Medicines Commission appeal

Under the Medicines Act, the licensing system for MAs, Manufacturer s, and Wholesale Dealer s Licences, and for Clinical Trial Certificates, allows the opportunity for an applicant or licence holder to appeal against an unfavourable recommendation or decision, right up to the High Court if necessary, although that has rarely happened. Nevertheless, appeals to the appropriate advisory committee such as the Committee on Safety of Medicines, and to the Medicines Commission, are commonplace in the process leading to grant of an MA. Appeals may also arise in connection with the suspension, revocation, or compulsory variation of MAs or certificates. Manufacturer s Licences and Wholesale Dealer s Licences are rarely subject of the need for such appeal action. 

The European Federation Pharmaceutical Association (EFFPA) commissioned a third party, the Centre for Medicines Research (CMR, UK), to collect data on a small number of targeted drugs. By direct appeal to manufacturers through an independent third party, compliance information between regions was made available, as well as PK data. In addition, data on efficacy and safety were also requested from firms operating in the three major areas. 

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