PART 17Miscellaneous and general

General

F1Regulation making powers344B.

(1)

Regulations made under a power in the regulations listed in paragraph (2)—

(a)

are to be made by statutory instrument;

(b)

may make different provision for different purposes and different areas; and

(c)

may include incidental, supplemental, consequential, transitional, transitory or saving provisions, including consequential amendments to these Regulations.

(2)

The regulations referred to in paragraph (1) are—

(a)

regulation B17(1) and (4) (good manufacturing practice);

(b)

regulation 50(5A) (Annex I to the 2001 Directive);

(c)

regulation 50G(5) (orphan criteria etc);

(d)

regulations 59(3A) and 61(7A) (post-authorisation efficacy studies);

(e)

regulation 65C(7) (variations of UK marketing authorisations);

(f)

regulation 102(7) (homoeopathic medicinal products);

(g)

regulation 205A(2) (further obligations in respect of pharmacovigilance activities);

(h)

regulation 257E (certain forms of labelling); and

(i)

regulation 344A (modifications to deal with serious shortages).

(3)

A statutory instrument containing regulations made under the powers listed in paragraph (2) is subject to annulment in pursuance of a resolution of either House of Parliament.