PARALLEL IMPORT OF MEDICINAL PRODUCTS

OBTAINING MARKETING AUTHORISATION FOR A PARALLEL IMPORTED MEDICINAL PRODUCT

Application for obtaining marketing authorisation for a parallel imported medicinal product may be submitted by wholesalers of medicinal products which:

  • hold wholesale distribution authorisation issued by JAZMP or have obtained such authorisation in another EU Member State and notified JAZMP that they intend to perform these activities in the Republic of Slovenia;
  • have not been appointed by the marketing authorisation holder to market the product that is the subject of the application or with whom they have business relations.

The application shall include a completed application form, the required information and certificates presented in the structure as indicated on the form. The application shall be submitted on the application form based on Rules on the marketing authorisation for parallel imported medicinal products and for parallel distribution of medicinal products (Official Gazette of the Republic of Slovenia, No. 26/2018 – Slovenian version only).

The application form for obtaining marketing authorisation for a parallel imported medicinal product: Obr. 342-02 (Slovenian version only).

  • The application form shall be completed in the Slovenian language.
  • The information and certificates may be in either in Slovenian or English language as copies of the required documents, except where specified by the Rules that the original or a certified copy is requested. 

 

VARIATIONS OF MARKETING AUTHORISATION FOR PARALLEL IMPORTED MEDICINAL PRODUCT

During the period of validity of the marketing authorisation for a parallel imported medicinal product its marketing authorisation holder is obliged to follow changes of the medicinal product in the source country and changes of the medicinal product, which has a marketing authorisation in the Republic of Slovenia (that parallel imported medicinal product is compared to), which are publicly available, and regularly notify JAZMP thereof.

  • If these changes apply to changes in the summary of product characteristics or package leaflet, the marketing authorisation holder of a parallel imported medicinal product shall notify JAZMP with the application within 60 days of the implementation of these changes in the source country or in the Republic of Slovenia (for implementation of changes for medicinal product that parallel imported medicinal product is compared to).
  • If the changes apply to medicinal product packaging (including repackaging), the marketing authorisation holder for a parallel imported medicinal product shall notify JAZMP with an application no later than within 90 days before the implementation thereof.

The procedure for variation of the marketing authorisation for a parallel imported medicinal product is initiated with a written application, which needs to be submitted to JAZMP together with a completed application form Obr. 344-02 (Slovenian version only). 

 

RENEWAL OF MARKETING AUTHORISATION FOR A PARALLEL IMPORTED MEDICINAL PRODUCT

If the holder of marketing authorisation for a parallel imported medicinal product decides to have the authorisation renewed, the relevant application for renewal must be submitted to JAZMP at least six months before the expiry of validity.

The procedure for the renewal of marketing authorisation for parallel imported medicinal products is initiated with a written application, which needs to be submitted to JAZMP together with a completed application form Obr. 343-02 (Slovenian version only).  

PARALLEL DISTRIBUTION OF MEDICINAL PRODUCTS

The content of the notice and issuing a confirmation on receiving the notice for parallel distribution of medicinal products

The parallel distribution of medicinal products is permitted in the Republic of Slovenia if performed by legal entities from Article 3 according to the Rules on the marketing authorisation for parallel imported medicinal products and for parallel distribution of medicinal products (Official Gazette of the Republic of Slovenia, No. 26/2018 – Slovenian version only) who have notified the European Medicines Agency (EMA) thereof, and EMA does not oppose intended paralel distribution.

Legal entities from previous paragraf, prior to the commencement of parallel distribution of medicinal products in the territory of the Republic of Slovenia, shall notify JAZMP with an application.

The application shall include:

  • the EMA’s document in which it is confirmed, that the conditions for parallel distribution are met;
  • the name of the medicinal product, pharmaceutical form, strength and packaging size;
  • data on the manufacturer, responsible for batch release, and manufacturing site;
  • the proposed packaging and patient information leaflet for the Slovenian market with a graphic presentation of the immediate packaging of the medicinal product.
  • proof that legal entity obtained:
    • national identification code for the medicinal product,
    • legal status for supply in the Republic of Slovenia ("blue-box" information),
    • pictogram(s) of precaution measures if applicable with respect to the nature of the medicinal product ("blue-box" information). 

FEES

Please see FEES  https://www.jazmp.si/en/fees/?key=1-11