The Veterinary Medicines Regulations 2013

Review E+W+S

46.—(1) Before the end of each review period, the Secretary of State must—

(a) carry out a review of these Regulations other than the fees provisions;

(b) set out the conclusions of the review in a report; and

(c) publish the report.

F1 (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2 (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The report must in particular—

(a) set out the objectives intended to be achieved by the regulatory system established by these Regulations, other than the fees provisions;

(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.

(5) In this regulation—

(a) “review period” means the period of five years [F3 ending on 31st December 2028], and, subject to paragraph (6), each successive period of five years thereafter; and

(b) “the fees provisions” means regulation 16 and Schedule 7.

(6) If a report under this regulation is published before the last day of the review period to which it relates, the following review period is to begin with the day on which that report is published.

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Reg. 46(2) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 26(a)

F2 Reg. 46(3) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 26(a)

F3 Words in reg. 46(5) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 26(b)

Review N.I.

46.—(1) Before the end of each review period, the Secretary of State must—

(a) carry out a review of these Regulations other than the fees provisions;

(b) set out the conclusions of the review in a report; and

(c) publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the EU instruments, or provisions of EU instruments, to which this regulation applies are implemented in F4 ... member States.

(3) The EU instruments, and provisions of EU instruments, to which this regulation applies are—

(a) Council Directive 90/167/EEC laying down conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community, so far it is not superseded by Regulation (EC) No 183/2005(1);

(b) Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products(2);

(c) Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products(3);

(d) Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, in so far as it applies to veterinary medicinal products used in feedingstuffs;

(e) Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, in so far as it applies to veterinary medicinal products used in feedingstuffs;

[F5 (f) Regulation (EU) 2017/625;]

(g) Regulation (EC) No 183/2005 of the European Parliament and of the Council laying down requirements for feed hygiene, in so far as it applies to veterinary medicinal products used in feedingstuffs;

(h) Commission Regulation (EC) No 1234/2008(4);

(i) Regulation (EC) No 470/2009 of the European Parliament and of the Council(5);

(j) Article 8 of Regulation (EC) No 767/2009 of the European Parliament and of the Council, and Articles 15 and 17 of that Regulation as they refer to the labelling requirements for feedingstuffs containing specified feed additives(6); and

(k) Commission Regulation (EU) No 37/2010(7).

(4) The report must in particular—

(a) set out the objectives intended to be achieved by the regulatory system established by these Regulations, other than the fees provisions;

(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.

(5) In this regulation—

(a) “review period” means the period of five years beginning with the day on which these Regulations come into force, and, subject to paragraph (6), each successive period of five years thereafter; and

(b) “the fees provisions” means regulation 16 and Schedule 7.

(6) If a report under this regulation is published before the last day of the review period to which it relates, the following review period is to begin with the day on which that report is published.

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F4 Word in reg. 46(2) omitted (N.I.) (31.12.2020) by virtue of The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(12)(a)

F5 Reg. 46(3)(f) substituted (N.I) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(12)(b)

(1)

OJ No L 92, 7.4.1990, p. 42.

(2)

OJ No L 228, 17.8.1991, p. 70.

(3)

OJ No L311, 28.11.2001, p. 1; last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council (OJ No L188, 18.7.2009, p. 14).

(4)

OJ No L334, 12.12.2008, p. 7.

(5)

OJ No L152, 16.6.2009, p. 11.

(6)

OJ No L229, 1.9.2009, p. 1, last amended by Commission Regulation (EU) No 939/2010 (OJ L277, 21.10.2010, p. 14).

(7)

OJ No L293, 11.11.2010, p.72; corrected at OJ L293, 11.11.2010, p. 72.