IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs
Terms of Reference (ToR) for the International Medicines Regulators’ Working Group on 3Rs
Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide
PSUSA/00003163/202403
Referral: Ocaliva, obeticholic acid Article 20 procedures European Commission final decision, 27/06/2024, 30/08/2024, 07/01/2025
List of signals discussed at PRAC since September 2012
New product information wording – Extracts from PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC
Pharmacovigilance Inspectors Working Group
PRAC recommendations on signals adopted at the 25-28 November 2024 PRAC meeting