Distribution, Manufacturing and Inspection

Good Manufacturing Practice

Good Manufacturing Practice (GMP) is part of a quality assurance system that ensures products are consistently manufactured and controlled to meet the quality standards appropriate for their intended use in accordance with applicable regulations.

The principles of manufacturing are published in the Good Manufacturing Practice guidelines, which are available on the European Commission's website, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.

Every manufacturer of medicinal products, veterinary medicinal products (VMP), and active substances intended for the EU market, regardless of the place of manufacture, must possess a Certificate of Good Manufacturing Practice issued by the competent authority of an EU Member State.

Certificate of Good Manufacturing Practice

The Certificate of Good Manufacturing Practice represents the final assessment of compliance of manufacturing or parts of manufacturing with the GMP principles within three years from the date of the inspection. The validity period may be extended or shortened based on a risk analysis during the planning of HALMED's GMP inspections.

In accordance with the provisions of the Medicinal Products Act (Official Gazette, No. 76/13, 90/14, 100/18) and 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), HALMED's inspection issues the Certificate of Good Manufacturing Practice within 90 days after the GMP inspection is conducted.

The certificate is issued for the manufacturing site, specific parts of the manufacturing process, manufacturing operations conducted at that site, and pharmaceutical forms produced at that site, with the date of inspection specified (in accordance with the template from the Compilation of Community Procedures on Inspections and Exchange of Information, published by the European Commission).

Manufacturers from non-EU countries may also submit an application for the certificate via their representative in the Republic of Croatia.

Details of issued Certificates of Good Manufacturing Practice are entered into the EudraGMDP database.