Legislative Framework
European Legislation
Legal documents establishing the principles of manufacturing and import, as well as the supervision of good manufacturing practice in the European Union:
- Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Directive 2001/82/EC on the Community Code relating to veterinary medicinal products
- Directive 2003/94/EC on the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
- Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
- Commission Delegated Regulation (EU) No. 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use.
Croatian Legislation
The European legal framework establishing the principles of manufacturing and import, as well as the supervision of good manufacturing practice, has been transposed into Croatian legislation through the provisions of the following acts and ordinances:
- Medicinal Products Act (Official Gazette No. 76/13, 90/14, 100/18)
- Veterinary Medicinal Products Act (Official Gazette, No. 84/08, 56/13, 15/15, and 32/19)
- Ordinance on the Conditions for Issuing Manufacturing Authorisations, on the Requirements of Good Manufacturing Practice and on the Certificate of Good Manufacturing Practice for Medicinal Products (Official Gazette No. 83/13, 24/18, 32/21)
- Ordinance on the Requirements and Method of Establishing the Requirements of Good Manufacturing Practice and Good Practice in the Wholesale of Active Substances and on the Procedure of the Entry in the Register of Manufacturers, Importers and Wholesalers of Active Substances, and on Issuing the Certificate for the Implementation of Good Manufacturing Practice (Official Gazette No. 83/13, 32/21)
- Ordinance on the Principles and Guidelines of Good Manufacturing Practice for Veterinary Medicinal Products (Official Gazette, No. 120/07).
