Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
- In force
- CELEX number: 32007R1394
- Official Journal: JOL_2007_324_R_0121_01
- Form: Regulation
- Procedure number: 2005/0227(COD), 2005/0227/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- ga
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - November 13, 2007
- December 10, 2007
- December 30, 2007
- Entry into force - Date pub. + 20 See Art 26
- December 30, 2008
- Application - See Art 30
Modified by
Corrected by:
- March 31, 2009 - 32007R1394R(01)
Modified by:
- Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, 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, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products Text with EEA relevance - detail
- Regulation (EU) 2019/1243 of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union (Text with EEA relevance) - detail
Modifies
Modifies:
- 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)
Affected by case
Legal basis
- Treaty establishing the European Community (consolidated version) Part Three - Community policies TITLE VI - Common rules on competition, taxation and approximation of laws Chapter 3 - Approximation of laws Article 95
- Treaty establishing the European Community (consolidated version) Part Five - Institutions of the Community TITLE I - Provisions governing the institutions Chapter 2 - Provisions common to several institutions Article 251
EuroVoc Vocabulary
- Market approval
- Marketing standard
- Labelling
- Public health
- Approximation of laws
- Qualitative analysis
- Proprietary medicinal products
- Drug surveillance
- Biotechnology
- Medicinal products
- Medicinal product