CERTIFICATION OF QUALITY OF MEDICINAL PRODUCTS FOR VETERINARY USE WHICH ARE ENTERING INTERNATIONAL MARKET
Certificates on the quality of medicinal products that are entering the international market (hereinafter: Certificates) 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):
- Certificate of a Pharmaceutical Product (CPP) is issued 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 submitted at JAZMP. Detailed instructions and explanation are part of the form (in English).
- Statement of licensing status of pharmaceutical products is a certificate on the regulatory status of the pharmaceutical product. JAZMP thereby confirms that the medicinal products have MA in the Republic of Slovenia.
Instructions to applicants:
The applicant submits an application for a Certificate in paper to the address of JAZMP, and electronically to the e-mail address . The application must include completed form. Forms are available here.
The applicant pays the fee on the basis of the information and notification received from JAZMP after submission of the application regarding the amount and type of the fee. When an applicant requests an amendment of an already issued certificate, it is considered as a new application.
JAZMP issues a certificate within 30 days.
Please follow the rules regarding the fees in the procedure.