The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Scope and application of the procedural provisions

2.—(1) Subject to paragraphs 3 and 4 below, this Schedule applies to any application for the grant or renewal of a marketing authorization for a relevant medicinal product where, throughout the period beginning with the date on which the application is made and ending with the date on which the licensing authority give a decision on the application, either—

(a) there is no other marketing authorization in force in respect of the product anywhere in the Community; or

(b) any day in that period falls within the period beginning with 1st January 1995, and ending with 31st December 1997.

(2) Subject to paragraphs 3 and 4 below, this Schedule also applies to every proposal to revoke, vary or suspend an authorization for a relevant medicinal product where there is no such other authorization in force at the time of the proposal.