Paragraph 1

Schedule 2 to the Marketing Authorization Regulations (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations) is amended as follows.

In paragraph 2, for sub-paragraph (a), substitute the following sub-paragraph—

“(a)

any application for the grant of an authorization for a relevant medicinal product, except where—

(i)

at any time during the period beginning with the date on which the application is made and ending with the date on which the licensing authority gave a decision on the application, there is a marketing authorization in force in respect of that product anywhere in the Community, or

(ii)

the application has been submitted to the licensing authority in accordance with Article 28(1) and (3) of the 2001 Directive;”.

In paragraph 14(8)(a), for “section” substitute “paragraph”.