Certification of medicinal products

This content applies to human and veterinary medicines.

The purpose of the European Medicines Agency's (EMA) certification scheme for human and veterinary medicines is to confirm the medicine's marketing authorisation status and that it complies with good manufacturing practice (GMP) standards. This aims to support the work of health authorities outside the European Union (EU). 

Electronic certificates during the COVID-19 pandemic (new)

As of 30 March 2020, EMA is only issuing certificates for human and veterinary medicines that are signed and authenticated electronically. It is not issuing paper certificates. This applies to all ongoing and future requests

The electronic system will enable EMA to continue to be able provide certificates during the COVID-19 pandemic.

The format is based on an electronically signed PDF document using an electronic signature fully compliant with Regulation (EU) No 910/2014 on the electronic identification and trust services for electronic transactions in the internal market (eIDAS Regulation). This guarantees the unique link to the signatory and the full authenticity and integrity of the document.

EMA can provide printed copies of the certificates upon request after measures to reduce the spread of COVID-19 are lifted.

EMA will consider whether the electronic signature should be implemented as a permanent solution as part of its efforts to digitalise its administrative processes for all documents requiring signature.

The legal bases are Article 127 of Directive 2001/83/EC (medicinal product for human use) and Article 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.

EMA issues such certificates 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 Article 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 Article 58 of Regulation (EC) No. 726/2004. Article 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 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.

EMA can certify a product only if the a valid application for marketing authorisation, or for the scientific opinion pursuant to Article 58, has been submitted to the Agency via the centralised procedure. For products authorised nationally by EU Member State national competent authorities (national authorisations and/or mutual recognition authorisations), the certificates are issued by the national authority granting the marketing authorisation.

The Agency can issue certificates of medicinal products to support the work of health authorities in any country outside the EU. Guidance on countries officially recognised by the EU, their official names and abbreviations used can be found in the list of countries, territories and currencies, published in the internet site of the EU as part of the Interinstitutional style guide.

EMA issues certificates within ten working days (standard procedure) or within two working days (urgent procedure) following receipt of a valid application form.

For more information on certificates of medicinal products, please use the information package below.

For more information on medicinal products authorised by the Agency, see:

For more information on EMA's plasma-master-file and vaccine-antigen-master-file certification schemes, see:

For information about certification of suitability for substances, please see the European Directorate for the Quality of Medicines and Healthcare (EDQM) website.

Guidance

For more information and guidance on certification of medicinal products, see:


Related documents
 

Requesting a certificate

For information on how to request a certificate, see:

Send requests for certificates via the:

Requests sent to the e-mail addresses of the Agency's staff members may be delayed. Send any questions and comments about certificates to certificate@ema.europa.eu.

Fees

EMA charges an administrative fee for issuing certificates.

For more information, see Fees payable to the European Medicines Agency.

How useful was this page?

Add your rating
Average
3 ratings
1 rating
2 ratings