85 Amendments of Margarita DE LA PISA CARRIÓN related to 2023/0131(COD)
Amendment 129 #
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders of critical medicinal products should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 245 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – introductory part
Article 40 – paragraph 3 – subparagraph 1 – introductory part
An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the followthrough advances in current antibiotics or through new emerging mecharacteristics:nisms of action.
Amendment 246 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
Amendment 249 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point b
Article 40 – paragraph 3 – subparagraph 1 – point b
Amendment 253 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c
Article 40 – paragraph 3 – subparagraph 1 – point c
Amendment 256 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 2
Article 40 – paragraph 3 – subparagraph 2
In the scientific assessment ofin the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union levelase of priority antibiotics, the Agency will develop a list of criterias.
Amendment 276 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date of 15 years after the date offrom the entry into force of this Regulation] or until the date. 15 years or when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.
Amendment 325 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for. Notably, this encompasses financial assistance and administrative support for application processes expressly designed to bolster the research endeavors of small- and medium-sized undertakings provided for in, in accordance with the framework programmes for research and technological development.
Amendment 328 #
Proposal for a regulation
Article 68 – paragraph 2 – subparagraph 1 (new)
Article 68 – paragraph 2 – subparagraph 1 (new)
For the purpose of paragraph 2, this Regulation and [revised Directive 2001/83/EC] as a whole, the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union.
Amendment 330 #
Proposal for a regulation
Article 70
Article 70
Amendment 347 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nine12 years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 352 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) ten13 years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70that are the first for that indication, that represent an important advance or that involve treatment for diseases of very low prevalence;
Amendment 361 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 372 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 378 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1 a (new)
Article 72 – paragraph 1 – subparagraph 1 a (new)
1. The period of market exclusivity shall be prolonged by 24 months for orphan medicinal products referred to in Article 71, paragraph 2, point (a), if one of its therapeutic indications fulfils one of the following requirements: i. there is no medicinal product authorised in the Union for such condition or where ii. despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement or iii. the condition affects not more than 0,5 in 10,000 persons in the Union when the application for an orphan designation is submitted. When applying to new therapeutic indications, this prolongation shall apply for indications approved at least two years before the end of the exclusivity period.
Amendment 380 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 387 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 124 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 409 #
Proposal for a regulation
Article 96 – paragraph 1
Article 96 – paragraph 1
Paediatric medicinal products shall be eligible for incentives made available by the Union and by the Member States to support the additional efforts necessary in this field, such as clinical trials and research into, and the development and availability of, paediatric medicinal products.
Amendment 430 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 434 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the marketlist of essential UE medicals. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available to the Agency and the competent authority of the Member State where the medicinal product is placed on the market.
Amendment 442 #
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit updated versions of a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may set a deadline for the submission of the information requested.
Amendment 444 #
Proposal for a regulation
Article 119 – paragraph 2
Article 119 – paragraph 2
2. To prepare the shortage mitigation plan referred to in Article 118(2), the marketing authorisation holder as defined in Article 116(1) shall include the minimum set of information set out in Part IV of Annex IV and take into account the guidance drawn up by the Agency according to Article 122(4), point (c). However, the marketing authorization holder is not required to establish or maintain a safety stock of critical medicinal products.
Amendment 449 #
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any relevant information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 453 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) assess information on potential or actual deficiencies provided by marketing authorisation holders authorised to market in a Member State in accordance with Article 5 of [Directive 2001/83/EC as revised] as defined in paragraph 1 of Article 116, importers and manufacturers of medicinal products or active ingredients and relevant suppliers thereof, wholesale distributors, associations representing interested parties or other legal persons or entities which are authorised or authorised to supply medicinal products to the public.
Amendment 465 #
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, without duplication of reporting including repositories system information on safety feature without duplication of reporting for marketing authorisation Holder, other actors involved in supply chain and National Competent Authorities.
Amendment 468 #
Proposal for a regulation
Article 123 – paragraph 1
Article 123 – paragraph 1
1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c) with MAHs and other actors of the supply chain, the MSSG shall adopt a list of critical shortages of medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).
