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.