The Veterinary Medicines (Amendment etc.) Regulations 2024

EXPLANATORY NOTE

(This note is not part of the Regulations)

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.