PART 17Miscellaneous and general
Review
F1Review346
1
The Secretary of State must from time to time carry out a review of the provisions listed in paragraph (2).
2
Those provisions are—
a
Chapters 1, 3 and 4 of Part 3;
b
Parts 11 and 12A;
c
regulations—
i
F1418(6),
ii
20(1),
F26iia
36(4) to (7),
iii
37(4)(b), (5), (6), (11) and (12),
F27iiia
42(4) and (5),
iv
43(5), (6)(a) F15and (d), 7(c)(iii) and (vii), (8) and (10) to (14),
F28iva
43A,
v
44(1) to (6),
vi
59,
vii
60(3)(b), (9) and (10),
viii
61,
ix
63,
x
64(4)(b), (d) and (e), (5)(a) and (6)(c),
xi
65(2),
xii
66(5) and (6),
xiii
68(2)(a) and (b), (5) and (12A),
xiv
69(2)(a) and (b), (5) and (10),
F2xiva
73(5A) to (5C),
xv
75(2)(b) and (c),
xvi
76,
xvii
79,
F3xviia
82(1)(c),
xviii
85,
xix
86,
F34xixa
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
xx
97,
xxi
105(3)(b),
xxii
107(2),
xxiii
108(5),
xxiv
110(8A),
F4xxiva
113(3A),
xxv
115(2)(b) and (c),
xxvi
132(2),
xxvii
133(5) and (6),
xxviii
135(10A),
F5xxviiia
142(5A) to (5C),
F36xxviiiaza
regulations 167A and 167B,
F32xxviiiaa
regulation 174A,
F6xxviiib
213(3),
F6xxviiic
217A,
F6xxviiid
218(2)(b) and (c), (3) and (5),
F12xxviiie
219 and 219A,
F17xxviiiea
223(3)(b),
F29xxviiieb
226A,
F23xxviiieb
228(2)(d)(iv),
F13xxviiifa
233(1)(a)(ivd) and (ive),
xxviiig
234(2)(e),
F33xxviiiga
regulation 247A,
F19xxviiih
248(1)(a) and (2)(a),
F30xxviiii
255A to 255C,
xxviiij
257A,
xxix
266(4) and (5),
xxx
327(2)(g) and insofar as the provision relates to active substances paragraphs (1)(c)(iii), (iv) and (viii), (2)(a) to (f), (3), (4) and (6),
xxxi
330(1) and (2),
xxxii
331, and
xxxiii
regulation 349 insofar as it repeals section 10(7) of the Medicines Act 1968; and
d
Schedules—
i
5 paragraphs 1(1)(b) to (d), (2)(b) to (d), 3(11)(b)(vi) to (viii), 5(2)(f) to (h),
F35ia
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii
7A,
iii
8 paragraphs 9A, 12, 13, 19 and 23,
iv
12 paragraph 21,
F10ivza
16, Part 2 entries relating to “Public Health England” and “Public Health Agency” and Part 3 entries relating to “search and rescue operations”,
F20iva
ivaa
23, paragraph 1(a)(vii) to F25(x),
F31ivab
24 paragraph 18A,
F11ivb
22, entries relating to “Public Health England”, “Public Health Agency” and “search and rescue operations”, and
v
27 paragraphs 14 and 15.
3
The Secretary of State must—
a
set out the conclusions of a review carried out in accordance with paragraph (1) in a report; and
b
publish the report.
F74
In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how—
a
the 2001 Directive;
b
Directive 2010/84/EU of the European Parliament and of the Council of 15 October 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;
c
Article 11 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare;
d
Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products; and
e
Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State,
are implemented in other member States in relation to the subject matter of the provisions mentioned in paragraph (2).
5
The report must in particular—
a
set out the objectives intended to be achieved by the regulatory system established by the provisions of these Regulations that implement those Directives in relation to the subject matter of the provisions mentioned in paragraph (2)(a), (b), (c)(i) to F8(xxxii) and (d);
b
assess the extent to which those objectives are achieved; and
c
assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.
6
The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.
7
Reports under this regulation are afterwards to be published at intervals not exceeding five years.