Regulation 2008/1234 - Examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products - Main contents
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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| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2008/1234 |
| CELEX number i | 32008R1234 |
| Document | 24-11-2008 |
|---|---|
| Publication in Official Journal | 12-12-2008; Special edition in Croatian: Chapter 13 Volume 029,OJ L 334, 12.12.2008 |
| Effect | 11-01-2009; Entry into force Date pub. + 20 See Art 28.1 01-01-2010; Application See Art 28.2 |
| End of validity | 31-12-9999 |
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,
Whereas:
(1) |
The Community legal framework regarding variations to the terms of marketing authorisations is laid down in 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 (4) and 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 (5). In the light of practical experience in the application of those two Regulations, it is appropriate to proceed to their review in order to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public and animal health protection. |
(2) |
The procedures laid down in Regulations (EC) No 1084/2003 and (EC) No 1085/2003 should therefore be adjusted, without departing from the general principles on which those procedures are based. For reasons of proportionality, homeopathic and traditional herbal medicinal products which have not been granted a marketing authorisation but are subject to a simplified registration procedure should remain excluded from the scope of the Regulation. |
(3) |
Variations to medicinal products can be classified in different categories, depending on the level of risk to public or animal health and the impact on the quality, safety and efficacy of the medicinal product concerned. Definitions for each of those categories should therefore be laid down. In order to bring further predictability, guidelines on the details of the various categories of variations should be established and regularly updated in the light of scientific and technical progress, taking in particular account of developments regarding international harmonisation. The European Medicines Agency (hereinafter the Agency) and the Member States should also be empowered to give recommendations on the classification of unforeseen variations. |
(4) |
It should be clarified that certain changes which have the highest potential impact on the quality, safety or efficacy of medicinal products require a complete scientific assessment, in the same way as for the evaluation of new marketing authorisation applications. |
(5) |
In order to further reduce the overall number of variations procedures and to enable competent authorities to focus on those variations that have a genuine impact on quality, safety or efficacy, an annual reporting system should... |
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