The aim of this guideline is to outline the procedure to be followed by the Competent Authorities when a batch of a vaccine is suspected to be contaminated with Bovine Viral Diarrhoea (BVD) Virus. Full document...

The objective of this guideline is to recommend maximum acceptable concentration limits for the residues of metal catalysts or metal reagents that may be present in pharmaceutical substances or in drug products. Full document...

This appendix provides some general regulatory guidance on issues to consider relating to definitions, frequency and methods of assessment, ascertainment bias, handling of deviations and missing data, and radiology review. Full document...

This guideline is applicable to applications for traditional use registration of traditional herbal medicinal products for human use. Full document...

The objective of the guideline is to provide applicants/Marketing Authorisation Holders (MAHs) guidance on the criteria applied by CVMP when reviewing the acceptability of the proposed names for medicinal products processed through the centralised procedure. Full document...

The main objective of this guideline is to define the timing of and conditions under which carcinogenicity studies should be conducted during development and before marketing authorisation for any new anti-HIV Medicinal Product, if applicable. Full document...

This guideline is applicable to applications for traditional use registration of traditional herbal medicinal products for human use. Full document...