously submitted a positive evaluation of that performance study. 2. The statement of the Ethics Committee shall cover in particular the medical justification, the consent of the test subjects participating in the clinical performance study following the provision of full information about the clinical performance study and the suitability of the investigators and investigation facilities. 3. The Ethics Committee shall ensure that the rights, safety and well-being of subjects participating in a clinical performance study are protected. 4. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and must abide by all relevant international norms and standards. 5. The Ethics Committee shall consist of a clearly defined number of members and substitutes which include healthcare professionals, laypersons and at least one well-experienced, knowledgeable patient or patient representative, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed clinical performance study. 6. Member States shall take the necessary measures to establish Ethics Committees where such committees do not exist, and to facilitate their work. Members States shall publish the number, the names and the professions of the members and substitutes of the Ethics Committees and inform the Commission about the composition of the Ethics Committees and the date on which they become operational.
Amendment 281 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1
Article 49 – paragraph 2 – subparagraph 1
The sponsor of a clinical performance study shall submit an application to the Member State(s) in which the study is to be conducted accompanied by the documentation referred to in Annex XIII. Within sixten days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical performance study falls within the scope of this Regulation and whether the application is complete.
Amendment 283 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 3 – subparagraph 1
Article 49 – paragraph 3 – subparagraph 1
Where the Member State finds that the clinical performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a maximum of sixten days for the sponsor to comment or to complete the application.
Amendment 284 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 3 – subparagraph 3
Article 49 – paragraph 3 – subparagraph 3
Where the Member State has not notified the sponsor according to paragraph 2 within threfive days following receipt of the comments or of the completed application, the clinical performance study shall be considered as falling within the scope of this Regulation and the application shall be considered complete.
Amendment 285 #
2012/0267(COD)
Proposal for a regulation
Article 49 – paragraph 5 – point c
Article 49 – paragraph 5 – point c
(c) after the expiry of 3560 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy.
Amendment 286 #
2012/0267(COD)
Proposal for a regulation
Article 50 – paragraph 1 – point g a (new)
Article 50 – paragraph 1 – point g a (new)
(g a) the methodology to be used, the number of subjects involved and the intended result of the study.
Amendment 287 #
2012/0267(COD)
Proposal for a regulation
Article 50 – paragraph 2 a (new)
Article 50 – paragraph 2 a (new)
2a. Upon completion of the clinical performance study, the sponsor shall enter in the electronic system referred to in Article 51 a summary of its results drawn up in a way that is easy for a lay person to understand.
Amendment 295 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […] of Regulation (EU) No [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 50, the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission. The Commission shall also ensure that healthcare professionals have access to the electronic system.
Amendment 297 #
2012/0267(COD)
Proposal for a regulation
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2a. Upon a reasoned request, all information on a specific in vitro diagnostic medical device available in the electronic system shall be made accessible to the party requesting it, save where the confidentiality of all or parts of the information is justified on any of the following grounds: (a) protection of personal data in accordance with Regulation (EC) No 45/2001; (b) protection of commercially sensitive information; (c) effective supervision of the conduct of the clinical performance study by the Member State(s) concerned.
Amendment 298 #
2012/0267(COD)
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Where a Member State has refused, suspended or terminated a clinical performance study, or has called for a substantial modification or temporary halt of a clinical performance study, or has been notified by the sponsor of the early termination of a clinical performance study on safety or efficacy grounds, that Member State shall communicate its decision and the grounds thereforfor that decision to all Member States and the Commission by means of the electronic system referred to in Article 51.
Amendment 299 #
2012/0267(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. If the sponsor has temporarily halted a clinical performance study on safety or efficacy grounds, he shall inform the Member States concerned within 15 days of the temporary halt.
Amendment 300 #
2012/0267(COD)
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 1
Article 55 – paragraph 2 – subparagraph 1
The sponsor shall notify each Member State concerned of the end of a clinical performance study in relation to that Member State, providing a justification in the event of early termination, so that all Member States can inform sponsors conducting similar clinical performance studies at the same time within the Union of the results of that clinical performance study. That notification shall be made within 15 days from the end of the clinical performance study in relation to that Member State.
Amendment 301 #
2012/0267(COD)
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 2
Article 55 – paragraph 2 – subparagraph 2
If the study is conducted in more than one Member State, the sponsor shall notify all Member States concerned of the overall end of the clinical performance study. Information on the reasons for the early termination of the clinical performance study shall also be provided to all Member States, so that all Member States can inform sponsors conducting similar clinical performance studies at the same time within the Union of the results of that the clinical performance study. That notification shall be made within 15 days from the overall end of the clinical performance study.
Amendment 303 #
2012/0267(COD)
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
2. In the single application, the sponsor shall propose one of the Member States concerned as coordinating Member State. The reporting Member State shall be chosen from among the Member States concerned in which most of the subjects participating in the clinical performance study in question live. If that Member State does not wish to be the coordinating Member State, it shall agree, within six days of submission of the single application, with another Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becomes coordinating Member State, the deadlines referred to in Article 49(2) shall start on the day following the acceptance.
Amendment 305 #
2012/0267(COD)
Proposal for a regulation
Chapter 7 – title
Chapter 7 – title
Chapter VII Chapter VIII Vigilance and market surveillance
Amendment 306 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 1 – subparagraph 1 – point a
Article 59 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident ,including date and place of incident, in respect of devices made available on the Union market; where available, the manufacturer shall include information on the patient or user and healthcare professional involved in the incident;
Amendment 308 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures, including targeted information campaigns, to encourage healthcare professionals, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure thatinform the manufacturer of the device concerned is informed of the incidentwithout delay. The manufacturer shall ensure the appropriate follow-up. Where a competent authority of a member State ascertains that the reports received pursuant to the first subparagraph relate to a serious incident it shall notify those reports to the electronic system referred to in Article 60 without delay, unless the same incident has already been reported by the manufacturer.
Amendment 311 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 2
Article 59 – paragraph 3 – subparagraph 2
The Member States shall coordinate between them theCommission, in cooperation with the Member States and in consultation with relevant partners including patient and consumer organisations, shall development of standard web-based structured forms for forms for electronic and non- electronic reporting of serious incidents by healthcare professionals, users and patients.
Amendment 314 #
2012/0267(COD)
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and, to the Agency, to the notified bodies and healthcare professionals..
Amendment 315 #
2012/0267(COD)
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
3. The Commission shall ensure that healthcare professionals and the public havehas an appropriate levels of access to the electronic system. In particular, it shall ensure that, in case information is requested on a specific in vitro diagnostic medical device, it is made available without delay and within 15 days.
Amendment 316 #
2012/0267(COD)
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 2
Article 61 – paragraph 1 – subparagraph 2
Amendment 318 #
2012/0267(COD)
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States and to the Commission, to the Commission, to the Agency and to healthcare professionals. The Commission shall also ensure that the public has an appropriate level of access to the electronic system. In particular, it shall ensure that, in case information is requested on a specific in vitro diagnostic medical device, it is made available without delay and within 15 days..
Amendment 319 #
2012/0267(COD)
Proposal for a regulation
Chapter 8 – title
Chapter 8 – title
Chapter VIII Chapter IX Cooperation between Member States, Medical Device Coordination Group, EU reference laboratories, device registers
Amendment 320 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point a a (new)
Article 77 – paragraph 1 – point a a (new)
(aa) to examine questions related to the mutual recognition procedure in accordance with provisions under Article 39e;
Amendment 330 #
2012/0267(COD)
Proposal for a regulation
Article 77 a (new)
Article 77 a (new)
Amendment 338 #
2012/0267(COD)
Proposal for a regulation
Article 79 – paragraph 1
Article 79 – paragraph 1
The Commission and the Member States shall take all appropriate measures to encouragsure the establishment of registers for specific types ofin vitro diagnostic devices to gather post- market experience related to the use of such devices. registers for class C and D shall be systematically established. Such registers shall contribute to the independent evaluation of the long-term safety and performance of devices.
Amendment 339 #
2012/0267(COD)
Proposal for a regulation
Chapter 9 – title
Chapter 9 – title
Chapter IX Chapter X Confidentiality, data protection, funding, penalties
Amendment 340 #
2012/0267(COD)
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
This Regulation shall be without prejudice to the possibility for Member States to levy fees for the activities set out in this Regulation, provided that the level of the fees is comparable and set in a transparent manner and on the basis of cost recovery principles. They shall inform the Commission and the other Member States at least three months before the structure and level of fees is to be adopted.
