The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

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).

(1)

S.I. 1991/1474. The relevant amending instruments are S.I. 1992/756 and 1994/691.

(2)

The Annex to Council Directive 75/318/EEC was replaced by Council Directive 91/507/EEC.