- GMP Assessment
Determine which GMP standard applies for the UK market. Post-Brexit, MHRA has its own GMP regime, though it remains closely aligned with EU-GMP.
- UK or Great Britain supply?
Northern Ireland may follow EU rules for some medicinal products under the Windsor Framework. Great Britain (England, Scotland, Wales) follows MHRA-GB rules.
- MHRA-GB GMP — Great Britain
MHRA issues its own GMP certificates post-Brexit. UK-manufactured products require MHRA certification. Imported products require a UK Responsible Person (Import) — RPi.
- MHRA GMP certificate for UK manufacturers
- UK RPi for imported batches (replaces EU QP role)
- RPi must be named on WDA(H)
- EU GMP Still Applies — Northern Ireland pathway
Under the Windsor Framework, NI has a unique dual regulatory status. EU-GMP certificates remain relevant for NI supply chains.
- EU-GMP certificate accepted for NI
- NI-specific supply chains may use EU QP
- Ongoing regulatory complexity — seek legal advice
- Manufacturer location?
Where is the manufacturing site? This determines certificate type and whether MHRA accepts it directly.
- UK Manufacturer — MHRA inspected
UK-based manufacturers are inspected by MHRA and hold UK GMP certificates. These are valid directly for GB supply without additional steps.
- MHRA GMP certificate
- Manufacturing Authorisation (MA) from MHRA
- No RPi required — QP signs release
- MRA / Recognised Country — EU, Australia, Canada, etc.
MHRA has mutual recognition arrangements (MRAs) or recognition agreements with EEA, Australia, Canada, Switzerland, Japan, NZ, Israel. Their GMP certificates are accepted.
- EU-GMP certificates accepted under MHRA recognition
- TGA, Health Canada, Swissmedic — accepted
- Israeli IMFA — accepted under bilateral arrangement
- UK RPi Required — All imports
For all imported batches to GB, a UK Responsible Person (Import) must certify each batch. The RPi takes on the role equivalent to an EU QP for imports.
- RPi named on importer's WDA(H)
- RPi reviews all batch documentation
- RPi signs the batch certificate for UK release
- RPi is legally liable for batch compliance
- Batch Released for UK Supply ✓
RPi-certified batch available for wholesale distribution to UK pharmacies under Schedule 2 controlled substance controls.