RETRACTED: International experience in drug names assessment: European Medicines Agency
Abstract
The present article considers the experience of a unitary expert and control authority regulating the circulation of medicines in the European Union (EU) – the European Medicines Agency. It also describes the main contents of the current EU regulatory documentation on the newly formed drug names eligibility criteria. These criteria are directed to protect consumer's rights and allow to prevent adverse effects on human health and life caused by the marketing authorization of new drugs, which names are identical or confusingly similar with the names of previously authorized products, but different in composition and effects.
About the Authors
A. N. MironovRussian Federation
I. V. Sakaeva
Russian Federation
V. V. Dudchenko
Russian Federation
L. V. Korneeva
Russian Federation
A. N. Yavorsky
Russian Federation
References
1. Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - London, 5 February 2007 CPMP/328/98, Revision 5.
2. Council Regulation (EEC) No 2309/93 laying down Community procedures for he authorization/and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal products.
3. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
4. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
5. Directive 2001/83/EC, as amended of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
6. Directive 2003/63/EC of the European Commission of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.
7. Communication on the Community marketing authorisation procedures for medicinal products (OJ C 229/4 of 22.07.1998).
Review
For citations:
Mironov A.N., Sakaeva I.V., Dudchenko V.V., Korneeva L.V., Yavorsky A.N. RETRACTED: International experience in drug names assessment: European Medicines Agency. Regulatory Research and Medicine Evaluation. 2013;(2):38-42. (In Russ.)
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