Amendment 481 #
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely mannerpro-actively where they deem it necessary or as requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 486 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), and Marketing Authoritation Holder, ensure the following:
Amendment 494 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) also Marketing Authorisation Holder, National Agencies and other actors. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 496 #
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), with the Marketing Autorisation Holder and other actors , the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may includeor recommendations on diversification of suppliers and inventory management that are justified and well balance, facing root causes of the supply risk and patients.
Amendment 500 #
Proposal for a regulation
Article 134 – paragraph 2
Article 134 – paragraph 2
2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt an implementing act to improve security of supply. The implementing act, in consultancy with Marketing Authorisation Holder, National Agencys, and other relevant actors, may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant well balance measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities responding for their responsabilities facing root causes of suply risk.
Amendment 521 #
Proposal for a regulation
Article 164 – paragraph 1
Article 164 – paragraph 1
1. The Agency shall ensure that micro, small and medium-sized enterprises (‘SMEs’), research institutes, academic institutions, and not-for-profit entities are offered a support scheme.
Amendment 522 #
Proposal for a regulation
Article 164 – paragraph 2
Article 164 – paragraph 2
2. The comprehensive support scheme shall be comprised ofincludes regulatory, procedural, and administrative support assistance, coupled with significandt reductions, deferrals, or waivers of fees.
Amendment 523 #
Proposal for a regulation
Article 164 – paragraph 4
Article 164 – paragraph 4
4. SMEs shall benefit from the incentives laid down in Commission Regulation (EC) No 2049/2005, ands well as [revised Council Regulation (EC) No 297/95]84 . _________________ 84 Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to th49. These incentives are designed to alleviate financial and adminstrative Eburopean Agency for the Evaluation of Medicinal Products (OJ L 35, 15.2.1995, p. 1)dens and promote innovation.
Amendment 556 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
Amendment 569 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) ‘Supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorization holder or a manufacturer.
Amendment 595 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Unionor expected to be of major interest from the point of view of public health in the diagnosis in the diagnosis, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, or upon request of the applicant offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 632 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
The applicant shall submit an environmental risk assessment referred to in Article 7(1) to the Agency and will be answer in a limit time of period.
Amendment 653 #
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 6 a (new)
Article 13 – paragraph 1 – subparagraph 6 a (new)
Amendment 655 #
Proposal for a regulation
Article 13 – paragraph 4 a (new)
Article 13 – paragraph 4 a (new)
4 a. The Commission decision-making phase shall not exceed 30 days from the date of CHMP opinion.
Amendment 662 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 670 #
Proposal for a regulation
Article 15 – paragraph 1 – point d a (new)
Article 15 – paragraph 1 – point d a (new)
(d a) the content or timelines of post- authorisation studies to further clarify environmental risk assessment, as required in article 20(c), cannot be agreed.
Amendment 699 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication including when grouped with an extension of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:
Amendment 701 #
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1
Article 18 – paragraph 2 – subparagraph 1
The maintenance of the authorised new therapeutic indication including when grouped with an extension of the marketing authorisation and the validity of the marketing authorisation granted in accordance with paragraph 1 shall be linked to the reassessment by the Agency of the conditions referred to in paragraph 1 after two years from the date when the new therapeutic indication was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the Agency and specified by the Commission in the marketing authorisation.
Amendment 707 #
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
In emergency situations, a conditional marketing authorisation or a new conditional therapeutic indication including when grouped with an extension of the marketing authorisation referred to in the first subparagraph may be granted also where comprehensive non- clinical or pharmaceutical data have not been supplied.
Amendment 710 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Conditional marketing authorisations or a new conditional therapeutic indication including when grouped with an extension of the marketing authorisation referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data.
Amendment 717 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Conditional marketing authorisations or a new conditional therapeutic indication including when grouped with an extension of the marketing authorisation granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.
Amendment 843 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – introductory part
Article 40 – paragraph 3 – subparagraph 1 – introductory part
An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the followthrough advances in current antibiotics or through new emerging mecharacteristics:nisms of action.
