The Veterinary Medicines Regulations 2013

[^M_E_d8e10065-cae8-47d0-a162-ef1337800e15]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_da06ec81-a3c3-4665-9906-0a158f663a74]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_daaa5b77-b9ee-4146-fe0e-d743b86eaabd]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_db16c54d-2977-4994-d2b3-ba373fee8efc]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_db24ca4d-d759-4fad-d9a5-b5ce27380801]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_dba2d448-6744-4e79-bdad-1f5d59418cd4]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_dbf7ca94-c9d3-4176-f957-39729a255336]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_dc0821c1-c241-4b72-ab85-7c081836d770]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_dde61a2b-594f-4791-ba1f-be4f10ceb9cc]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_df5d0af3-7cbc-4acb-e28c-cfb41dd08f9b]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_dfebd5bb-94a3-490d-8d95-fd9015148217]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e12d631c-faa6-4fd1-d76d-b2781b459100]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e2344fff-dd72-4202-bf12-6e3fd8e845e7]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_e24ba8eb-2ade-4369-82b3-d0158210d123]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e2d47872-4306-4f2a-b9a6-e7f132577fb1]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_e57907be-8689-434b-8b52-29c6ead1b3e1]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e606abb6-22af-4776-ced4-9f57293378cf]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e6832935-d4e1-4043-bbe6-b91cc28e783a]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e6f1b664-ea9d-44ee-e308-afa6fa21c5b1]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_e740a3e8-e107-4d52-c7f1-3ab7d5490577]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e7f2f464-3453-4665-a24a-6b28064d8736]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e824a786-b550-430f-ed97-4b73095d958d]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e8aed68e-6ad2-4359-9e18-d9f99a9e5f78]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e955679b-7ba1-441b-fa9d-3f1fa78378b4]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ea6b0ef6-5955-4ac3-ae36-185f93936f14]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_ecf5700b-029e-4b96-a775-778405923532]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ed9d84c6-fe44-4a6a-d0ff-61725f11e15f]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_ee22e2ba-0785-40f5-f852-169a0f8352ac]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ef93abf5-b0c9-4961-d86c-100543a293de]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_efef9dd7-c5c8-4e6f-e9a6-79a656d889ae]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f14afada-d164-425e-c892-e35f76bd57b7]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f2a9b8a1-ca02-4d62-81e7-e0ef794cd992]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f37cd934-15ba-4595-896c-ec31450e0007]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f3ab0e61-0c49-47e4-ab74-ed9e2dffab53]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f3b3ab19-e07b-4f63-f6c0-ee2614965c98]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f3bea0c2-0b44-4f09-df3c-d5152e4f009e]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f40c5ec4-bd34-47ea-a123-8a4ee9a44c90]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f4dae998-bf88-4d05-bb8a-81b1eb99dfe6]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f541f913-189c-4dce-81bd-612c860fd413]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f5457050-eafe-4891-d33b-1abe54aded7c]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f62f7cca-afad-4806-9bf1-980e290d6818]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f693bcc2-0083-47e2-9590-bd5738e50021]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f6dff9e8-63c5-4d87-9791-3e32ef6bbede]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f73e0d3c-a32c-4d50-a77c-e9175982d157]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f87b4430-6c12-4f95-8048-b81ae9155279]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f9905052-aad6-43a5-dcbc-5a951f7effcf]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_fa1509fa-1650-4e6b-abdb-08eb8ffeabfb]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_fb1e4ad3-b304-470b-975e-b11c02ff56b4]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_fb1ef421-9c15-467d-8354-0f5e5c09fda2]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_fbd2ff39-c486-41fc-f210-1de4d7666f1e]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_fe548e8b-bf53-4e06-ff43-52504846f43b]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_fe62c984-d0f3-47ab-984c-2721eceb1e78]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_ff56c828-da07-4ac0-ece9-8b71a04a056f]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_F_263eafae-f410-4fec-dd02-789a91ccb713]: Sch. 1 para. 39(3) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(23) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_414931e1-b9ab-4cbd-b966-dc59a396ba25]: Sch. 6 para. 3(1)(b) omitted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(36)(b)(ii) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(i)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_5160974a-d190-4671-b374-cce54cc498d5]: Words in reg. 2(2) omitted (E.) (14.12.2019) by virtue of The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) Regulations 2019 (S.I. 2019/1488), regs. 1(1), 27(a)(i); and words omitted (W.) (31.1.2020) by virtue of The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) (Wales) Regulations 2020 (S.I. 2020/44), regs. 1(2), 24(1)(a)(i); and words omitted (S.N.I.) (31.12.2020) by virtue of The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 3(2)(a)

[^M_F_8fbbc7f8-015d-4918-d539-1ff63f2f731d]: Sch. 7 para. 48(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 193(c)

[^M_F_a290f7f1-de47-4213-e1f6-8d41900a246e]: Words in Sch. 5 para. 11(1)(e) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 133(a)(v)(aa)

[^M_F_a8d5ada6-3f2d-4243-a9dc-fb278c5abe42]: Words in Sch. 6 para. 3(1)(a) substittued (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(36)(b)(i) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(i)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_cb182376-27b4-4d7d-adbd-d54098148a73]: Sch. 6 para. 3(1)(c) omitted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(36)(b)(ii) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(e)(i)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_cfa011ea-4dbd-4a5a-a14c-179923ab74cc]: Word in reg. 31(2) omitted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(6)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_d47c2486-040d-4239-f297-f8184dbc37af]: Words in Sch. 5 para. 4 heading substituted (E.) (14.12.2019) by The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) Regulations 2019 (S.I. 2019/1488), regs. 1(1), 27(d)(ii); and said words substituted (W.) (31.1.2020) by The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) (Wales) Regulations 2020 (S.I. 2020/44), regs. 1(2), 24(1)(d)(ii); and said words substituted (S.N.I.) (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 3(4)(b)

