Guidance

General licence to vaccinate against bluetongue serotypes 1,2,4 and 8

Updated 26 September 2024

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This publication is available at https://www.gov.uk/government/publications/bluetongue-general-licence-for-vaccination-against-the-disease/general-licence-to-vaccinate-against-bluetongue-serotypes-124-and-8

This licence allows, subject to compliance with the conditions of the licence, the vaccination of ruminating animals or camelids pursuant to Regulation 19(1) of the 2008 Regulations with inactivated bluetongue vaccines that protect against bluetongue serotypes 1, 2, 4 or 8, provided that the vaccine is covered by a marketing authorisation granted by the Veterinary Medicines Directorate.

The general licence dated 23 August 2012 which came into force at 00:01am on 24 August 2012 is hereby revoked and replaced by this general licence with effect from 9:00am on 26 September 2024.

Signed: Gordon Hickman

Date: 26 September 2024

Authorised by the Secretary of State.

Legislation

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

Conditions of the licence

  1. 1. The person administering vaccine under this licence must only vaccinate the animals with bluetongue vaccine which has been prescribed by the vet normally responsible for caring for the animals.
  2. 2. The animal keeper must keep a record of every animal vaccinated which must be provided to an inspector if required. The record must be retained 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)
    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 (that is, 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
    11. k. county parish holding (CPH) number and address of the holding where vaccination took place
  3. 3. The animal keeper is responsible for making and retaining an accurate record as stipulated in Condition 2.
  4. 4. The animal keeper must complete the record required in condition 3, with the ‘report your use of the BTV-1, 2, 4 and 8 vaccine’ form, as soon as possible and no more than 48 hours from the date of vaccination.
  5. 5. Any person in possession of BTV vaccine must store the vaccine according to the manufacturer’s instructions.
  6. 6. The animal keeper must ensure all excess doses (opened or otherwise) are returned to the prescribing vet.
  7. 7. Any adverse side effects associated with the vaccine, including suspected lack of efficacy, should be reported 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 (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. “Veterinary surgeon” means a suitably qualified person registered with the Royal College of Veterinary Surgeons (RCVS).
  3. 3. “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.
  4. 4. If you suspect notifiable disease, you must report this immediately with the Defra Rural Services Helpline on 03000 200 301.
  5. 5. Nothing in this licence removes your obligation to comply with relevant legislation.
  6. 7. Bluetongue legislation can be found at Bluetongue: how to prevent it and stop it spreading.
  7. 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.
  8. 9. Information on how we use your personal data is set out in APHA’s personal information charter  and privacy notices.

Failure to observe the measures required in this licence is an offence under the 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 APHA on 03003 038 268 or your local authority.

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