Examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products - EU monitor

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1.

Current status

The regulation entered into force on Januaryá11,á2009.

2.

Key information

Official title 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
EURlex-codeái 32008R1234
Legal instrument Regulation
Addressee Member States of the European Union
Date of decision 24-11-2008
Entry into forceái 11-01-2009; Entry into force Date pub. + 20 See Art 28.1
01-01-2010; Application See Art 28.2
Date of end of validity 31-12-9999

3.

Legislative text

Text

12.12.2008   

EN

Official Journal of the European Union

L 334/7


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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to 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 (1), and in particular Article 39(1) thereof,

Having regard to 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 (2), and in particular Article 35(1) thereof,

Having regard to 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 (3), and in particular of Article 16(4) and Article 41(6) thereof,


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