Product Registration

Workflow steps

1. Product Defined
   CBMP product specifications defined. Two pathways: full MHRA Marketing Authorisation (MA) or 'specials' unlicensed import route.
2. MA or Specials route?
   Most CBMPs in the UK currently operate under the specials/unlicensed import route. Full MA provides commercial stability but requires significant investment.
3. Full MHRA MA Pathway — Licensed route
   Full marketing authorisation requires a complete CTD dossier, clinical data, and MHRA review. Provides exclusivity and NHS listing eligibility.
   • Complete CTD Module 1–5 dossier
   • Clinical trial data or bibliographic application
   • £130k–£500k+ regulatory submission costs
   • 12–18 month MHRA review timeline
4. Specials / Unlicensed Import — Named patient or stock
   Most common current pathway. UK pharmacies can import unlicensed CBMPs as 'specials' to fulfil a specific prescription. Importers need a Specials Manufacturing Authorisation.
   • Specialist prescriber issues prescription
   • Importer holds Specials Manufacturing Authorisation
   • Home Office CD import license per shipment
   • MHRA Specials notification for new products
5. Prepare CTD Dossier
   Full Chemistry, Manufacturing and Controls (CMC) data, clinical evidence, and risk management plan required.
   • Module 3: full CMC including GMP
   • Module 4/5: non-clinical and clinical data
   • MHRA scientific advice recommended pre-submission
6. Home Office CD License
   Obtain per-shipment Home Office import license. Required for every import regardless of MA or specials status.
   • Per-shipment Schedule 2 import license
   • ~10 working day processing time
7. MHRA Review
   MHRA assesses the dossier. May issue Day 70/120/150 questions. Clock stops during response periods.
   • Respond to MHRA questions within stated timelines
   • Scientific Advisory Group input for novel products
8. MA Granted ✓
   Full marketing authorisation. Product can be promoted, listed on NHS formulary subject to NICE/SMC/AWMSG assessment.
9. Supply Under Specials ✓
   Ongoing supply against individual prescriptions. No formulary listing. Cannot be actively promoted. RPi certifies each batch.