25 Amendments of Stanislav POLČÁK related to 2023/0131(COD)
Amendment 241 #
Proposal for a regulation
Recital 29
Recital 29
(29) Legal entities that are not engaged in an economic activity as their main activity such as universities, public bodies, research centres or not-for-profit organisations, represent an important source of innovation and should also benefit from this support scheme. Whereas it should be possible to take account of the particular situation of these entities on an individual basis, such support can best be achieved by means of a dedicated support scheme, including administrative support and through the reduction, deferral and waiver of fees.
Amendment 280 #
Proposal for a regulation
Recital 45
Recital 45
(45) To avoid unnecessary administrative and financial burdens for applicants, marketing authorisation holders and competent authorities, certain streamlining measures should be introduced. Marketing authorisation applications, like any other application submitted to the Agency, including applications for a variation to the terms of marketing authorisations, should follow the digital by default principle and hence be sent to the Agency in electronic form. Applications should be assessed based on the file submitted by the applicant in accordance with the different legal basis provided by [revised Directive 2001/83/EC]. At the same time, the Agency and the relevant committees may take into account any information that is in its possession. Applicants shall be requested to generally submit raw data, in particular with regard to the clinical trials performed by the applicant in order to ensure a full assessment of the quality, safety and efficacy of the medicinal product.
Amendment 292 #
Proposal for a regulation
Recital 51
Recital 51
(51) As a general rule a marketing authorisation should be granted for an unlimited time; however, one renewalthe granting of marketing authorisation for a limited period may be decided only on justified grounds related to the safety of the medicinal product. The marketing authorisation holder should be given the opportunity to apply for an extension of the marketing authorisation. If granted by the Commission, the extension of the marketing authorisation should be valid for an indefinite period.
Amendment 297 #
Proposal for a regulation
Recital 54
Recital 54
(54) [revised Directive 2001/83/EC] permits Member States to temporarily allow the use and supply of unauthorised medicinal products for public health reasons or individual patient needs and that includes medicinal products to be authorised under this Regulation. It is also necessary, that Member States are allowed under this Regulation to make a medicinal product available for compassionate use prior to its marketing authorisation. In those exceptional and urgent situations, where there is a lack of a suitable authorised medicinal product, the need to protect public health or the health of individual patients must prevail over other considerations, in particular the need to obtain a marketing authorisation and consequently, to have available complete information about the risks posed by the medicinal product, including any risks to the environment from medicinal products containing or consisting of genetically modified organisms (GMOs). To avoid delays in making these products available or uncertainties as regards their status in certain Member States, it is appropriate, in those exceptional and urgent situations, that for a medicinal product containing or consisting of GMOs, an environmental risk assessment or consent in accordance with Directive 2001/18/EC or Directive 2009/41/EC of the European Parliament and of the Council52[1] should not be a prerequisite. Nevertheless, in these cases, Member States should implement appropriate measures to minimise foreseeablin line with the precautionary principle to minimise negative environmental impacts resulting from the intended or unintended release of the medicinal products containing or consisting of GMOs into the environment. _________________ 52[1] Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (OJ L 125, 21.5.2009, p. 75).
Amendment 315 #
Proposal for a regulation
Recital 70
Recital 70
(70) In the event of a risk to public health or the environment, the marketing authorisation holder or the competent authorities should be able to make urgent safety or efficacy restrictions on their own initiative to ensure a swift adaption of the marketing authorisation to maintain the safe and efficacious use of the medicinal product by healthcare professionals and patients. If a review is launched on the same safety or efficacy concern addressed by urgent restrictions initiated by a competent authority, any written observations by the marketing authorisation holder should be considered in that review to avoid duplication of assessment.
Amendment 317 #
Proposal for a regulation
Recital 72
Recital 72
Amendment 321 #
Proposal for a regulation
Recital 74
Recital 74
Amendment 499 #
Proposal for a regulation
Recital 140
Recital 140
(140) It is recognised that improved access to information contributes to public awareness and increases public trust, gives the public the opportunity to express its observations and enables authorities to take due account of those observations. The general public should therefore have access to information in the Union Register of medicinal products, the Eudravigilance database and the manufacturing and wholesale distribution database, after the deletion of any commercially confidential information by the competent authority. Regulation (EC) No 1049/2001[1] of the European Parliament and of the Council57 gives the fullest possible effect to the right of public access to documents and lays down the general principles and limits on such access. The Agency should therefore give the widest possible access to the documents while carefully balancing the right for information with existing data protection requirements. Certain public and private interests, such as personal data and commercially confidential information, should be protected by way of exception in accordance with Regulation (EC) No 1049/2001. _________________ 57[1] Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 503 #
Proposal for a regulation
Recital 141
Recital 141
(141) To ensure the enforcement of certain obligations relating to the marketing authorisation for medicinal products for human use granted in accordance with this Regulation, the Commission should be able to impose financial penalties. When assessing the responsibility for failures to comply with those obligations and imposing such penalties, it is important that means exist to address the fact that marketing authorisation holders could be part of a wider economic entity. Otherwise, there is a clear and identifiable risk that the responsibility for a failure to comply with those obligations could be evaded, which might have an impact on the ability to impose effective, proportional and dissuasive penalties. The penalties imposedpenalties, which should be effective, proportionate and dissuasive, having regard to the circumstances of the specific case. For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to set maximum amounts for penalties. Those maximum amounts should not be linked to the turnover of a particular medicinal product but the economic entity involved.