[^M_F_e5bb6a8c-f8fd-4dfe-fc6c-bc83c6d41bf3]: Words in Sch. 5 para. 4 substituted (E.) (14.12.2019) by The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) Regulations 2019 (S.I. 2019/1488), regs. 1(1), 27(d)(ii); and said words substituted (W.) (31.1.2020) by The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) (Wales) Regulations 2020 (S.I. 2020/44), regs. 1(2), 24(1)(d)(i); and said words substituted (S.N.I.) (31.12.2020) by The Official Controls (Animals, Feed and Food, Plant Health etc.) (Amendment) (EU Exit) (No. 2) Regulations 2020 (S.I. 2020/1631), regs. 1(2), 3(4)(b)

[^V_NI_0a218585-2d8e-58d6-6f16-fd75c0c52348]: Sch. 5 para. 20(3) substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 3(2)

[^V_NI_1041a6b5-6164-51e4-6212-2c85641e762f]: Reg. 45(3)(a) substituted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(3)(a)

[^V_NI_151890c8-2769-6c01-f6ac-52e8ceb7a391]: Words in reg. 2(2) inserted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(2)(a)

[^V_NI_19ed9122-2fec-1fa0-6202-0318c8065e96]: Words in reg. 2(2) inserted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(2)(c)

[^V_NI_222ac420-19cb-813f-278c-be6178a57d8c]: Words in Sch. 5 para. 3(1) substituted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(4)(b)

[^V_NI_390a2e38-d61b-b9d6-22d2-711a5039101f]: Words in Sch. 5 para. 22(1) substituted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(4)(e)

[^V_NI_4f5c3230-eb27-46b5-0746-a48e8ed235b1]: Sch. 5 para. 29(1) substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 3(3)

[^V_NI_70de797d-2a22-f48a-49d7-bb20996edd82]: Reg. 45(3)(b) substituted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(3)(b)

[^V_NI_8f914ad7-660b-96e8-47ef-db191a8e132b]: Words in reg. 2(2) inserted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(2)(f)

[^V_NI_c0f1723c-ff6a-13fb-f03a-6ca09b6b720a]: Words in reg. 2(2) inserted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(2)(b)

[^V_NI_e3a472f9-0a92-9d20-974c-1937d6ae1e10]: Words in reg. 2(2) inserted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(2)(e)

[^V_NI_f5fa3dd3-0bc9-f271-6bf8-43b37a413978]: Word in Sch. 5 para. 31(q) substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 3(4)

[^V_NI_f7bfe53b-32f6-3232-4d7e-6b067c23bc24]: Words in Sch. 7 para. 17 substituted (14.4.2014) by The Veterinary Medicines (Amendment) Regulations 2014 (S.I. 2014/599), regs. 1, 4(2)

[^V_NI_fb0c3331-1fb6-e6ca-ec34-32800ab3841a]: Reg. 45(3)(d) substituted (26.3.2019) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(a), 2(3)(d)

Application in a member State

SCHEDULE 1A — Converted EU marketing authorisations

1

In this Schedule—

• “converted EU marketing authorisation” means an EU marketing authorisation to which paragraph 2 applies;

• “EU marketing authorisation” means a marketing authorisation for a veterinary medicinal product granted by the European Commission in accordance with Title 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

2

This paragraph applies to an EU marketing authorisation which—

• (a) was granted before exit day, and

• (b) remains in force immediately before exit day.

3

A converted EU marketing authorisation has effect on and after exit day for the purposes of these regulations as if it were a marketing authorisation granted by the Secretary of State under these Regulations on the date it was originally granted—

• (a) on the terms which were in force immediately before exit day,

• (b) with the benefit of any periods of data marketing exclusivity from which the holder benefited immediately before exit day, and

• (c) subject to any suspension or post-authorisation obligations which were in force immediately before exit day.

4

Without prejudice to the generality of paragraph 3—

• (a) the holder of a converted EU marketing authorisation is subject to the annual fee as set out in paragraph 26 of Schedule 7;

• (b) a converted EU marketing authorisation is to be treated as having been granted in accordance with regulation 4(3) and Schedule 1 for the purposes of Regulation (EC) No 469/2009.

SCHEDULE1B — Qualifying Northern Ireland good (QNIG) certificates

1

In this Schedule—

• “QNIG certificate” means a certificate issued under paragraph 3;

• “QNIG certificate holder”, in relation to a QNIG certificate, means the person to whom that certificate was issued under paragraph 3;

• “qualifying Northern Ireland goods” has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

• “Northern Ireland VMRs” means the Veterinary Medicines Regulations 2013 as they have effect in Northern Ireland.

2

This Schedule applies to a veterinary medicinal product which is—

• (a) a qualifying Northern Ireland good in respect of which there is a marketing authorisation valid in Northern Ireland under the Northern Ireland VMRs,

• (b) not a product in respect of which there is a marketing authorisation which is valid in Great Britain (including any marketing authorisation which has effect under paragraph 3 of Schedule 1A),

• (c) not a product in respect of which a QNIG certificate issued under this Schedule already applies, and

• (d) not a product to which Article 41(1) of the EU withdrawal agreement applies.

3

If the condition in paragraph 4 is met in respect of the veterinary medicinal product, the Secretary of State must issue a QNIG certificate in respect of that product to the person who holds a marketing authorisation in respect of the product which is valid in Northern Ireland under the Northern Ireland VMRs.

4

The condition is that the person who holds a marketing authorisation in respect of the product which is valid in Northern Ireland under the Northern Ireland VMRs, who must be a person established in Northern Ireland, has provided the Secretary of State with the following information—

• (a) the Northern Ireland address of that person;

• (b) all necessary administrative information, and all scientific documentation necessary for demonstrating the safety, quality and efficacy of the veterinary medicinal product, equivalent to that which would need to be provided under Schedule 1 if an application for a marketing authorisation was to be made in respect of that product under paragraph 1 of that Schedule (allowing for any relevant derogations provided for in Part 2 of that Schedule);

• (c) the name and address of a person who resides in the United Kingdom or in a member State who is to provide in respect of the veterinary medicinal product, permanently and continuously, the services of a qualified person (pharmacovigilance) for the purposes of Part 8 of Schedule 1.

5

A QNIG certificate has effect as if it were a marketing authorisation granted by the Secretary of State under these Regulations subject to the modification that the qualified person (pharmacovigilance) for the purposes of Part 8 of Schedule 1 is the person identified under paragraph 4(c).