Amendment 343 #
2012/0267(COD)
Proposal for a regulation
Chapter 10 – title
Chapter 10 – title
Chapter X Chapter XI Final provisions Final provisions
Amendment 344 #
2012/0267(COD)
Proposal for a regulation
Article 90 – paragraph 2
Article 90 – paragraph 2
2. It shall apply from [fivthree years after entry into force].
Amendment 349 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.2 – paragraph 1 – point xv
Annex 1 – part III – point 17 – point 17.2 – paragraph 1 – point xv
(xv) If the device is intended for single use, an indication of that fact. The manufacturer shall provide sufficient evidence that the device cannot be reprocessed safely. A manufacturer's indication of single use shall be consistent across the Union;
Amendment 352 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 5
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 5
– if the device is intended for single use, an indication of that fact. The manufacturer shall provide sufficient evidence that the device cannot be reprocessed safely. A manufacturer's indication of single use shall be consistent across the Union;
Amendment 353 #
2012/0267(COD)
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 6
Annex 1 – part III – point 17 – point 17.3 – point 17.3.1 – point xii – indent 6
– if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, decontamination, packaging, the maximum number of allowable reuses and, where appropriate, the validated method of re- sterilization. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses.
Amendment 360 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 1 – point 1.1 – point 1.1.4 – paragraph 1
Annex 6 – point 1 – point 1.1 – point 1.1.4 – paragraph 1
The organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel with influence upon the performance and results of the conformity assessment activities shall be clearly documented. This information shall be made publicly available.
Amendment 361 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 1 – point 1.2 – point 1.2.3 a (new)
Annex 6 – point 1 – point 1.2 – point 1.2.3 a (new)
1.2.3 a. The notified body shall provide evidence to the national authority that there are no conflicts of interest in compliance with point 1.2.3. The national authority shall report to the Commission twice a year in full transparency.
Amendment 362 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 1 – point 1.2 – point 1.2.6
Annex 6 – point 1 – point 1.2 – point 1.2.6
1.2.6. The notified body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, do not affect its independence, impartiality or objectivity of its conformity assessment activities. The notified body shall provide evidence to the national authority of its compliance with this point.
Amendment 363 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 1 – point 1.3 – paragraph 1
Annex 6 – point 1 – point 1.3 – paragraph 1
The personnel of a notified body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, only in justified cases and except in relation to the national authorities responsible for notified bodies, competent authorities or the Commission. Proprietary rights shall be protected. To this end, the notified body shall have documented procedures in place. Where information and data are requested by the public or healthcare professionals, the notified body shall make publicly available the reasons for such information being subject to non- disclosure.
Amendment 364 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 1 – point 1.6 – point 1.6.1
Annex 6 – point 1 – point 1.6 – point 1.6.1
1.6.1. The notified body shall participate in, or ensure that its assessment personnel is informed of the relevant standardisation activities and the activities of the notified body coordination group and that its assessment and decision making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation. The notified body shall keep a record of the actions it takes to inform its personnel.
Amendment 365 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
This presupposes the permanent availability within its organisation of sufficient scientific personnel who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Regulation and, in particular, those set out in Annex I.
Amendment 366 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.2
Annex 6 – point 3 – point 3.1 – point 3.1.2
3.1.2. At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organisation the necessary administrative, technical and scientific personnel with pharmacological, medical and technical knowledge and sufficient and appropriate experience relating to in vitro diagnostic medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data.
Amendment 367 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.3 a (new)
Annex 6 – point 3 – point 3.1 – point 3.1.3 a (new)
3.1.3 a. The notified body shall make available the list of its personnel and their expertise to the Commission and, upon request, to other parties. That list shall be kept up to date.
Amendment 368 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 7 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.3 – indent 7 a (new)
- at least three years' appropriate experience in the field of conformity assessments within a notified body,
Amendment 369 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.4 – introductory part
3.2.4. NClinical experts: notified bodies shall have available personnel with clinical expertise, on a permanent basis, personnel with expertise in clinical investigation design, medical statistics, clinical patient management, Good Clinical Practice in the field of clinical performance studies and pharmacology. This personnel shall be integrated in the notified body's decision-making process in a steady way in order to:
Amendment 370 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 1
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 1
– identify when specialist input is required for the assessment of the clinical performance studies plans and the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;
Amendment 371 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 3
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 3
– be able to discuss the clinical data contained within the manufacturer's clinical evaluarationale of the planned study design, the clinical performance study plans and the selection of the control intervention with the manufacturer and with external clinical experts and to appropriately guide external clinical experts in the assessment of the clinical evaluation;
Amendment 372 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 4
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 4
– be able to scientifically challenge the clinical performance study plans and the clinical data presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation;
Amendment 373 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 6 a (new)
Annex 6 – point 3 – point 3.2 – point 3.2.4 – indent 6 a (new)
- provide an understanding of active substances.
Amendment 374 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.5 – introductory part
3.2.5. TProduct assessors: the personnel responsible for carrying out product related review (e.g. design dossier review, technical documentation review or type examination including aspects such as clinical evaluation, sterilisation, software validation) shall have the following proven qualification:
Amendment 376 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part
Annex 6 – point 3 – point 3.2 – point 3.2.6 – introductory part
3.2.6. TAuditors: the personnel responsible for carrying out audits of the manufacturer's quality management system shall have the following proven qualification:
Amendment 378 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.3.1
Annex 6 – point 3 – point 3.3 – point 3.3.1
3.3.1. The notified body shall have a process in place to fully document the qualification of each personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall appropriately justify the authorisation of this personnel to carry out specific conformity assessment activities.
Amendment 379 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.1
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.1
3.4.1. Without prejudice to the limitations emanating from Section 3.2., the notified bodies may subcontract clearly defined parts of the conformity assessment activities(-1). Notified body shall have permanent "in house" competent personnel and expertise, not only in technical fields linked with the assessment of the performance of the devices, but also in the medical sector. They shall have the capacity to evaluate "in house" the quality of subcontractors. By derogation, the following paragraphs apply. 3.4.1. Without prejudice to the limitations emanating from Section 3.2., the notified bodies may subcontract clearly defined parts of the conformity assessment activities to public entities. Contracts can also be awarded to external experts for the assessment of innovative medical devices or technologies where clinical expertise is limited. The subcontracting of the auditing of quality management systems or of product related reviews as a whole is not allowed.
Amendment 380 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.2
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.2
3.4.2. Where a notified body subcontracts conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place. Any subcontracting or consultation of external experts shall be properly documented, be publicly available and be subject to a written agreement covering, among others, confidentiality and conflict of interests.
Amendment 381 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.4 a (new)
Annex 6 – point 3 – point 3.3 – point 3.4 – point 3.4.4 a (new)
3.4.4 a. The policy and procedures under points 3.4.2 and 3.4.4 shall be communicated to the national authority before any subcontracting takes place.
Amendment 382 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 3 – point 3.3 – point 3.5 – point 3.5.2
Annex 6 – point 3 – point 3.3 – point 3.5 – point 3.5.2
3.5.2. It shall review the competence of its personnel and identify training needs and ensure that necessary measures are taken accordingly, in order to maintain the required level of qualification and knowledge.
Amendment 383 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 4 – point 4.3 – introductory part
Annex 6 – point 4 – point 4.3 – introductory part
4.3. The notified body shall have in place documented procedures that are publicly available covering at least:
Amendment 384 #
2012/0267(COD)
Proposal for a regulation
Annex 6 – point 4 – point 4.3 – indent 2
Annex 6 – point 4 – point 4.3 – indent 2
– the processing of the application, including the verification of the completeness of the documentation, the qualification of the product as in vitro diagnostic medical device and its classification, as well as the minimum time for its audit assessments,
Amendment 765 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – introductory part
Annex 1 – part II – point 7 – point 7.4 – introductory part
7.4. The devices shall be designed and manufactured in such a way as to reduce as far as possible and appropriate the risks posed by substances that may leach or leak from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 , and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health andor which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) , or are known or presumed endocrine disrupters pursuant to Commission Recommendation (2013/.../EU) on criteria for the identification of endocrine disrupters.
Amendment 766 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – introductory part
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – introductory part
Amendment 768 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
Annex 1 – part II – point 7 – point 7.4 – paragraph 1 – indent 3 – paragraph 1
shall not contain, in a concentration of 0.1% by mass of the plasticised material or above, phthalator above by mass per homogeneous material, substances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008, or substances identified as endocrine disrupters pursuant to the first subparagraph, unless the manufacturer can show that there are no suitable safer substances or devices without these substances. In case the manufacturer can show that there are no suitable safer substances or devices without these substances, these devices shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as devices containing phthalates. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, tsubstances which are classified as carcinogenic, mutagenic or toxic to reproduction of category 1A or 1B or substances identified as endocrine disrupters. The manufacturer shall provide a specific justification for the use of these substances with regard to compliance with the general safety and performance requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures. (Linked to the amendment by the same authors to the first eight words of this subparagraphOr. en (AT4AM aberration).)
