Awaiting committee decision
Next event: Indicative plenary sitting date, 1st reading/single reading 2016/05/09
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Opinion | AGRI | POLČÁK Stanislav (EPP) | |
Lead | ENVI | TĂNĂSESCU Claudiu Ciprian (S&D) | CIRIO Alberto (EPP), PIECHA Bolesław G. (ECR), MEISSNER Gesine (ALDE), KYLLÖNEN Merja (GUE/NGL), HÄUSLING Martin (Verts/ALE), PEDICINI Piernicola (EFD) |
Opinion | IMCO | ||
Opinion | ITRE |
Legal Basis TFEU 114, TFEU 168-p4
Activites
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2016/05/09
Indicative plenary sitting date, 1st reading/single reading
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2014/10/20
Committee referral announced in Parliament, 1st reading/single reading
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2014/09/10
Legislative proposal published
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COM(2014)0557
summary
PURPOSE: to amend 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. PROPOSED ACT: Regulation of the Council and the European Parliament. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) 726/2004 of the European Parliament and of the Council constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the Commission has presented a proposal that will repeal and replace Directive 2001/82/EC on veterinary medicinal products. This proposal lays down procedures for the authorisation and supervision of medicinal products for human and veterinary use. It is therefore necessary to amend Regulation (EC) No 726/2004 to take account of the fact that centralised marketing authorisation for veterinary products is being decoupled from that for medicines for humans. IMPACT ASSESSMENT: the consultation and a study, An assessment of the impact of the revision of veterinary pharmaceutical legislation, formed the basis of an impact assessment carried out for the Commission between November 2009 and June 2011. The Commission’s Impact Assessment Board (IAB) released its final opinion in September 2013. CONTENT: the proposal seeks to amend Regulation (EC) No 726/2004 so as to: delete from Regulation (EC) No 726/2004 the provisions regarding granting and maintaining marketing authorisations for veterinary medicinal products. The rules on marketing authorisations valid in all EU Member States are part of the proposal for a Regulation on veterinary medicinal products. The new Regulation on veterinary medicinal products will cover all routes granting marketing authorisations for veterinary medicinal products in the Union – both at centralised and national level; establish certain principles applicable to fees payable to the Agency, including the need to take into account, as appropriate, the specific needs for SMEs. The provisions regulating fees should be brought into line with the Treaty of Lisbon; align the powers conferred on the Commission under Regulation (EC) No 726/2004 to Articles 290 and 291 (delegated and implementing acts) of the Treaty on the Functioning of the European Union. BUDGETARY IMPLICATION: the costs for the EMA for implementing and applying the new rules are entirely covered by fees charged to industry. Therefore, the proposal is not expected to have any financial impact on the budget of the EU. As set out in the legislative financial statement the additional resource needs for EMA are approximately 8 staff plus expenditure for meetings, translation, IT, etc. The level of fees, their structure and modalities and exceptions will be set at a later stage by the Commission by way of implementing acts. DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the treaty on the Functioning of the European Union.
- DG {'url': 'http://ec.europa.eu/dgs/health_consumer/index_en.htm', 'title': 'Health and Consumers'}, BORG Tonio
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COM(2014)0557
summary
Documents
- Legislative proposal published: COM(2014)0557
Amendments | Dossier |
67 |
2014/0256(COD)
2015/04/30
AGRI
29 amendments...
Amendment 11 #
Proposal for a regulation Recital 1 (1) Directive 2001/82/EC of the European Parliament and of the Council5 and Regulation (EC) 726/2004 of the European Parliament and of the Council6 constituted the Union regulatory framework for the manufacture, authorisation and distribution of veterinary medicinal products. In the light of the experience acquired and following the assessment by the Commission of the functioning of the internal market for veterinary medicinal products, the regulatory framework for veterinary medicinal products has been reviewed, and Regulation (EU) No […] of the European Parliament and of the Council
Amendment 12 #
Proposal for a regulation Recital 4 (4) As a consequence of the entry into force of the Treaty of Lisbon, the powers conferred on the Commission under Regulation (EC) No 726/2004 should be aligned to Articles 290 and 291 of the Treaty on the Functioning of the European Union. In order to supplement or amend certain non-essential elements of Regulation (EC) No 726/2004, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of amending the Annex with regard to technical and scientific progress so as to facilitate the placing on the market of new medicinal products, determining the situations in which post-
Amendment 13 #
Proposal for a regulation Recital 4 (4) As a
Amendment 14 #
Proposal for a regulation Recital 5 (5) It is of
Amendment 15 #
Proposal for a regulation Recital 6 (6) In
Amendment 16 #
Proposal for a regulation Recital 6 (6) In order to ensure uniform conditions for the implementation of Regulation (EC) No 726/2004, implementing powers should be conferred on the Commission to adopt implementing acts in relation to marketing authorisations for medicinal products for human and veterinary use. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council8. ___________ 8 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 17 #
Proposal for a regulation Article 1 – paragraph 1 – point 3 Regulation (EC) No 726/2004 Article 2 – point 1 The definitions laid down in Article 1 of Directive 2001/83/EC and in Regulation (EU) ... of the European Parliament and of the Council on veterinary medicinal products (2014/0257(COD) shall apply for the purposes of this Regulation.
