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).
- Free Sale and GMP Certificate (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. 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 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.
- A statement that the medicinal product is manufactured in Slovenia is issued 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.
Instructions to applicants:
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 of medicinal products entering international market within 30 days.
Please follow the rules regarding the fees in the procedure.