Amendment 769 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 7 – point 7.6
Annex 1 – part II – point 7 – point 7.6
7.6. The devices shall be designed and manufactured in such a way as to reduce to a minimum the risks linked to the size and the properties of particles used. Special care shall be applied when devices contain or consist of nanomaterial that can be released into the patient's or user's body. The manufacturer shall provide specific evidence that the use of the nanomaterial complies with the general safety and performance requirements within the technical documentation. The specific evidence has to be shown to respond to the specific characteristics of the nanomaterial. The manufacturer shall also provide within the instructions for use, information on residual risks for patients and, if applicable, on appropriate precautionary measures.
Amendment 772 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 9 – introductory part
Annex 1 – part II – point 9 – introductory part
9. Devices incorporating a substance considered to be a medicinal product and devices composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally
Amendment 776 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
Amendment 165 #
2012/0192(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) In order to streamline and facilitate the flow of information between sponsors and Member States as well as between Member States, the European Medicines Agency, on behalf of the Commission, should set up and maintain a database, accessed through a portal.
Amendment 252 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and must abide by all relevant international norms and standards. The Ethics Committee shall consist of a clearly defined number of members and substitutes which include healthcare professionals, laypersons and at least one well-experienced, knowledgeable patient or patient representative, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work. Members States shall publish the number, the names and the profession of the members and substitutes of the Ethics Committee and inform the European Commission about the composition of the Ethics Committee and its start of work.
Amendment 259 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member Statereporting Member State shall be chosen among those five Member States concerned where most of the subjects participating in the clinical trial in question live. This decision shall be taken in line with a procedure which the Commission shall develop, establish and control. The decision procedure shall ensure that the chosen reporting Member State has the capacities and scientific infrastructure to assess the possible clinical trial in question.
Amendment 264 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 280 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 310 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 359 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 425 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 454 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 474 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;
Amendment 491 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 570 #
2012/0192(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 605 #
2012/0192(COD)
Proposal for a regulation
Article 58 – paragraph 5 – point a
Article 58 – paragraph 5 – point a
(a) labelling, re-labelling, packaging, re- packaging or reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State to carry out such processes, and if the investigational medicinal products are intended to be used exclusively by those institutions;
Amendment 606 #
2012/0192(COD)
Proposal for a regulation
Article 58 – paragraph 5 – point c
Article 58 – paragraph 5 – point c
(c) the preparation of medicinal products referred to in Article 3(1) and (2) of Directive 2001/83/EC or in accordance with the study plan provided by the sponsor.
Amendment 57 #
2011/2193(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Expects all Member States to establish public tissue and cell databases;
Amendment 58 #
2011/2193(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Calls for European standards and requirements for private tissue and cell databases;
Amendment 84 #
2011/2193(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Expects all Member States to establish at least one public stem cell database;
Amendment 88 #
2011/2193(INI)
Motion for a resolution
Paragraph 17 e (new)
Paragraph 17 e (new)
17e. Calls for European standards and requirements for private stem cell databases;
Amendment 23 #
2011/0455(COD)
Proposal for a regulation
Article 1 – point 13
Article 1 – point 13
Staff Regulations
Article 42a
Article 42a
13. Article 42a shall be amended as follows: (a) In the second sentence of the first paragraph, the word 'institutions' shall be replaced by 'appointing authority of each institution'; (b) In the last sentence of the third paragraph, the word 'adapted' shall be replaced by 'updatedreplaced by the following: 'Article 42a An official shall be entitled to up to six months of parental leave without basic salary for every child, to be taken during the first twelve years after the birth or adoption of the child. The duration of the leave may be doubled for single parents recognised under general implementing provisions adopted by the appointing authority of each institution. The minimum leave taken at any one time shall not be less than one month. During parental leave, the official's membership of the social security scheme shall continue; the acquisition of pension rights, dependent child allowance and education allowance shall be maintained. The official shall retain his post, and continue to be entitled to advancement to a higher step or promotion in grade. The leave may be taken as full-time or half-time leave. Where parental leave is taken in the form of half-time leave, the maximum period provided for in the first paragraph shall be doubled. During parental leave, the official shall be entitled to an allowance of EUR 911.73 per month or 50 % of such sum if on half-time leave but may not engage in any other gainful employment. The full contribution to the social security scheme provided for in Articles 72 and 73 shall be borne by the institution and calculated on the basis of the basic salary of the official. However, in the case of half-time leave this provision shall apply only to the difference between the full basic salary and the proportionally reduced basic salary. For the part of the basic salary actually received, the official's contribution shall be calculated by using the same percentages as if he were in full-time employment. The allowance shall be EUR 1 215.63 per month, or 50 % of such sum if the official is on half-time leave, for the single parents referred to in the first paragraph and during the first three months of parental leave where such leave is taken by the father during maternity leave or by either parent immediately after maternity leave or during or immediately after adoption leave. The parental leave may be extended for a further six months with an allowance limited to 50 % of the amount referred to in the second paragraph. For single parents as referred to in the first paragraph, the parental leave may be extended for a further twelve months with an allowance limited to 50% of the amount referred to in the third paragraph. The amounts mentioned in this Article shall be updated in line with remuneration.';
Amendment 34 #
2011/0455(COD)
Proposal for a regulation
Article 2 – point 19
Article 2 – point 19
Conditions of Employment of Other Servants
Article 47
Article 47
19. Point (a) of Article 47 shall be replaced by the following: 'at the end of the month in which the servant reaches the age of 65, or, on an exceptional basisArticle 47 Apart from cessation on death, the employment of temporary staff shall cease: (a) at the end of the month in which the servant reaches the age of 65 years or, where applicable, at the date fixed in accordance with Article 50c(2); or (b) where the contract is for a fixed period: (i) on the date stated in the contract; (ii) at the end of the period of notice specified in the contract giving the servant or the institution the option to terminate earlier. The period of notice shall not be less than one month per year of service, subject to a minimum of one month and a maximum of three months. For temporary staff whose contracts have been renewed the maximum shall be six months. The period of notice shall not, however, commence to run during pregnancy duly established by a medical certificate, maternity leave or sick leave, provided such sick leave does not exceed three months. It shall, moreover, be suspended during pregnancy duly established by a medical certificate, mat the date fixed in accordance with the second subparagraph of Article 52(b) of the Staff Regulations; or' ernity or sick leave subject to the limits aforesaid. If the institution terminates the contract, the servant shall be entitled to compensation equal to one third of his basic salary for the period between the date when his duties end and the date when his contract expires; (iii) where the servant no longer satisfies the conditions laid down in Article 12(2), point (a), subject to the possibility of authorising an exception under that provision. Should the exception not be authorised, the period of notice referred to in subpoint (ii) of this point (b) shall apply; or (c) where the contract is for an indefinite period: (i) at the end of the period of notice stipulated in the contract; the length of the period of notice shall not be less than one month for each completed year of service, subject to a minimum of three months and a maximum of 10 months. The period of notice shall not, however, commence to run during pregnancy duly established by a medical certificate, maternity leave or sick leave, provided such sick leave does not exceed three months. It shall, moreover, be suspended during pregnancy duly established by a medical certificate, maternity or sick leave subject to the limits aforesaid; or (ii) where the servant no longer satisfies the conditions laid down in Article 12(2), point (a), subject to the possibility of authorising an exception under that provision. Should the exception not be authorised, the period of notice referred to in subpoint (i) of this point (c) shall apply.';
Amendment 37 #
2011/0455(COD)
Proposal for a regulation
Article 2 – point 33 a (new)
Article 2 – point 33 a (new)
Conditions of Employment of Other Servants
Article 139 – paragraph 1 – point d
Article 139 – paragraph 1 – point d
Amendment 65 #
2011/0435(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Directive 2005/36/EC only applies to professionals who want to pursue the same profession in another Member State. There are cases where the activities concerned are part of a profession with a larger scope of activities in the host Member State. If the differences between the fields of activity are so large that in reality a full programme of education and training is required from the professional to compensate for shortcomings and if the professional so requests, a host Member State should under these particular circumstances grant partial access. However, in case of overriding reasons of general interest, such as in the case of a doctor of medicine or other health professionals and involving patient safety, a Member State should be able to refuse partial access.
Amendment 67 #
2011/0435(COD)
Proposal for a directive
Recital 15
Recital 15
(15) The nursing and midwifery professions have significantly evolved in the last three decades: community-based healthcare, the use of more complex therapies and constantly developing technology presuppose a capacity for higher responsibilities for nurses and midwives. In order to prepare them to meet such complex healthcare needs, nursing and midwifery students need to have a solid general education background before they start the training. Therefore, admission to that training should be increased to twelve years of general education or success in an examination of an equivalent level.
