EU Commission Pharma Reg Rethink

Following a special meeting of the Notice to Applicants working groupthis month, the European Commission has given a new interpretation to the first paragraph of Article 7a of Directive 65/65/EEC.

The paragraph reads: "With effect from 1 January 1998, where a Member State is informed in accordance with point 11 of the second paragraph of Article 4 that another Member State has authorized a medicinal product which is the subject of an application for authorization in the Member State concerned, that Member State shall forthwith request the authorities of the Member State which has granted the authorization to forward to it the assessment report referred to in the second paragraph of Article 4b."

The practical consequences of the new interpretation are that for a product with a new active substance, after obtaining a marketing authorization in one member state, the mutual recognition procedure is compulsory in the other member states.