Medicines And Medical Devices Act 2021

Part 3: Veterinary Medicines

Chapter 1: Regulations

Section 10: Power to make regulations about veterinary medicines

91. Section 10(1) confers a delegated power to amend or supplement the Veterinary Medicines Regulations 2013 (SI 2013/2033) by regulations.
92. The power is targeted in its scope because regulations made under it may only contain provision relating to the matters specified on the face of the Act at sections 11 and 12. The lists of matters specified in sections 11 and 12 are exhaustive, meaning that only regulatory changes that fall within these descriptions may be made under this power.
93. Section 10(2) provides that when making regulations under section 10(1), the appropriate authority's overarching objective must be to promote one or more of the following:
    • the health and welfare of animals;
    • the health and safety of the public;
    • the protection of the environment.

94. Section 10(3) provides that when considering whether regulations would contribute to the objective set out in section 10(2), the appropriate authority must at least have regard to the three factors set out at paragraphs (a) to (c). These are the safety of veterinary medicines, the availability of veterinary medicines, and the likelihood of a relevant part of the UK (England, Scotland, Wales or Northern Ireland) being seen as a favourable place in which to develop, manufacture or supply veterinary medicines. Other factors may of course be relevant to any decision to exercise the delegated power.
95. Section 10(4) provides that the appropriate authority may make regulations under section 10(1) that may have an impact on the safety of veterinary medicines only if the authority considers that the benefits of doing so outweigh the risks.
96. The delegated power is conferred on the "appropriate authority" as defined in section 10(6). In relation to England, Scotland and Wales, the "appropriate authority" is the Secretary of State. "Secretary of State" is defined in the Interpretation Act 1978 to mean any Secretary of State but in practice it would be the Secretary of State for Environment, Food and Rural Affairs exercising this power. In relation to Northern Ireland, the "appropriate authority" is the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting alone, or the Secretary of State and the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting jointly.

Section 11: Manufacture, marketing, supply and field trials

97. Subsection (1) lists matters relating to the manufacture, marketing, supply and field trials of veterinary medicines that regulations made under the power at section 10(1) can cover.
98. Subsection (1)(a) allows provision to be made in relation to manufacturing authorisations for veterinary medicines. As a general rule, a manufacturing authorisation is required by any person manufacturing a veterinary medicine in the UK as set out in regulation 5 (manufacture of veterinary medicinal products) of the Veterinary Medicines Regulations 2013. If someone wishes to manufacture an authorised veterinary medicine, they must obtain a manufacturing authorisation and comply with Good Manufacturing Practice. This describes the minimum standard that a medicines manufacturer must meet in their production processes.
99. Subsection (1)(b) allows provision to be made in relation to authorisations to import veterinary medicines. In general, regulations are in place to secure supply chains for veterinary medicines entering the UK. In respect of most veterinary medicines, in order to import those medicines into the UK, one or more authorisations are required, for example a wholesale dealing authorisation. These requirements are detailed in regulation 9 of the Veterinary Medicines Regulations 2013.
100. Subsection (1)(c) allows provision to be made in relation to wholesale dealing authorisations. Generally, a wholesale dealing authorisation is required by any person supplying medicines by way of wholesale dealing in the UK as set out in regulation 13 (wholesale dealing) of the Veterinary Medicines Regulations 2013. Wholesale dealers are the middle-persons in the supply chain moving products from manufacturers to the persons who will actually supply the product to its end user. Regulations made under section 10(1) that rely on section 11(1)(c) could, for example, amend the process for applying for such an authorisation, add to the requirements that must be met by the holder of a wholesale dealing authorisation, or amend the exceptions to the requirement for a wholesale dealing authorisation.
101. Subsection (1)(d) allows provision to be made in relation to marketing authorisations for veterinary medicines. As a general rule, a marketing authorisation is required to place a medicine on the UK market for sale and supply as set out in regulation 4 (placing a veterinary medicinal product on the market) of the Veterinary Medicines Regulations 2013. An authorised product will have an authorisation number preceded by the symbol "Vm" on its product literature. This offers users a clear guarantee that the product has been assessed and approved in accordance with the instructions on the product literature. Subsection (d) combined with paragraphs (a), (b), (g), and (i) could be used to make provision in regulations under section 10 about using a medicine outside the terms of a marketing authorisation if there is clinical need and benefit (the Cascade).

