Reference Member State , RMS (Abkürzung)

For mutual recognition applications the assessment report prepared by the Reference Member State is also considered by the CSM.

ERIK network – ‘Database Good Practices’ website Reference Member State:

Inforegio Panorama periodical No 16, May 2005 – ‘Best practice in regional development’ Reference Member State:

DG REGIO – ‘Success stories database, Inforegio website Reference Member State:

The MCA continues to remain as one of the leading rapporteurs in the European Centralised procedure and leading Reference Member State in the Mutual Recognition procedure.

As with previous Sativex MRP filings, the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), is acting as the Reference Member State.

For mutual recognition applications the Reference Member State (RMS) should be identified along with all Member States in which the product is authorised, that is the Concerned Member States (CMS).

Alimera has filed with the Medicines and Healthcare Products Regulatory Agency in the U.K. as the Reference Member State for 10 additional European Union (EU) country approvals through the Mutual Recognition Procedure.

 Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States.

The decentralized procedure, as indicated above, is typically for traditional biologicals and traditional medicinal products and it involves the selection of one of the EU countries, such as France, as the rapporteur country or Reference Member State (RMS).

One Member State (the 'Reference Member State' - RMS) is responsible for evaluating the application.

Following payment of the fee, the Reference Member State (RMS) will validate the application and begin work on evaluating the application within the time frame specified in EU BPR.

A copy of the official authorisation granted by the Reference Member State or statement that this is available via R4BP.

The submitted application and dossier will be evaluated in accordance with the requirements of EU BPR to check the risks to health and the environment, intended use and efficacy have been evaluated by the Reference Member State.

The Reference Member State and Concerned Member States all authorise the product at the same time.