Batch Testing of Medicinal Products in Great Britain
The Department of Health & Social Care have opened an important consultation on the future pathways for batch testing and release of medicines in the UK.
Brexit brought many changes and resulted in the UK becoming removed of the constraints of EU law and the freedom to set new regulatory policies and procedures. The views are now being sought on how best the UK accepts batch testing results from third countries, or as an alternative, the requirement for specific batch testing in the UK for products intended for the UK market.
Four potential strategies of approach have been put forward. These are:
No import testing or UK QP certification/release for listed countries
No import testing but the implementation of UK QP certification/release for listed countries
Full quality control batch testing & implementing UK QP certification/release
Reduced umber of import tests & implementing QP certification/release for listed countries.
The link to the consultation can be found here:
You have until the 26th of July to respond. Your response will shape the future requirements to this very important pathway in the supply of products.