MHRA has expanded the practical PLPI submission instructions
MHRA updated its Medicines: apply for a parallel import licence guidance on August 26, 2026.
The update note states that the parallel-import application guidance has been revised to provide more detailed information on the submission process.
The page concerns medicines and the Parallel Import Licence, or PLPI, pathway.
The guidance now gives more operational detail on the submission package
Applications must be submitted through the MHRA Portal.
The guidance states that submissions not meeting the submission requirements will be invalidated and rejected.
At a minimum, applicants need supporting documentation including a cover letter, proposed labelling artwork, patient information leaflet and related leaflet artwork, a readability user-test report, and current company-functions information.
The guidance also requires a complete scan of the imported sample pack showing the full pack contents, patient information leaflet, relevant tablet or capsule markings, and Braille where applicable.
The one-RFI approach increases the importance of first-submission quality
MHRA describes a “One RFI Rule” for both initial and variation applications.
The Agency will normally issue one Request for Further Information covering missing information or required changes.
Applicants are given one opportunity to resolve the outstanding issues. If the response is not satisfactory within 30 calendar days, MHRA may refuse the application.
That makes dossier completeness and artwork accuracy especially important before submission.
This is not a medical-device parallel-import licensing route
The scope distinction is important for diversified healthcare companies.
The PLPI guidance is structured around medicine marketing authorisations, patient information, pharmacovigilance, medicine manufacturing/import authorisations, and related medicine-specific requirements.
Medical devices in the UK continue to follow their own registration, conformity-assessment, UK Responsible Person, and importer obligations.
The fact that MHRA regulates both product categories does not make the medicine PLPI pathway applicable to devices.
What companies can check
- Classify this PLPI source under medicines rather than medical devices in regulatory-source registries.
- For medicine parallel-import operations, update Portal, sample-scan, artwork, and company-functions procedures against the revised guidance.
- Improve first-submission completeness to reduce refusal risk under the one-RFI approach.
- Keep medicine and device importer, licence, registration, and market-access responsibilities separate in internal matrices.
For medical-device teams, the update is mainly a scope correction. For medicine parallel importers, it is a substantive operational refresh of how applications should be prepared and submitted.
Sources
- Primary official sourceMedicines: apply for a parallel import licence (opens in a new tab)Medicines and Healthcare products Regulatory Agency