Manufacturing of medicinal products and active ingredients

The pharmaceutical inspection conducts inspections on compliance with good manufacturing practice in the field of medicinal products.

The certificate of good manufacturing practice is issued by a pharmaceutical inspector within the deadline and in accordance with conditions stipulated in paragraph one of Article 95 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14, hereinafter: ZZdr-2) and in accordance with the procedures and in the form as determined in the Compilation of Community Procedures on Inspections and Exchange of Information.

In accordance with Article 33 of the Rules on the production of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 81/2016), the certificate for good manufacturing practice for medicinal products or active ingredients is valid for a period of three years from the date of inspection, unless:

The manufacturing authorization for medicinal products is issued for a period shorter than three years or a shorter period is determined based on the outcome of a risk assessment performed by a pharmaceutical inspector, taking into account findings of the inspection at the person liable.