6

The QNIG certificate holder must provide to the Secretary of State from time to time such further information as is appropriate to ensure that the information provided under paragraph 4 remains accurate and complete.

7

Without prejudice to any other power to suspend a marketing authorisation under Schedule 1, if the Secretary of State considers that a QNIG certificate holder is in breach of these Regulations as modified by paragraph 5, or that the information provided in respect of the matters specified in paragraph 4 is no longer accurate or complete, the Secretary of State may by notice suspend the QNIG certificate.

8

The Secretary of State must publish any notice given under paragraph 7 in such manner as the Secretary of State considers appropriate from time to time.

9

Paragraphs 39 and 40 of Schedule 1 apply to the suspension of a QNIG certificate under paragraph 7 as they would to the suspension of such a certificate under paragraph 38 of that Schedule as read with paragraph 5.

Enforcement of Regulation (EU) 2017/625

Trade between countries

Application for a marketing authorisation for a pharmaceutical , immunological or biological that is not immunological veterinary medicinal product

Application for a marketing authorisation based on informed consent

Application for the renewal of a ... marketing authorisation

Inducements and hospitality

10A

• (1) Subject to paragraphs (2) and (4), where veterinary medicinal products are being promoted to persons qualified to prescribe or supply veterinary medicinal products, no person may supply, offer or promise to any person any gift, pecuniary advantage or benefit in kind unless it is inexpensive and relevant to the practice of veterinary medicine or pharmacy.

• (2) The provisions of paragraph (1) do not prevent any person offering hospitality (including the payment of travelling or accommodation expenses) at events for purely professional or scientific purposes to persons qualified to prescribe or supply veterinary medicinal products, provided that—

• (a) it is subordinate to the main scientific objective of the event; and

• (b) it is offered only to animal health professionals.

• (3) Subject to paragraph (4), no person may offer hospitality (including the payment of travelling or accommodation expenses) at a meeting or event held for the promotion of veterinary medicinal products unless—

• (a) it is subordinate to the main purpose of the meeting or event, and

• (b) the person to whom it is offered is an animal health professional.

• (4) Nothing in this regulation affects measures or trade practices relating to prices, margins or discounts which were in existence on the date on which the Veterinary Medicines (Amendment, etc.) Regulations 2024 came into force.

• (5) No person qualified to prescribe or supply veterinary medicinal products may solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship prohibited by this regulation.

Advertising of prescription products and products containing psychotropic drugs or narcotics

Defence of publication in the course of business

Wholesale dealing

Feedingstuffs

Exemptions

Fees

Reporting of sales and usage data in relation to antibiotics

24A

• (1) Where the Secretary of State serves a notice in writing on any person mentioned in paragraph (2) requiring that person to provide any information held by that person in relation to sales and usage of antibiotics from any records made for the purposes of these Regulations the person must provide that information.

• (2) The persons are—

• (a) the holder of a manufacturing authorisation;

• (b) the holder of a marketing authorisation;

• (c) the holder of a wholesale dealer’s authorisation;

• (d) a keeper of food-producing animals;

• (e) a feedingstuffs manufacturer;

• (f) a veterinary surgeon.

Information with the application: general

Information with the application: format

2A

• (1) An application must be submitted electronically.

• (2) Subject to sub-paragraph (3), the application must be structured as a single dossier in four parts—

• (a) Part 1 (administrative information);

• (b) Part 2 (pharmaceutical quality (physicochemical, biological or microbiological) data);

• (c) Part 3 (safety documentation, including safety and residue tests);

• (d) Part 4 (efficacy documentation, including pre-clinical studies and clinical trials).

• (3) An application concerning the release of GMOs must set out the environmental risk assessment in respect of that release as a separate document, and that assessment must be presented in accordance with the following provision of the GMO Deliberate Release Regulations—

• (a) as regards England or Scotland, regulation 6;

• (b) as regards Wales, regulation 7.

Information with the application: animal testing

2B

• (1) Where information to be included in an application under paragraph 2(8) includes information concerning experiments on animals, this paragraph applies in respect of that information.

• (2) The application must state whether the information was obtained from an experiment conducted in accordance with the requirements in sub-paragraph (4).

• (3) The Secretary of State must, in assessing the application, disregard any information to which this paragraph applies which was not obtained from an experiment conducted in accordance with the requirements in sub-paragraph (4).

• (4) The requirements are—

• (a) the experiment was conducted in accordance with a detailed written protocol prepared in advance;

• (b) the experiment was designed to use the minimum number of animals and cause the least pain, suffering or lasting harm, and there was no satisfactory alternative in vitro test available to be used which would have reduced these impacts;

• (c) informed consent to the experiment and its consequences (including as regards disposal of treated animals and the taking of produce from treated animals) was obtained in writing from the owner of the animal before the animal was first treated under the experiment;

• (d) the welfare of the animals was subject to veterinary supervision throughout the experiment.

Information with the application: POM-VPS, NFA-VPS and AVM-GSL

2C

• (1) Where an applicant proposes, under paragraph 2(2)(d), that a marketing authorisation be granted on the basis that the veterinary medicinal product is classified as POM-VPS, NFA-VPS or AVM-GSL, the requirements in this paragraph apply.

• (2) The application must include a document which sets out a detailed justification for the suitability of such classification, having regard to—

• (a) animal safety (both as regards treated animals and other animals);

• (b) public health; and

• (c) environmental safety.

Summary of product characteristics

Supply of a copy of the summary of product characteristics

Time limits for applications for products for use in food-producing animals

Application for a generic veterinary medicinal product

Hybrid veterinary medicinal products

10A

An applicant for a marketing authorisation must provide the results of relevant pre-clinical studies or clinical trials where—

• (a) bioavailability studies are not capable of demonstrating bioequivalence between the veterinary medicinal product for which the authorisation is sought and a reference veterinary medicinal product for the purposes of paragraph 10; or

• (b) the veterinary medicinal product for which the authorisation is sought is not pharmacologically equivalent to a reference veterinary medicinal product for the purposes of paragraph 10 as a result of a difference in relation to—

• (i) the active substance or substances contained in the product;

• (ii) the strength of the product;

• (iii) the indications for use of the product;

• (iv) the pharmaceutical form of the product;

• (v) the route of administration of the product;

• (vi) the withdrawal period for the product.

