Regulation 8 Amendment of regulation 2 of the General Fees Regulations

(1)

Regulation 2 of the General Fees Regulations (interpretation) is amended as follows.

(2)

In paragraph (1)—

(a)

in the definition of “the 2001 Directive”, after “human use” insert “ , as amended ”; and

(b)

in the definition of “variation” for “Article 2.1 of Commission Regulation (EC) No. 541/95” substitute “ Article 3.1 of Commission Regulation (EC) No. 1084/2003 ”.

(3)

After paragraph (2) insert the following paragraph—

“(3)
In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation, and any reference to an applicant for a variation to a marketing authorization includes a reference to a person submitting such a notification.”.