The purpose of the European Medicines Agency’s (EMA) certification of medicinal products scheme is to support the work of health authorities outside the European Union (EU).
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.
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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 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.
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.