Time limits for marketing authorisations granted under the procedure for a generic veterinary medicinal product

Extension of time limits

Time limits – supplementary

12A

• (1) Subject to sub-paragraph (3), a study, residue test or pre-clinical study in relation to the establishment of residue limits submitted by an applicant in relation to an application for a marketing authorisation or a variation of a marketing authorisation may not be used for any other such application or variation until the period of five years from that submission has elapsed.

• (2) Subject to sub-paragraph (3), a study, residue test or preclinical study submitted by an applicant for a marketing authorisation or a variation in a marketing authorisation which demonstrates a reduction in antimicrobial resistance in relation to a reference product may not be used for any other such application until a period of four years in addition to the relevant protection period has elapsed.

• (3) Sub-paragraphs (1) and (2) do not apply where an applicant has obtained a written authorisation to access a study, residue test or pre-clinical study mentioned in the relevant sub-paragraph.

Parallel imports

Specific batch control scheme

Similar immunological products

Marketing a product authorised in another country

Withdrawal of application for marketing authorisation

22A

• (1) Where an applicant for a marketing authorisation withdraws the application before the Secretary of State has produced an assessment of the dossier under paragraph 21 the applicant must give written reasons for so doing.

• (2) Where an applicant withdraws an application for a marketing authorisation in the circumstances mentioned in sub-paragraph (1) the Secretary of State must publish—

• (a) the fact that the application has been withdrawn; and

• (b) a summary of the reasons for withdrawal.

Marketing authorisations for food-producing species

Refusal of a marketing authorisation

Publication following the grant , refusal, suspension, variation or revocation of a marketing authorisation

Marketing authorisations in exceptional circumstances

Provisions of samples and expertise

Records and supply of information

Duties on the holder of a marketing authorisation relating to an immunological product

Control tests

Placing on the market

Duration and validity of marketing authorisation

Variation procedure

33A

• (1) Subject to sub-paragraphs (2) and (6), an application for a variation must be submitted to the Secretary of State electronically.

• (2) Sub-paragraph (1) does not apply where the application is an emergency application.

• (3) The application must contain—

• (a) a description of the proposed variation;

• (b) information in relation to any of the matters referred to in paragraph 2 which are relevant to the proposed variation;

• (c) details of any marketing authorisation which may be affected by the proposed variation; and

• (d) where the proposed variation requires consequential variations to the terms of the marketing authorisation, a description of those variations.

• (4) The Secretary of State must produce an assessment of the application.

• (5) The Secretary of State may require the applicant to provide additional information during the assessment process.

• (6) Where the Secretary of State is satisfied that it is not necessary for the application to contain certain information for the purposes of conducting an assessment, having regard to the risks involved with the proposed variation, the Secretary of State may waive the requirement to provide that information under sub-paragraph (3) (and the requirement in sub-paragraph (4) does not apply in respect of that information).

• (7) The Secretary of State must send a copy of the assessment mentioned in sub-paragraph (4) to the applicant.

• (8) Having assessed the application, the Secretary of State must—

• (a) amend the authorisation to correspond with the proposed variation; or

• (b) reject the proposed variation.

• (9) Where the Secretary of State amends the authorisation in accordance with sub-paragraph (8)(a) the Secretary of State must notify the applicant in writing.

• (10) The Secretary of State must ensure that the determination of an application for a variation of a marketing authorisation is completed within a maximum of 180 days after the submission of the application.

Refusal of a variation of a marketing authorisation

Administrative variations

Changes after a marketing authorisation has been issued

Compulsory variation

Suspension , revocation, etc of a marketing authorisation: grounds

Temporary restrictions

41A

Where urgent action is necessary for protecting human or animal health or the environment, the Secretary of State may, on a temporary basis—

• (a) restrict the supply of a veterinary medicinal product;

• (b) restrict the use of a veterinary medicinal product;

• (c) suspend the authorisation of a veterinary medicinal product;

• (d) require the holder of a marketing authorisation for a veterinary medicinal product to submit an application for variation of the authorisation.

Restrictions in relation to immunological veterinary medicines

41B

The Secretary of State may prohibit the manufacture, importation, distribution, supply or use of immunological veterinary medicines in any part of Great Britain where—

• (a) the administration of the product to an animal interferes with the implementation of a programme for the diagnosis, control or eradication of animal disease;

• (b) the administration of the product to an animal causes difficulty in relation to the certifying of absence of disease in live animals or contamination of foodstuffs or other products from treated animals; or

• (c) the strains of disease agents in relation to which the product is intended to confer immunity are largely absent from the territory concerned.

Labelling of immediate packaging of veterinary medicinal products

Labelling of the outer packaging of veterinary medicinal products

Labelling of small immediate packaging units of veterinary medicinal products

Package leaflet of veterinary medicinal products

Duties of marketing authorisation holder in relation to pharmacovigilance

Duties of marketing authorisation holder in relation to signal management process

56A

• (1) A marketing authorisation holder must carry out the signal management process mentioned in paragraph 56C on reports received (whether those reports derive from the United Kingdom or any other country) in relation to any veterinary medicinal product for which it holds an authorisation.

• (2) The marketing authorisation holder must record on an annual basis the results of the signal management process mentioned in paragraph 56C in relation to the product.

• (3) Where, as a result of the carrying out of the signal management process, a new risk or a change in the benefit-risk balance of the product is identified, the marketing authorisation holder must notify the Secretary of State promptly and in any event within 30 days of such identification.

• (4) Where the signal management process identifies the necessity for a variation in an authorisation the marketing authorisation holder must submit an application for such a variation to the Secretary of State promptly.