Amendment 102 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2005/36/EC
Article 4d – paragraph 5
Article 4d – paragraph 5
5. Where the host Member State fails to take a decision within the time limits set out in the paragraphs 2 and 3ree months or to request additional information within onetwo months from the date of receipt of the European Professional Card by the home Member State, without justifiable grounds for doing so having to be given, the European Professional Card shall be deemed to be validated by the host Member State and to constitute recognition of the professional qualification to the regulated profession concerned in the host Member State. The obtaining of further information shall interrupt the three- month approval period.
Amendment 109 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2005/36/EC
Article 4f – paragraph 2
Article 4f – paragraph 2
2. Partial access may be rejected if such rejection is justified by an overriding reason of general interest, such as public health and patient safety, it would secure the attainment of the objective pursued and it would not go beyond what is strictly necessary.
Amendment 115 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 22 – point a
Article 1 – point 22 – point a
Directive 2005/36/EC
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Admission to training for nurses responsible for general care shall be contingent upon completion of general education of 120 years up to the age of 16 at least, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing.
Amendment 117 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 22 – point a
Article 1 – point 22 – point a
Directive 2005/36/EC
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Admission to training for nurses responsible for general care shall be contingent upon completion of general education of 12at least 10 years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing.
Amendment 119 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 22 – point a
Article 1 – point 22 – point a
Directive 2005/36/EC
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Admission to training for nurses responsible for general care shall be contingent upon completion in principle of general education of 12 years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing. In the case of admission to training for nurses responsible for general care after only ten years of general education, recognition shall be based on Article 21 provided that the terms specified in Article 31(6) have successfully been met. Successful completion shall be attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing.
Amendment 123 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 27 – point b
Article 1 – point 27 – point b
Directive 2005/36/EC
Article 40 – paragraph 2 –point a
Article 40 – paragraph 2 –point a
(a) completion of at least the 1210 years of general school education up to the age of 16 at least or a certificate attesting success in an examination, of an equivalent level, for admission to a midwifery school for route I;
Amendment 124 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 27 – point b
Article 1 – point 27 – point b
Directive 2005/36/EC
Article 40 – paragraph 2 – point a
Article 40 – paragraph 2 – point a
(a) completion of at least the 1210 years of general school education or a certificate attesting success in an examination, of an equivalent level, for admission to a midwifery school for route I;
Amendment 127 #
2011/0435(COD)
Proposal for a directive
Recital 15
Recital 15
(15) The nursing and midwifery professions have significantly evolved in the last three decades: community-based healthcare, the use of more complex therapies and constantly developing technology presuppose a capacity for higher responsibilities for nurses and midwives. In order to prepare them to meet such complex healthcare needs, nursing and midwifery students need to have a solid general education background before they start the training. Therefore, admission to that training should be increased to twelve years of general education or success in an examination of an equivalent level.
Amendment 476 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point a
Article 1 – paragraph 1 – point 22 – point a
Directive 2005/36/EC
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Admission to training for nurses responsible for general care shall be contingent upon completion of general education of 12at least 10 years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing.".
Amendment 478 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point a (new)
Article 1 – paragraph 1 – point 22 – point a (new)
Directive 2005/36/EC
Article 31 – paragraph 1 – subparagraph a (new)
Article 31 – paragraph 1 – subparagraph a (new)
a. The criteria governing admission to training for nurses or nurses responsible for general care referred to in paragraph 1 shall also be deemed to have been met if after successful completion of 10 years’ compulsory general education a person is entitled to start practical training as a nurse responsible for general care whilst attending at the same time a vocational nursing school.
Amendment 520 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 27 – point b
Article 1 – paragraph 1 – point 27 – point b
Directive 2005/36/EC
Article 40 – paragraph 2 – point a
Article 40 – paragraph 2 – point a
(a) completion of at least the 120 years of general school education or a certificate attesting success in an examination, of an equivalent level, for admission to a midwifery school for route I;
Amendment 51 #
2011/0429(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem. Current evaluation and control of the risk to or via the aquatic environment of medicinal products does not provide adequate attention to Union environmental objectives. An ongoing Commission study on the risks of environmental effects of medicinal products aims therefore at providing an analysis of the relevance of the current legislative framework to, and its effectiveness at, protecting the environment and human health via the aquatic environment, and finally an identification of possible measures to better address the problem.
Amendment 52 #
2011/0429(COD)
Proposal for a directive
Recital 8 b (new)
Recital 8 b (new)
(8b) This proposal aims at ensuring a better quality of water for public health and biodiversity reasons. The pharmaceutical substances which have been prioritised are identified due to a significant risk that they pose to or via the aquatic environment at Union level and not due to a risk on public health via human consumption.
Amendment 53 #
2011/0429(COD)
Proposal for a directive
Recital 8 c (new)
Recital 8 c (new)
(8c) Control measures which may be taken by the Member States shall take into account the therapeutic importance of the pharmaceutical substances and be in accordance with Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products1 and Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use2. These measures may include take- back and labelling schemes for unused pharmaceuticals. ______________ 1 OJ L 348, 31.12.2010, p. 1 2 OJ L 348, 31.12.2010, p. 74
Amendment 91 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 3 a (new)
Article 2 – point 3 a (new)
Directive 2008/105/EC
Article 7 a (new)
Article 7 a (new)
Amendment 222 #
2011/0429(COD)
Proposal for a directive
Annex II a (new)
Annex II a (new)
Directive 2008/105/EC
Annex II (new)
Annex II (new)
Amendment 154 #
2011/0339(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 3 – indent 3.2 a (new)
Article 4 – paragraph 1 – point 3 – indent 3.2 a (new)
– 3.2a. Supporting the early diagnosis of neurogenerative and other brain diseases, by sharing knowledge and best practice and developing joint activities;
Amendment 181 #
2011/0339(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. At the request of the Commission, which shall avoid causing any disproportionate increase in the administrative burden on the Member States, Member States shall submit any available information on the implementation and impact of the ProgrammeThe Member States shall report every two years on the measures undertaken and the resources spent on actions under the programme, including, in particular, networking activities, exchange of best practices and expertise across borders.
Amendment 185 #
2011/0339(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The Commission shall make the results of actions undertaken pursuant to this Regulation publicly available and shall ensure they are widely disseminated. in order to document the contribution of the programme to increasing quality in health care for Union citizens.
Amendment 222 #
2011/0339(COD)
Proposal for a regulation
Annex 1 – point 3 – point 3.2
Annex 1 – point 3 – point 3.2
3.2. Chronic diseases: support European cooperation and networking through joint actions on preventing and improving the response to chronic diseases including cancer, by sharing knowledge, good practice and developing joint activities on prevention. Cancer:; follow-up work already undertaken; set up a European cancer information system and an information system on chronic diseases with comparable data; support cancer screening and early diagnosis of chronic diseases, including voluntary accreditation mechanisms; support the development of European guidelines for prevention and early diagnosis where major inequalities exist.
Amendment 27 #
2011/0229(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Making EID mandatory throughout the Union may have economically adverse effects on certain operators. It is therefore appropriate that a voluntary regime for the introduction of EID is established. Under such a regime, EID would be chosen by keepers that are likely to have immediate economic benefitstransition period for the implementation of mandatory EID be established.
Amendment 33 #
2011/0229(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Member States have very different husbandry systems, farming practices and sector organisations. Member States should therefore be allowed to make EID compulsory on their territory only when they deem it appropriate, after considering all those factorintroduce and implement mandatory EID on their territory on a step-by-step basis.
Amendment 45 #
2011/0229(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Section II of Title II of Regulation (EC) No 1760/2000 lays down rules for a voluntary beef labelling system which provide for the approval of certain labelling specifications by the competent authority of the Member State. The administrative burden and the costs incurred by Member States and economic operators in applying this system are not proportionate to the benefits of the system. ThatAll labelling specifications which go beyond the mandatory labelling, for example, breed, feed and husbandry, are extremely important to consumers as well as to farmers who use this labelling to market their products. In order to ensure that the information is accurate and reliable, this Section shouldmust therefore be deletmaintained.
Amendment 62 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
Regulation (EC) No 1760/2000
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. The Member States shall introduce mandatory electronic identification not later than ten years after the entry into force of this Regulation.
Amendment 85 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 1760/2000
Articles 16 - 18
Articles 16 - 18
Amendment 100 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 15
Article 1 – point 15
Regulation (EC) No 1760/2000
Article 19 – point b
Article 19 – point b
(b) definition of and requirements for the specific indications that may be put on labels;
Amendment 65 #
Amendment 66 #
2011/0177(APP)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Insists on the importance of providing for a sufficient ceiling of commitments under Heading 5 in order to ensure that Institutions and Agencies can perform and carry out their duties in the most efficient way; stresses that the successful implementation and monitoring of multiannual programmes and policies, for the benefit of the citizens of the Union and of Member States, requires highly qualified, multilingual and independent staff drawn from the widest possible geographical basis and fully committed to the values of the European project;
Amendment 23 #
2010/2249(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Dismisses the Commission proposal to reduce EU funding for research on TSEs
Amendment 36 #
2010/2249(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Asks the Commission to inform third countries about any changes made to the TSE Regulation and measures related to TSEs;
Amendment 61 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/18/EC
Article 26 a – paragraph 1
Article 26 a – paragraph 1
Directive 2001/18/EC shall be amended as follows: (-1) Article 26a(1) shall be replaced by the following: ‘1. Member States shall take appropriate measures to avoid the unintended presence of GMOs in other products.’