Amendment 18 #
Proposal for a regulation Article 1 – paragraph 1 – point 4 – point c Regulation (EC) No 726/2004 Article 3 – paragraph 4 ‘The
Amendment 19 #
Proposal for a regulation Article 1 – paragraph 1 – point 6 – point b – introductory part Regulation (EC) No 726/2004 Article 10 – paragraph 5 (b) paragraph 5 is replaced by the following: (Linguistic change not affecting the English version.)
Amendment 20 #
Proposal for a regulation Article 1 – paragraph 1 – point 9 Regulation (EC) No 726/2004 Article 16 – paragraph 4 Amendment 21 #
Proposal for a regulation Article 1 – paragraph 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 55 – paragraph 2 (10a) Article 55(2) is replaced by the following: ‘The Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human and veterinary use.’
Amendment 22 #
Proposal for a regulation Article 1 – paragraph 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 56 – paragraph 1 Amendment 23 #
Proposal for a regulation Article 1 – paragraph 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 1 – points u, v and w (new) (10a) In Article 57(1) the following points are added: "(u) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under Union procedures, for the purpose of implementing a review system (Monograph system); (v) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the Union procedures, for the purpose of implementing a review system (Monograph System); (w) setting up a free of charge public database that lists information on active substances of veterinary medicinal products according to the review system (Monograph System), and updating on a regular basis. The respective information shall be presented in an easily understandable manner.".
Amendment 24 #
Proposal for a regulation Article 1 – paragraph 1 – point 11 Regulation (EC) No 726/2004 Article 57 – paragraph 2 – subparagraph 1 2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC. The database shall subsequently be extended to include any medicinal product for human use authorised in the Union.
Amendment 25 #
Proposal for a regulation Article 1 – paragraph 1 – point 11 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 3 (new) (11a) In Article 57, the following paragraph is added: '(3) The database according to point (w) paragraph 1 of this Article, shall contain data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database shall list information on all veterinary medicines marketed in the Union. The Agency shall prepare a list of all veterinary medicines and active substances marketed in the Union in accordance with Article 51 of Regulation (EU) No .../... of the European Parliament and of the Council of ... on veterinary medicinal products (2014/0257(COD)).'.
Amendment 26 #
Proposal for a regulation Article 1 – paragraph 1 – point 13 Regulation (EC) No 726/2004 Article 61 – paragraph 1 – subparagraph 1 Each Member State shall, after consultation of the Management Board, appoint, for a three-year
Amendment 27 #
Proposal for a regulation Article 1 – paragraph 1 – point 13 Regulation (EC) No 726/2004 Article 61 – paragraph 1 – subparagraph 2 The alternates shall represent and vote for the members in their absence and may also act as rapporteurs in accordance with Article 62.
Amendment 28 #
Proposal for a regulation Article 1 – paragraph 1 – point 15 Regulation (EC) No 726/2004 Article 67 – paragraph 3 – subparagraph 1 Amendment 29 #
Proposal for a regulation Article 1 – paragraph 1 – point 15 Regulation (EC) No 726/2004 Article 67 – paragraph 3 – subparagraph 1 The Agency’s revenue shall consist of a contribution from the Union, fees paid by undertakings for obtaining and maintaining Union marketing authorisations
Amendment 30 #
Proposal for a regulation Article 1 – paragraph 1 – point 16 Regulation (EC) No 726/2004 Article 70 Amendment 31 #
Proposal for a regulation Article 1 – paragraph 1 – point 16 Regulation (EC) No 726/2004 Article 70 Amendment 32 #
Proposal for a regulation Article 1 – paragraph 1 – point 16 Regulation (EC) No 726/2004 Article 70 – paragraph 1 – introductory part 1. The Commission shall, on the basis of the principles set out in paragraph 2,
Amendment 33 #
Proposal for a regulation Article 1 – paragraph 1 – point 16 Regulation (EC) No 726/2004 Article 70 – paragraph 2 – introductory part 2.
