Pursuant to the Medicinal Products Act Marketing (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 and 66/19) marketing authorisation holders, holders of authorisation of parallel imported medicinal products and wholesalers performing parallel distribution of medicinal products should notify the JAZMP regarding actual date of launch of medicinal product in the Republic of Slovenia, disruptions of the supply or cessation of marketing of a medicinal product. The information is of vital importance for providing alternative medicines to maintain a stable supply.
Above mentioned holders of authorisation should notify the JAZMP about the actual date of launch of medicinal product in the Republic of Slovenia. JAZMP should be notified about temporary or permanent cessation of medicinal product marketing or disruption in the supply no later than two months before the enforcement of a decision, except in cases of force majeure.
According to Article 6(38) of the Medicinal Products Act, disruption in the supply of a medicinal product is defined as a state of the market where business entites responsible for market supply in the Republic of Slovenia fail to provide the required amounts of medicinal products at the appropriate time.
METHOD OF REPORTING BY APPLICANTS
The person liable to communicate information submits a completed form Obr.281-04 in unchanged format to the e-mail address: