Scientific guidelines for veterinary medicines
Scientific guidelines for veterinary medicines
Scientific guidelines for veterinary medicines
Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations
Confidentiality arrangement between the EU and the Republic of Korea
Working arrangement between the Ministry of Food and Drug Safety of the Republic of Korea and the Directorate-General for Health and Food Safety of the European Commission and EMA for the Exchange of Non-Public Information on Medicinal Products
Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
QRD Form 2 and checklist for the submission of day +25 files - veterinary
Summary of opinion: Alecensa, 25/04/2024 Positive
Human medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Status: Opinion
Human medicines European public assessment report (EPAR): Eribulin Baxter, eribulin, Status: Opinion
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024