With the possibility of a no-deal Brexit still looming, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday released six new guidance documents related to a no-deal scenario—five on importing and exporting medicines and active substances, and one on pediatric studies.
The guidance documents deal more specifically with:
- The approved countries for importing and batch testing of medicines and manufacturing active substances
- Importing medicines from a European Economic Area (EEA) state which is on an approved country for import list
- How the management and oversight of the import of investigational medicinal products from listed countries will work in a no-deal scenario
- Information on the “Written Confirmation” process that will be adopted in a no-deal scenario for active substances manufactured in the UK
- Guidance on Good Distribution Practice requirements for air freight to ensure that medicinal product quality and security are protected.
As far as the lists of approved countries, MHRA says it will allow importation of human medicines under a UK wholesale dealer’s license from the EU countries plus Iceland, Liechtenstein and Norway…