Duties of qualified person (pharmacovigilance)

56B

A qualified person (pharmacovigilance) must—

• (a) establish and maintain a system which ensures that all suspected adverse events which are brought to the attention of the marketing authorisation holder in relation to a veterinary medicinal product are collected and recorded;

• (b) monitor the performance of each product which is the subject of a marketing authorisation, apply the signal management process mentioned in paragraph 56C and ensure that any relevant requirements in accordance with the process are carried out;

• (c) maintain the pharmacovigilance system master file for each such product;

• (d) provide to the Secretary of State any information relevant to detecting a change to the benefit-risk balance of a veterinary medicinal product including the results of any study or clinical trial carried out in relation to the product;

• (e) communicate the fact that a regulatory measure has been taken in a country other than the United Kingdom as a consequence of pharmacovigilance data and the nature of such measure to the Secretary of State within 30 days of the receipt of such information, if no equivalent to that regulatory measure has already been taken in the United Kingdom;

• (f) answer fully and promptly any request from the Secretary of State for the provision of additional information necessary for the evaluation of the benefit-risk balance of that product;

• (g) monitor the pharmacovigilance system and ensure that, if required, an appropriate preventative or corrective action plan is prepared and implemented on behalf of the marketing authorisation holder through the use of audits and routine monitoring;

• (h) following any action taken in accordance with paragraph (g), ensure that any relevant amendments are made to the pharmacovigilance system master file;

• (i) liaise with the Secretary of State in relation to any pharmacovigilance inspection carried out under paragraph 60A;

• (j) ensure that any person employed by the marketing authorisation holder who is engaged in pharmacovigilance receives ongoing training which is relevant to that person’s duties.

Signal management process

56C

• (1) For the purposes of these Regulations, “signal management process” means a process for performing active surveillance of pharmacovigilance data for veterinary medicinal products in order to assess the pharmacovigilance data and determine whether there is any change to the benefit-risk balance of those veterinary medicinal products, with a view to detecting risks to animal or public health or protection of the environment.

• (2) A signal management process must consist of tasks of signal detection, validation, confirmation, analysis and prioritisation, assessment and recommendation for action.

• (3) A signal management process must be capable of identifying, at a minimum, in relation to a product—

• (a) a sudden and unexpected increase in the number of adverse events;

• (b) an unexpected increase in the frequency of a known clinical sign;

• (c) a new clinical sign;

• (d) reports in scientific literature of any of the matters mentioned in paragraphs (a) to (c).

Adverse events following administration of a veterinary medicinal product

Adverse reactions to a veterinary medicinal product administered in another country

Annual benefit-risk reports

Release of information by the marketing authorisation holder

Pharmacovigilance inspections by Secretary of State

60A

• (1) The Secretary of State must, from time to time, inspect the pharmacovigilance systems of marketing authorisation holders for the purpose of verifying compliance with the provisions of this Schedule in relation to pharmacovigilance.

• (2) The frequency of inspections under sub-paragraph (1) must be based on the risks associated with each marketing authorisation holder’s history and the nature of the products included in their pharmacovigilance system.

• (3) Within 90 days after an inspection, the Secretary of State must issue an inspection report to the holder of the marketing authorisation if the inspection established compliance with best practice in good veterinary pharmacovigilance practice.

Powers of Secretary of State in relation to signal management process

60B

The Secretary of State may decide to perform a targeted signal management process for a given veterinary medicinal product or a group of veterinary medicinal products.

Action taken on account of pharmacovigilance

Manufacturing authorisation

Application for authorisation

Procedure for grant of authorisations and time limits

Application for variation to the authorisation

4A

• (1) The holder of a manufacturing authorisation must notify the Secretary of State, and apply for a variation of the authorisation, before—

• (a) making a material alteration to the premises or facilities used under the authorisation, or to the operations for which they are used;

• (b) changing the qualified person (manufacture), the person with responsibility for quality control or the person with responsibility for production.

• (2) The Secretary of State must process an application under sub-paragraph (1) within 30 days of receiving it unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days.

• (3) The Secretary of State must grant the application under sub-paragraph (1) if satisfied in respect of the matters in paragraph 3(3) as regards the proposed variation.

• (4) The Secretary of State may inspect any site to which the manufacturing authorisation or proposed variation relates in connection with the application.

• (5) Where the Secretary of State is not satisfied for the purposes of sub-paragraph (3), the Secretary of State may—

• (a) reject the application; or

• (b) grant a conditional variation to the manufacturing authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

• (6) The Secretary of State may extend the period for which a conditional variation to the marketing authorisation is granted under sub-paragraph (5)(b).

• (7) Where a conditional variation to the manufacturing authorisation is granted under sub-paragraph (5)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect as so varied without those conditions.

Suspension, revocation etc of the authorisation

Good manufacturing practice certificates and inspection of sites

Report following inspection

Duties on the holder of a manufacturing authorisation

Good manufacturing practice

8A

• (1) A holder of a manufacturing authorisation must ensure that the veterinary medicinal product is manufactured in accordance with this paragraph, whether the manufacturing is performed by the holder or another person.

• (2) The manufacturing operations must be conducted in accordance with a written methodology, to be known as the “pharmaceutical quality system” or “PQS”.

• (3) The PQS must be—

• (a) clear;

• (b) systematically reviewed from time to time in the light of experience; and

• (c) capable of consistently manufacturing veterinary medicinal products which are of the required quality and which meet the requirements of the relevant marketing authorisation.

• (4) The critical steps of the manufacturing process set out in the PQS must be validated.

• (5) Any significant amendments to the PQS must be validated.

• (6) The PQS must provide for—

• (a) appropriately qualified and trained personnel;

• (b) adequate premises and space;

• (c) suitable equipment and access to services;

• (d) suitable materials, containers and labelling;

• (e) relevant procedures and instructions;

• (f) suitable storage and transport;

• (g) investigation into complaints and defects.

• (7) The PQS must provide for any significant deviations from its provisions to be—

• (a) fully recorded, and

• (b) investigated, with appropriate corrective and preventative action implemented.

• (8) The holder of a manufacturing authorisation must ensure that records of the manufacturing process, including distribution, are kept in a comprehensible and accessible form until the later of—

• (a) the date which is five years after the date on which the veterinary medicinal product is placed on the market;

• (b) the date which is one year after the expiry date of the batch of veterinary medicinal product.

