PUBLIC CONSULTATION ON THE REVISION OF THE BEST PRACTICE GUIDES FOR SPC HARMONISATION

After the first experiences with the SPC harmonisation procedure and comments received from industry a reflection took place at the SPC harmonisation WG and on CMDv level. A complete overhaul was carried out, incorporating numerous suggestions and lessons learned. Please send your comments to CMDv@ema.europa.euuntil 15 September 2026, using the following template.

Best Practice Guide for the selection of the products for the SPC harmonisation  

Best Practice Guide for the harmonisation procedure of the SPC of the reference products

Best Practice Guide for the harmonisation procedure of the SPC of generic/hybrid veterinary medicinal products