Mutual recognition procedure /decentralised procedure

Mutual recognition procedure (MRP)

The mutual recognition procedure (MRP) is the procedure for obtaining marketing authorisation for a medicinal product initiated in the Concerned Member States (CMS) after approval in the Reference Member State (RMS) , and is compulsory for medicinal products that are not subject to the centralised or decentralised procedures for obtaining the marketing authorisation and will be marketed in more than one EU Member State, as laid down by Directive 2001/83/EC, as amended and the Medicinal Products Act (Official Gazette of the RS, No 17/14) (hereinafter: the Act).

Decentralised procedure (DCP)

The decentralised procedure (DCP) is a procedure for obtaining medicinal product marketing authorisation, which is started simultaneously in the Reference Member State (RMS) and in the Concerned Member States (CMS).  It is compulsory for medicinal products that are not subject to the centralised procedure, have not yet obtained marketing authorisation in the EU and will be marketed in more than one EU Member State, as laid down in Directive 2001/83/EC, as amended and the Act.

National phase of the MRP/DCP

After a positive conclusion of the MRP/DCP procedure the applicant should submit high quality translations of the product information within 5 days, via the e-mail address: . The applicant must follow the  Best practice guide on the submission of high quality national translations (Doc. Ref.: CMDh/255/2012/Rev0 April 2012) published on the CMDh webpage. Upon receipt of the Slovenian translations, JAZMP issues the national marketing authorisation.

Please also refer to the JAZMP Instructions for the national phase of the marketing authorisation approval in Slovenia.

CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human)

All issues related to obtaining and maintenance of marketing authorisations through MRP or DCP procedures fall within the competence of the CMDh coordination group acting on behalf of the competent authorities for medicinal products in the EU Member States. At the same time, in order to promote harmonisation of medicinal product authorisations issued in the Community, on the basis of proposals from Member States the CMDh group will draw up a list of drugs and send it to the Commission. On its website, CMDh regularly publishes the press releases, annual work plan, adopted instructions, guidelines, templates, etc.

OBTAINING MARKETING AUTHORISATION

The applicant obtains marketing authorisation in accordance with the conditions defined in detail in 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).

For further information on international procedures, application preparation and additional information from individual EU Member States see:

RENEWAL OF A MARKETING AUTHORISATION

In accordance with Article 63 of the Act, medicinal product marketing authorisation may be renewed after five years have elapsed on the basis of reassessment of the risk-benefit ratio drawn up by RMS. After its first renewal, the granted medicinal product marketing authorisation is generally valid for an unlimited period of time, unless RMS and CMS decide, on the basis of pharmacovigilance data, that another five-year period of monitoring the safety of the medicinal product is necessary.

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.

VARIATIONS TO A MARKETING AUTHORISATION

Commission Regulation (EC) No 1234/2008 (changed 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, apart from the national legislation.

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.

Unforseen variations

Before submitting a variation for which classification is not provided in the Regulation on variations, the holder may request the competent authority of a member state for recommendation on classification of the variation for medicinal products that obtained marketing authorisation via NP, MRP or DCP. The applicant should use the form which is accessible in digital format at the CMDh website (http://www.hma.eu/293.html). The competent authority for medicinal products requests the recommendation on classification of the variation from CMDh. CMDh recommendations are accessible at http://www.hma.eu/293.html.

TRANSFER OF A MARKETING AUTHORISATION

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.

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.

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)

REQUEST FOR SLOVENIA TO ACT AS REFERENCE MEMBER STATE (RMS) IN THE PROCEDURES FOR MARKETING AUTHORISATION UNDER MRP OR DCP

MRP

If the marketing authorisation holder has already obtained marketing authorisation (MA) for the concerned medicinal product under national procedure in the Republic of Slovenia and wishes to initiate a mutual recognition procedure in other EU Member States, the RMS-ship and subsequent update of documentation must be agreed with JAZMP.

DCP

JAZMP actively participates in the decentralised procedure as a RMS. JAZMP will accept to act as RMS for as many submissions as possible within the capacity of our resources. Generic applications are of particular interest.

Request for the JAZMP to act as a RMS in DCP can be submitted at any time and is not limited to certain time periods.

Request for time slot for applications via DCP with Slovenia as RMS

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