Paragraph 5

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch. 6 para. 6 inserted by Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) 2010 Sch. 5 para. 4
Sch. 6 para. 4A inserted by Medicines (Marketing Authorisations and Miscellaneous Amendments) 2004 reg. 3(5)
Sch. 6 para. 4B inserted by Medicines (Marketing Authorisations Etc.) 2005 reg. 2(15)

Until 31st March 1995 the Medicines (Products for Human Use—Fees) Regulations 1991^f1 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^f2.

Annotations

Footnotes

f1: S.I. 1991/1474. The relevant amending instruments are S.I. 1992/756 and 1994/691.
f2: The Annex to Council Directive 75/318/EEC was replaced by Council Directive 91/507/EEC.