GUIDELINES FOR THE IMPLEMENTATION OF ARTICLE 54 OF THE MEDICINAL PRODUCTS ACT – THE ISSUE OF MARKETING AUTHORISATION AS AN URGENT MEASURE
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 (Official Gazette of the Republic of Slovenia [Uradni list 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 products and 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.
PROCEDURE FOR ISSUING A MARKETING AUTHORISATION PURSUANT TO ARTICLE 54 OF THE ZZdr-2
- The JAZMP shall send a proposal to the Slovenian representative of the manufacturer to act as the representative of the prospective marketing authorisation holder and ask him to provide the contact details of the marketing authorisation holder in the Member State where a regular marketing authorisation was granted.
- The JAZMP shall officially notify the marketing authorisation holder in the Member State concerned of the intention to issue a marketing authorisation under Article 54 of the ZZdr-2 (Article 126a of Directive 2001/83/EC), including a notice on the necessary documentation and obligations.
- The JAZMP shall request that the competent authority in that Member State submit data on the medicinal product (assessment report, etc.).
- The JAZMP shall review the documentation received / submitted by the competent authority in that Member State and the prospective marketing authorisation holder and shall issue a marketing authorisation pursuant to Article 54 of the ZZdr-2.
- The JAZMP shall notify the European Commission of the issued marketing authorisation.
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.
DOCUMENTS AND OBLIGATIONS OF THE PROSPECTIVE HOLDER OF A MARKETING AUTHORISATION PURSUANT TO ARTICLE 54 OF THE ZZdr-2
- Basic information for a medicinal product: name, strength, pharmaceutical form, packaging and ATC code;
- Marketing authorisation in the Member State in which the medicinal product is authorised: marketing authorisation number, date of the first granting of the marketing authorisation, date the marketing authorisation renewal, date of validity of the marketing authorisation, classification of the medicinal product concerning its supply;
- a copy of the valid marketing authorisation in the Member State concerned;
- the accurate and complete quality and quantity of the composition of the medicinal product (active substances and excipients (e.g. also capsule composition); data on the material of animal / human origin in respect of the TSE;
- nature and contents of container, closure and special equipment (devices) for dosage / application;
- shelf life of the medicinal product and storage conditions;
- the manufacturer of the medicinal product, the manufacturer responsible for batch release, the manufacturers of the active substances, the scheme of manufacturing sites and of testing the medicinal product (including a description of activities);
- a written declaration(s) from the qualified person of the manufacturing authorisation holder(s) that the active substance is manufactured in compliance with the principles and guidelines of good manufacturing practices for staring materials. The declaration should refer to an audit and the date of the audit;
- the latest valid SmPC (Summary of Product Characteristics), PIL (Patient Information Leaflet), labelling and Slovenian translations in accordance with the valid QRD template;
- data on the marketing authorisation holder in the Republic of Slovenia and the contact person authorised for communication on regulatory issues;
- a statement that the marketing authorisation holder will notify JAZMP of any quality defects and batch/product recalls, as well as the contact details of the responsible person for quality defects and batch/product recalls of medicinal product;
- a statement that the marketing authorisation holder will regularly submit any variation regarding the marketing authorisation that refer to the SmPC, the PIL, the labelling, and any change of data in the submitted documentation;
- a statement of compliance with pharmacovigilance obligations, a summary of the pharmacovigilance system, a risk management plan, if any, and the pharmacovigilance contact person;
- data on the scientific service and contact person for the medicinal product information.
The form for issuing a marketing authorisation (Slovenian language only).
OBLIGATIONS OF THE MARKETING AUTHORISATION HOLDER
The marketing authorisation holder shall be responsible for placing a medicinal product on the market as follows:
- for providing information pursuant to Article 24 of the ZZdr-2;
- for the summary of the product characteristics, labelling, the patient information leaflet of the medicinal product in accordance with Chapter VI of the ZZdr-2 and the Rules on the labelling and package leaflet for medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/14), and for submitting variations to the marketing authorisation that refer to these information on the medicinal product, not later than within 30 days of being approved in the Member State in which the medicinal product concerned is regularly authorised;
- for submitting any changes that refer to data contained in the documentation;
- for carrying out pharmacovigilance obligations in accordance with Chapter XII of the ZZdr-2 and the Rules on the pharmacovigilance of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/14 and 27/17);
- for advertising a medicinal product in accordance with Chapter XIV of the ZZdr-2 and the Rules on advertising medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 105/08, 98/09 – ZMedPri, 105/10 and 17/14 – ZZdr-2);
- for pricing a medicinal product in accordance with Chapter ΧVI of the ZZdr-2 and the Rules determining the prices of medicinal products for human use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 32/15, 15/16,19/18, 11/19, 26/20, 51/21 and 52/21 -popr.);
- for providing documentation and reference materials for the performance of regular and extraordinary official quality controls of the medicinal product and the payment of official quality control costs in accordance with paragraph two of Article 155 of the ZZdr-2.
The form for variations of marketing authorisation will be published on the JAZMP website.
There shall be no fee for the issuance of a marketing authorisation in accordance with Article 54 of the ZZdr-2.
Fees for a review of educational materials for the safe and effective use of medicinal products shall be paid in accordance with paragraph one of Article 24 of the JAZMP Tariff (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 209/21).
For pricing a medicinal product, fees shall be paid in accordance with Articles 38 and 39 of the JAZMP Tariff.
These guidelines may be amended or supplemented as appropriate.
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.
15. 3. 2022