Guidance

Animal testing and research: guidance for the regulated community

Guidance and regulatory advice on how to apply for licences issued under ASPA and how your compliance with ASPA and your licence conditions will be assessed.

From:
Home Office
Published
26 March 2013
Last updated
18 December 2024 — See all updates

Animals in Science Regulation Unit (ASRU) guidance and regulatory advice

You can read ASRU guidance that explains how the act is administered and enforced including detailed regulatory advice for licence holders

From 5 July 2021, ASRU now provides regulatory delivery through 2 teams covering different areas each of which has a dedicated inbox. Read the Bridging ways of working guidance for advice.

Apply for licences

Three licences are required by the Animals (Scientific Procedures) Act 1986 (ASPA) before testing on animals is allowed. The 3 licences needed are:

  • personal licence for each person carrying out procedures on animals

  • project licence for the programme of work

  • establishment licence for the place at which the work is carried out

You should use the Animals in Science Procedures e-Licensing (ASPeL) system for all personal and project licence applications.

Contact your establishment’s Home Office liaison contact/administrator to start your application online.

If you are from an establishment that is not yet licensed, email [email protected].

Before applying, please read the standard conditions for personal licences, project licences and establishment licences.

You can also read guidance on:

Add a named person role

People in named person roles are responsible for specific activities under the establishment licence (PEL), and you must add their names to the PEL in ASPeL. For example, the Named Animal Care and Welfare Officer (NACWO) oversees the care and welfare of animals.

Read about the requirements for named person roles in

When you add a named person to a PEL, this is classed as an amendment.

Find out how to nominate someone for a:

Any named person responsible for animal welfare on the PEL will need to complete a conflict of interest declaration form.

Prospective authority licensing requests

Animal studies carried out to meet regulatory requirements will be performed in compliance with UK and EU legislative bodies.

Where studies are performed for other regulatory bodies, for example the US, and the study requirements exceed the UK or EU regulatory requirements, you must submit a prospective authorisation request form to ASRU.

The project licence holder at the establishment should complete the Prospective authorisation form (MS Word Document, 107 KB). Submit the completed form to [email protected].

Project Licence Standard Condition 18 notification

All project licences are subject to a set of standard conditions. Standard Condition 18 requires that the project licence holder (PPLh) notifies the Secretary of State as soon as possible if constraints on the severity limits, or observance of other controls described in the licence, have been breached or are likely to have been breached.

You can read the Advice note - Project Licence Standard Condition 18 Notification (PDF, 544 KB, 22 pages), and use the form Project Licence Standard Condition 18 Notification form (ODT, 31.8 KB) to make reports.

Annual returns on the use of protected animals

Statistics are collected annually in the UK to meet the requirements of the Animals (Scientific Procedures) Act 1986 to collect and publish statistical information on the use of protected animals in regulated procedures.

If you are a project licence holder, read the guidance on the annual returns process.

Newsletters

The Animals in Science Regulation Unit newsletters are sent out by the ASRU. If you have any questions about their content, email [email protected].

Register for updates

Sign up for email updates on this topic.

Contact information

Use [email protected] for:

  • specific queries relating to an individual licence application

  • evidence to support an exemption from mandatory training

  • requests to re-home animals where not already authorised

  • advice on interpretation of licence authorities

  • guidance on becoming an establishment

  • advice on whether work needs to be regulated

  • advice on applying for licences

  • guidance on how we will assess applications

  • information to support a PEL application or amendment notification of AWERB dates

  • AWERB terms of reference

Use [email protected] for:

  • reports of potential non-compliance

  • reports required by a licence condition or as a result of enforcement action

  • advice on whether a non-compliance may have occurred

  • contact during a non-compliance investigation

Use [email protected] for:

  • requests to keep animals alive

  • Standard Condition 18 reports

Use [email protected] for:

  • audit related queries

Use [email protected] for:

  • technical advice on the use of ASPeL

Use [email protected] for:

  • raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction

  • raising concerns about the timeliness or completeness of response from any of our teams or any other concerns about any individual request or interaction from the regulated community

Use [email protected] for:

  • notifying ASRU of upcoming work at a POLE - please ensure the email subject line includes the PPL number, PPL holder’s surname and the name of the establishment

Report a non-compliance

Please use this form to notify ASRU of any incidents where there has been a potential breach of ASPA or a licence condition, this includes the code of practice.

