Requests or proposals
Article 3
1. A request for a conditional marketing authorisation may be presented by the applicant together with an application in accordance with Article 6 of Regulation (EC) No 726/2004. The request shall be accompanied by details showing that the product falls within the scope of this Regulation and satisfies the requirements laid down in Article 4(1). The Agency shall immediately inform the Commission of applications containing a request for a conditional marketing authorisation. 2. The Committee for Medicinal Products for Human Use, hereinafter ‘the Committee’, may, in its opinion on an application submitted in accordance with Article 6 of Regulation (EC) No 726/2004, propose a conditional marketing authorisation, after having consulted the applicant.