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. 299-12. Detailed instructions and explanation are part of the form (in English).
- 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. 363-09. JAZMP thereby confirms that the medicinal products have MA in the Republic of 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,Â
- Issuing of statement: Statement of licensing status of pharmaceutical products.
NATIONAL LEGISLATION
- Medicinal Products Act (Uradni list RS, No 31/2006 and 45/2008) and Medicinal Products Act (Official Gazette of the RS, No 17/14 and 66/19)
- Rules on the production of medicinal products (Official Gazette of the RS, No, No 81/16).
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 , together with the filled-in forms of certificates in two copies:
- Certificate of a pharmaceutical product (CPP), Obr. 299-12;
- Statement of licensing status of pharmaceutical products (Statement), Obr.363-09.
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.