Amendment 512 #
Proposal for a regulation
Recital 154
Recital 154
(154) This Regulation is based on the double legal basis of Article 114 and Article 168(4), point (c), TFEU. It aims at achieving an internal market as regards medicinal products for human use, taking as a base a high level of protection of health. At the same time, this Regulation sets high standards of quality and safety for medicinal products in order to meet common safety concerns as regards these products. Both objectives are being pursued simultaneously. These two objectives are inseparably linked and one is not secondary to another. Regarding Article 114 TFEU, this Regulation establishes a European Medicines Agencyregulates the functioning of the European Medicines Agency, established by Regulation (EC) No 726/2004, and provides specific provision with regard to the central authorisation of medicinal products, therefore ensuring the functioning of the internal market and the free movement of medicinal products. Regarding Article 168(4), point (c), TFEU, this Regulation sets high standards of quality and safety for medicinal products.
Amendment 520 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down Union procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human use at Union level, establishes rules and procedures at Union and at Member State level relating to the security of supply of medicinal products and lays down rules on the governance provisionsand functioning of the European Medicines Agency (‘the Agency’) established by Regulation (EC) No 726/2004 which shall carry out the tasks relating to medicinal products for human use that are laid down in this Regulation, Regulation (EU) No 2019/6 and other relevant Union legal acts.
Amendment 610 #
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
The marketing authorisation applicant shall not carry out animal testsing in case scientifically satisfactory non-animal testing methods are available, or where the results of animal studies previously carried out by the applicant or others may be used for the medicinal product.
Amendment 622 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Without prejudice to Article 22 of [revised Directive 2001/83/EC], the marketing authorisation application of a medicinal product for human use containing or consisting of genetically modified organisms as defined in Article 2(2) of Directive 2001/18/EC shall be accompanied by an environmental risk assessment identifying and evaluating potential adverse effects of the genetically modified organisms on human health and the environment, and shall set out measures to prevent or minimise such effects.
Amendment 625 #
Proposal for a regulation
Article 7 – paragraph 4 – introductory part
Article 7 – paragraph 4 – introductory part
4. Articles 6 to 11 of [revised Directive 2001/183/EC] as well as Articles 4 to 13 of Directive 2009/41/EC shall not apply to operations related to the supply and clinical use, including the packaging and labelling, distribution, storage, transport, preparation for administration, administration, destruction or disposal of medicinal products containing or consisting of genetically modified organisms, with the exception of their manufacture, in any of the following cases:
Amendment 626 #
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1
Article 7 – paragraph 5 – subparagraph 1
In the cases referred to in paragraph 4, Member States shall implement appropriate measures to minimise foreseeablbased on the precautionary principle to minimise negative environmental impacts resulting from the intended or unintended release of the medicinal products containing or consisting of genetically modified organisms into the environment.
Amendment 656 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
If an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application by the Committee for Medicinal Products for Human Use, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly available and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature.
Amendment 666 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment havare not beening sufficiently addressed by the applicant;
Amendment 678 #
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Article 16 – paragraph 3 – subparagraph 1
The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for itsthe opinion of the Committee for Medicinal Products for Human Use in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature.
Amendment 773 #
Proposal for a regulation
Article 28 – title
Article 28 – title
Amendment 779 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
During a public health emergency, the Commission may grant a temporary emergency marketing authorisation (‘TEMA’) for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information. However, prior to the submission of a full environmental risk assessment as referred to in Article 7(1), a temporary emergency authorisation may only be granted if the best available scientific information indicates that there is no risk of serious or irreversible harm to the environment, animals or human health arising from the manufacture or use of the medicinal product containing or consisting of the GMO.
Amendment 811 #
Proposal for a regulation
Article 35 – paragraph 1 – point b
Article 35 – paragraph 1 – point b
(b) it is appropriate to protect public health or the environment;
Amendment 955 #
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 1
Article 44 – paragraph 1 – subparagraph 1
If, in the event of a risk to public health or the environment, the marketing authorisation holder takes urgent safety or efficacy restrictions on their own initiative, the marketing authorisation holder shall immediately inform the Agency.
Amendment 956 #
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 1
Article 44 – paragraph 2 – subparagraph 1
In the event of a risk to public health or the environment, the Commission may vary the marketing authorisation to impose urgent safety or efficacy restrictions on the marketing authorisation holder.
Amendment 964 #
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Article 48 – paragraph 1 – subparagraph 1
An entity not engaged in an economic activity as its main activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non- clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.
Amendment 1442 #
Proposal for a regulation
Article 113 – paragraph 8 – subparagraph 1 – point b
Article 113 – paragraph 8 – subparagraph 1 – point b
(b) it is appropriate to protect public health or the environment.