Authorisation procedures - The mutual recognition procedure
Basic arrangements for implementing the mutual recognition procedure laid down in Directive 2001/83/EC have been made in all Member States. To be eligible for this procedure, a medicinal product must have already received a marketing authorisation in one Member State.
Since 1 January 1998, the mutual recognition procedure is compulsory for all medicinal products to be marketed in a Member State other than that in which they were first authorised. Any national marketing authorisation granted by an EU Member State's national authority can be used to support an application for its mutual recognition by other Member States.
How does the mutual recognition procedure work?
The mutual recognition procedure is based on the principle of the mutual recognition by EU Member States of their respective national marketing authorisations. An application for mutual recognition may be addressed to one or more Member States. The applications submitted must be identical and all Member States must be notified of them. As soon as one Member State decides to evaluate the medicinal product (at which point it becomes the "Reference Member State"), it notifies this decision to other Member States (which then become the "Concerned Member States"), to whom applications have also been submitted. Concerned Member States will then suspend their own evaluations, and await the Reference Member State's decision on the product.
This evaluation procedure undertaken by the Reference Member State may take up to 210 days, and ends with the granting of a marketing authorisation in that Member State. It can also occur that a marketing authorisation had already been granted by the Reference Member State. In such a case, it shall update the existing assessment report in 90 days. As soon as the assessment is completed, copies of this report are sent to all Member States, together with the approved summary of product characteristics (SPC), labelling and package leaflet. The Concerned Member States then have 90 days to recognise the decision of the Reference Member State and the SPC, labelling and package leaflet as approved by it. National marketing authorisations shall be granted within 30 days after acknowledgement of the agreement.
Should any Member State refuse to recognise the original national authorisation, on the grounds of potential serious risk to public health, the issue will be referred to the coordination group. Within a timeframe of 60 days, Member States shall, within the coordination group, make all efforts to reach a consensus. In case this fails, the procedure is submitted to the appropriate EMA scientific committee (CHMP or CVMP, as appropriate), for arbitration. The opinion of the EMA Committee is then forwarded to the Commission, for the start of the decision making process. As in the centralised procedure, this process entails consulting various Commission Directorates General and the Standing Committee on Human Medicinal Products or the Standing Committee on Veterinary Medicinal Products, as appropriate. The Rules of Procedure of these Committees are available here:
- Rules of Procedure for the Standing Committee on Veterinary Medicinal Products (Examination procedure)
- Rules of Procedure for the Standing Committee on Veterinary Medicinal Products (Regulatory procedure with Scrutiny)
- Standing Committee on Medicinal Products for Human Use (Examination procedure)
- Standing Committee on Medicinal Products for Human Use (Regulatory procedure with Scrutiny)