Issuing of certificates on the quality of medicinal products that are entering the international market

Certificates on the quality of medicinal products that are entering the international market may vary with respect to the type of data contained, and are based on the forms published on the WHO website (Information on the issuance of certificates on the quality of medicinal products – WHO):

  • For medicinal products that have obtained marketing authorisation from JAZMP (hereinafter: MA) or for which an application for obtaining or renewal of MA has been lodged with JAZMP, a Certificate of a Pharmaceutical Product (hereinafter: CPP) shall be issued on form Obr. 299-08. Detailed instructions and explanation are part of the form (in English).
  • Free Sale and GMP Certificate (hereinafter: FSC) is a certificate on the sale and manufacturing of medicinal product in compliance with good manufacturing practice (GMP), issued by JAZMP as the competent authority for medicinal products of the exporting country upon the applicant's request on form Obr. 362-07.The certificate contains information on the regulatory status of the pharmaceutical product in the Republic of Slovenia. JAZMP thereby confirms that the premises where the product is manufactured are subject to regular monitoring and that the manufacturer complies with the requirements of good manufacturing practice.
  • Statement of licensing status of pharmaceutical products (hereinafter: Statement) is a certificate on the regulatory status of the pharmaceutical product and is issued on form Obr. 363-06. JAZMP thereby confirms that the medicinal products have MA in the Republic of Slovenia.
  • A statement that the medicinal product is made in Slovenia (hereinafter: Statement) should be issued on form Obr. 364-06 in cases where the applicant requires – for the needs of regulatory authorities abroad – a certificate that the manufacturing premises are subject to regular GMP control, or when further explanation of compliance with GMP is required. JAZMP issues the statement in cases where a medicinal product is manufactured in Slovenia but does not have marketing authorisation in Slovenia.

Competences of JAZMP regarding the issuing of certificates on the quality of medicinal products that are entering the international market

  • Issuing of certificate: Certificate of a pharmaceutical product, 
  • Issuing of certificate: Free sale and GMP certificate,
  • Issuing of statement: Statement of licensing status of pharmaceutical products,
  • Issuing of statement that the medicinal product is made in the Republic of Slovenia.

National legislation

  • Medicinal Products Act (Uradni list RS, No 31/2006 and 45/2008) and Medicinal Products Act (Uradni list RS, No 17/2014)
  • Rules on the detailed conditions for pursuing the activity of medicinal product manufacturing, and on assessing the compliance with these conditions as well as on the procedure of issuing and withdrawal of GMP certificate (Uradni list RS, No 91/2008).

How to obtain certificates on the quality of medicinal products that are entering the international market

The applicant submits an application for a certificate on the quality of medicinal products that are entering the international market in paper form to the address of JAZMP, or in electronic form to the e-mail address CPP@jazmp.si, together with the filled-in forms of certificates in two copies:

  • Certificate of a pharmaceutical product (CPP), Obr. 299-08;
  • Free sale and GMP certificate (FSC), Obr.362-07,
  • Statement of licensing status of pharmaceutical products (Statement), Obr.363-06,
  • Certificate that the medicinal product is made in the Republic of Slovenia (Certificate), Obr.364-06.

In cases where the applicant applies for an amendment of an already issued certificate, this will be regarded as a new application.

JAZMP will issue the certificate on the quality of medicinal products that are entering the international market within 30 days of the receipt of a complete application.