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Pre-authorisation procedural guidance is available from the European Medicines Agency (EMA) on initial marketing authorisation procedures for centrally authorised veterinary medicines under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).
The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorisation regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).
The European Medicines Agency (EMA) carries out scientific advice processes in cooperation with other decision-making bodies in the European Union (EU) and beyond. Some of these processes have distinct purposes and refer to specific product types. For instance, EMA can participate in parallel joint scientific consultations with the Member State...
The Pharmacovigilance Inspectors Working Group (PhV IWG) was established by the European Medicines Agency with the remit to focus on harmonisation and co-ordination of PhV-related activities at the European Union (EU) level.
The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the...
Following the positive evaluation of a plasma master file (PMF) under the PMF certification scheme, the European Medicines Agency (EMA) issues a certificate of compliance with European legislation which is valid throughout the European Union. EMA publishes the list of all the issued PMF certificates.
This page lists the submission deadlines for applications for orphan designation.
The European Medicines Agency (EMA) charges fees for the services it provides. As of 1 January 2025, EMA's fees are governed by Regulation (EU) 2024/568. This is known as the 'New fee regulation'.
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...