Certificate of good manufacturing practice

The holder of the authorisation for the manufacture of medicinal products can require a confirmation or certificate on good manufacturing practice (GMP certificate) from the authority competent for medicinal products. The certificate on the implementation of good manufacturing practice can be issued based on the performed special fact-finding procedure within the scope of the authorisation issue or performed control of the fulfilment of conditions for the manufacture of medicinal products at the holder of authorisation.

The certificate on good manufacturing practice is issued by the pharmaceutical inspector to the inspected business entity ex officio within 90 days from the date of inspection, if it is found that the business entity manufactures medicinal products or active substances in accordance with the good manufacturing practices principles and guidelines or within 15 days from the issue of modification of the authorisation for manufacturing medicinal products or the entry or the modification of the entry in the register of manufacturers of active substances.

The certificate on good manufacturing practice is issued on a form in Slovenian and English languages as stipulated in the Compilation of Community Procedures.

The certified application lodged by the holder of the authorisation contains:

  • full and short name and address of the applicant;
  • the number of the authorisation for manufacturing medicinal products;
  • location and activity from the authorisation for which the applicant requests a certificate;
  • the number of existing certificates for such activities.

The certificate contains only the information on the conformity of the applicant's activities in the scope of the supervision which is the basis for the issue of the certificate.

The validity of the certificate is usually three years. The validity can be shortened based on the opinion of the pharmaceuticals supervisor.

Legal protection

  • Judicial remedy: Appeal
  • Competent authority: Ministry of Health
Last updated: 10. 02. 2016