UK’s MHRA Offers 6 New No-Deal Brexit Guidances on Importing, Exporting Medicines
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.
Batch testing (quality control testing) of human medicines will be accepted also from all EU countries, plus Iceland, Liechtenstein and Norway, as well as Australia, Canada, Israel, Japan, New Zealand, Switzerland and the US in certain cases.
But the guidance notes that “no batch testing is accepted” from the US as the mutual recognition agreement between the US and UK does not include it. Advanced therapy medicinal products and several other select products are also excluded from mutual recognition agreements with Australia, Canada, Israel, Japan and New Zealand.
Meanwhile, MHRA notes that it will continue to accept importation of active substances into the UK without a written confirmation from all EU countries, plus Iceland, Liechtenstein and Norway, as well as Australia, Brazil, Israel, Japan, Switzerland and the US.
If a sponsor of a UK clinical trial is using investigational medicinal products (IMPs) imported from an EU or EEA country, the sponsor will require a “UK Manufacturing and Import Authorisation (MIA(IMP))” holder to put in place an assurance system to check these IMPs have been certified by a Qualified Person in a listed country, before they are released to the trial.
The guidance on pediatric studies focuses on the submission, processing and assessment of all completed pediatric studies sponsored by Marketing Authorisation Holders (MAHs) in the event of a no-deal scenario.
Collection of MHRA guidance and publications on a possible no deal scenario