Provide as much information as possible. Incidents of non-compliance should be reported to ASRU. Self-reporting indicates that an establishment is making efforts to ensure compliance. It demonstrates that role holders are aware of their responsibilities and are committed to building a compliant culture.

ASRU expects self-reporting to be embedded within good governance frameworks and that employees are aware of the process for raising concerns within their establishment. This is set out in ASRU’s published compliance policy and guidance on the operation of the ASPA.

Complaints feedback

If you want to give feedback on how we handled your complaint, please email [email protected].

Make a complaint

Please only complete this complaints form if you wish to make a formal complaint.

Please send the completed form to [email protected].

Updates to this page

Published 26 March 2013
Last updated 18 December 2024 + show all updates

  1. Added a new section 'Add a named person role'.

  2. Replaced Potential non-compliance notification form.

  3. Replaced Potential non-compliance notification form as a Word version.

  4. Added the prospective authorisation word document form.

  5. Added the prospective authorisation form and guidance.

  6. Adding information on the complaints procedure.

  7. Updated email address for requesting content about the ASRU newsletter.

  8. Non-compliance notification form published.

  9. Removed link to improving your project licence application - guidance is out of date.

  10. Added link to 'Guidance notes for project license applications' and new section on when to contact [email protected].

  11. Added the following documents: standard genetically altered rodents protocols, standard genetically altered zebrafish protocols, guidance on the use of standard genetically altered animals.

  12. Updated email addresses under 'Apply for licence' and 'Contact information and forms'. Updated 'Register for updates' form link.

  13. Updated 'Bridging ways of working guidance' PDF.

  14. Added link to "Process and standards for establishment full system audits" in "Animals in Science Regulation Unit (ASRU) Guidance and regulatory advice" section.

  15. 'Contact us' section updated to include (word) enquiry form.

  16. Bridging ways of working guidance added.

  17. Added link to non-technical summaries granted in 2020.

  18. Added link to non-technical summaries granted in 2019.

  19. Added a link to the 2019 statistics on scientific procedures on living animals.

  20. Updated to change link from 2017 annual report to 2018 annual report.

  21. Added a link to non-technical summaries granted in 2018.

  22. Added link to non-technical summaries granted in 2017.

  23. Added a link to the 2018 statistics on scientific procedures on living animals.

  24. Updated to add 2017 annual report

  25. Added a new section called, Project Licence Standard Condition 18 notification.

  26. Published 2016 annual report

  27. Updated guidance.

  28. Added 2016 scientific procedures on living animals report.

  29. Newsletter published.

  30. Latest newsletters published.

  31. 2017 annual return form and guidance published.

  32. Newsletter added

  33. Updated application guidance published

  34. Updated scientific procedures on living animals link to the 2015 publication.

  35. Information about working with animals taken from the wild included.

  36. Guidance on standard breeding protocols for genetically modified animals

  37. Added non-technical summaries for projects granted in 2014.

  38. Guidance on the use of human material in animals published.

  39. Form for 2016 annual returns of procedures published.

  40. Updated instructions for the annual returns procedures 2015 published.

  41. New animal use data return procedures form published.

  42. Removed form for outstanding returns from 2014.

  43. Three advice notes published.

  44. Updated guidance.

  45. Updated overview summary.

  46. Updated version.

  47. Explanatory memorandum to the code of practice for the care and accommodation of animals published.

  48. Code of practice for the care and accommodation of animals (short guide) published.

  49. Added links to 'Statistics of scientific procedures on living animals, Great Britain 2012' and 'Animals in Science Regulation Unit Annual Report 2012'.

  50. Link to section 24 online consultation added.

  51. Guidance on Animals (Scientific Procedures) Act 1986 (ASPA) has been published.

  52. Guidance on the naming of products and substances in project licences for batch quality control and regulatory toxicology added.

  53. Volume 1 of the non-technical summaries from licences granted during 2013 released.

  54. Annual returns instructions, notes and form updated

  55. First published.

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