Amendment 34 #
Proposal for a regulation Article 1 – paragraph 1 – point 17 Regulation (EC) No 726/2004 Article 84 – paragraph 3 – subparagraph 1 Amendment 35 #
Proposal for a regulation Article 1 – paragraph 1 – point 17 Regulation (EC) No 726/2004 Article 84 – paragraph 3 – subparagraph 3 For the conduct of the investigation the Commission
Amendment 36 #
Proposal for a regulation Article 1 – paragraph 1 – point 17 Regulation (EC) No 726/2004 Article 84 – paragraph 3 – subparagraph 4 Amendment 37 #
Proposal for a regulation Article 1 – paragraph 1 – point 18 Regulation (EC) No 726/2004 Article 86 At least every
Amendment 38 #
Proposal for a regulation Article 1 – paragraph 1 – point 20 Regulation (EC) No 726/2004 Article 87b Amendment 39 #
Proposal for a regulation Article 1 – paragraph 1 – point 20 Regulation (EC) No 726/2004 Article 87 b – paragraph 4 4. As soon as it adopts a delegated act, the Commission shall
source: 557.072
2015/06/17
ENVI
38 amendments...
Amendment 16 #
Proposal for a regulation Recital 3 (3) The costs of the procedures and services associated with the operation of this Regulation need to be recovered from those making medicinal products available on the market and from those seeking authorisation.
Amendment 17 #
Proposal for a regulation Recital 5 (5)
Amendment 18 #
Proposal for a regulation Recital 5 a (new) (5a) The Commission should be able to include, in its general report on the experience acquired as a result of the application of the procedures laid down in this Regulation, information concerning a proposal to revise Council Regulation No (EC) 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products;
Amendment 19 #
Proposal for a regulation Recital 6 a (new) (6a) Advances in alternative testing require the creation of a validation framework capable of adapting to new developments in this field, particularly in relation to the recognition and evaluation of in silico testing.
Amendment 20 #
Proposal for a regulation Recital 6 b (new) (6b) Animal testing currently plays a key regulatory and scientific role in the development of medicines, and is subject to Directive 2010/63/EU relating to the replacement, reduction or refinement of animal testing.
Amendment 21 #
Proposal for a regulation Recital 7 a (new) (7a) In the interest of public health, authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy, and taking into consideration cost-effectiveness of the medicinal product concerned.
Amendment 22 #
Proposal for a regulation Recital 7 b (new) (7b) Provision should be made for the quality, safety and efficacy criteria in Directives 2001/83/EC and 2001/82/EC to apply to medicinal products authorised by the Community and it should be possible to assess both the risk-benefit balance and the cost-effectiveness of all medicinal products when they are placed on the market, at the time of the renewal of the authorisation and at any other time the competent authority deems appropriate.
Amendment 23 #
Proposal for a regulation Recital 7 c (new) Amendment 24 #
Proposal for a regulation Article 1 – point 2 a (new) Regulation (EC) No 726/2004 Article 1 – paragraph 2 (2a) In Article 1, the second paragraph is replaced by the following: "The provisions of this Regulation shall not affect the powers of Member States' authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions, provided that Member States take in due consideration the reference comparative efficacy and reference cost-effective evaluation of medicinal product as per the provisions stated in Article 9(4). In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies."
Amendment 25 #
Proposal for a regulation Article 1 – point 5 a (new) Regulation (EC) No 726/2004 Article 6 – paragraphs 4 a and 4 b (new) (5a) In Article 6, the following paragraphs are added: "4a. The Agency shall verify that applicants for marketing authorisations have acted in accordance with Article 13(1) of Directive 2010/63/EU. 4b. The Agency shall develop a framework for the validation of in silico models and take into consideration the opportunities presented by in silico concepts developed in toxicology aiming for predictive medicine. These can be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways."
