OBTAINING A MARKETING AUTHORISATION

The applicant shall obtain the marketing authorisation in accordance with the conditions defined in detail in the Medicinal Products Act (Official Gazette of the RS, No 17/14; hereinafter: the Act).
The documentation for an application for medicinal product marketing authorisation must be prepared in accordance with Articles 5 to 20 of the Rules on marketing authorisation of medicinal products for human use (Official Gazette of the RS, No 57/14 and 41/17; hereinafter: the Rules on marketing authorisation).

Application form for obtaining a marketing authorisation 

RENEWAL OF A MARKETING AUTHORISATION

Marketing authorisation holders must submit their application for renewal of the marketing authorisation at least 9 months prior to the expiry of the initial five-year period of validity of the medicinal product marketing authorisation.

The documentation for an application for renewal of medicinal product marketing authorisation must be prepared in accordance with Articles 50 to 58 of the Rules on marketing authorisation.

The recommendations and guidelines drafted by the CMDh group that are available at http://www.hma.eu/95.html should also be taken into account as applicable.

Application form for renewal of a marketing authorisation

VARIATIONS TO A MARKETING AUTHORISATION

Commission Regulation (EC) No 1234/2008 (amended by the Commission Regulation (EC) No 712/2012) concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (hereinafter: Regulation on variations) is the applicable legislation in the field of variations for a marketing authorisation.

In addition to applicable legislation in the area of medicinal products, applications for variation to a marketing authorisation should take into account the EU guidelines relating to changes:

Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures (2013/C 223/01)

Each application for a variation of mareketing authorisation must be prepared in accordance with Annex IV to Regulation on variations, and Article 40 to 43 of the Rules on marketing authorisation.

The recommendations and guidelines drafted by the CMDh group that are available at http://www.hma.eu/96.html should also be taken into account as applicable.

TRANSFER OF A MARKETING AUTHORISATION

In accordance with the Article 70 of the Act, a marketing authorisation holder may transfer the marketing authorisation to another legal entity or natural person that meets the conditions set out in the Act.

The application for the transfer of marketing authorisation should always be submitted to the competent authorities for medicinal products by the current marketing authorisation holder or his/her authorised legal or natural person.

All applications for the transfer of marketing authorisation, irrespective of the type of procedure through which the marketing authorisation was obtained (national procedure, MRP or DCP), shall be dealt with as  national procedures.

Applications for the transfer of marketing authorisation for medicinal products that obtained the marketing authorisation via a centralised procedure are processed by the European Medicines Agency.

The documentation for an application for the transfer of marketing authorisation must be prepared in accordance with Article 63 of the Rules on marketing authorisation.

Application form for transfer of a marketing authorisation (in Slovenian)

WITHDRAWAL OF A MARKETING AUTHORISATION AT REQUEST OF THE MARKETING AUTHORISATION HOLDER

The documentation for an application for the withdrawal of marketing authorisation must be prepared in accordance with Article 64 of the Rules on marketing authorisation.

Application form for withdrawal of a marketing authorisation (in Slovenian)

JAZMP GUIDELINES

In preparing the product information in all of the above mentioned procedures, marketing authorisation holders should also consider the JAZMP guidelines (mostly only available in Slovene language).

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