Certificates of medicinal products

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The purpose of the European Medicines Agency Certificates of Medicinal Products scheme is to support the work of Health Authorities outside the European Union. The legal bases are Art. 127 of Directive 2001/83/EC (medicinal product for human use) and Art. 93 of Directive 2001/82/EC (veterinary medicinal products). As foreseen by the legislation, the Agency's certification scheme is based on World Health Organisation recommendations.

The European Medicines Agency Certificates are issued by the Agency, on behalf of the European Commission, to confirm the Marketing Authorisation status of products either authorised by the European Commission through the centralised procedure or products for which a centralised application has been submitted to the Agency, and products pursuant to Art. 58 of Regulation 726/2004/EC. The certificates also confirm the Good Manufacturing Practice (GMP) compliance status of the manufacturing site(s) producing the medicinal product bulk pharmaceutical form. For further information on manufacturing sites certified by the Agency, please see the information package below.

The Agency also certifies products pursuant to art. 58 of Regulation (EC) No. 726/2004. Art. 58 provides that the Agency can give a scientific opinion, in the context of cooperation with the WHO, for the evaluation of certain medicinal products intended exclusively for markets outside the European Community. Such opinions are drawn up by the Committee for Medicinal Products for Human use (CHMP), following a review of the Quality, Safety and Efficacy data, analogous to the review undertaken via the centralised procedure, after consultation with the WHO.

The European Medicines Agency can certify a product only if the a valid application for Marketing Authorisation or for the Scientific Opinion pursuant to art. 58, has been submitted to the Agency via the Centralised Procedure. For products authorised nationally by EU Member States National Competent Authorities (National Authorisations and/or Mutual Recognition Authorisations), the certificates are issued by the national authority(s) granting the Marketing Authorisation.

The Agency can issue Certificates of Medicinal Products to support the work of Health Authorities in any country outside the European Union. Guidance on countries officially recognised by the European Union, their official names and abbreviations used can be found in the list of countries, territories and currencies, published in the internet site of the European Union as part of the Interinstitutional style guide.

The European Medicines Agency issues certificates within 10 working days (standard procedure) or within 2 working days (urgent procedure) following receipt of a valid application form.

For more information on Certificates of Medicinal Products, please click the information package below. For more information on medicinal products authorised by the Agency, please see European Public Assessment Reports (EPAR) Human and Veterinary. Clink on the links to see information about Plasma Master File certification (PMF) and Vaccine Antigen Master File certification (VAMF). For information about Certification of Suitability of substances please see EDQM website.

Requests for certificates submitted through standard procedure should be sent to certificate@ema.europa.eu. Requests for certificates submitted through urgent procedure should be sent to  certificate_urgent@ema.europa.eu. Requests that are sent to the e-mail addresses of the Agency's staff members may be delayed. Questions and comments about the Certificates of Medicinal Products are welcome at certificate@ema.europa.eu.

General information

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Document(s) Language Status First published Last updated Effective Date
Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2016 (English only)   2016-12-01    
Notification on arrangements for requesting European Medicines Agency certificates through urgent and standard procedure for December 2015 (English only)   2015-11-25    
Statistics on certificates of medicinal products 2014 (English only)   2015-07-09    
Statistics on certificates of medicinal products 2013 (English only)   2014-12-22    
Notification on arrangements for requesting European Medicines Agency certificates through urgent and standard procedure for December 2014 (English only)   2014-11-04    
Notification about a change to the certificates paper (English only)   2014-07-31    
Notification on urgent procedure and fees for issuing certificates of medicinal products (English only)   2012-11-05    
Notification on increase of the administrative charge for European Medicines Agency certificates of medicinal products (English only)   2012-04-04    
What's new for European Medicines Agency certification of medicinal products? (English only)   2006-04-03 2011-06-28  
Information package for certificates of medicinal products issued by the European Medicines Agency (English only)   2008-07-11 2013-03-11  
Notification on authenticity of European Medicines Agency certificates (English only)   2011-06-28    
Notification on annex II – manufacturers of the biological active substance (English only)   2011-06-28