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Community Referral Procedures

Posted 01 March 2010 | By

A Community Referral, also called an arbitration, is a unique and binding procedure by which the European Medicines Agency is requested to conduct, on behalf of the European Community, a scientific assessment of a particular medicine or class of medicines. European pharmaceutical legislation (Directive 2001/83/EC,1 as amended) provides for Community Referrals in the following cases: applications made using the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DP) (Article 29), divergent decisions (Article 30), community interest (Article 31) and follow-up referrals (Articles 35 and 36). In such cases a scientific evaluation is undertaken by one of the committees of the European Medicines Agency, leading to an opinion by the agency that provides the basis upon which the European Commission issues a single, uniform decision. This decision is addressed to all Member States (MSs) and is enforced upon the applicant or the marketing authorization holder (MAH). The commission has published a guidance document on this topic under Notice to Applicants, Volume 2A Procedures for marketing authorisation, Chapter 3 Community Referral Procedures.2

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