Explainer: transitional provisions in new Regulations
Explainer for businesses and persons regulated by the Veterinary Medicines Regulations 2013, as amended, on the transitional provisions included in the amending legislation: the Veterinary Medicines (Amendment etc.) Regulations 2024.
Background
The Veterinary Medicines (Amendment etc.) Regulations 2024 amend the Veterinary Medicines Regulations 2013 in respect of Great Britain. The new legislation came into force on 17 May 2024.
To provide stakeholders with time to ensure compliance with specific new or amended requirements, the amending Regulations include transitional provisions in Part 10. Below, we explain what these transitional provisions mean.
VMR 2013
Means the Veterinary Medicines Regulations 2013, as applicable in Great Britain, as they were until immediately before the coming into force of the Veterinary Medicines (Amendment etc.) Regulations 2024 on 17 May 2024.
VMR 2024
Means the Veterinary Medicines (Amendment etc.) Regulations 2024.
Amendments to regulations in the VMR 2013
Regulation 201, transitional provision for amendments to advertising requirements:
- regulation 10 - advertising the product
- regulation 11 - advertising of prescription products, etc
The amendments (including new regulation 10A) apply from 17 May 2024, but you may continue to advertise in accordance with regulations 10 and 11 as set out in the VMR 2013 until 17 August 2024.
Amendments to Schedule 1 - Marketing authorisations
Regulation 200, transitional provision for amended labelling requirements for authorised veterinary medicines and registered homeopathic remedies:
- paragraph 48 - labelling of immediate packaging of veterinary medicinal products
- paragraph 49 - labelling of the outer packaging of veterinary medicinal products
- paragraph 50 - labelling of small immediate packaging units of veterinary medicinal products
- paragraph 51 - package leaflet of veterinary medicinal products
- paragraph 52 - small containers other than ampoules
- paragraph 53 - homeopathic remedies
Marketing authorisation holders and registration holders for homeopathic remedies have until 1 April 2029 to apply for a variation and make the required changes to their labelling/packaging. This means that the labelling should be varied before 1 April 2029.
Marketing authorisation holders and registration holders can continue to supply products with packaging in line with the VMR 2013 until 1 April 2029, provided there were no changes to the marketing authorisation or registration that involve changes to the labelling approved by the VMD since 17 May 2024 and the information on the labelling remains accurate.
Amendments to Schedule 2 - Manufacturing
Regulation 93, registration of manufacturers, importers and distributors of active substances:
- new requirement in paragraph 28 - application for registration
Existing manufacturers, importers and distributors of active substances must register with the VMD by 17 July 2024.
Amendments to Schedule 3 - Supply
Regulation 202, transitional provision for wholesale supply by marketing authorisation holders:
- paragraph 2 - wholesale supply of veterinary medicinal products
Marketing authorisation holders can continue to wholesale supply a veterinary medicine or be in possession of a veterinary medicine for the purpose of wholesale supply until 17 November 2024; from that date they must have a wholesale dealer’s authorisation to wholesale supply.
Regulation 98, registration of online retailers of veterinary medicines (unless they only supply veterinary medicines in the AVM-GSL category):
- new paragraph 3C - application for registration
Existing online retailers must register with the VMD by 17 July 2024.
Regulation 203, transitional provision for new requirement to non-written prescriptions:
- paragraph 5 - prescriptions
Vets, pharmacists and suitably qualified persons have until 17 November 2024 to start recording the reason for prescribing a POM-V/POM-VPS product, for products prescribed without a written prescription.
Regulation 204, transitional provision for amended prescription requirements for veterinary medicines:
- paragraph 6 - written prescriptions
Vets, pharmacists and suitably qualified persons can continue to make a written prescription in accordance with Schedule 3 paragraph 6(1) in the VMR 2013 until 17 November 2024.
A written prescription that is made before 17 November 2024 in accordance with paragraph 6 of Schedule 3 to the VMR 2013 (including a written prescription to which sub-paragraph (1)(b) applies) continues to be valid until it expires in accordance with paragraph 6(2) or (3) of the VMR 2013.
Amendments to Schedule 5 - Medicated feed
Regulation 205, transitional provision for amended labelling requirements for feedingstuffs:
- paragraph 12 - labelling an intermediate feedingstuff containing a veterinary medicinal product
- paragraph 14 - labelling of feedingstuffs containing a medicinal premix
You can continue to supply medicated feed and intermediate feedingstuff labelled in accordance with the VMR 2013 until 17 November 2024.
Regulation 206, transitional provision for amended prescription requirements for medicated feed:
- paragraph 19 - prescriptions for feedingstuffs containing a medicinal premix
A prescription made before 17 November 2024 in accordance with Schedule 5 paragraph 19 in the VMR 2013 continues to be valid until it expires in accordance with paragraph 19(2) of the VMR 2013.
Note that new sub-paragraphs 19(2A) and (2B) and amended sub-paragraph 19(3) apply from 17 May 2024.
Regulation 207, transitional provision for amended tolerances for the level of active ingredient in medicated feedingstuff:
- paragraph 22 - sampling and analysis
Stakeholders may apply the tolerance table as set out in the VMR 2013 in respect of samples taken before 17 November 2024; from this date the amended tolerance table applies.
Regulation 208, transitional provision for new requirements for sampling for cross-contamination of non-target feeds:
- new paragraph 22A - sampling for cross-contamination
Feed business operators must comply with the new requirements from 17 November 2024 onwards.
Amendments to Schedule 6 - Exemption for small pet animals
Regulation 157, registration of persons placing veterinary medicines on the market in accordance with the exemption for small pet animals:
- new paragraph 3A - Register of persons placing veterinary medicinal products on the market (small pet animals)
Existing persons marketing products under Schedule 6 must register with the VMD by 17 November 2024.