Amendment 62 #
2010/0208(COD)
Proposal for a regulation – amending act
Article 1 - point -1 a (new)
Article 1 - point -1 a (new)
Directive 2001/18/EC
Article 26 a - paragraph 2
Article 26 a - paragraph 2
Amendment 84 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a
Article 26 b – paragraph 1 – point a
(a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment, raised by Member States, related to environmental or health impacts which might arise from the deliberate release or the placing on the market of GMOs, or other legitimate factors;
Amendment 155 #
2009/0076(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
4a. 1. Active substances as such or in biocidal products may only be placed on the market in the Union for use in biocidal products if they have been included in Annex I in accordance with the provisions of this Regulation. 2. Unless otherwise provided in this Regulation, all manufacturers of an active substance, as such or in a biocidal product, shall submit to the Agency an application for inclusion in Annex I.
Amendment 288 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. 1. The receiving competent authority or, in the case of evaluation of an application for a Community authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewalfor a renewal, subject to this Regulation, of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1). Comparative assessment shall be applied to all biocidal products for the same purpose when there is sufficient experience, and a minimum of five years, in use.
Amendment 290 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application forrenewal of a Community authorisation, also to the Commission.
Amendment 293 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 3 – introductory part
Article 21 – paragraph 3 – introductory part
3. The receiving competent authority or, in the case of a decision on an application for renewal of a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:
Amendment 296 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 3 – point a
Article 21 – paragraph 3 – point a
a) for the uses specified in the application, another authorised biocidal products or a non-chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment and which prove equally effective and involve no significant increase in the risks for any other parameter;
Amendment 300 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 3 – point b
Article 21 – paragraph 3 – point b
b) the biocidal product or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages;
Amendment 302 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 3 a (new)
Article 21 – paragraph 3 a (new)
3a. The Commission shall, on the basis of paragraph 3, adopt implementing measures laying down the procedure necessary for the definition of an application for comparative assessment of biocidal products. These measures shall define the criteria and algorithms to be used in a comparative assessment to ensure that there is a uniform application throughout the Community. Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure without scrutiny referred to in Article 72(3).
Amendment 303 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 4
Article 21 – paragraph 4
Amendment 311 #
2009/0076(COD)
Proposal for a regulation
Article 21 – paragraph 7 a (new)
Article 21 – paragraph 7 a (new)
7a. By way of derogation from paragraph 1, a comparative assessment shall not be required for biocidal products whose use has been shown to be safe.
Amendment 449 #
2009/0076(COD)
Proposal for a regulation
Article 70 – paragraph 2 – point a
Article 70 – paragraph 2 – point a
a) a reduced fee shall be set for small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises; this shall have no bearing on the responsibility of the relevant competent authority to carry out a careful assessment in accordance with the provisions of this Regulation;
Amendment 452 #
2009/0076(COD)
Proposal for a regulation
Article 70 – paragraph 2 – point d
Article 70 – paragraph 2 – point d
d) an annual fee shall be paid by persons placing biocidal products on the market; aneleted
Amendment 455 #
2009/0076(COD)
Proposal for a regulation
Article 70 – paragraph 2 – point e
Article 70 – paragraph 2 – point e
e) tfees shall be charged only when genuinely necessary. The structure and amount of the fees shall take account of the work required by this Regulation to be carried out by the Agency and the competent authorities and shall be fixed at such level as to ensure that the revenue derived from the fees when combined with other sources of the Agency's revenue pursuant to this Regulation is sufficient to cover the cost of the services delivered.
Amendment 1 #
2008/2026(BUD)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Welcomes the Commission's proposal, in the interests of public health and particularly the health of children and young people, to establish an EU school fruit programme in order to improve the dietary habits and thus the health of young EU citizens, as already described in the White Paper of 30 May 2007 on 'A Strategy for Europe on Nutrition, Overweight and Obesity related health issues' (COM(2007)0279); calls in this connection for the programme only to promote measures with the aim of distributing fresh products, while excluding ready-made fruit products or fruit preparations from this package of measures so that the change in dietary habits from ready-made to fresh products can achieve its full impact;
Amendment 74 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 178 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point a a (new)
Article 1 – point 3 – point a a (new)
Directive 2001/83/EC
Article 46 – point f – subparagraph 2
Article 46 – point f – subparagraph 2
(aa) The second subparagraph of point (f) is replaced by the following: The Commission shall establish, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, a list of certain categories of excipients identified on a risk-based approach taking into account their source and their intended use. For these categories of excipients, the manufacturer shall apply the appropriate good manufacturing practices on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the second paragraph of Article 47, taking into account other suitable quality system requirements, and document this.
Amendment 191 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – point b
Article 46b – paragraph 2 – point b
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community, and that the plant is subject to control and enforcement, including repeated and unannounced inspections, ensuring that those good manufacturing practices cannot be circumvented.
Amendment 231 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b
Article 54a – paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without openingany changes to the immediate packaging as defined in Article 1(23) other than for the purposes set out in Article 55;
Amendment 276 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 a (new)
Article 54 a – paragraph 4 a (new)
4a. By five years after the date of entry into force of the implementing measure of this Article, the Commission should submit to the European Parliament and to the Council an assessment report on the application of the safety features referred to in point (o) of Article 54 and their contribution to the reduction of the number of falsified medicines in the legal supply chain in the Union and the potential benefits of alternative technologies and the possibilities for authentication of individual dosage forms.
Amendment 296 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 10 a (new)
Article 1 – point 10 a (new)
Directive 2001/83/EC
Article 63 – paragraph 1
Article 63 – paragraph 1
Amendment 330 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)
Title VII a (new) – Article 85 c (new)
Amendment 355 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 1 – point b
Article 111b – paragraph 1 – point b
(b) the regularity of repeated and unannounced inspections of good manufacturing practices;
Amendment 118 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
Directive 2001/83/EC
Article 16c – paragraph 4 – subparagraph 2
Article 16c – paragraph 4 – subparagraph 2
3a. In Article 16c(4), subparagraph 2 is replaced by the following: The Committee shall consider whether the other criteria for a simplified registration as referred to in Article 16a are fully complied with. If the Committee considers it possible, it shall establish a Community herbal monograph as referred to in Article 16h(3) which shall be complied with by the Member State when taking its final decision.
Amendment 34 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Regulation EC/726/2004
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
In paragraph 2 of Article 3, point b is replaced by the following: (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients, or could result in better availability of a medicinal product for patients or animal health at EU level.
Amendment 70 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 12 – point b a (new)
Article 1 – point 12 – point b a (new)
Regulation EC/726/2004
Article 56 – paragraph 1 – point g
Article 56 – paragraph 1 – point g
(ba) point (g) is replaced by the following: "(g) an Executive Director General, who shall exercise the responsibilities set out in Article 64;"
Amendment 72 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation EC/726/2004
Article 61a – paragraph 1
Article 61a – paragraph 1
1. The Pharmacovigilance Risk Assessment Advisory Committee shall be composed of the following: (a) ten members and ten alternates appointed by the Management Board, on the basis of proposals by the national competent authorities; (b) five members and five alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament. The alternates shall represent and vote for the members in their absence. The Commission may adapt the number of members and alternates in the light of technical and scientific needs. Those measures, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a)following consultation with the national competent authorities and on the basis of their relevant expertise in pharmacovigilance and the risk assessment of medicinal products for human use, as laid down in paragraph 2; (b) seven additional members and five alternates appointed by the Commission, including at least one healthcare professional representative, and at least one patient representative, on the basis of a public call for expressions of interest, after consulting the European Parliament. A Member State may request another Member State to represent it in the committee. The alternates shall represent and vote for the members in their absence.
Amendment 77 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 14
Article 1 – point 14
Regulation EC/726/2004
Article 61a – paragraph 6
Article 61a – paragraph 6
6. Representatives of the national competent authorities shall be entitled to attend all meetings of the Pharmacovigilance Risk Assessment Advisory Committee and to participate in discussions in order to facilitate appropriate coordination between the tasks of the Agency and the work of national competent authorities. They may provide clarification or information if invited to do so but shall not seek to influence discussions.”