• (9) In this paragraph, a process (or part of a process) is “validated” if scientific evidence is assembled which demonstrates that it is capable of consistently delivering expected results.

Recalled and counterfeit products

8B

• (1) The holder of a manufacturing authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation.

• (2) The holder of a manufacturing authorisation must record any veterinary medicinal product which is—

• (a) recalled (whether or not the holder physically receives the recalled product); or

• (b) discovered to be counterfeit.

• (3) Where any veterinary medicinal product is recalled and physically received, the qualified person (manufacture) must assess the recalled product in order to determine whether—

• (a) the product has been stored (including during transport) in accordance with the summary of product characteristics;

• (b) the product is a genuine product and not counterfeit.

• (4) Where the qualified person (manufacture) determines that a recalled veterinary medicinal product does not satisfy sub-paragraph (3)(a) or (b), or where it is not possible for the qualified person (manufacture) to determine whether the product does so, the product may not be re-sold.

• (5) The qualified person (manufacture) must record any assessment and determination made under sub-paragraphs (3) and (4).

• (6) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a manufacturing authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph.

• (7) The holder of a manufacturing authorisation must keep any information recorded under this paragraph for five years.

Qualified persons for manufacture

Refusal, revocation, suspension or variation of appointment

Duties on a qualified person

Register

Test sites

Authorisation to manufacture specific veterinary medicinal products

Prohibition

Personnel

Process of authorisation

Authorisation in relation to blood banks

Authorisation in relation to stem cells

Authorisation in relation to products for administration under the cascade

Suspension, compulsory variation or revocation of authorisation

Labelling

Records

Adverse events

Inspection of sites

PART 2A — Active Substances

Prohibition on manufacture, importation or distribution of active substances unless registered

Application for registration

Good manufacturing or distribution practice

Supply of information

Inspection of sites

Report following inspection

PART 2B — Schedule 2 Offences

Offences

Records

Inspection of premises

Offences

Supply of samples

3A

• (1) Subject to sub-paragraph (2) a person mentioned in paragraph 2(1) or 3(2) may not supply a veterinary medicinal product for promotional purposes.

• (2) Subject to sub-paragraph (3), the person may supply samples of product labelled in a way that clearly identifies them as such to—

• (a) sales representatives who are responsible for promoting the product; or

• (b) those entitled to supply the product during sponsored events.

• (3) Sub-paragraph (2) does not apply in relation to a product containing an antimicrobial substance.

Register of online suppliers of veterinary medicinal products

3B

• (1) No person may supply or offer to supply a veterinary medicinal product classified as POM-V, POM-VPS or NFA-VPS by means of the internet to persons in Great Britain unless the person—

• (a) is established within Great Britain;

• (b) has an address within Great Britain; and

• (c) appears on the register maintained under sub-paragraph (2).

• (2) The Secretary of State must establish, maintain and publish on a website a register of persons who supply veterinary medicinal products by means of the internet.

Application for registration

3C

• (1) An applicant for registration under paragraph 3B must, at least two months before commencing the activity mentioned in paragraph 3B(1) (or in the case of an existing supplier of veterinary medicinal products by means of the internet within two months of the date on which this provision comes into force), submit to the Secretary of State the name and the address within Great Britain of the proposed registration holder.

• (2) Information may be submitted to the Secretary of State pursuant to sub-paragraph (1) prior to the date on which this provision comes into force, and in such a case—

• (a) as regards an applicant for registration who is not an existing supplier of veterinary medicinal products by means of the internet, the relevant period of two months is to be treated as having started on the date of submission;

• (b) as regards an applicant for registration who is an existing supplier of veterinary medicinal products by means of the internet, the information is to be treated as having been submitted within the relevant period of two months.

Duties in relation to online supply

3D

Where a person offers to supply a veterinary medicinal product by means of the internet, that person must make available on each part of the website where the product is offered—

• (a) the statement “registered internet retailer of veterinary medicines”;

• (b) the contact details of the Secretary of State; and

• (c) a link to the published register.

Retail storage of veterinary medicinal products

3E

A retailer of veterinary medicinal products must store (including during transport) a veterinary medicinal product in accordance with the terms of any specific instructions on the label of the product and in accordance with the relevant summary of product characteristics.

Prescriptions by a veterinary surgeon

Prescriptions

Written prescriptions

Duties when a product is prescribed or supplied

Duties in relation to prescribing of antibiotic veterinary medicinal products

7A

• (1) Subject to sub-paragraphs (2) and (3) a veterinary surgeon may not prescribe a veterinary medicinal product which is an antibiotic for prophylactic purposes.

• (2) Without prejudice to paragraph 6(1A), a veterinary surgeon may only prescribe a veterinary medicinal product which is an antibiotic for administration to an animal for prophylactic purposes in exceptional circumstances where the risk of an infection or of an infectious disease is very high and where the consequences of not prescribing the product are likely to be severe.

• (3) Subject to sub-paragraph (2), a veterinary surgeon may only prescribe a veterinary medicinal product which is an antibiotic for administration to a group of animals for prophylactic purposes where the circumstances set out in sub-paragraph (4) apply.

• (4) For the purposes of sub-paragraph (3) the circumstances are that—

• (a) the rationale for prescribing the product to the group of animals is clearly recorded by the veterinary surgeon prescribing it; and

• (b) a management review is carried out by a veterinary surgeon at, or as soon as reasonably practicable after, administration of the product in order to identify factors and implement measures for the purpose of eliminating the need for any future such administration.

• (5) A veterinary surgeon who prescribes a veterinary medicinal product which is an antibiotic must make a record of the satisfaction of the relevant conditions for the purposes of its use in accordance with this paragraph and keep that documentation for at least five years.

Supply by a veterinary surgeon from registered premises

Supply by a veterinary surgeon

Supply by a pharmacist

Supply of a medicinal premix

Labelling at the time of retail supply

Supply of veterinary medicinal products for use under the cascade

Supply by a suitably qualified person

Audit

Wholesale dealer’s authorisation

Application for authorisation

Procedure and time limits for authorisations

Periodic inspections and suspension etc. for lack of use

Application for variation to the authorisation

19A

• (1) The holder of a wholesale dealer’s authorisation must notify the Secretary of State, and apply for a variation of the authorisation, before making a material alteration to the premises or facilities used under the authorisation or the operations for which the premises or facilities are used or where there is a change in the personnel carrying out the role of wholesale qualified person.

