WHOLESALE DISTRIBUTION AND BROKERAGE OF MEDICINAL PRODUCTS AND ACTIVE INGREDIENTS
The pharmaceutical inspection conducts inspections on compliance with the guidelines of good distribution practices at wholesale distribution authorization holders (wholesale traders of medicinal products).
In accordance with Article 16 of the Rules on the precise conditions for performing the activity of wholesale distribution of medicinal products and determining compliance with these conditions, and on the notification procedure of the activity, or obtaining a wholesale distribution authorization of medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No.46/2009), pharmaceutical inspection performs routine and non-routine inspections.
Routine inspections are conducted by the pharmaceutical inspection as per official duty every 2 to 3 years. Non-routine pharmaceutical inspections are conducted in case of violations or when there are reasonable grounds for suspecting that a violation of legislation regarding the field of medicinal products is present.