The Home Office Animals in Science Regulation Unit is changing the way that it is structured and operates as a regulator, to provide greater consistency, clarity and a more structured approach to inspections via a new audit system.
In practice this means that there will be new ways of communicating with ASRU, removing the dependence upon one-to-one communication with local inspectors in favour of dedicated teams for different regulatory activities.
The changes take effect from 5th July 2021. Any currently planned Inspector visits after that date are likely to be cancelled, unless these related to a specific ongoing matter.
These changes form part of a transitionary period for ASRU, so it is important to provide regular feedback on how they are working in your establishments.
No changes to the primary legislation governing animal research are expected. However, there will be updates made to key guidance documents, including the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 and the Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes.
Routine inspections by the Animals in Science Regulation Unit are no longer going to be conducted by a local Inspector. Instead, there will be three different types of formal audit carried out by dedicated members of the new Compliance Assurance team:
It is expected that more than one member of the Compliance Assurance team will attend each audit, to ensure objectivity. Each audit will provide a clear outcome and contribute to the establishment’s overall risk profile.
You will no longer direct queries to a single allocated Inspector or Single Point of Contact (SPoC). There will be dedicated teams for Regulatory Advice, Compliance Assurance and Licensing. All queries will be sent to dedicated inboxes for each team and will receive centralised, consistent responses. Urgent matters should be marked as such and will be triaged by dedicated staff.
Get in touch with Agenda today, we can help you prepare your facility for these changes.
Contact us today – hello@agendalifesciences.co.uk