Determination of applications made under the Decentralised and Mutual Recognition Procedures

In accordance with Directive 2001/83 and commencing 1 April 2008, the Agency will determine Marketing Authorisation applications submitted through the Decentralised and Mutual Recognition Procedures within the designated thirty day period from the conclusion of the procedure.

In line with CMD(h) Best Practice Guide for Decentralised and Mutual Recognition Procedures (external link), mock-ups of the labels and leaflets agreed during the procedure should be submitted within five days of the end of procedure. In the event that such mock-ups are not provided, the application will be determined by day 30, based on the Summary of Product Characteristics (SmPC), patient leaflet and label TEXTS as approved during the procedure.

As a consequence, and in accordance with Medicines Regulations, the product cannot be marketed in the UK until approval of the product labelling and leaflet mock-ups has been obtained.

For products for which the Marketing Authorisation has been determined based on text, mock-ups of Patient Leaflets and Labels may be submitted for review under Article 61(3) of Directive 2001/83/EC.

A reminder encompassing the above and detailing the information to be provided and the format required, will be sent to the applicant by e-mail at the conclusion of the procedure.