# The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003, 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.”.

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Source: https://www.legislation.gov.uk/uksi/2003/2321/regulation/8 (the official version)
Page: https://openlegislation.uk/medicines-for-human-use-fees-and-miscellaneous-amendments-regulations-2003/regulation-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.