Statutory guidance

General licence to use inactivated bluetongue 3 vaccine in England (EXD568(BT)(E))

Published 14 February 2025

Applies to England

• Publication for Northern Ireland
• Publication for Scotland
• Publication for Wales

This licence allows, subject to compliance with the conditions of the licence, the vaccination of ruminating animals or camelids with inactivated bluetongue 3 (BTV-3) vaccine, provided that the vaccine is covered by:

• a marketing authorisation granted by the Veterinary Medicines Directorate; or
• a permit granted by the Secretary of State under schedule 4(4) of the Veterinary Medicines Regulations 2013.

A specific risk assessment has been carried out in accordance with regulation 19(4) of the 2008 Regulations.

The general licence which came into force at midday on 18 October 2024 is hereby revoked and replaced by this general licence with effect from 3:00pm on 14 February 2025.

This general licence applies in England only.

This general licence may be amended, suspended or revoked in writing at any time by the Secretary of State.

Signed: Gordon Hickman

Date: 14 February 2025

Time: 3:00pm

Authorised by the Secretary of State.

Legislation

This licence is made under regulation 19 of the Bluetongue Regulations 2008 SI 2008/962 (as amended).

Conditions of the licence

1. 1. The vaccine shall be administered by a private veterinary surgeon, or the animal keeper may administer the prescribed BTV-3 vaccine and must do so according to the manufacturer’s instructions and veterinary instruction.
2. 2. The person administering the vaccine under this licence must only vaccinate the animals with BTV-3 vaccine which has been prescribed by the vet normally responsible for caring for the animals.
3. 3. Written or digital records must be kept of every animal vaccinated and must be provided to an inspector on request. The record must be retained by the keeper for at least 5 years and contain the following:
   1. a. Species vaccinated,
   2. b. Individual permanent ID number (ear tag or other permanent official animal ID mark),
   3. c. Date of first dose,
   4. d. Date of any further doses,
   5. e. Vaccine product name and batch number,
   6. f. Name and job title of the person who administered the vaccine,
   7. g. Dose administered (ml),
   8. h. Route of administration (i.e. intramuscularly or subcutaneously),
   9. i. The stated withdrawal period of the vaccine used,
   10. j. Any excess doses and the amount (ml), to be returned as per condition 6 below.
   11. k. CPH and address of the holding where vaccination took place,
4. 4. The animal keeper is responsible for making and retaining an accurate record as stipulated in condition 3.
5. 5. As well as retaining a record (written or digital) as required by conditions 3 and 4, the licensee must also submit a digital record of the vaccination activity, compliant with the requirements in condition 3, using the online service to report the use of the BTV vaccine in England. This must be done as soon as possible and no later than 48 hours after the time vaccination takes place.
6. 6. Any person in possession of BTV-3 vaccine must store the vaccine according to the manufacturer’s instructions.
7. 7. The animal keeper must ensure all excess doses (opened or otherwise) are returned to the prescribing vet.
8. 8. Any adverse side effects associated with the vaccine, including suspected lack of efficacy, should be reported by the animal keeper within 7 calendar days of the adverse effects first being observed to the relevant pharmaceutical company (as detailed on the package leaflet) or the Veterinary Medicines Directorate (see guidance on how to report a suspected problem with an animal medicine or microchip).

Explanatory notes

1. 1. The general licence only permits the use of permitted or authorised vaccines to be administered in England.
2. 2. Vaccinated animals must comply with the same movement controls and bluetongue regulations as unvaccinated animals.
3. 3. ‘Veterinary surgeon’ means a suitably qualified person registered with the Royal College of Veterinary Surgeons (RCVS).
4. 4. ‘Animal’ means a ruminating animal or camelid. Ruminating animals includes but is not limited to cattle, sheep, goats and deer. Camelid includes camels, llamas and alpacas.
5. 5. If you suspect notifiable disease, you must report this immediately to the Defra Rural Services Helpline on 03000 200 301.
6. 6. Nothing in this licence removes your obligation to comply with relevant legislation.
7. 7. Bluetongue legislation can be found at Bluetongue: how to prevent it and stop it spreading
8. 8. Vaccinated animals should not be tested as part of pre-movement testing within 7 days of receiving a vaccination dose to minimise the risk of false positives.
9. 9. Information on how we use your personal data is set out in the bluetongue virus (BTV) vaccination recording privacy notice.

Failure to observe the measures required in this licence is an offence under Bluetongue Regulations 2008 (as amended). The penalty on conviction of an offence under this section is a maximum of 3 months’ imprisonment or a fine not exceeding Level 5 on the standard scale or both.

Contact us

For further advice on biosecurity measures and any other legislation that may apply, contact the APHA on 03003 038 268 or your local authority.