Pursuant to the Medicinal Products Act (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, wholesalers performing parallel distribution of medicinal products and holders of temporary marketing authorisation for medicinal products that comply in their common name, pharmaceutical form and strength with the items on the List of Essential Medicinal Products or the List of Indispensable medicinal products should notify JAZMP of the actual date of launch of a medicinal product in the Republic of Slovenia, temporary or permanent cessation of marketing of a medicinal product and shortages of a medicinal product.
The information is of vital importance for providing alternative medicines to maintain a stable supply. These activities have significant influence on market functioning and JAZMP’s ability to reduce the risk due to notified or on-going shortages as well as to ensure supply of alternative medicinal products.
Above mentioned holders of authorisation should notify the JAZMP about the actual date of launch of medicinal product in the Republic of Slovenia on the date of launch at the latest. JAZMP should be notified about temporary or permanent cessation of medicinal product marketing or shortages no later than two months before the expected date of cessation or shortage, except in cases of force majeure.
According to Article 6(38) of the Medicinal Products Act, a shortage 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: .