Amendment 110 #
2008/0142(COD)
Council position
Recital 20
Recital 20
(20) Systematic and continuous efforts should be made to ensure that quality and safety standards are improved, in line with the Council Conclusions and taking into account advances in international medical science and generally recognised good medical practices as well as taking into account new health technology.
Amendment 115 #
2008/0142(COD)
Council position
Recital 27
Recital 27
(27) It is appropriate to require that also patients who seek healthcare in another Member State in other circumstances than those provided for in Regulation (EC) No 883/2004 should be able to benefit from the principles of free movement of serpatients and goods such as medicinal products and medical devices in accordance with the Treaty and with this Directive. Patients should enjoy a guarantee of assumption of the costs of that healthcare and goods connected with healthcare provided in a Member State other than their Member State of affiliation at least at the level as would be provided for the same healthcarreatment which is the same or equally effective, had ithey been provided or purchased in the Member State of affiliation. This should fully respect the responsibility of the Member States to determine the extent of the sickness cover available to their citizens and prevent any significant effect on the financing of the national healthcare systems. Member States may nevertheless provide in their national legislation for reimbursement of the costs of the treatment at the tariffs in force in the Member State of treatment if this is more beneficial for the patient. That may be the case in particular for any treatment provided through European reference networks. Or.en (EP position recital 27)
Amendment 144 #
2008/0142(COD)
Council position
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) patients receive from the national contact point upon request relevant information, inter alia via electronic means, on the standards and guidelines referred to in paragraph 1, including provisions on supervision and assessment of healthcare providers, and information on which healthcare providers are subject to these standards and guidelines;
Amendment 148 #
2008/0142(COD)
Council position
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
(c) there are complaints procedures and mechanisms in place for patients to s, in order to guaranteek remedies and compensation in accordance with the legislation of the Member State of treatment if they suffer harm arising from the healthcare they receive;
Amendment 152 #
2008/0142(COD)
Council position
Article 4 – paragraph 3 – subparagraph 2 a (new)
Article 4 – paragraph 3 – subparagraph 2 a (new)
Amendment 156 #
2008/0142(COD)
Council position
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) there are easily accessible mechanisms in place to provide patients on request with information, inter alia via electronic means, on their rights and entitlements in that Member State relating to receiving cross-border healthcare, in particular as regards procedures for accessing and determining those entitlements, conditions for reimbursement of costs and systems of appeal and redress if the patients considers that their rights have not been respected; and the terms and conditions that would apply, inter alia whenever harm is caused as a result of healthcare received in another Member State. That information shall be published in a format accessible to persons with disabilities. Member States shall consult stakeholders, including patients' organisations, to ensure information is clear and accessible. In information about cross-border healthcare, a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004.
Amendment 158 #
2008/0142(COD)
Council position
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
(c) patients who seek to receive or do receive cross-border healthcare have access to at least a copy of their medical records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC. Data shall be transmitted only with the express written consent of the patient or the patient's relatives. Or.en (EP position Art 6(6))
Amendment 160 #
2008/0142(COD)
Council position
Article 6 – paragraph 3
Article 6 – paragraph 3
3. National contact points in the Member State of treatment shall provide patients with information, inter alia via electronic means, concerning healthcare providers, including on request information on a specific provider's right to provide services or any restrictions on its practice, information referred to in Article 4(2)(a), and information on the protection of personal data, the level of accessibility to healthcare facilities for people with disabilities, as well as information on patients' rights, complaints procedures and mechanisms for seeking remedies, according to the legislation of that Member State. , as well as the options available to settle any dispute, and help to identify the appropriate out-of-court settlement scheme for the specific case. Or.en (EP position Article 14(4))
Amendment 163 #
2008/0142(COD)
Council position
Article 6 – paragraph 4 – subparagraph 1 a (new)
Article 6 – paragraph 4 – subparagraph 1 a (new)
Amendment 164 #
2008/0142(COD)
Council position
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Subject to the provisions of Articles 8 and 9, the Member State of affiliation shall ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits provided for by the legislation, administrative regulations and guidelines to which the insured person is entitled in the Member State of affiliation. Without prejudice to Regulation (EC) No 883/2004, the Member State of affiliation shall reimburse the costs to the Member State of treatment or the insured person which would have been paid for by its statutory social security system, had equally effective healthcare been provided on its territory. If a Member State of affiliation rejects the reimbursement of this treatment, that Member State shall have to give a medical justification for its decision. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. Without prejudice to Regulation (EC) No 883/2004, patients affected by rare diseases shall have the right to access healthcare in another Member State and to receive reimbursement for methods of treatment that are sufficiently tried and tested by international medical science even if the treatment in question is not among the benefits provided for by the legislation, administrative regulations and guidelines of the Member State of affiliation. Such treatment shall be subject to prior authorisation. Or.en (EP position Article 6(2) and 6(3))
Amendment 179 #
2008/0142(COD)
Council position
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) involves treatments presenting a particular risk for the patient or the population or which could raise serious and specific concerns relating to the quality or safety of the care with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union.
Amendment 199 #
2008/0142(COD)
Council position
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
If a medicinal product is authorised to be marketed on their territory in accordance with Article 6(1) of Directive 2001/83/EC, Member States shall ensure that prescriptions issued for such a product in another Member State for a named patient can be dispensed on their territory in compliance with their national legislation in force, and that any restrictions on recognition of individual prescriptions are prohibited unless such restrictions are:
Amendment 210 #
2008/0142(COD)
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of cross-border healthcare regardless of how it is organised, delivered and financed or whether it is public or private.
Amendment 226 #
2008/0142(COD)
Council position
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by….** They shall forthwith inform the Commission thereof. ** OJ: 3 years from the date of entry into force of OJ: 1 year from the date of entry into force of this Directive.
Amendment 247 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) "healthcare" means a health service provided by or under the supervision of a health professional in exercise of his profession, ands and goods provided or prescribed by health professionals to patients to assess, maintain or restore their state of health or prevent them from becoming ill, regardless of the ways in which it is organised, delivered and financed at national level or whether it is public or private;
Amendment 256 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (b)
Article 4 - point (b)
(b) "cross-border healthcare" means healthcare provided in a Member State other than that where the patient is an insured person or healthcare provided in a Member State other than that where the healthcare provider resides, is registered or is established;
Amendment 267 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (d)
Article 4 - point (d)
(d) "health professional" means a doctor of medicine or a nurse responsible for general care or a dental practitioner or a midwife or a pharmacist within the meaning of Directive 2005/36/EC or another professional exercising activities in the healthcare sector which are restricted to a regulated profession as defined in Article 3(1)(a) of Directive 2005/36/EC or a person legally exercising healthcare activities in the Member State of treatment;
Amendment 272 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (f)
Article 4 - point (f)
(f) "patient" means any natural person who receives or wisheseeks to receive healthcare in a Member State;
Amendment 289 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (k a) (new)
Article 4 - point (k a) (new)
(ka) "health technology" means a medicinal product or a medical device or medical and surgical procedures as well as measures for disease prevention, diagnosis or treatment used in healthcare.
Amendment 371 #
2008/0142(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. In so far as it is necessary to facilitate the provision of cross-border healthcare and taking as a basis a high level of protection of health, the Commission, in cooperationMember States shall develop guidelines in order to facilitate the implementation of paragraph 1 and inform the Commission about the content of the guidelines within theree months after the entry into force of the legislation. If Member States, shall fail to develop such guidelines in order to facilitate the implementation of paragraph 1, the Commission, in cooperation with the Member State, shall develop those guidelines. The Member States and the Commission shall make sure that those guidelines are easily accessible by healthcare providers and patients.
Amendment 384 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the Member State of treatment or the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is providedf there are several methods available for treating a certain disease or injury, the patient shall have the right to reimbursement for all methods of treatment that are sufficiently tried and tested by international medical science, even if they are not available in the patient’s Member State of affiliation. If a Member State of affiliation rejects the reimbursement of such a treatment, the Member State has to give a medical justification for its decision. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided. The Member State of affiliation shall put in place appropriate and coherent mechanisms to pay healthcare providers directly for those costs.
Amendment 401 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The costs of healthcare provided in another Member State shall be reimbursed or paid by the Member State of affiliation in accordance with the provisions of this Directive up to the level of costs that would have been assumed had the same or similar healthcare been provided in the Member State of affiliation, without exceeding the actual costs of healthcare received.
Amendment 490 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The prior authorisation system shall be limited to what is necessary and proportionate to avoid such impact, shall be based on fair, clear and transparent criteria and shall not constitute a means of arbitrary discrimination.
Amendment 551 #
2008/0142(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Member States of affiliation shall ensure that there are mechanisms in place to provide patients on request with information on receiving healthcare in another Member State, and the terms and conditions that would apply, inter alia, whenever harm is caused as a result of healthcare received in another Member State. Patients' organisations may be involved in cooperating with competent national authorities in the process of providing and disseminating information to patients.