     Example (3): The Cascade If there is no suitable veterinary medicine authorised in the UK to treat a condition in a species, a vet can treat an animal under his or her care in accordance with the Cascade. The Cascade is provided for in Schedule 4 (Administration of a Veterinary Medicinal Product Outside the Terms of a Marketing Authorisation) of the Veterinary Medicines Regulations 2013. An authorisation sets out the indication(s), species, recommended dosage, methods of administration, and contra-indications (e.g. do not use in pregnant animals). Therefore, in accordance with the Cascade, a medicinal product can be used to treat a disease outside of its authorisation or to treat a different species from that which it is authorised for. For example, vets can prescribe Gabapentin, a human medicine, for use in animals to treat chronic pain, particularly of neuropathic origin, as there is no equivalent veterinary medicine.

102. Subsection (1)(e) allows provision to be made in relation to manufacturing, importing and distributing active substances. Active substances are the raw ingredients used to make veterinary medicines which give the finished product its therapeutic effect. The quality of the active substance is critical to assure the safety, quality and efficacy of the finished veterinary medicine. Regulations relying on this provision could be made, for example, to provide for a registration scheme for importers, manufacturers and distributors of active substances.

     Example (4): Veterinary Medicines prescribing policy Some veterinary medicines can only be supplied against a prescription issued by an appropriate practitioner. An appropriate practitioner can be a Vet, a Pharmacist, or a Suitably Qualified Person (SQP). An SQP is a legal category of professionally qualified persons who are entitled to prescribe and/or supply certain veterinary medicines. The Veterinary Medicines Regulations 2013 set out which groups of professionals have the appropriate qualifications to prescribe and sets out which categories of authorised veterinary medicines they are qualified and registered to prescribe or supply. The Veterinary Medicines Regulations 2013 set out which groups of professionals have the appropriate qualifications to prescribe and sets out which categories of authorised veterinary medicines they are qualified and registered to prescribe or supply. The distribution categories for authorised medicines are: Prescription Only Medicine – Veterinarian (POM-V) Prescription Only Medicine – Veterinarian, Pharmacist, SQP (POM-VPS) Non-Food Animal – Veterinarian, Pharmacist, SQP (NFA-VPS) Authorised Veterinary Medicine – General Sales List (AVM-GSL) Over time the roles of professionals within the veterinary industry will evolve and certain professionals may be added to or removed from this list by amending the Regulations.

103. Subsection (1)(f) covers who can supply veterinary medicines – meaning provision could be made to add additional prescribing professions who would be given appropriately restricted prescribing rights.
104. Subsection (1)(g) covers the requirements that need to be met in relation to the supply of veterinary medicines. Current requirements are detailed in Schedule 3 of the Veterinary Medicines Regulations 2013.
105. Subsection (1)(h) covers the registration or accreditation of persons who sell veterinary medicines over the internet. This could include mandating registration and registration being conditional on specified requirements being met. Currently the Veterinary Medicines Directorate (an executive agency of the Department for Environment, Food and Rural Affairs that aims to protect animal health, public health and the environment) operates a voluntary scheme that accredits UK-based retailers.
106. Subsection (1)(i) allows provision to be made about the circumstances in which veterinary medicines can be administered. This could include provision about circumstances in which veterinary medicines may be administered under the Cascade.
107. Subsection (1)(j) allows provision to be made in relation to notification and reporting requirements. This would include requirements relating to the reporting of adverse reactions to veterinary medicines which are used to ensure that emerging risks in connection with a medicine are identified and acted upon as early as possible.
108. Subsection (1)(k) allows provision to be made in relation to the labelling and packaging of veterinary medicines.

     Example (5): Labels and pictograms The Veterinary Medicines Regulations 2013 includes requirements for the labelling of authorised veterinary medicines. An example of a change that could be made is the introduction of pictograms (standardised pictorial symbols for a word or phrase) to replace or supplement some of the written labelling requirements.

