Generics Industry Rejects EU Proposal On Mutual Recognition

The European Generic medicines Association, the EGA, last week submitteda position paper to the European Commission and European Union member states, effectively rejecting the Commission's latest attempt to "patch up" the Mutual Recognition Procedure for the registration of low-priced generic drugs. The Commission's draft paper was presented to interested parties on May 26.

The EGA calls on the Commission and the member states to develop a structure within the MRP that accommodates generic drugs and fulfils the objectives of the single market.

"Reinterpretation" Fails To Allow MRP The EGA says it believes that the Commission's "reinterpretation" of pharmaceutical law fails to allow the MRP to meet the specific requirements of generic applications, which must have the same product information and therapeutic use as that of the originator product on each national market.