Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
- No longer in force
- CELEX number: 31993R2309
- Official Journal: JOL_1993_214_R_0001_006
- Form: Regulation
- Procedure number: 1990/0309(SYN), 1990/0309/SYN
- Languages:
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- sk
- sl
- es
- sv
Dates
Date of document: - July 22, 1993
- August 24, 1993
- November 30, 1993
- Entry into force - See Art 74 And 493Y1130(01)
- January 1, 1995
- Entry into force - See Art 74
- November 19, 2005
- Repealed by 32004R0726
Modified by
Modified by:
- Council Regulation (EC) No 807/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in Council instruments adopted in accordance with the consultation procedure (unanimity) - detail
- Council Regulation (EC) No 1647/2003 of 18 June 2003 amending Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products - detail
- Commission Regulation (EC) No 649/98 of 23 March 1998 amending the Annex to Council Regulation (EEC) No 2309/93 (Text with EEA relevance) - detail
All documents based on this document:
- Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93
- Commission Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorization falling within the scope of Council Regulation (EEC) No 2309/93
- Commission Regulation (EC) No 1662/95 of 7 July 1995 laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use
- Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93
- Commission Regulation (EC) No 649/98 of 23 March 1998 amending the Annex to Council Regulation (EEC) No 2309/93 (Text with EEA relevance)
- Commission Regulation (EC) No 1069/98 of 26 May 1998 amending Regulation (EC) No 542/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation falling within the scope of Council Regulation (EEC) No 2309/93
- Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (Text with EEA relevance)
Modifies
Affected by case
- Judgment of the Court (Sixth Chamber) of 19 September 2002. Aventis Pharma Deutschland GmbH v Kohlpharma GmbH and MTK Pharma Vertriebs-GmbH. Reference for a preliminary ruling: Landgericht Köln - Germany. Trade mark rights - Medicinal products - Central marketing authorisation - Repackaging. Case C-433/00.
- Case C-165/21: Request for a preliminary ruling from Københavns Byret (Denmark) lodged on 11 March 2021 — Orion Corporation v Lægemiddelstyrelsen
- article 12 paragraph 2
Legal basis
- TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY, PART SIX - GENERAL AND FINAL PROVISIONS, ARTICLE 235
EuroVoc Vocabulary
- Veterinary medicinal product
- Public health
- Technical barriers
- Pharmaceutical legislation
- Marketing standard
- Internal market - Principles
- European organisation
- Medicinal product
- Proprietary medicinal products