Question to the Home Office:

To ask the Secretary of State for the Home Department, pursuant to the Answer of 3 June 2026 to Question 4646, how the Animals in Science Regulation Unit (ASRU) ensures statutory requirements are met in practice when granting generic licences for regulatory testing.

Trained Home Office Inspectors assess applications for animal research on a case-by-case basis. All such research must meet the rigorous legal and ethical requirements set out in the Animals (Scientific Procedures) Act 1986.

The use of animals in scientific procedures is only authorised where the proposed work is for a permissible purpose and where the expected benefits to human health, animal health, and the environment, justify the harms to the animals involved. In all cases, the principles of the 3Rs (Replacement, Reduction and Refinement) must be fully applied.

Inspectors consider the scientific purpose of the proposed studies, the regulatory questions they are intended to address, and whether suitable non-animal alternatives are available. These studies support the safe development and use of medicines and other products, meaning the benefits of the work are clearly defined in advance, even where the specific test substance is not known at the outset. In practice, inspectors may request additional information or amendments from applicants to ensure that harms to animals are minimised and that the scientific justification for the work is robust. Once authorised, work must remain within the scope, severity limits and conditions of the licence.