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  3. Standard Conditions of Project Licences

Standard Conditions of Project Licences

  1. The licence holder is responsible for the overall implementation of the programme of work specified in this licence and for ensuring that the programme of work is carried out in compliance with the conditions of the licence.
  2. The licence holder shall ensure that the specified programme of work does not involve the application of any regulated procedure to which there is a scientifically satisfactory alternative method or testing strategy not entailing the use of a protected animal.
  3. The licence holder shall ensure that regulated procedures are not applied to an animal as part of the specified programme of work if the data to be obtained from the application of those procedures is already available in a Member State and has been obtained there by procedures which satisfy any relevant regulatory requirements of the EU.
  4. The licence holder shall ensure that the regulated procedures applied as part of the programme of work specified in this licence are those which to the greatest extent use the minimum number of animals; involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm; cause the least pain, suffering, distress or lasting harm; and are most likely to provide satisfactory results.
  5. The licence holder shall ensure that the regulated procedures applied as part of the programme of work specified in this licence are designed so as to result in the death of as few protected animals as possible; and to reduce to the minimum possible the duration and intensity of suffering caused to those animals that die and, as far as possible, ensure a painless death.
  6. The licence holder shall ensure that the appropriate level of supervision is provided for all personal licensees carrying out regulated procedures under the authority of this licence.
  7. The licence holder shall ensure that a regulated procedure is not applied to an animal as part of the programme of work specified in this licence if the procedure may cause the animal severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.
  8. The licence holder shall ensure that where a regulated procedure is being applied to an animal as part of the programme of work specified in this licence, any unnecessary pain, suffering, distress or lasting harm that is being caused to the animal shall be stopped.
  9. The licence holder shall ensure that where a regulated procedure is applied to an animal as part of the specified programme of work, death as the end point of the procedure is avoided as far as possible and is replaced by an early and humane endpoint; and as soon as the purpose of the procedure has been achieved, the procedure is stopped and appropriate action is taken to minimise the suffering of the animal.
  10. The licence holder shall ensure that where a regulated procedure has been applied to an animal as part of the programme of work specified in this licence, a suitably qualified person classifies the severity of the procedure as “non-recovery”, “mild”, “moderate” or “severe” using the criteria in Annex 8 of the Animals Directive. For the purposes of this condition, a series of regulated procedures applied to an animal for a particular purpose is to be treated as constituting a single regulated procedure.
  11. Where a series of regulated procedures are applied to an animal for a particular purpose the licence holder shall ensure that the animal is killed at the end of the series unless a veterinary surgeon or other competent person has determined that the animal is not suffering and is not likely to suffer adverse effects, as a result of the regulated procedures.
  12. Regulated procedures shall not be carried out on any stray animal of a domestic species as part of the programme of work specified in this licence.
  13. Except with the authorisation of the Secretary of State, regulated procedures shall not be carried out as part of the programme of work specified in this licence on any of the following types of animal—
    1. any feral animal of a domestic species;
    2. any animal taken from the wild;
    3. a marmoset unless it is the offspring of marmosets bred in captivity or has been obtained from a self-sustaining colony of marmosets;
    4. any animal of a description specified in Schedule 2 to the Act unless it has been bred for use in procedures.
  14. If the application of regulated procedures to animals taken from the wild is authorised in this licence the holder shall ensure—
    1. that animals taken from the wild are captured by a competent person using a method which does not cause the animal avoidable pain, suffering, distress or lasting harm; and
    2. that an animal taken from the wild which is found to be injured or in poor health is not subjected to a regulated procedure unless and until it has been examined by a veterinary surgeon or other competent person; and, unless the Secretary of State has agreed otherwise, action has been taken to minimise the suffering of the animal.
  15. The licence holder must give any necessary assistance to inspectors carrying out visits by virtue of section 18(2A)(b); and to experts of the European Commission carrying out duties under Article 35 of the Animals Directive.
  16. If the licence holder becomes aware of a failure to comply with any conditions of the licence the holder must take appropriate steps to rectify the failure (if it is capable of being rectified); and keep a record of the steps taken.
  17. All authorised procedures shall be carried out under general or local anaesthesia unless—
    1. anaesthesia would be more traumatic to the animal concerned than the procedures themselves; or
    2. anaesthesia would be incompatible with the purposes of the procedures.
  18. The licence holder shall ensure adherence to the severity limits as specified in the project licence and observance of any other controls described in the licence. If these constraints appear to have been or are likely to be, breached, the holder shall ensure that the Secretary of State is notified as soon as possible.
  19. The licence holder shall maintain a contemporaneous record of all animals on which procedures have been carried out under the authority of the project licence. This record shall show the procedures used and the names of personal licensees who have carried out the procedures. The record shall, on request, be submitted to the Secretary of State or made available to an Inspector.
  20. The licence holder shall send to the Secretary of State, before 31 January each year (and within 28 days of the licence having expired or been revoked), a report in a form specified by the Secretary of State, giving details of the number of procedures and animals used, and the nature and purpose of the procedures performed under the authority of the project licence during the calendar year.
  21. The licence holder shall maintain a list of publications resulting from the licensed programme of work and a copy of any such publication shall be made available to the Secretary of State on request. The list shall, on request, be submitted to the Secretary of State or made available to an Inspector, and it shall be submitted to the Secretary of State when the licence is returned to him on expiry or for revocation.
  22. The project licence holder shall submit such other reports as the Secretary of State may from time to time require.
  23. The project licence holder shall ensure that details of the programme of work and regulated procedures specified in the licence, and any additional conditions imposed on those procedures, are known to—
    1. all personal licensees performing those procedures;
    2. the named person responsible for compliance;
    3. the named animal care and welfare officers responsible for the day today care of the animals;
    4. the named veterinary surgeon, on request; and
    5. the named information officer and named training and competency officer, on request.
  24. The licence holder must obtain the permission of the Secretary of State before—
    1. any animal undergoing regulated procedures is moved from a place specified in one section 2C licence to a place specified in another section 2C licence; or
    2. any animal is released for slaughter, unless this is already explicitly authorised by the project licence.
  25. The licence remains the property of the Secretary of State, and shall be surrendered to him on request.
Standard Conditions of Establishment Licences can be downloaded from the Home Office web site.
Updated on 12th May 2020

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