Amendment 851 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
Amendment 858 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point b
Article 40 – paragraph 3 – subparagraph 1 – point b
Amendment 859 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c
Article 40 – paragraph 3 – subparagraph 1 – point c
Amendment 865 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 2
Article 40 – paragraph 3 – subparagraph 2
In the scientific assessment ofin the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.ase of priority antibiotics, the Agency will develop a list of criterias
Amendment 951 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date of 15 years after the date offrom the entry into force of this Regulation] or until the date. 15 years or when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.
Amendment 1054 #
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 1058 #
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementing acts in accordance with the procedure laid down in Article 173(2) in order to further specify the requirements referred to in paragraph 1.
Amendment 1069 #
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.
Amendment 1072 #
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2.
Amendment 1122 #
Proposal for a regulation
Article 70
Article 70
Amendment 1161 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1181 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) therteen years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;that are the first for that indication, that represent an important advance or that involve treatment for diseases of very low prevalence
Amendment 1201 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 1226 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1238 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1241 #
Proposal for a regulation
Article 72 – paragraph 1 a (new)
Article 72 – paragraph 1 a (new)
1 a. The period of market exclusivity shall be prolonged by 24 months for orphan medicinal products referred to in Article 71, paragraph 2, point (a), if one of its therapeutic indications fulfils one of the following requirements: i. there is no medicinal product authorised in the Union for such condition or; ii. despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement or; iii. the condition affects not more than 0,5 in 10,000 persons in the Union when the application for an orphan designation is submitted. When applying to new therapeutic indications, this prolongation shall apply for indications approved at least two years before the end of the exclusivity period.
Amendment 1248 #
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 124 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 1285 #
Proposal for a regulation
Article 74 – paragraph 2 – subparagraph 1 – point a
Article 74 – paragraph 2 – subparagraph 1 – point a
(a) when the active substance concerned is not yet authorised in any medicinal product in the EU and is intended to treat a novelthe first of its kind intended to treat, diagnose or prevent a paediatric condition;
Amendment 1286 #
Proposal for a regulation
Article 75 – paragraph 1 – point b
Article 75 – paragraph 1 – point b
(b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations, unless wheon the product is directed at a molecular targetbasis of existing scientific data, there is medical plausibility that on the basis of existing scientific data, is responsible forproduct, due to its mechanism of action, could address an unmet medical need in a different disease or condition in the same therapeutic area in children than the one for which the specific medicinal product or class of medicinal products is intended for in the adult population. Where that is the case, the applicant shall be required to conduct one paediatric investigation plan based on the product’s mechanism of action in a single disease or condition for which there is such an unmet medical need, and no more than one such paediatric investigation plan for any given active substance;
Amendment 1291 #
Proposal for a regulation
Article 75 – paragraph 1 – point c
Article 75 – paragraph 1 – point c
(c) that the specific medicinal product is likely to not represent a significant therapeutic benefit over existing treatments for paediatric patients. methods of diagnosis, prevention or treatments for paediatric patients, including when clinical studies are not feasible.
Amendment 1296 #
Proposal for a regulation
Article 75 – paragraph 3 a (new)
Article 75 – paragraph 3 a (new)
3 a. In consultation with the Commission and with interested parties, the Agency shall draw up guidelines for the application of this Article.
Amendment 1301 #
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. A paediatric investigation plan or an application for waiver shall be submitted to the Agency with a request for agreement, except in duly justified cases, before the initiation of confirmatory safety and efficacy clinical studies in adults or children so as to ensure that a decision on use in the paediatric population of the medicinal product concerned can be given at the time of the marketing authorisation or other application concerned.
Amendment 1327 #
Proposal for a regulation
Article 84 – paragraph 1 a (new)
Article 84 – paragraph 1 a (new)
1 a. The procedure foreseen in paragraph 1 shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2).
Amendment 1329 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 1
Article 84 – paragraph 2 – subparagraph 1
If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraphs 1, 2 and 4, or on the basis of the updated paediatric investigation plan received in accordance with Article 77(3), the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request thebased on detailed scientific grounds, that the to applicant to proposes changes to the paediatric investigation plan. The applicant shall submit a response to the request for changes within 60 days. Within 30 days, the Agency shall review the applicant’s response and adopt a decision on its refusal or acceptance.
Amendment 1332 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 2
Article 84 – paragraph 2 – subparagraph 2
The applicant shall submit the changes requesteda response to the request for changes within 690 days.