• (2) The Secretary of State must process an application under sub-paragraph (1) within 30 days of receiving it unless the Secretary of State notifies the applicant in writing that the time has been extended to 90 days.

• (3) The Secretary of State must grant the application under sub-paragraph (1) if satisfied in respect of the matters in paragraph 18(2) as regards the proposed variation.

• (4) The Secretary of State may inspect any site to which the wholesale dealer’s authorisation or proposed variation relates in connection with the application.

• (5) Where the Secretary of State is not satisfied for the purposes of sub-paragraph (3), the Secretary of State may—

• (a) reject the application; or

• (b) grant a conditional variation to the wholesale dealer’s authorisation for a period specified by the Secretary of State until the deficiency has been addressed.

• (6) The Secretary of State may extend the period for which a conditional variation to the wholesale dealer’s authorisation is granted under sub-paragraph (5)(b).

• (7) Where a conditional variation to the wholesale dealer’s authorisation is granted under sub-paragraph (5)(b) and the deficiency is addressed within the specified period to the satisfaction of the Secretary of State, the authorisation continues to have effect as so varied without those conditions.

Suspension, variation or revocation of the authorisation

Duties on the holder of a wholesale dealer’s authorisation

Register of authorised wholesale dealers

21A

The Secretary of State must establish, maintain and publish on a website a register of authorised wholesale dealers and their sites.

Documentation accompanying veterinary medicinal products supplied wholesale

21B

• (1) This paragraph applies in relation to wholesale supply of veterinary medicinal products.

• (2) The holder of a wholesale dealer’s authorisation must ensure that a document accompanies each consignment of veterinary medicinal products specifying—

• (a) the name of the veterinary medicinal product;

• (b) the strength and pharmaceutical form;

• (c) the date on which the veterinary medicinal product was supplied;

• (d) the quantity of product supplied;

• (e) the batch number;

• (f) the expiry date;

• (g) the name and address of the wholesale dealer supplying the product;

• (h) the means by which the product was transported and the required conditions of storage;

• (i) the name of the person to whom the product was supplied and the address to which it is to be delivered.

• (3) The holder of a wholesale dealer’s authorisation must make a record of the information mentioned in sub-paragraph (2) and must keep it for at least five years.

Recalled, counterfeit or returned products

21C

• (1) The holder of a wholesale dealer’s authorisation must comply with any requirement by the Secretary of State to recall a veterinary medicinal product and must record the details of the recall operation.

• (2) The holder of a wholesale dealer’s authorisation must record any veterinary medicinal product which is—

• (a) recalled (whether or not the holder physically receives the recalled product);

• (b) discovered to be counterfeit; or

• (c) returned.

• (3) Where any veterinary medicinal product is recalled or returned and physically received, the wholesale qualified person must assess the product received in order to determine whether the product has been stored (including during transport) in accordance with the summary of product characteristics.

• (4) Where a recalled or returned veterinary medicinal product has not been stored (including during transport) in accordance with the summary of product characteristics or where it is not possible for the wholesale qualified person to determine whether the product has been stored in accordance with the summary of product characteristics, the product may not be re-sold.

• (5) Any veterinary medicinal products which may not be re-sold must be identified, held separately and destroyed and the holder of a wholesale dealer’s authorisation must develop a suitable procedure to set out the steps to be taken in accordance with this sub-paragraph.

• (6) The holder of a wholesale dealer’s authorisation must keep any information recorded under this paragraph for five years.

Audit

21D

• (1) At least once a year, the holder of a wholesale dealer’s authorisation must carry out a detailed audit of stock and compare the incoming and outgoing veterinary medicinal products recorded with products currently held and record the results of the audit in written form.

• (2) Where, as a result of the audit mentioned in sub-paragraph (1), the holder identifies a discrepancy the holder must—

• (a) make a record of that fact,

• (b) conduct an investigation for the purpose of discovering the cause of the discrepancy, and

• (c) maintain records of that investigation.

• (3) The holder must keep the records mentioned in sub-paragraphs (1) and (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.

Contractual arrangements between holders of wholesale dealer’s authorisations

21E

Where the holder of a wholesale dealer’s authorisation contracts out any wholesale dealing activities to another such holder, the arrangement must record in writing the responsibilities of each party in relation to their respective roles in the supply process and, in particular, in connection with the recall of a veterinary medicinal product under paragraph 21C.

Self-inspection programme

21F

• (1) The holder of a wholesale dealer’s authorisation must have in place a self-inspection programme which ensures that every aspect of its business is inspected at least once a year in order to ensure that it is complying with good distribution practice.

• (2) Where, as a result of the self-inspection mentioned in sub-paragraph (1), the holder identifies any non-compliance the holder must—

• (a) make a record of that fact,

• (b) conduct an investigation for the purpose of discovering the cause of the non-compliance, and

• (c) maintain records of that investigation.

• (3) The holder must keep the records mentioned in sub-paragraph (2) for a period of five years from the date of the audit and the Secretary of State may require the holder to provide a copy of them at any time within that period.

Administration of autogenous vaccines

6A

• (1) An autogenous vaccine may only be administered to animals in exceptional circumstances where no suitable immunological veterinary medicinal product has been authorised in relation to the target species and indication.

• (2) Where a vaccine is used in accordance with sub-paragraph (1) it must be administered in accordance with a prescription under the cascade.

Treatment in exceptional circumstances

Administration of a homeopathic remedy

Administration under an animal test certificate

Misuse of the cascade

9A

A person must not promote or facilitate any purported use of the cascade which is not in accordance with this Schedule.

Offences

Authorisation of manufacturers and distributors of feedingstuffs containing medicinal premixes

Incorporation of a medicinal premix into an intermediate feedingstuff

Incorporation of a medicinal premix into feedingstuffs

Labelling an intermediate feedingstuff containing a medicinal premix

Supply of intermediate feedingstuff or specified feed additive

Supply of feedingstuffs containing a medicinal premix

Medicated feedingstuff prescriptions for feedingstuffs containing a medicinal premix

Writing the medicated feedingstuff prescription

Sampling for cross-contamination

22A

• (1) A feed business operator must ensure that cross-contamination of non-target feeds is as low as is reasonably achievable.

