Entity Licensing

Manufacturers of Medicinal Products for human use: instruction of the notification process; preparation of Site Master File; GMP compliance.

Manufacturers of Medical Devices: instruction of the notification process; GMP compliance.

Wholesale Distributors of Medicinal Products for Human Use, Medical Devices, Medicinal Products for Veterinary Use: instruction of the process to obtain authorisation, elaboration of GDP quality dossier.

Herbal Medicinal Products: instruction of the process to obtain authorisation, elaboration of GACP quality dossier.