The Veterinary Medicines (Amendment etc.) Regulations 2024

UK Statutory Instrument 2024 No. 567 — creates 5 criminal offences.

Made

25 April 2024

In force from

17 May 2024

Extent

Not stated

Subject

Drugs and medicines

Made under

Medicines and Medical Devices Act 2021

Explanatory note

(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.

These Regulations amend the Veterinary Medicines Regulations 2013 (S.I. 2013/2033, “the 2013 Regulations”) in respect of Great Britain only. Part 2 amends Parts 1 to 5 of the 2013 Regulations. New and amended provision is made in respect of— the manufacture of veterinary medicinal products (regulation 5); the prohibition of supply of veterinary medicinal products after their expiry date (regulation 6); advertising and promotion of veterinary medicinal products (regulations 7 to 9); exemptions from the scope of the 2013 Regulations (regulation 10); record-keeping requirements (regulations 11 to 15); imports of unauthorised veterinary medicinal products (regulation 16); appeals (regulation 17); exports (regulation 18); time limits (regulation 19); enforcement (regulations 20 to 25). Regulation 4 amends the interpretation provision in the 2013 Regulations, and regulation 26 amends the statutory review clause so as to provide that the report in respect of the next review must be published by 31st December 2028. Part 3 amends Schedule 1 to the 2013 Regulations, which governs applications for marketing authorisations in respect of veterinary medicinal products. Part 4 amends Schedule 2 to the 2013 Regulations, which governs the manufacture of veterinary medicinal products. Regulation 92 inserts new Part 2 to that Schedule, concerning the authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade. Regulation 93 inserts new Part 2A (regulating active substances) and Part 2B (offences) to that Schedule. Part 5 amends Schedule 3 to the 2013 Regulations, which governs classification and supply of veterinary medicines, wholesale dealers and sheep dip. Part 6 amends Schedule 4 to the 2013 Regulations, which governs administration of veterinary medicines outside the terms of a marketing authorisation. Part 7 amends Schedule 5 to the 2013 Regulations, which governs medicated feedingstuffs and specified feed additives. Part 8 amends Schedule 6 to the 2013 Regulations, which governs exemptions from the 2013 Regulations in respect of small pet animals. Part 9 amends Schedule 7 to the 2013 Regulations, which sets out fees in respect of the 2013 Regulations. Part 10 sets out transitional provisions in respect of certain amendments in earlier Parts of the instrument concerning— labelling of veterinary medicinal products (regulation 200); advertising (regulation 201); wholesale supply of veterinary medicinal products by marketing authorisation holders (regulation 202); prescriptions (regulations 203 and 204); feedingstuffs labelling requirements (regulation 205); medicated feedingstuffs prescription requirements (regulation 206); sampling (regulations 207 and 208). Part 11 contains a consequential amendment to assimilated direct legislation, revoking Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (EUR 2008/1234). A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen.

Offences created by this instrument

• It is an offence to fail to comply with— a paragraph 3A(1); b paragraph 3B; or c paragraph 9(1) regulation 10 · Status not determined · Strict liability
• A written prescription must include— a the full name, address and contact details of the person prescribing the… regulation 101 · Status not determined · Strict liability
• Offences 10 It is an offence to fail to comply with— a paragraph 3A(1); b paragraph 3B; or c paragraph 9(1) regulation 160 · Status not determined · Strict liability
• It is an offence to fail to comply with— a paragraph 1; b paragraph 4(3); c paragraph 8; d paragraph 11; e paragraph… regulation 32 · Status not determined · Mixed — some elements strict, some not
• PART2B Schedule 2 Offences Offences 32 It is an offence to fail to comply with— a paragraph 1; b paragraph 4(3); c… regulation 93 · Status not determined · Mixed — some elements strict, some not

What Parliament said about it

Contributions, debates and written statements mentioning this instrument by name. Parliamentary material is reused under the Open Parliament Licence v3.0.

• Veterinary Medicines (Amendment etc.) Regulations 2024 Lords · Grand Committee · 18 April 2024 · Lord Douglas-Miller

  That the Grand Committee do consider the Veterinary Medicines (Amendment etc.) Regulations 2024. Relevant document: 18th Report from the Secondary Legislation Scrutiny Committee

• Veterinary Medicines (Amendment etc.) Regulations 2024 Lords · Grand Committee · 18 April 2024
• Draft Veterinary Medicines (Amendment etc.) Regulations 2024 Commons · General Committees · 23 April 2024 · The Minister for Food, Farming and Fisheries (Sir Mark Spencer)

  I beg to move, That this Committee has considered the draft Veterinary Medicines (Amendment etc.) Regulations 2024. It is a pleasure to serve under your chairmanship, Dame Maria. The draft regulations, which were laid before the House on 4 March, will amend the Veterinary Medicines Regulations 2013 in respect of Great Britain to ensure that our legislative regime for veterinary medicines is fit for purpose to protect animal health, the environment and public health, including the people handling the medicines or the treated animal and those consuming produce from treated animals. It is…

• Draft Veterinary Medicines (Amendment etc.) Regulations 2024 Commons · General Committees · 23 April 2024

How Parliament handled it

Parliament's Statutory Instruments service has no record of this instrument, although it covers the period. Nothing is inferred from that.

Check the source

• This instrument on legislation.gov.uk The authoritative text, including amendments made since
• Other instruments from 2024