It is very important and also in accordance to the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 and 66/19 that 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 inform JAZMP about 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.
Above listed holders of authorisation should notify the JAZMP about the actual date of launch of the medicinal product in the Republic of Slovenia on the date of launch at the latest and no later than two months before the expected date of cessation or shortage in the case of the temporary or permanent cessation of the medicinal product marketing or shortage, except in cases of force majeure.
In the case of the temporary or permanent cessation of the medicinal product marketing or shortage holders of authorisation notify the JAZMP about the reasons for the temporary or permanent cessation of medicinal product marketing, about the risk assessment for the protection of public health in the Republic of Slovenia, and measures to reduce any potential risk.
A shortage of a medicinal product is according to Article 6(38) of the Medicinal Products Act, 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.
The acquired 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.
All the necessary information should be reported to JAZMP by the person liable to communicate with submission of a completed form Obr.281-04 in unchanged format to the e-mail address: porocanje_24clen@jazmp.si.
Source: JAZMP web page and the Medicinal Products Act (Off. Gaz. Of RS No. 17/14 and 66/19)