109. Subsection (1)(l) allows provision to be made in relation to the advertising of veterinary medicines. The existing requirements can be found in regulations 10, 11 and 12 of the Veterinary Medicines Regulations 2013. Regulations made under section 10(1) and relying on this provision could, for example, provide for the inclusion of a detailed definition of advertising to provide clarity to industry and improve compliance with the Regulations.
110. Subsection (1)(m) allows provision to be made in relation to animal test certificates granted under paragraph 9 of Schedule 4 to the Veterinary Medicines Regulations 2013. An animal test certificate is required to carry out a veterinary field trial of a veterinary medicine.
111. Subsection (2) provides that regulations may make corresponding or similar provision to EU Regulations 2019/4 and 2019/6, as the appropriate authority sees fit.

Section 12: Fees, offences, powers of inspectors, costs

112. Subsection (1) lists further matters that regulations made under the power at section 10(1) can cover.
113. Subsection (1)(a) allows regulations made under section 10(1) to introduce or amend charges where they relate to functions conferred by regulations made under section 10(1) of the Act or by the Veterinary Medicines Regulations 2013.
114. Subsection (1)(b) allows regulations made under section 10(1) to make the breach of requirements or prohibitions introduced by the regulations a criminal offence. Subsection (2) provides that those regulations may not provide for a criminal offence to carry a sentence of imprisonment of more than two years.
115. Subsection (1)(c) allows regulations made under section 10(1) to apply the existing powers of entry and inspection in veterinary medicines legislation to new prohibitions and requirements introduced by the regulations. The powers of entry and inspection may be applied with modifications. The existing powers in veterinary medicines legislation are at regulations 34 (powers of entry) and 35 (powers of an inspector) of the Veterinary Medicines Regulations 2013.
116. Subsection (1)(d) allows provision to be made in relation to recovering costs which are incurred as a result of administering improvement notices (which are issued when an inspector believes any person is not complying with the Veterinary Medicines Regulations 2013) and seizure notices (which are issued to the person appearing to be in charge of the veterinary medicinal product to be seized).
117. Subsection (2) provides that regulations made under section 10(1) cannot provide for any offence, whether new or existing, to be punishable with a sentence of imprisonment of more than two years.
118. Subsection (3) provides that a power of entry conferred by regulations relying on subsection (1)(c) must not include a power of entry in respect of premises used wholly or mainly as a private dwelling unless those premises, or any part of them, are approved, registered or authorised for the sale or supply of veterinary medicines under a veterinary medicines provision.
119. Subsection (4) defines "veterinary medicines provision" as meaning provision in regulations made under section 10(1) or the Veterinary Medicines Regulations 2013.

Chapter 2: International Agreements: Disclosure of Information

Section 13: Disclosure of information in accordance with international agreements

120. Section 13 confers a power on the Secretary of State and the Department of Agriculture, Environment and Rural Affairs in Northern Ireland to disclose information they hold relating to veterinary medicines.
121. Subsection (2) provides that information may be disclosed to a relevant person outside the UK where it is required in order to give effect to an international agreement or arrangement concerning the regulation of veterinary medicines and the relevant authority considers that the disclosure is in the public interest.
122. Subsection (3) provides that the relevant authority may not disclose commercially sensitive information under this section unless the relevant authority considers the disclosure to be necessary and proportionate.
123. Subsection (4) sets out that, except as provided by subsection (5), a disclosure of information in accordance with this section does not breach the restrictions on disclosure at (a) and (b).
124. Subsection (5) provides that nothing in this section allows disclosures of information that breach data protection legislation or are prohibited by Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016 .
125. Subsection (6) makes it clear that this section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law (for example under common law powers).
126. Subsection (7) provides definitions for terms used in section 13.

Chapter 3: Interpretation etc

Section 14: Interpretation of Part 3 and supplementary provision

127. Section 14 provides definitions for certain terms used in Part 3 of the Act. This section also includes a supplementary provision to update an outdated reference to "the Veterinary Medicines Regulations 2011" to now include the new "Veterinary Medicines Regulations 2013" in section 2, subsection (8)(d) of the Animals (Scientific Procedures) Act 1986.