Awaiting committee decision
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
-
2014/10/20
Committee referral announced in Parliament, 1st reading/single reading
-
2014/09/10
Legislative proposal published
-
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
-
COM(2014)0557
summary
Documents
- Legislative proposal published: COM(2014)0557
Amendments | Dossier |
29 |
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
|
History
(these mark the time of scraping, not the official date of the change)
activities/0/docs/0/celexid |
CELEX:52014PC0557:EN
|
activities/0/docs/0/celexid |
CELEX:52014PC0557:EN
|
links/European Commission/title |
Old
PreLexNew
EUR-Lex |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/0/docs/0/url |
Old
http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdfNew
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf |
activities/1/committees/1/shadows/3 |
|
activities/1/committees/1/shadows/5 |
|
committees/1/shadows/3 |
|
committees/1/shadows/5 |
|
activities/0/docs/0/celexid |
CELEX:52014PC0557:EN
|
activities/0/docs/0/celexid |
CELEX:52014PC0557:EN
|
activities/1/committees/1/shadows/1 |
|
activities/1/committees/1/shadows/3 |
|
committees/1/shadows/1 |
|
committees/1/shadows/3 |
|
activities/1/committees/1/date |
2014-11-25T00:00:00
|
activities/1/committees/1/rapporteur |
|
activities/1/committees/1/shadows/1 |
|
committees/1/date |
2014-11-25T00:00:00
|
committees/1/rapporteur |
|
committees/1/shadows/1 |
|
activities/1/committees/1/shadows |
|
committees/1/shadows |
|
activities/1/committees/0/date |
2014-10-22T00:00:00
|
activities/1/committees/0/rapporteur |
|
committees/0/date |
2014-10-22T00:00:00
|
committees/0/rapporteur |
|
activities/0/docs/0/text |
|
activities/1 |
|
procedure/dossier_of_the_committee |
ENVI/8/01656
|
procedure/stage_reached |
Old
Preparatory phase in ParliamentNew
Awaiting committee decision |
activities |
|
committees |
|
links |
|
other |
|
procedure |
|