Based on the Medicinal Products Act (Official Gazette of the Republic of Slovenia, No. 17/14), medicinal product marketing authorisation holders, parallel-imported medicinal product marketing authorisation holders, parallel distribution wholesalers, and temporary authorisation holders for marketing medicinal products classified on the list of essential medicinal products or strictly necessary medicinal products with active ingredients must inform JAZMP about the actual beginning of marketing the medicinal product in the Republic of Slovenia, temporary or permanent termination of marketing the medicinal product or interruptions to the supply of the medicinal product.
Communication is essential in providing substitute medicinal products for maintaining an uninterrupted supply. All listed activities have an important effect on market operation and on JAZMP efficiency in reducing the risk due to foreseen or current interruptions in medicinal product supply and in ensuring system conditions for supplying the market with substitute medicinal products.
The listed marketing authorisation holders must notify JAZMP about temporary termination of medicinal product marketing or medicinal product supply interruption no later than two months before the termination or interruption, unless there is an instance of force majeure.
In accordance with item 34 of Article 6 of the Act, interruption of medicinal product supply on the market is a situation wherein business entities responsible for the market supply of the Republic of Slovenia fail to provide the required medicinal product quantities in the appropriate amount of time.
REPORTING BY APPLICANTS
The person liable to communicate information submits a completed form Obr.281-04 in unchanged format to the e-mail address:
From 01/01/2013, additional submission by fax or mail is no longer required!
- Information on the presence of medicinal products for veterinary use on the market on the stated cut-off date (Slovenian language only)
- Information on the announced arrivals of medicinal products to the market, interruptions in medicinal product supply, temporary or permanent withdrawals from the market of medicinal products for veterinary use (Slovenian language only)