The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations 2004

Amendment of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994

2.—(1) The Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(1) are amended as follows.

(2) In regulation 1 (title, commencement and interpretation), for paragraph 4, substitute the following paragraph—

“(4) For the purposes of these Regulations—

(a) “the Committee for Medicinal Products for Veterinary Use” has the same meaning as in Title IV of Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (“Regulation (EC) No. 726/2004”);

(b) obligations imposed on applicants under regulation 4(4)(a) and (8), on the Ministers under regulations 5(a) and 11, and on the holders of marketing authorisations under regulation 6(1)(a), shall be construed in accordance with sub-paragraph (c) of this paragraph;

(c) references to “the Agency” in Articles 12, 13, 74, 75 and 91 of Directive 2001/82/EC shall be taken to refer to the European Medicines Agency established by Article 55 of Regulation (EC) No. 726/2004; and

(d) unless the context otherwise requires, any other expressions used have the meanings they bear in Directive 2001/82/EC(2).”.

(3) In regulation 6 (duties on persons responsible for placing products on the market), in paragraph (2), in sub-paragraph (c), after “Medicines Commission” insert “established under section 2 of the Medicines Act 1968, the Committee for Medicinal Products for Veterinary Use”.

(1)

S.I. 1994/3142; relevant amending instruments are S.I. 1998/1048 and 2002/269

(2)

OJ No. L311, 28.11.2001, p.1.