Generic Medicines Approval Route - European Union - Marketing Authorization Application (MAA)

                                             

The EMA defines a generic medicine as: a medicine that is developed to be the same as a medicine that has already been authorised (the ‘reference medicine’). A generic medicine contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s) as the reference medicine. However, the name of the medicine, its appearance (such as colour or shape) and its packaging can be different from those of the reference medicine.

 Authorisation of a medicine in the EU can be done via three different routes: the Centralised Procedure [CP], the Decentralised Procedure [DCP] or the Mutual Recognition Procedure [MRP]. Additionally, National Procedures [NP] are in place in individual member states, which allow a medicine to be authorised by the competent authority in that specific member state.

 The Centralised Procedure (CP), which came into operation in 1995, allows applicants to obtain a marketing authorisation that is valid throughout the EU. It is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human medicine products containing a new active substance which was not authorised in the Community before 20 May 2004 (date of entry into force of Regulation (EC) No 726/2004) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals. CP applications are made to, and approved by, the EMA.

 Mutual Recognition Procedure (MRP): To be eligible for the MRP, a medicinal product must have already received a marketing authorisation in one Member State. Since 1 January 1998, the MRP 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. The MRP is based on the principle of mutual recognition, by EU Member States, of their respective national marketing authorizations. 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, if successful, results in the granting of a marketing authorisation in that Member State. When the assessment is completed, copies of the report are sent to all Member States. The Concerned Member States then have 90 days to recognise the decision of the Reference Member State. National marketing authorizations are granted within 30 days after acknowledgement of the agreement.

 The Decentralised Procedure (DCP) is similar to the MRP but the difference lies in that it applies to medicinal products that have not received a marketing authorisation at the time of application. With the DCP, an identical application for marketing authorisation is submitted simultaneously to the competent authorities of the Reference Member State and of the Concerned Member States. At the end of the procedure, the product dossier, as proposed by the Reference Member State, is approved. The subsequent steps are identical to the mutual recognition procedure.