In order to protect public health, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: the JAZMP) shall, with regard to medicinal products without marketing authorisations in the Republic of Slovenia in accordance with paragraphs one and two of Article 20 of the Medicinal Products Act (Off. Gazette of the RS, No. 17/14 and No. 66/19, hereinafter: the ZZdr-2), begin implementing the provisions of Article 54 of the ZZdr-2, which transposed Article 126a of Directive 2001/83/EC into Slovenian law. This means that the JAZMP may issue, ex officio, a provisional marketing authorisation for a medicinal product on the basis of the facts established from the valid marketing authorisation for the medicinal product in a Member State of the European Union, and from the assessment report of the medicinal product obtained from the competent authority for medicinal products in the Member State concerned, if available. The marketing authorisation shall be issued to the manufacturer/marketing authorisation holder in the Member State concerned or its representative in the Republic of Slovenia. For medicinal products that will obtain such marketing authorisation, provisional permits for the entry of medicinal products pursuant to paragraph three of Article 20 of the ZZdr-2 shall no longer be issued.
Criteria for medicinal products that are candidates for the issuance of a marketing authorisation pursuant to article 54 of the zzdr-2
The above procedure aimed at improving the accessibility of medicinal products shall be carried out by the JAZMP primarily for the medicinal products that cumulatively meet the following criteria:
- the medicinal product is on the list of essential medicinal productsand is subject to medical prescription;
- the medicinal product was entered in the previous year in accordance with paragraph three of Article 20 of the ZZdr-2 in a quantity exceeding 20.000 boxes;
- the medicinal product obtained marketing authorisation in a Member State before 2004 and contains an active substance or a combination of active substances with a well-established medical use and has a valid marketing authorisation in one of the Member States, but its documentation does not fully comply with the latest EU guidelines and it has not (yet) been included in the MRP/DCP procedure;
- a direct link between the manufacturer of the medicinal product/marketing authorisation holder in the Member State concerned and the marketing authorisation holder in the Republic of Slovenia (representative) is possible.
The JAZMP shall issue, within 60 days of receipt of the relevant documentation, a marketing authorisation pursuant to Article 54 of the ZZdr-2 with a validity period of 5 years (as a rule), or until the marketing authorisation in respect of a medicinal product with the same active substance, pharmaceutical form and therapeutic indications is granted in accordance with Articles 44 to 51 of the ZZdr-2.
This procedure shall be used exceptionally and shall not in any way replace the regular procedures for obtaining a marketing authorisation for a medicinal product pursuant to Articles 44 to 51 of the ZZdr-2. The MRP / DCP procedures which shall also include Slovenia should be used for obtaining marketing authorisations in Slovenia for the medicinal products that were granted marketing authorisations or that are in the process of obtaining marketing authorisations in another Member State. All business entities concerned are therefore invited to regularly include Slovenia in the MRP / DCP procedures as the concerned Member State.
Source: Jazmp web page