Mutual recognition procedure
Mutual recognition procedure refers to a process where an EU Member State recognises the marketing authorisation granted by another Member State within 90 days of start of the process.
The Member State whose evaluation statement is used as grounds for recognising the marketing authorisation is known as the Reference Member State (RMS). The application filed with a Concerned Member State (CMS) in the mutual recognition procedure must be identical with the original application. The national specific requirements are detailed in the Fimea regulation 2/2013 (‘Applying for and maintaining a marketing authorisation and registration for a medicinal product’) and in the latest Notice to Applicants.
The mutual recognition procedure is based on the basic principle that a CMS must recognise a decision made by another Member State unless the use of the product constitutes a threat to public health, animal health or the environment. If such a major concern is raised by the CMS, the RMS shall be notified by a certain date. The Member States involved will endeavour to find a solution within 90 days. In most cases, the marketing authorisation can be granted, and a national marketing authorisation decision is issued for the product. If the Member States fail to reach a solution within the prescribed time, the case is first referred to the Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary, CMD(v)) and, if necessary, to a conciliation procedure, in which case final decision will be made by the EU Commission.