• (2) A feed business operator must analyse samples of non-target feeds in order to determine whether cross-contamination into non-target feed has occurred.

• (3) Where as a result of the process mentioned in sub-paragraph (2) it is determined that a cross-contamination rate has occurred which is 1% or more but less than 3% compared to the authorised maximum content, the feed business operator must make a record of this cross-contamination.

• (4) Where as a result of the process mentioned in sub-paragraph (2) it is determined that a cross-contamination rate has occurred of 3% or more compared to the authorised maximum content, the feed business operator must conduct an investigation in order to discover the cause of the occurrence and make a record of the fact and any conclusions.

• (5) The feed business operator must keep the records under sub-paragraphs (3) and (4) for at least five years.

• (6) Upon request of the Secretary of State, the feed business operator must provide any information in the feed business operator’s possession relating to the matters mentioned in this paragraph.

Storage

Packages and other containers

Transport

Possession, placing on the market and use of feedingstuffs

Unused and expired medicated feedingstuffs

26A

No person may feed medicated feedingstuffs which have passed their expiry date to an animal.

Imports from third countries

Trade between countries

Import for incorporation into intermediate feedingstuffs or feedingstuffs for export

Animals on domestic premises

Offences

Register of persons placing veterinary medicinal products on the market (small pet animals)

3A

• (1) A person placing the product on the market must be registered in accordance with this paragraph.

• (2) An application for registration in respect of that person must be submitted under sub-paragraph (4)—

• (a) at least two months before that person places the product on the market, or

• (b) where that person has already placed the product on the market, within six months of the date on which this provision comes into force.

• (3) Information may be submitted to the Secretary of State pursuant to sub-paragraph (2) prior to the date on which this provision comes into force, and in such a case—

• (a) as regards an applicant for registration who has not already placed the product on the market, the period of two months is to be treated as having started on the date of submission;

• (b) as regards an applicant for registration who has already placed the product on the market, the information is to be treated as having been submitted within the period of six months.

• (4) An application for registration must be made to the Secretary of State electronically and must include—

• (a) the name and address of the person placing the product on the market;

• (b) the individual making the application in respect of that person;

• (c) the telephone number and email address of the individual mentioned in sub-paragraph (b);

• (d) the name and address of the manufacturer of the product;

• (e) the brand name of the product;

• (f) the names and quantities of the active substances;

• (g) the method and (where applicable) route of administration;

• (h) the dosage instructions;

• (i) the category of animal mentioned in paragraph 1 for which the product is intended.

• (5) For the purposes of sub-paragraph (1) the Secretary of State must establish and maintain a register of persons placing on the market products to which this Schedule applies.

• (6) The particulars entered on the register must include the name and the address of the person mentioned in sub-paragraph (1).

Persons registered in accordance with paragraph 3A: annual return

3B

At least once each calendar year a person registered under paragraph 3A must notify the Secretary of State in writing of the following in respect of each product placed on the market—

• (a) the name and registered address of the person (if different from that listed on the register);

• (b) the individual designated for the purpose of making the annual return under this paragraph;

• (c) the telephone number and email address of the individual mentioned in sub-paragraph (b);

• (d) the name and address of the manufacturer of the product;

• (e) the brand name of the product;

• (f) the names and quantities of the active substances;

• (g) the method and (where applicable) route of administration;

• (h) the dosage instructions;

• (i) the category of animal mentioned in paragraph 1 for which the product is intended.

Approval of the active substance

The product

Labelling

Administration

Pack size

Adverse events

Offences

10

It is an offence to fail to comply with—

• (a) paragraph 3A(1);

• (b) paragraph 3B; or

• (c) paragraph 9(1).

Application for a marketing authorisation for specific applications

7A

The fee for an application for a marketing authorisation which involves one or more of the following is £45,000—

• (a) any biotechnical process involving recombinant DNA or the controlled expression of genes;

• (b) a veterinary medicinal product containing a new active substance;

• (c) a biopharmaceutical product.

Decentralised pharmaceutical application where the United Kingdom is the reference member State

Application for a marketing authorisation for an immunological or biosimilar product

Decentralised immunological application where the United Kingdom is the reference member State

Application for a marketing authorisation based on informed consent

Application for an exceptional marketing authorisation (pharmaceutical)

Fees for an application for an exceptional marketing authorisation (immunological or biological non-immunological)

Fee for the conversion from an exceptional to a full marketing authorisation

Application for a marketing authorisation relating to a parallel import

Fee for a generic marketing authorisation

15A

• (1) The fee for a marketing authorisation in respect of a generic veterinary medicinal product is to be calculated in accordance with the following table.

Application	Fee (£) per authorisation	Fee (£) per authorisation
	Hybrid	Standard
Base Fee	13,950	12,390
Fee for 1st additional strength	4,590
Fee for each subsequent additional strength	1,465.

• (2) In this paragraph “hybrid” means an application to which paragraph 10A of Schedule 1 applies.

Application to change the distribution category of a product authorised through the centralised procedure

Application for a variation to a marketing authorisation ....

Application for a variation to a marketing authorisation dealt with under worksharing procedures

Application for an extension dealt with under the decentralised procedure where the United Kingdom is the reference member State

Provision of information relating to the recognition of a United Kingdom marketing authorisation or an extension

Exception for a variation relating to animal testing

Application for a reassessment of an exceptional marketing authorisation

Application for the renewal of a marketing authorisation obtained through mutual recognition or the decentralised procedure

Registration of a homeopathic remedy

Renewal of a homeopathic remedy

Annual fees for marketing authorisations

Auditor’s certificate

Inspection of sites authorised to manufacture a product for administration under the cascade

Autogenous vaccines

30A

• (1) The fee for the scientific assessment of an authorisation (or an application for authorisation) to manufacture an autogenous vaccine is £6,962.

• (2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) to manufacture autogenous vaccines are set out in the following table—