MEDICINAL PRODUCT MANUFACTURING

The field of manufacturing of medicinal products is defined by the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/2014; hereinafter: ZZdr2) and the Rules on production of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 81/2016).

Business entities may only manufacture medicinal products pursuant to and in accordance with the authorisation for medicinal product manufacturing. The authorisation includes the manufacturing of medicinal products and selling them to the business entities referred to in the first indent of the second, third and fourth paragraphs of Article 104 of this Act and must be obtained for:

• individual manufacturing activities, activity
• individual pharmaceutical form,
• for import of medicinal products from third countries.
 
Manufacturers of medicinal products must also obtain a licence for production / a manufacturing authorisation of for medicinal products which intended to be sold outside the territory of the Republic of Slovenia or for clinical tests.

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