Amendment 26 #
Proposal for a regulation Article 1 – point 5 a (new) Regulation (EC) No 726/2004 Article 9 – paragraph 1 – point d a (new) Amendment 27 #
Proposal for a regulation Article 1 – point 7 Regulation (EC) No 726/2004 Article 10b– paragraph 1 The Commission shall
Amendment 28 #
Proposal for a regulation Article 1 – paragraph 1 – point 8 Regulation (EC) No 726/2004 Article 14 – paragraph 7 – subparagraph 3 The Commission shall
Amendment 29 #
Proposal for a regulation Article 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 1 – subparagraph 1 (10a) In Article 57(1), subparagraph 1 is replaced by the following: "1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety
Amendment 30 #
Proposal for a regulation Article 1 – point 10 b (new) Regulation (EC) No 726/2004 Article 57 – paragraph 1 – subparagraph 2 – point i a (new) Amendment 31 #
Proposal for a regulation Article 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 1– subparagraph 2 – points t a, t b and t c (new) (10a) In subparagraph 2 of Article 57(1), the following points are added: "(ta) co-ordination of the provision of information on active substances of veterinary medicinal products authorised under community procedures, for the purpose of implementing a review system (Monograph system); (tb) assisting Member States in providing information on active substances of veterinary medicinal products authorised under procedures other than the community procedures, for the purpose of implementing a review system (Monograph System); (tc) setting up a free of charge public database that lists information on active substances of veterinary medicinal products according to the review system (Monograph System), and updating on a regular basis. The respective information should be presented in an easily understandable manner."
Amendment 32 #
Proposal for a regulation Article 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 1 – subparagraph 2 – point t a (new) (10a) In subparagraph 2 of Article 57(1), the following point is added: "(ta) in cooperation with EFSA and ECDC annually publish a report on the use of antimicrobials for human and veterinary medicine as well as the current situation on the antimicrobial resistance in the Union."
Amendment 33 #
Proposal for a regulation Article 1 – point 10 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 1 – subparagraph 2 – point t a (new) (10a) In subparagraph 2 of Article 57(1), the following point is added: "(ta) cooperating with health technology assessment bodies and other national authorities involved in market access, in particular to facilitate their assessment."
Amendment 34 #
Proposal for a regulation Article 1 – point 11 a (new) Regulation (EC) No 726/2004 Article 57 – paragraph 2 a (new) (11a) In Article 57, the following paragraph is added: "2a. The database according to point (tc) of paragraph 1 of this Article contains data on physico-chemical, ecotoxicological and behavioural properties of the active substance and its respective metabolites. The database lists information of all veterinary medicines marketed in the Union. Therefore, the Agency shall prepare a list of all veterinary medicines and active substances marketed in the Union in accordance with Article 51 of Regulation (EU) 2015/xxx of the European Parliament and of the Council1a+. ___________________________ 1aRegulation (EU) 2015/xxx of the European Parliament and of the Council of ... on veterinary medicinal products (OJ L ...). ' + OJ: please insert the number and in the footnote, the number, date and OJ reference of Regulation in document COD 2014/0257."
Amendment 35 #
Proposal for a regulation Article 1 – point 13 Regulation (EC) No 726/2004 Article 61– paragraph 1 – subparagraph 1 Each Member State shall, after consultation of the Management Board, appoint, for a three-year term which may be renewed, one member and one alternate to the Committee for Medicinal Products for Human Use. Full and alternate members may be dismissed ad nutum by the appointing Member State and dismissed where there is a conflict of interest.
Amendment 36 #
Proposal for a regulation Article 1 – point 13 a (new) Regulation (EC) No 726/2004 Article 62 – paragraph 2 (13a) Article 62(2) is amended as follows: "2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products
Amendment 37 #
Proposal for a regulation Article 1 – point 14 Regulation (EC) No 726/2004 Article 62 – paragraph 3 – subparagraph 2 Amendment 38 #
Proposal for a regulation Article 1 – point 14 a (new) Regulation (EC) No 726/2004 Article 64 – paragraph 1 (14a) Article 64(1) is amended as follows: "1. The Executive Director shall be appointed by the Management Board, on a proposal from the Commission, for a period of five years on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and elsewhere. Before appointment, the candidate nominated by the Management Board shall be invited forthwith to make a statement to the European Parliament and to answer any questions put by its Members. His mandate may be renewed once by the Management Board, in consultation with the Commission. The Management Board may, upon a proposal from the Commission, remove the Executive Director from his post."
