The European Medicines Agency's Committee for Medicinal Products for Veterinary Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for veterinary medicines. Guidelines reflect a harmonised approach of the EU Member...

The main objective of the small and medium-sized enterprises (SME) Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to these enterprises through the SME office of the European Medicines Agency (EMA). It also aims to address the needs of smaller companies in the pharmaceutical sector.

The European Medicines Agency (EMA) provides support to patient and consumer representatives invited to participate in its activities as well as training sessions plus a collection of training videos and documents for anyone interested in learning more about EMA's activities.

The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short...

This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP.

Guidance is available from the European Medicines Agency (EMA) on variations for centrally authorised veterinary medicines not requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders need to submit as part of the variation...