European Union Mutual Recognition Of SPCs

In December, the European Commission Committee on Proprietary Medicinal Products announced that, in order to maximize the efficiency of European Union member states' undertaking to "use their best endeavors to reach agreement on the action to be taken in respect of the application" submitted for mutual recognition of the Summary of Product Characteristics, they have agreed to follow a three-step procedure.

This states that before the mutual recognition procedure is initiated, the reference member state is required to achieve an "acceptable" SPC through discussion with the applicant, taking account of all existing national SPCs. Through this updating process, it expected that harmonization should be achieved, either on "core" issues or also on additional issues, says the CPMP. Both the RMS and the applicant "are expected to react in a flexible manner," it adds.

The next stage of the procedure covers the 90-day clarification and discussion phase, which is required to concentrate on indications, dosage, contraindications and shelf-life. Concerned member states are to forward, in writing and within 60 days, their concerns and alternative wordings for the sections causing concern. The remainder of the RMS' SPC would be mutually recognized.