Distribution, Manufacturing and Inspection

Good Manufacturing Practice

Good Manufacturing Practice (GMP) is part of the quality assurance system, which ensures that products are uniformly manufactured and inspected to a quality standard appropriate for their application based on valid regulations.

The manufacturing principles are published in the good manufacturing practice guidelines and are available on the European Commission website via link EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.

Every manufacturer of medicinal products, veterinary medicinal products and active substances intended for the EU market regardless of the location of manufacturing site must possess a Certificate of Implementation of Good Manufacturing Practice issued by the competent body of an EU member state.

Good Manufacturing Practice (GMP) certificate

The Good Manufacturing Practice certificate is a document containing the final assessment that a manufacturing process or parts of the process complies with the principles of good manufacturing practice, covering a period of three years from the date of the inspection taking place. The validity period may be extended or reduced based on a risk analyses when planning the GMP inspection by HALMED.

In accordance with the provision of the Medicinal Products Act (Official Gazette No. 76/13, 90/14 and 100/18) and the 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), the Good Manufacturing Practice certificate is issued by the HALMED Inspectorate within 90 days of conducting inspection of good manufacturing practice.

The certificate is issued for the manufacturing site, for particular parts of the manufacturing process, manufacturing processes which take place at that site and the pharmaceutical forms manufactured at that site along with citing the date of inspection (in accordance with the form from the Collection of Community procedures on inspection and exchanging information, which is issued by the European Commission).

The application for granting the certificate may also be submitted by a manufacturer from a third country through a local representative in the Republic of Croatia.

Information on issued good manufacturing practice certificates is entered into the EudraGMDP database.