Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)
- In force
- CELEX number: 32008R1234
- Official Journal: JOL_2008_334_R_0007_01
- Form: Regulation
- Procedure number: --
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - November 24, 2008
- December 12, 2008
- January 11, 2009
- Entry into force - Date pub. + 20 See Art 28.1
- January 1, 2010
- Application - See Art 28.2
Modified by
Modified by:
- Commission Delegated Regulation (EU) 2021/756 of 24 March 2021 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) - detail
- Commission Regulation (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Text with EEA relevance - detail
- Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use - detail
Modifies
Repeal:
- Commission Regulation (EC) No 1084/2003 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 granted by a competent authority of a Member State (Text with EEA relevance)
- 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)
Legal basis
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
- Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
EuroVoc Vocabulary
- Veterinary drug
- Market approval
- Marketing standard
- Public health
- Consumer protection
- Veterinary legislation
- Medicinal product
- Pharmaceutical legislation
- Proprietary medicinal products