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.