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The Medicines (Products for Human Use) (Amendments to Fees for Variations) Regulations 2009
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The Marketing Authorisations Regulations 1994
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9.—(1) The Marketing Authorisations Regulations 1994 are amended as follows.
(2) In regulation 1 (citation, commencement and interpretation), in paragraph (2)—
(a)after the definition of “Regulation (EC) No 726/2004” insert—
““Regulation (EC) No 1234/2008” means Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products”; and
“in the definition of “the relevant Community provisions” after “Regulation (EC) No 726/2004;” insert “Regulation (EC) No 1234/2008;”.
(3) In Schedule 2 (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations) in paragraph 1 (interpretation) for the definition of “Type II variation application” substitute—
““Type II variation application” means an application for a variation to the terms of a marketing authorisation which falls within the meaning of a major variation of type II in Article 2(3) of Commission Regulation (EC) No 1234/2008”.
(4) In Schedule 3 (offences, penalties etc) in paragraph 3A for “1085/2003” substitute “1234/2008”.
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