Home / Human Medicines / Marketing authorisation / MRP and DCP
Licencing by the Competent AuthorityHuman MedicinesVeterinary MedicinesMedical devicesPricingQuality ControlBloodTissues & Cells

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 17/2014) (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 procedure

After a positive conclusion of the MRP/DCP procedure the applicant should submit high quality translations of the product information within 5 calendar days, via the e-mail address: mrp_dcp@jazmp.si. 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 for medicinal products

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 57/2014, hereinafter: the rules on marketing authorisation).

Relevant application form/cover letter:

-       Application form for obtaining a marketing authorisation (in English)

-       Cover letter template – new applications (in Slovenian)

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.

Relevant application form/cover letter:

-       Application form for renewal of a marketing authorisation  (in English)

-       Cover letter template – renewal, variations (in Slovenian)

For further information on preparing applications see also:

Variation of 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) has replaced Commission Regulations (EC) No 1084/2003 (MRP and DCP) and No 1085/2003 (CP) of 3 June 2003 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary use.

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)

The documents drafted by the CMDh group that are available at the webpage http://www.hma.eu/96.html should also be taken into account.

Relevant application form/cover letter:

-       Application form for variation to a marketing authorisation (in English)

-       Cover letter template – renewal, variations (in Slovenian)

Unforeseen variations

Article 5 of the variation Regulation provides the basis for a marketing authorisation holder (MAH) to request the Reference Member State (RMS), EMA (in case of centralised marketing authorisations) or a national competent authority of a Member State (NCA) (in case of purely national marketing authorisations) to deliver a recommendation on classification of an unforeseen variation before submission of the variation. This recommendation shall be consistent with the Commission guidelines and be delivered to the MAH, EMA, CMDh and CMDv within 45 days following the receipt of the request.

Article 5 of the variation Regulation also provides the basis for a NCA to request the CMDh or CMDv to deliver a recommendation on classification of an unforeseen variation before examination of the variation. This recommendation shall be consistent with the Commission guidelines and be delivered to the MAH, EMA and all NCAs within 45 days following the receipt of the request.

 

Please refer to the Chapter 8 of the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure (Revision 19, March 2013) for the detailed information.

Withdrawal of a marketing authorisation at request of the MAH

The request for withdrawal of the marketing authorisation must be prepared in accordance with the 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 is receiving more requests for RMS time slots than the agency is able to accommodate. 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.

In order to better schedule expected DCP applications and optimising the use of resources a procedure for requesting time slots was agreed by Heads of Medicines Agencies (HMA) in 2009. As of September 2013 we made changes to procedure of requesting time slots, these changes mean that a request for the JAZMP to act as a RMS in DCP can be submitted at any time and is no longer limited to certain time periods.

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

  • The request can be made at any time by filling in the request form (request form).
  • The request form should be sent to the following address only: mrp_dcp@jazmp.si. Please include the following text in the heading of the e-mail: DCP RMS request.
  • The enclosed form must contain all relevant details. The applicant is requested to consider the list of Concerned Member States and how many duplicate applications, if any, will be included in the procedure.
  • Applicants are asked to send a request no later than 9 months before planned submission.
  • The JAZMP will reply to the request as soon as possible but no later than 1 month.
  • Applicants who receive a JAZMP verification of time slot have to confirm the slot within two weeks and must be prepared to keep the submission deadline and notify the JAZMP as soon as possible in case of delay. Submission dates must be re-confirmed two months in advance of the intended submission.


 

© 2014 - Javna agencija RS za zdravila in medicinske pripomočke, Ptujska ulica 21, 1000 Ljubljana, tel: +386 (0)8 2000 500, faks: +386 (0)8 2000 510, info@jazmp.si  Creative Commons licenca