Amendment 563 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall designate national contact points for cross-border healthcare and communicate their names and contact details to the Commission. These national contact points should be established in an efficient and transparent way. Information about their existence shall be disseminated across Member States, so that patients have easy access to the information.
Amendment 567 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – introductory paragraph
Article 12 – paragraph 2 – introductory paragraph
2. The national contact point in the Member State of affiliation shall, in close cooperation with other competent national authorities, and with national contact points in other Member States, in particular in the Member State of treatment, with patients' organisations and with the Commission:
Amendment 569 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate information to patients in particular on their rights related to cross-border healthcare and the guarantees of quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and coutgoing patients on receiving healthcare in another Member State, and the terms and conditions which apply, in particular on their rights related to cross-border healthcare; national contact points shall also help outgoing patients to protect their rights and seek appropriate redress in the event of harm caused by the use of healthcare in another Member State; the national contact point shall in particular inform patients about the options available to settle any dispute, help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monditions applicableor their dispute where necessary;
Amendment 581 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – point b
Article 12 – paragraph 2 – point b
(b) help patients to protect their rights and seek appropriate rprovide and disseminate information to incoming patients about the existing national standards on quality and safety, protection of personal data, proceduress in the event of harm caused by the use of healthcare in another for complaints and means of redress available for healthcare received in this Member State; t. The national contact point shall in particular inform patients, where necessary, about the options available to settle any dispute, and help to identify the appropriate out-of-court settlement scheme for the specific case and help patients to monitor their dispute where necessary;.
Amendment 586 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
Amendment 588 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
Amendment 604 #
2008/0142(COD)
Proposal for a directive
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. The Commission shall encourage and support cooperation among Member States to share experiences and information (such as about best-practice, treatments available, clinical trials and results from research projects) and thus contribute to an improved quality and safety of healthcare throughout the EU.
Amendment 663 #
2008/0142(COD)
Article 15 - paragraph 3 - point a - introductory part
(a) a list of specific criteria and conditions that the European reference networks must fulfil, including also a list of rarer disease areas to be covered and the conditions and criteria required from healthcare providers wishing to join the European reference networks, in order to ensure, in particular, that the European reference networks:
Amendment 4 #
2008/0045(COD)
Proposal for a directive – amending act
Recital 6
Recital 6
(6) For reasons of public health, legal consistency and predictability for economic operators, variations to all types of marketing authorisations, with the exception of purely national ones based on Article 10a of Directive 2001/83/EC, should be subject to harmonised rules.
Amendment 17 #
2008/0045(COD)
Proposal for a directive – amending act
Article 2 – point 1
Article 2 – point 1
Directive 2001/83/EC
Article 23 b – paragraph 1
Article 23 b – paragraph 1
The Commission shall adopt appropriate arrangements for the examination of variations to the terms of marketing authorisations granted in accordance with this Directive. Variations of purely national marketing authorisations based on Article 10a of this Directive may continue to follow existing national procedures provided that the products concerned are not part of the decentralised or mutual recognition authorisation procedure.
Amendment 26 #
2008/0045(COD)
Proposal for a directive – amending act
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [124 months after entry into force] at the latest. They shall forthwith communicate to the Commission the text of those provisions and a table showing the correlation table between those provisions and this Directive.
Amendment 212 #
2008/0028(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) It is also important to provide consumers with information on the other alcoholic beverages. Specific Community rules already exist on the labelling of wine. Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine provides an exhaustive set of technical standards which fully cover all oenological practices, manufacturing methods and means of presentation and labelling of wines, thus ensuring that all stages in the chain are covered and that consumers are protected and properly informed. In particular, this legislation describes in a precise and exhaustive manner the substances likely to be used in the production process, together with the conditions for their use via a positive list of oenological practices and treatments; any practice not included in this list is prohibited. Therefore, it is appropriate to exempt wine at this stage from the obligation to list the ingredients and to provide for a nutrition declaration apart from the energy content. The energy content should be given very legibly on the front of the product. As regards beer and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89, and in order to ensure a consistent approach and coherence with the conditions established for wine, the same kind of exemptions shall apply. However, the Commission will produce a report after five years of the entry into force of this Regulation and may propose, if necessary, specific requirements in the context of this Regulation.
Amendment 220 #
2008/0028(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The indication of the country of origin or of the place of provenance of a food should be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In other cases, the provision of the indication of country of origin or place of provenance is left to the appreciation of food business operatorsor its main ingredient should always be provided.
Amendment 223 #
2008/0028(COD)
Proposal for a regulation
Article 25 – paragraph 2 – point b
Article 25 – paragraph 2 – point b
(b) for– meat falling within the Combined Nomenclature (‘CN’) codes listed in Annex XI. The application of this point shall be subject to adoption of implementing rules referred to in paragraph 6. ; – poultry; – dairy products; – fresh fruit and vegetables; – other single-ingredient products; and – meat, poultry and fish when used as an ingredient in processed foods. For meat and poultry, the country or place of provenance may be given as a single place for animals only where the animals have been born, reared and slaughtered in the same country or place. In other cases information on each of the different places of birth, rearing and slaughter shall be given. Where there are reasons which would make it impractical to label the country of origin, the following statement may be given instead: ‘Of unspecified origin’.
Amendment 233 #
2008/0028(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) To appeal to the average consumer and to serve the informative purpose for which it is introduced, and given the current level of knowledge on the subject of nutrition, the information provided should be simple and easily understood. Research has indicated that consumers find the information on the energy content in the principal field of view or ‘front of pack’ is useful when making purchasing decisions. Therefore, to ensure that consumers can readily see the essential nutrition information when purchasing foods such information should be in the principal field of viewNutrition information together with the energy content should be given in a clear format in the same place ofn the labelproduct packaging.
Amendment 242 #
2008/0028(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) Member States should retain the right, depending on local practical conditions and circumstances, to lay down rules in respect of the provision of information concerning non-prepacked foods. Although in such cases the consumer demand for other information is limited, information on the energy content and on potential allergens is considered very important. Evidence suggests that most food allergy incidents can be traced back to non-prepacked food. Therefore such information should always be provided to the consumer.
Amendment 254 #
2008/0028(COD)
Proposal for a regulation
Article 25 – paragraph 5 – subparagraph 1 – introductory part
Article 25 – paragraph 5 – subparagraph 1 – introductory part
Amendment 288 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The energy value and the amount of nutrients referred to in Article 29(1) to (5) shall be expressed per 100 g or per 100 ml‘back of pack mandatory nutrition declaration’ shall include the amount of energy in kcal and all the mandatory nutrients referred to in Article 29(1) and where appropriate the voluntary nutrients referred to in Article 29(2). It shall be expressed as appropriate, in the order of presentation provided for in Annex XV, both per 100 g/ml and per portion. It shall be presented in tabular form, with the numbers aligned.
Amendment 288 #
2008/0028(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point i
Article 9 – paragraph 1 – point i
(i) the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance; in such cases the indication shall bplace of origin or provenance in accordance with the rules laid down in Article 35(3) and (4) and those established in accordance with Article 35(5);
Amendment 300 #
2008/0028(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point i
Article 9 – paragraph 1 – point i
i) the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance; in such cases the indication shall be in accordance with the rules laid down inhaving regard to Article 35(3) and (4), and thosee rules established in accordance with Article 35(5);
Amendment 329 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Without prejudice to specific Community legislation applicable to particular foods as regards to the requirements referred to in Article 9(1)(a) to (k), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in characters of a font size of at least 31.5 mm and shall be presented in a way so as to ensure a significant contrast between the print and background.
Amendment 339 #
2008/0028(COD)
Proposal for a regulation
Article 14 - paragraph 1
Article 14 - paragraph 1
(1) Without prejudice to specific Community legislation applicable to particular foods as regards to the requirements referred to in Article 9(1)(a) to (k), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in characters of a font size of at least 31 mm and shall be presented in a way so as to ensure a significant contrast between the print and background.
Amendment 342 #
2008/0028(COD)
Proposal for a regulation
Article 14 - paragraph 1
Article 14 - paragraph 1
(1) Without prejudice to specific Community legislation applicable to particular foods as regards to the requirements referred to in Article 9(1)(a) to (k), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printed on the package or on the label in characters of a font size of at least 32 mm and shall be presented in a way so as to ensure a significant contrast between the print and background.
Amendment 356 #
2008/0028(COD)
Proposal for a regulation
Article 17 – paragraph 2 and 3
Article 17 – paragraph 2 and 3
Omission of certain mandatory particulars particulars 2. In the case of packaging or containers the largest printable surface of which has an area of less than 180 cm2 only the particulars listed in Article 9(1) (a), (c), (e) and (f) and Article 29(1)(a) shall be mandatory on the package or on the label. The particulars referred to in Article 9(1)(b) shall be provided through other means or shall be available at the request of the consumer. 3. Without prejudice to other Community legislation requiring mandatory nutrition declaration, the nutrition declaration referred to in Article 9(1)(l) shall not be mandatory for the foods listed in Annex IV.
