BETA
This is a historical view (2016/03/02)

Changes: 2021/12/18docs.docs.url, procedure.Other_legal_basis, events, events.type, events.docs, procedure.Modified_legal_basis, committees.shadows, 2020/01/19events.date, events, docs.body, events.docs.url, committees, 2019/07/12events.docs.url, 2019/07/06activities, procedure.title, events, procedure.final, procedure.dossier_of_the_committee, procedure.Mandatory_consultation_of_other_institutions, procedure.summary, other, procedure.subject, commission, procedure.stage_reached, procedure.instrument, docs, otherinst, procedure.Modified_legal_basis, committees, procedure.other_consulted_institutions, council, 2018/09/12procedure.legal_basis, activities.docs.url, procedure.Modified_legal_basis, 2017/11/01activities.docs.url, 2017/06/17activities.docs.url, 2017/05/09activities.docs.url, 2017/04/11activities.docs.url, 2017/03/19procedure.Mandatory_consultation_of_other_institutions, procedure.legal_basis, other.dg.url, activities.commission.DG.url, 2017/03/14activities.docs.url, 2017/03/13activities.docs.celexid, 2017/03/12activities.docs.celexid, 2017/02/16other.dg.url, other.dg.title, activities.docs.url, activities.commission.DG.title, activities.commission.DG.url, 2016/12/12activities.docs.url, 2016/12/05activities.docs.url, 2016/11/22activities.type, activities.docs.url, activities.docs, 2016/05/11activities.docs.url, 2016/05/10activities.docs.url, 2016/05/09activities.docs.url, 2016/05/07activities.docs.url, 2016/05/04activities.docs.url, 2016/05/03activities.docs.url, 2016/04/29activities.docs.url, 2016/04/25activities.docs.url, 2016/04/24activities.docs.url, 2016/04/22activities.docs.url, 2016/04/18activities.docs.url, 2016/04/17activities.docs.url, 2016/04/15activities.docs.url, 2016/04/13activities.docs.url, 2016/04/07activities.docs.url, 2016/04/03activities.docs.url, 2016/04/01activities.docs.url, 2016/03/31activities.docs.url, 2016/03/26activities.docs.url, 2016/03/23activities.docs.url, 2016/03/22activities.docs.url, 2016/03/20activities.docs.url, 2016/03/18activities.docs.text, activities.docs.url, 2016/03/15activities.docs.url, 2016/03/13activities.docs.url, 2016/03/12procedure.legal_basis, activities, activities.docs, activities.type, activities.body, 2016/03/11activities.type, 2016/03/05activities.docs.url, activities.docs.text, activities, activities.type, activities.date, 2016/03/03activities.docs.url, 2016/03/02activities.docs.url

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Awaiting Parliament 1st reading / single reading / budget 1st stage



2014/0256(COD) Medicinal products for human use: authorisation and supervision
Next event: Indicative plenary sitting date, 1st reading/single reading 2016/03/07
RoleCommitteeRapporteurShadows
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
Lead committee dossier: ENVI/8/01656
Legal Basis TFEU 114, TFEU 168-p4

Activites

  • 2016/03/07 Indicative plenary sitting date, 1st reading/single reading
  • 2016/02/23 Committee report tabled for plenary, 1st reading/single reading
  • 2016/02/17 Vote in committee, 1st reading/single reading
  • 2014/10/20 Committee referral announced in Parliament, 1st reading/single reading
  • 2014/09/10 Legislative proposal published
    • COM(2014)0557 summary
    • DG {'url': 'http://ec.europa.eu/dgs/health_consumer/index_en.htm', 'title': 'Health and Consumers'}, BORG Tonio

Documents

  • Legislative proposal published: COM(2014)0557
  • Committee report tabled for plenary, 1st reading/single reading: A8-0035/2016
AmendmentsDossier
67 2014/0256(COD)
2015/04/30 AGRI 29 amendments...
source: 557.072
2015/06/17 ENVI 38 amendments...
source: 560.745

History

(these mark the time of scraping, not the official date of the change)

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activities/1/committees/1/shadows/3
group
GUE/NGL
name
KYLLÖNEN Merja
activities/1/committees/1/shadows/5
group
EFD
name
PEDICINI Piernicola
committees/1/shadows/3
group
GUE/NGL
name
KYLLÖNEN Merja
committees/1/shadows/5
group
EFD
name
PEDICINI Piernicola
activities/0/docs/0/celexid
CELEX:52014PC0557:EN
activities/0/docs/0/celexid
CELEX:52014PC0557:EN
activities/1/committees/1/shadows/1
group
ECR
name
PIECHA Bolesław G.
activities/1/committees/1/shadows/3
group
Verts/ALE
name
HÄUSLING Martin
committees/1/shadows/1
group
ECR
name
PIECHA Bolesław G.
committees/1/shadows/3
group
Verts/ALE
name
HÄUSLING Martin
activities/1/committees/1/date
2014-11-25T00:00:00
activities/1/committees/1/rapporteur
  • group: S&D name: TĂNĂSESCU Claudiu Ciprian
activities/1/committees/1/shadows/1
group
ALDE
name
MEISSNER Gesine
committees/1/date
2014-11-25T00:00:00
committees/1/rapporteur
  • group: S&D name: TĂNĂSESCU Claudiu Ciprian
committees/1/shadows/1
group
ALDE
name
MEISSNER Gesine
activities/1/committees/1/shadows
  • group: EPP name: CIRIO Alberto
committees/1/shadows
  • group: EPP name: CIRIO Alberto
activities/1/committees/0/date
2014-10-22T00:00:00
activities/1/committees/0/rapporteur
  • group: EPP name: POLČÁK Stanislav
committees/0/date
2014-10-22T00:00:00
committees/0/rapporteur
  • group: EPP name: POLČÁK Stanislav
activities/0/docs/0/text
  • 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.

activities/1
date
2014-10-20T00:00:00
body
EP
type
Committee referral announced in Parliament, 1st reading/single reading
committees
procedure/dossier_of_the_committee
ENVI/8/01656
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision
activities
  • date: 2014-09-10T00:00:00 docs: url: http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/com/2014/0557/COM_COM(2014)0557_EN.pdf title: COM(2014)0557 type: Legislative proposal published celexid: CELEX:52014PC0557:EN type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers Commissioner: BORG Tonio
committees
  • body: EP responsible: False committee_full: Agriculture and Rural Development committee: AGRI
  • body: EP responsible: True committee_full: Environment, Public Health and Food Safety committee: ENVI
  • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
  • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
links
European Commission
other
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: BORG Tonio
procedure
Mandatory consultation of other institutions
Economic and Social Committee Committee of the Regions
reference
2014/0256(COD)
subtype
Legislation
legal_basis
stage_reached
Preparatory phase in Parliament
summary
Amending Regulation (EC) No 726/2004
instrument
Regulation
title
Medicinal products for human use: authorisation and supervision
type
COD - Ordinary legislative procedure (ex-codecision procedure)
subject