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 mitigate the risk due to notified or on-going shortages as well as to ensure supply of alternative medicinal products.
As risk management of shortages is a key challenge in public health protection, the Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices provided framework for European Medicines Agency (EMA) to monitor and mitigate shortages that could lead to a public health emergency or could emerge in such situations. Following the recognition of a public health emergency, EMA adopts a list of critical medicinal products, for which supply and demand will be closely monitored in EU/EEA countries.
To support Member States in introducing measures to manage shortages of medicines, an EU4Health Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network Joint Action (JA CHESSMEN) is ongoing, including 22 EU/EEA countries. JAZMP is a partner in JA CHESSMAN and a lead of Work Package 6 (WP6: Identification of best practices to address medicines shortages), focusing on the identification of established practices in reporting, monitoring and managing medicine shortages. Based on those data, a common protocol for reporting, monitoring and managing EU Member States shortages will be defined. Joint Action has started on 16th January 2023 and will continue for 3 years.
METHOD OF REPORTING BY APPLICANTS
Above mentioned holders of authorisation should notify the JAZMP about the actual date of start of marketing of a medicinal product in the Republic of Slovenia on the date of its start of marketing at the latest. JAZMP should be notified about temporary or permanent cessation of marketing and temporary disruptions in supply no later than two months before the expected date of cessation or disruption, except in cases of force majeure.
According to Article 6(38) of the Medicinal Products Act, a temporary disruption in supply of a medicinal product is defined as a state of the market where business entities responsible for market supply in the Republic of Slovenia fail to provide the required amounts of medicinal products in appropriate time.
The notifications should be submitted using Zvonček online tool. Prior to the first submission of notification, a user account should be created. Please fnd the enclosed English translations for ease of reference, as the forms are available in Slovene language only.