If the UK leaves the EU without a deal, the Human Medicines Regulations 2012 will refer to lists of approved countries for:
- Importation of medicines under a wholesale dealer’s licence
- Batch testing of medicines
- Manufacturing of active substances with regulatory standards equivalent to the UK
The list of approved countries will enable UK importers and wholesalers to continue to recognise batch testing, QP certification and regulatory standards for active substance manufacture performed in certain countries in the same way as before exit day.
This guidance provides the lists of countries and a summary of the circumstances under which the lists can be used.
This guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019…