Amendment 39 #
Proposal for a regulation Article 1 – point 14 a (new) Regulation (EC) No 726/2004 Article 66 – point j (14a) In Article 66, point (j) is amended as follows: (j) adopt provisions for providing ‘assistance to small and medium-sized pharmaceutical companies
Amendment 40 #
Proposal for a regulation Article 1 – point 15 Regulation (EC) No 726/2004 Article 67 – paragraph 3 – subparagraph 1 The Agency’s revenue shall co
Amendment 41 #
Proposal for a regulation Article 1 – point 15 a (new) Regulation (EC) No 726/2004 Article 67 – paragraph 3 – subparagraph 1 a (new) Amendment 42 #
Proposal for a regulation Article 1 – point 15 b (new) Regulation (EC) No 726/2005 Article 67 – paragraph 6 – subparagraph 1 a (new) (15b) In Article 67(6), the following subparagraph is added: "The draft establishment plan shall contain the number of staff required by the Agency to provide the services financed through fees and the number of staff financed by the Union budget."
Amendment 43 #
Proposal for a regulation Article 1 – point 15 c (new) Regulation (EC) No 726/2004 Article 67 – paragraph 8 (15c) Article 67(8) is amended as follows: "8. On the basis of the estimate, the Commission shall enter in the preliminary draft general budget of the European Union the estimates it deems necessary for the establishment plan concerning the staff financed by the Union budget and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 272 of the Treaty."
Amendment 44 #
Proposal for a regulation Article 1 – point 15 d (new) Regulation (EC) No 726/2004 Article 67 – paragraph 9 – subparagraph 2 (15d) In Article 67(9), subparagraph 2 is amended as follows: "The budgetary authority shall adopt the establishment plan for the staff financed by the EU budget for the Agency."
Amendment 45 #
Proposal for a regulation Article 1 – point 15 a (new) Regulation (EC) No 726/2004 Article 68 (15a) Article 68 is replaced by the following: "1. The Executive Director shall implement the budget of the Agency. 2. By 1 March
Amendment 46 #
Proposal for a regulation Article 1 – point 16 Regulation (EC) No 726/2004 Article 70 Amendment 47 #
Proposal for a regulation Article 1 – point 16 Regulation (EC) No 726/2004 Article 70 – paragraph 1 – subparagraph 1 – introductory wording The Commission shall propose to Parliament and the Council, on the basis of the principles set out in paragraph 2, a
Amendment 48 #
Proposal for a regulation Article 1 – point 16 Regulation (EC) No 726/2004 Article 70 – paragraph 1 – subparagraph 2 The fees shall be set at such a level as to avoid a deficit
Amendment 49 #
Proposal for a regulation Article 1 – point 16 Regulation (EC) No 726/2004 Article 70 – paragraph 2 – point a (a) fees shall be set at such a level as to ensure that the revenue derived from them is, in principle, sufficient to cover the costs of the services delivered
Amendment 50 #
Proposal for a regulation Article 1 – point 16 Regulation (EC) No 726/2004 Article 70 – paragraph 2 – point b (b) the level of the fees shall take into account the results of a transparent and objective evaluation of the costs of the Agency and the costs of the tasks carried out by the national competent authorities. It shall take account of the economic prospects of the market sought by the applicant and of the place where the medicinal product was manufactured so as to promote production within the Union;
Amendment 51 #
Proposal for a regulation Article 1 – point 17 Regulation (EC) 726/2004 Article 84 – paragraph 3 – subparagraph 1 The Commission may impose financial penalties on the holders of marketing authorisations granted under this Regulation if they fail to observe obligations laid down in connection with the marketing authorisations granted in
Amendment 52 #
Proposal for a regulation Article 1 – point 18 Regulation (EC) No 726/2004 Article 86 At least every
Amendment 53 #
Proposal for a regulation Article 1 – point 20 Regulation (EC) No 726/2004 Article 87b – paragraph 2 2. The delegation of power referred to in Articles 3(4), 10b (1), 14(7), 16(4) and 84(3) shall be conferred on the Commission for
source: 560.745
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