Amendment 359 #
2008/0028(COD)
Proposal for a regulation
Article 14 - paragraph 4
Article 14 - paragraph 4
(4) The minimum font size referred to in paragraph 1 shall not apply in case of packaging or containers the largest printable surface of which has an area of less than 180 cm2.
Amendment 369 #
2008/0028(COD)
Proposal for a regulation
Article 22 – paragraph 1 – subparagraph 1
Article 22 – paragraph 1 – subparagraph 1
1. Any ingredient listed in Annex II or any substance originating from an ingredient listed in that Annex, subject to the exceptions theretof provided for in that Annex, shall always be indicated oin the label with a precise reference to the name of the ingredientist of ingredients in such a way that the potential for allergy or intolerance is immediately clearly recognisable.
Amendment 380 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – point b
Article 29 – paragraph 1 – point b
(b) the amounts of fat, saturatesprotein, fibre, carbohydrates with specific reference to sugars, fat, saturates, and salt.
Amendment 392 #
2008/0028(COD)
Proposal for a regulation
Annex VII – Part B – table – point 15a (new)
Annex VII – Part B – table – point 15a (new)
15a. Natural extracts ‘Coloring food’ from fruit, vegetables and edible plants or parts of plants obtained by means of mechanical/physical procedures and used in concentrated form to colour food.
Amendment 392 #
2008/0028(COD)
Proposal for a regulation
Article 17 - paragraph 2
Article 17 - paragraph 2
(2) In the case of packaging or containers the largest printable surface of which has an area of less than 180 cm2 only the particulars listed in Article 9(1) (a), (c), (e) and (f) shall be mandatory on the package or on the label. The particulars referred to in Article 9(1)(b) shall be provided through other means or shall be available at the request of the consumer.
Amendment 394 #
2008/0028(COD)
Proposal for a regulation
Article 17 - paragraph 3
Article 17 - paragraph 3
(3) Without prejudice to other Community legislation requiring mandatory nutrition declaration, the nutrition declaration referred to in Article 9(1)(l) shall not be mandatory for the foods listed in Annex IV.
Amendment 403 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. The nutrition declaration may alsodditionally include the amounts of one or more of the following: (a) trans fats; (b) mono-unsaturates; (c) polyunsaturates; (d) polyols; (e) starch; (f) (g)da) cholesterol; (e) starch; fibre; protein; (h) any of the minerals or vitamins listed in point 1 of Part A of Annex XI, and present in significant amounts as defined in point 2 of Part A of Annex XI. (ha) other substances within the meaning of Part A of Annex XIII and constituents of those nutrients.
Amendment 413 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 2
Article 29 – paragraph 1 – subparagraph 2
Amendment 414 #
2008/0028(COD)
Proposal for a regulation
Article 22 - paragraph 1
Article 22 - paragraph 1
(1) Any ingredient listed in Annex II or any substance originating from an ingredient listed in that Annex, subject to the exceptions thereof provided for in that Annex, shall be indicated oin the label with a precise reference to the name of the ingredientist of ingredients in such a way that the potential for allergy or intolerance is immediately recognisable.
Amendment 422 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml orand in addition, subject to Article 32(2) and (3), per portion.
Amendment 442 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b
Article 29 – paragraph 1 – subparagraph 1 – point b
b) the amounts of fat, saturatesprotein, carbohydrates with specific reference to sugars,, sugars, fat, saturates, fibres and saltodium.
Amendment 448 #
2008/0028(COD)
Proposal for a regulation
Article 32 – paragraphs 1 and 2
Article 32 – paragraphs 1 and 2
1. In addition to the nutrition declaration per 100g or per 100ml referred to in Article 31(2), the information mayust be expressed per portion as quantified on the label, provided that the number of portions contained in the package is stated. 2. The nutrition declaration may be expressed on a per portion basis alone if the food is prepacked aIn the case of foods which are not prepacked as an individual portion, the portion indication must be made 'per single item' or using a unit which consumers can iundividual portionerstand, such as 'per dessert spoon', 'per teaspoon' or 'per cup'.
Amendment 464 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
1. The particulars referred to in Article 31(1) and (2) related to the mandatory nutrition declaration shall be included in the principalsame field of vision. They shall be presented, where appropriate, together in a clear format in the following order: energy, fat, in a single table. The mandatory indications shall be presented in the following order: energy, protein, fibre, fat, with specific reference to saturates, carbohydrates with specific reference to sugars, andsalt. Additional voluntary indications shaltl be provided in the order laid down in Annex XIII.
Amendment 466 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. In addition to the presentation pursuant to Article 34(1) and per 100 g/ml and per portion pursuant to Article 31(2), the energy content labelling in kcal required pursuant to Article 29(1)(a) and Annex XI, Part B, shall appear in the bottom right-hand corner of the front of the packaging, in a font size of 3 mm and surrounded by a border.
Amendment 473 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
(2) The nutrition declaration may, in addition, also include the amounts of one or more of the following: a) trans fats; b) mono-unsaturates; c) polyunsaturates; d) polyols; e) starch; f) fibre; g) proteinda) cholesterol; e) starch; h) any of the minerals or vitamins listed in point 1 of Part A of Annex XI, and present in significant amounts as defined in point 2 of Part A of Annex XI; ha) other substances as defined in Part A of Annex XIII; and constituents of those nutrient substances.
Amendment 517 #
2008/0028(COD)
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
2. Member States may decide not to require the provision of some of the particulars referred to in paragraph 1, other than those referred to in Article 9(1) (c) and Article 29(1)(a), provided that the consumer or mass caterer still receives sufficient information.
Amendment 561 #
2008/0028(COD)
Proposal for a regulation
Article 34 - paragraphs 1 and 1 a (new)
Article 34 - paragraphs 1 and 1 a (new)
1. The particulars referred to Article 31(2) related to the mandatory nutrition declaration shall be included in the principal field of vision. They shall be presenconcerning energy value pursuant to Article 19(1)(a) shall, in accordance with Article 31(2), be included in the principal field of vision. 1a. The particulars concerning nutrients pursuant to Article 29(1)(b) concerning protein, carbohydrateds, where appropriasugar, fat, saturates, fibre and sodium shall be presente,d together in a clear format in the following order: energy, fat, saturates, carbohydrates with specific reference to sugars, and saltprotein, carbohydrates, sugar, fat, saturates, fibre and sodium. The particulars shall be presented as laid down in Article 31(3), first sentence.
Amendment 647 #
2008/0028(COD)
Proposal for a regulation
Article 53
Article 53
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. Article 14(1) shall apply from [the first day of the month 3 years after the entry into force]. Articles 29 to 34 shall apply from [the first day of the month 3 years after the entry into force] except in the case of foods labelled by food business operators with, on the date of entry into force, less than 150 employees and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million where they shall apply [the first day of the month 5 years after the entry into force]. Food placed in circulation before the entry into force of this Regulation may continue to be placed in circulation until stocks are exhausted.
Amendment 711 #
2008/0028(COD)
Proposal for a regulation
Annex VIII – title and paragraph 1
Annex VIII – title and paragraph 1
NET QUANTITY DECLARATION 1. The net quantity shall not be mandatory in the case of foods: (a) which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser; or (b) the net quantity of which is less than 5 g or 5 ml; however, this provision shall not apply to spices and herbs; (c) concentrated soups, broths, gravies, condiments and salad sauces which are marked with the volume of ready-to-use product in litres or millilitres; (d) prepacked products with baking powder and baker's yeast which are marked with the weight of the flour, for the processing of which the quantity is still sufficient after the foreseeable period of storage in the trading system; (e) prepacked products with custard powder and related products; dried products for purées, dumplings and similar garnishings which are marked with the quantity of fluid required in order to prepare them.
Amendment 19 #
2007/0064(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) In order to protect public health, maximum residue limits should be established in accordance with generally recognised principles of safety assessment, taking into account toxicological risks, environmental contamination, as well as unintended microbiological and pharmacological effects of residues. Other scientific assessments of the safety of substances concerned which may have been undertaken by international organisations or scientific committees established within the Community should also be taken into account.
Amendment 20 #
2007/0064(COD)
Proposal for a regulation
Recital 16
Recital 16
Amendment 55 #
2007/0064(COD)
Proposal for a regulation
Article 9 — paragraph 3
Article 9 — paragraph 3
3. Within 15 days of the adoption of the final opinion, the Agency shall forward it to the Commission and, as the case may be, to the Member State or party which made the request, stating the grounds for its conclusions.
Amendment 95 #
2007/0064(COD)
Proposal for a regulation
Article 18
Article 18