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FOI release

FOI2026/00807 - Regulatory Verification Request — Schedule 6 SEAS Exemption

Published 13 July 2026

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This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-april-2026/foi202600807-regulatory-verification-request-schedule-6-seas-exemption

1. Your request

  1. Please confirm whether the following products, manufactured by Naqua Ltd under ManA1338, are validly listed or exempt under Schedule 6 of the Veterinary Medicines Regulations 2013 (SEAS):
       — IVEBXS623 — Ivermectin Spot-On, Birds & Small Animals Over 500g, 5ml
       — IVEBXS624 — Ivermectin Spot-On, Rodents & Birds Over 60g, 10ml
       — IVEBXS625 — Ivermectin Oral, Birds Over 60g, 5ml
       — IVEBXS626 — Ivermectin Spot-On, Small Animals Over 300g, 0.5ml x 6 pipettes
       — IVEBXS627 — Ivermectin Pour-On, Reptiles Over 80g, 125ml
       — IVEBXS628 — Ivermectin Pour-On, Small Animals Over 500g, 125ml

  2. Please confirm whether each of the above products appears on the VMD’s published register or database of exempted veterinary medicines under Schedule 6.

  3. If any of the above products are not validly covered by Schedule 6 SEAS, or if there are any conditions or restrictions on their wholesale supply that we should be aware of, please advise accordingly.

2. Our reply

Certain veterinary medicines for small pet animals are exempt from the marketing authorisation requirements of the Veterinary Medicines Regulations (VMR), as amended, under Schedule 6. 

Under this exemption, the Veterinary Medicines Directorate (VMD) specifies the active substances, along with their permitted target species and routes of administration, that may be used in eligible products.

Further information, including the list of approved active substances is available on GOV.UK: Exemption from authorisation for medicines for small pet animals - GOV.UK

Unlike most veterinary medicines marketed in the UK, veterinary medicines marketed under the Schedule 6 Exemption do not require a marketing authorisation.

Since November 2024, it has been a legal requirement for any company intending to place a Schedule 6 veterinary medicine on the UK market to register the product with the VMD at least two months prior to marketing. Products may only be registered, and subsequently marketed, if they comply with the published list of approved active substances. 

Each product must be registered individually. This means that where a company markets multiple products containing the same active substance, but with differences such as formulation, target species, route of administration, indications or dosing instructions, or product name, each product must be registered separately with the VMD.

The VMD maintains an internal register of Schedule 6 veterinary medicines, however, this is not currently published. This differs from authorised veterinary medicines, where details are publicly available via the Product Information Database: Product Information Database - Home

Response to Questions 1 and 2: The VMD has provided details of all of Naqua products containing the active substance ivermectin that are currently registered under the Schedule 6 Exemption. 

These products may be legally marketed in the UK, provided they comply with all relevant Schedule 6 requirements, as outlined on GOV.UK.

We note that the product names listed in your request differ from those recorded by the VMD. You may therefore wish to seek clarification from Naqua on this point.  Any products not included in the list provided by the VMD are not currently permitted to be legally marketed in the UK.

Response to Question 3: As outlined above, veterinary medicines may only be marketed in the UK under Schedule 6 if they have been successfully registered with the VMD and meet the conditions set out in the legislations and associated guidance. 

Beyond this, there are no specific additional restrictions for a registered wholesaler. However, exempt products must still comply with the relevant provisions of the VMR, including those relating to manufacture (Good Manufacturing Practice) and wholesale dealing.

There are no restrictions on the retail supply of Schedule 6 products within the UK. However, wholesale supply may only be undertaken by the holder of a valid Wholesale Dealer Authorisation (WDA)

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