European Medicines Agency (EMA)

The European Medicines Agency is the Union body responsible for the scientific evaluation and supervision of medicinal products for human and veterinary use. Established in 1993, operational since 1995 and now governed by Regulation (EC) No 726/2004, it has been based in Amsterdam since 2019, having left London following the withdrawal of the United Kingdom. It delivers opinions but does not itself grant marketing authorisations, which are a matter for the European Commission under the centralised procedure.

Organisation of the Agency

The Agency’s scientific work is carried out by committees composed of experts appointed by the Member States. The Committee for Medicinal Products for Human Use assesses applications for authorisation of medicinal products for human use. Other committees deal with pharmacovigilance, orphan medicinal products, paediatric medicinal products, advanced therapies, herbal medicinal products and veterinary medicinal products. The Agency operates as a network with the national authorities, whose experts carry out most of the assessments as rapporteurs.

Tasks of the Agency

In addition to assessing applications, the Agency provides scientific advice to companies on their development plans, manages support schemes such as accelerated assessment and the PRIME scheme, coordinates pharmacovigilance at Union level and maintains the common databases. It publishes a European public assessment report for each medicinal product authorised under the centralised procedure. Its role was extended in 2022 to crisis preparedness and the monitoring of medicine shortages.

Transparency and trade secrets

The Agency holds the authorisation dossiers, which contain clinical data and manufacturing information of great value to competitors. Requests for access to documents are governed by the general rules on public access to documents of the Union institutions, and the Agency also pursues a policy of publishing clinical data. The EU courts refuse to recognise a general presumption of confidentiality for clinical study reports, so that a company opposing disclosure must show specifically and precisely how disclosure would undermine its commercial interests. Protection of trade secrets therefore depends on identifying sensitive information precisely from the moment the dossier is compiled.

Key points

The European Medicines Agency assesses, advises and monitors, but the authorisation decision belongs to the Commission. Its committees, composed of national experts, are where the scientific assessment actually takes place. Its publications, in particular the public assessment reports, are a valuable source of information for competitors and in litigation. Requests for access to documents should be anticipated from the time of filing, by flagging precisely the information whose disclosure would cause commercial harm.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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