Drug product registration and marketing authorization procedures in EU-A perspective

Abstract

ABSTRACT
There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and
European Free Trade Association (EFTA) states. For a company willing to market the medicinal
product in to the EEA, marketing authorization (MA) for the respective product must
be issued by competent authority of member state or authorization granted according to
Regulation (EC) No. 726/2004 for entire community. Europe constitutes large population and
European government is alert regarding safety of the public in EU. There are changes in the
procedures for the marketing authorization by the EU. Different types of procedures for the
application of marketing authorization are available in the EU and these procedures are discussed
here.
KEYWORDS: European Economic Area, marketing authorization.

Keywords

• European Economic Area, marketing authorization.

There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and

Abstract

References

1. What We Do. European Medicines Agency. Available from:http://www.ema.europa.eu/ema/index. jsp?curl=pages/about_us/general/general_content_000091.jsp&mid=WC0b01ac0580028a42#[Accessed: 3 November 2011].
2. New risks and institutional imbalances: the European Medicines Agency’s Centralized procedure for medicines authorization. Available from: http://euce.org/ eusa/2011/papers/12c_barroso.pdf [Accessed: 5 November 2011].
3. Directive 65/65/EEC. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products. Available from: http:// www.echamp.eu/fileadmin/user_upload/Regulation/ Directive_65-65-EEC__-__Consolidated_Version.pdf [Accessed: 20 November 2011].
4. Commission of The European Communities. Report from the Commission to the Council on the activities. Available from: http://aei.pitt.edu/3854/1/3854.pdf [Accessed: 5 November 2011].
5. Marketing Authorization. Procedures for Marketing Authorization Chapter 1. Revision 3. November 2005. Available from: http://ec.europa.eu/health/files/eudralex/vol-2/a/ vol2a_chap1_2005-11_en.pdf [Accessed: 20 October 2011].
6. Centralized Procedure. Procedure for Marketing Authorization. Volume 2A. Chapter 4 –Centralized Procedure. April 2006. Available from http://ec.europa.eu/ health/files/eudralex/vol-2/a/chap4rev200604_en.pdf [Accessed: 20 October 2011].
7. 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. Available from: http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF [Accessed: 20 October 2011].
8. Scientific Aspects and Working Definitions For The Mandatory Scope Of The Centralized Procedure [Regulation (EC) No 726/2004 of the European parliament and of the council of 31 March 2004]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/

9. Regulatory_and_procedural_guideline/2009/10/
10. WC500004085.pdf [Accessed: 11 October 2011].
11. Narla SK. Marketing authorization of human medicinal products to European union/European economic area. Int J Pharm Sci Rev Res 2011; 10: 1-8.
12. Mutual Recognition. Procedure for Marketing Authorization. Volume 2A. Chapter 2. Revision5. February 2007. Available from: http://www.imb.ie/images/uploaded/ documents/Chap2NTA.pdf [Accessed: 11 October 2011].