Saturday, 2 June 2018

Drug approval process in European countries

       CP Centralised Procedure


Marketing authorisations granted under the "centralised procedure" allow the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.Under the centralised procedure, a company may only obtain one marketing authorisation per medicinal product. However, in specific cases a company may apply for a duplicate marketing authorisation. Requests to submit an application for a duplicate should be sent to the Commission DCP Decentralised Procedure

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 draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved.
The subsequent steps are identical to the mutual recognition procedure.
The mutual recognition procedure (MRP) is a European authorisation route resulting in a mutually recognised product.
Mutual recognition must be used when a product is already authorised in at least one Member State on a national basis and the Marketing Authorisation Holder wishes to obtain a Marketing Authorisation ( MA ) for the same product in at least one other Member State.
The Member State that has already authorised the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member States (CMS). The CMS is asked to mutually recognise the MA of the RMS.
If the applicant is successful, the CMS will then issue a MA for that product permitting the marketing of that product in their country.
The majority of medicines available in the EU were authorised at national level, either because they were authorised before EMA’s creation or they were not in the scope of the centralised procedure.
Each EU Member State has its own national authorisation procedures.

(AP) Authorisation procedures

(MRP)Mutual Recognition Procedure

(NP) National procedure

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