5. Until 31st March 1995 the Medicines (Products for Human Use—Fees) Regulations 1991(1) shall have effect as if—
(a)any reference to a product licence or to licences under Part II of the Act included a reference to a United Kingdom marketing authorization;
(b)in regulation 2(1), the definition of “medicinal product” included a reference to a relevant medicinal product;
(c)in regulation 7, the reference to an application under section 30 of the Act to vary a product licence included a reference to an application under regulation 4 above to vary a United Kingdom marketing authorization; and
(d)in head 1(a)(i) in Column 1 of the Table in Part II of Schedule 1, paragraphs 2 and 2A of Part III of that Schedule and in the definition of “limited use drug” in paragraph 1 of Part I of Schedule 3, the references to paragraph 5 of Schedule 2 to the Applications Regulations included references to section G of Part 4 of the Annex to Council Directive 75/318/EEC(2).
S.I. 1991/1474. The relevant amending instruments are S.I. 1992/756 and 1994/691.
The Annex to Council Directive 75/318/EEC was replaced by Council Directive 91/507/EEC.