Pursuant to the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 with amendments) 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.

List with the main therapeutic groups of medicinal products that are necessary for emergency care, surgery and intensive care, implemented according to the provisions of Article 6 (1) of the Regulation

The EU (Union) list of critical medicines 

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.

They should also inform the JAZMP of any anticipated shortages at least two months before they are expected to occur, except in cases of force majeure, where notification should be provided as soon as possible.

In the event of a temporary or permanent cessation of the marketing of a medicinal product, marketing authorisation holders, holders of a parallel import licence, and holders of a parallel distribution certificate should notify the JAZMP no later than six months before the cessation of marketing of the medicinal product.

Holders of a temporary marketing authorisation for a medicinal product that, by its active substance, pharmaceutical form, and strength, is included on the list of essential or indispensable medicines should notify the JAZMP no later than two months before the cessation of marketing of the medicinal product.

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 find the enclosed English translations for ease of reference, as the forms are available in Slovene language only.

 

CONTACT DETAILS

Any further questions can be sent to the e-mail address: .

 

CURRENT LIST OF MEDICINAL PRODUCTS ON THE MARKET

Data on the scheduled arrivals of medicinal products on the market, disruptions in their supply, temporary or permanent cessation of marketing of medicinal products for human use (pdf  and xls).