European Medicines Agency centralised procedure

In the Centralised Procedure a Rapporteur and a Co-Rapporteur, appointed from within the member states of EU, have to evaluate the product and report to the European Medicines Agency within 210 days. If the UK is selected as Rapporteur or Co-Rapporteur, the evaluation of the medicinal product is carried out by the MHRA. Occasionally, when there is particular interest in a novel medicinal product, or when a new medicinal product would have a significant affect on drug usage in the NHS, the MHRA will get involved and opinions will be sought from scientific advisory committees. A recent example of this was when the first inhaled formulation of human insulin was licensed. 

As a result of Council Regulation (EEC) No. 2309/93 of July 22, 1993, which established the European Agency for the Evaluation of Medicinal Products, three types of procedures for authorising the placing of medicinal products on the market were introduced, depending on the characteristics and specific nature of the medicinal product in question centralised procedure, decentralised procedure and national procedure. 

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