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 who:
- 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 arranged in the order as indicated on the form. The application shall be submitted on the application form that is part of the Rules on the acquisition of marketing authorisation for parallel imported medicinal products and for parallel distribution of medicinal products (Official Gazette of the Republic of Slovenia, [Uradni list RS], No. 49/2009 – Slovenian version only).
The application form for obtaining marketing authorisation for a parallel imported medicinal product: Obr. 342-01 (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 to be submitted.
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 monitor changes in the medicinal product in the source country 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 for a parallel imported medicinal product shall notify JAZMP with the application within 60 days of the implementation of these changes in the source country.
- If the changes apply to medicinal product packaging, 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 the applicant is to submit to JAZMP together with a completed application form Obr. 344-01 (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 90 days 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 the applicant is to submit to JAZMP together with a completed application form Obr. 343-01 (Slovenian version only).
PARALLEL DISTRIBUTION OF MEDICINAL PRODUCTS
Conditions for pursuing the parallel distribution of medicinal products
The parallel distribution of medicinal products is permitted in the Republic of Slovenia if performed by natural persons or legal entities established according to the Rules who have notified the European Medicines Agency (EMA) thereof, and who within 30 days of receipt of this notice have not received a negative reply from the EMA.
This notice must include the following:
- the EMA’s proof of receipt of notification of parallel distribution;
- the applicant’s statement of not having received a negative reply from the EMA within 30 days of its receipt of the notification referred to in the preceding point;
- the name of the medicinal product, pharmaceutical form, strength, and packaging size;
- data on the manufacturer and manufacturing site;
the proposed draft packaging and patient information leaflet in Slovenian with a graphic presentation of the immediate packaging of the medicinal product.
There is no prescribed application form.