Description

This part of the website provides access to information relating to medicinal products for human use and their professional and regulatory background.

A medicinal product may be marketed:

  • if it has obtained the marketing authorisation in accordance with the Act, or, via the centralised procedure, in accordance with the regulations of the European Union;
  • if it has obtained the marketing authorisation for a parallel imported medicinal product or the approval of notification of parallel distribution in accordance with the Act;
  • if it has obtained the authorisation for compassionate use in accordance with the Act
  • if JAZMP authorises its use for individual patients' needs on the basis of a request by a hospital or institute at the personal responsibility of the patient's attending physician;
  • if in exceptional cases (e.g. infections, poisoning, radiation, etc.) or for other reasons relevant for public health protection JAZMP temporarily permits marketing of an unauthorised medicinal product;
  • if it is assured by the state budget of the Republic of Slovenia in accordance with Article 141 of the Act, if no authorised product with the same composition is on the market.
  • if it is on the list of essential or urgently needed medicinal products referred to in Article 17 of the Act that do not have marketing authorisation.

In the marketing authorisation procedure, JAZMP checks whether the quality, safety and efficacy of the medicinal product in question have been proven, and whether the risk-benefit ratio for its use is favourable. JAZMP also decides on the prescription status (OTC/prescription/restricted prescription) and the terms of supply (pharmacies only/non-pharmacy outlets and pharmacies) of the product.

After medicinal product placement on the market, JAZMP monitors, collects and evaluates reports on the adverse effects of medicinal products, and takes measures aimed at reducing the risks associated with medicinal products. If necessary, JAZMP requests approves an appropriate update of the product information (SmPC, labelling  and package leaflet), or suspends or withdraws marketing authorisation.

All relevant information about a medicinal products is included in the summary of product characteristics (SmPC), which is intended for healthcare professionals. Information from the SmPC is summarised in the package leaflet (patient information leaflet – PIL) that must be enclosed with each medicinal product placed on the market and which should be written in a language that is clear and easy to understand by the patient.