Amendment 1336 #
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 3
Article 84 – paragraph 2 – subparagraph 3
Within 30 days, the Agency shall review these changes applicant’s response and adopt a decision on theirits refusal or acceptance.
Amendment 1393 #
Medicinal products subject to additional surveillance 1.The Agency, in cooperation with the Member States, shall establish, maintain and make public a list of medicinal products subject to additional monitoring. That list shall include the names and active substances of: (a) medicinal products authorised in the Union containing a new active substance not contained in any medicinal product authorised in the Union; (b) any biological medicinal product not referred to in point (a) authorised after [date of application]; (c) medicinal products authorised under this Regulation, under the conditions laid down in Article 12, paragraph 4, point f), Article 20, paragraph 1, point a), or Articles 18, 19, 30 or 113. (d) medicinal products authorized under [Directive 2001/83/EC as revised] under the conditions referred to in Article 44, first paragraph b) and c) or in Article 45 or a) of the first paragraph of Article 87 thereof. At the request of the Commission, after consulting the Pharmacovigilance Risk Assessment Committee, medicinal products authorized under this Regulation under the conditions referred to in Article 12, paragraph d), e) or g), Article 20.1 b) or 46.2 may also be included in the list referred to in paragraph 1 of this Article.At the request of a competent national authority, after consulting the Pharmacovigilance Risk Assessment Committee, medicinal products authorised under [Directive 2001/83/EC revised] under the conditions referred to in the first paragraph of Article 44 a), d) or f), in the first subparagraph of Article 87 b), or in paragraph 2 of Article 100, may also be included in the list referred to in paragraph 1 of this Article. 2.The list referred to in paragraph 1 shall include an electronic link to the product information and the summary of the risk management plan. 3.In the cases referred to in paragraphs a) and b) of this Article, the Agency shall remove a medicinal product from the list five years after the Union reference date referred to in paragraph 5 of Article 108 of [Revised Directive 2001/83/EC] In the cases referred to in points c) and d) of paragraph 1 of this Article, the Agency shall remove a medicinal product from the list once the conditions have been met. 4.For medicinal products included in the list referred to in paragraph 1, the summary of product characteristics and the package leaflet shall include the statement "This medicinal product is subject to additional monitoring".The declaration shall be preceded by an inverted black triangle and followed by a standard explanatory phrase. 5. The Agency, in cooperation with the competent authorities, shall develop and carry out awareness-raising campaigns on the promotion of information on medicinal products subject to additional monitoring. These campaigns shall aim to raise awareness among healthcare professionals, patients, consumers and the general public about the pharmacovigilance system and the additional monitoring of medicinal products
Amendment 1478 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1490 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available to the Agency and the competent authority of the Member State where the medicinal product is placed on the market.
Amendment 1499 #
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the marketlist of esencial UE medicals. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1517 #
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit updated versions of a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may set a deadline for the submission of the information requested.
Amendment 1546 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) assess information on potential or actual deficiencies provided by marketing authorisation holders authorised to market in a Member State in accordance with Article 5 of [Directive 2001/83/EC as revised] as defined in paragraph 1 of Article 116, importers and manufacturers of medicinal products or active ingredients and relevant suppliers thereof, wholesale distributors, associations representing interested parties or other legal persons or entities which are authorised or authorised to supply medicinal products to the public.
Amendment 1587 #
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, without duplication of reporting. including repositories system information on safety feature without duplication of reporting for marketing authorisation Holder, other actors involved in supply chain and National Competent Authorities
Amendment 1594 #
Proposal for a regulation
Article 123 – paragraph 1
Article 123 – paragraph 1
1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c) with MAHs and other actors of the supply chain, the MSSG shall adopt a list of critical shortages of medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).
Amendment 1652 #
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and marketing authorisation holders, ensure the following:
Amendment 1678 #
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) also markreting authorisation holders, national agencys and other actors. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 1686 #
Proposal for a regulation
Article 132 – paragraph 1
Article 132 – paragraph 1
1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), with the marketing autorisation holders and other actors, the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may includeor recommendations on diversification of suppliers and inventory management. that ate justified and well balance, facing root causes of the supply risk and patients