Division 10.3 Regulatory use and Routine production

‘Regulatory use’ covers the use of animals in procedures with a view to satisfying regulatory requirements, that is to say for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed.

This includes tests carried out in respect of products/substances for which a regulatory submission was foreseen but ultimately not made, for instance because they were deemed unsuitable for the market by the developer and thus fail to reach the end of the development process.

‘Routine production’ includes animals used in the manufacturing process of products such as antibodies and blood based products, for example, animals used in the manufacturing of serum-based medicinal products shall be included within this category.

Efficacy testing during the development of new medicinal products is excluded and shall be reported under category ‘Translational and applied research’.