Keywords
Summary

Keywords

Approximation of laws — Proprietary medicinal products — Marketing authorisation — Withdrawal of authorisation — Authorisations granted in accordance with the mutual recognition procedure, coupled with arbitration procedures — Competence of the Commission with regard to authorisation initially granted under national procedures — None — (Council Directive 75/319, Art. 15a)

Summary

Article 15a of Directive 75/319 relating to proprietary medicinal products, as amended by Directive 93/39, applies to marketing authorisations which have been granted in accordance with the mutual recognition procedure, coupled with arbitration procedures, provided for in Chapter III of Directive 75/319. That provision cannot be used as a legal basis for Commission decisions ordering the Member States to withdraw marketing authorisations initially granted under purely national procedures.

see paras 45-46, 51