MRP/DCP authorisation

MRP - Mutual recognition procedure

The Mutual Recognition Procedure (MRP) is chosen if a marketing authorisation already exists in one EU country and the marketing authorisation holder wishes to enter other EU countries. After the application has been filed in an EU Member State, the marketing authorisation holder applies for recognition of the national marketing authorisation in other EU countries of his choice within the framework of the so-called mutual recognition.

In the MRP procedure, the first country to be approved is the reference member state (RMS) and prepares an assessment report for all countries involved in the procedure (concerned member state, CMS) on the quality, efficacy and harmlessness of the drug, which the countries can, but do not have to, follow.

RUP - repeat use procedure

The repeat use procedure is a special form of the mutual recognition procedure. In this case, a CMS is added in a further procedure (second wave, third wave, ...) to an already completed MRP/DCP procedure. If Austria/ or Liechtenstein is added as a new CMS, these procedures are handled like a mutual recognition procedure and lead to an authorisation.

DCP - Decentralised procedure

In the case of the decentralised procedure or DCP (Decentralised Procedure), on the other hand, no EU member state has approved the drug speciality. An authorisation is sought for several EU states and the corresponding applications are submitted simultaneously.

EU reference product

Reference marketing authorisation using a medicinal product authorised in Austria as an EU reference medicinal product in accordance with Art 10 Directive 2001/83/EC or Art 13 Directive 2001/82/EC.

Liechtenstein as CMS

Since 01.12.2010 it has been possible, according to BGBl. III Nr. 126/2010 (Agreement between the Austrian Federal Government and the Government of the Principality of Liechtenstein concerning the automatic recognition of human and veterinary medicinal products authorised or registered in Austria in Liechtenstein), to submit an application for authorisation of a medicinal speciality for Liechtenstein via Austria.

The following prerequisites must be taken into account:

  • The application for authorisation in Liechtenstein must be submitted to the Austrian authority (BASG) together with the application for authorisation in Austria in one application form. If both Austria and Liechtenstein are Concerned Member States (CMS), both must be listed as CMS. If Austria is the leading member state (Reference Member State/RMS), then Austria must be listed as RMS and Liechtenstein as CMS. Or
  • In the event that an authorisation has already been granted in Austria for this drug speciality, there is the possibility of including Liechtenstein in the procedure later with a new authorisation procedure (Repeat Use Procedure with Liechtenstein as CMS).
  • An application for authorisation for Liechtenstein alone without Austrian participation is not possible.

Information on submission and communication

Application for authorisation of a medicinal product:

  • The handling of an authorisation procedure for Liechtenstein is handled exclusively via Austria.
  • The application form, in which Austria and Liechtenstein (new application for marketing authorisation) or Liechtenstein alone (new marketing authorisation procedure/repeat use procedure) was ticked, must be submitted to the Austrian authority together with all relevant documents.
  • The authority in Liechtenstein must be informed in advance by the applicant of the planned submission of an authorisation for Liechtenstein in Austria.
  • Letter to: Office of Health, Aeulestrasse 51, 9490 Vaduz
  • E-mail to: pharminfo@llv.li
  • The fee regulation, according to the Austrian fee tariff, is carried out after validation of the application.

 

Modification procedure:

  • Any further changes must also be submitted to the Austrian authority. It is also important here that a joint application form for Austria and Liechtenstein is submitted, in which both countries are ticked.
  • According to the fee tariff, an additional one-off payment is charged for Liechtenstein, which also covers later change procedures. No separate fee will be charged for Liechtenstein.

 

Withdrawal:

  • Should the authorisation be revoked in Austria, the revocation shall also apply to Liechtenstein.
  • It is not possible to maintain authorisation for Liechtenstein alone.
  • A withdrawal for the CMS Liechtenstein alone, however, is possible.

 

Reference

http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm

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