UK MHRA Guidance: Applying for a Parallel Import Licence

The UK parallel import licensing scheme allows a medicine authorised in a European Economic Area (EEA) Member State to be marketed in the UK, provided the imported product has no therapeutic difference from the UK cross-referenced product.

The Medicines and Healthcare products Regulatory Agency (MHRA) guidance, “Medicines: apply for a parallel import licence,” explains the requirements for obtaining and maintaining a parallel import licence, including application procedures, packaging, variations, post-licensing obligations and inspections. The guidance was last updated on 26 August 2026.

Parallel Import Licence Application Categories

MHRA classifies parallel import applications as simple, complex or standard.

• A simple parallel import may apply where the UK marketing authorisation holder and the imported product’s marketing authorisation holder belong to the same company group or have a licensing agreement.

• A complex parallel import applies where the products do not share a common origin and meet specified criteria, including certain differences involving excipients, active ingredient manufacturing routes, controlled-release preparations, sterile products, influenza vaccines, metered-dose inhalers or powders for inhalation.

• A standard parallel import applies where the products do not share a common origin but do not meet the complex criteria.

Windsor Framework and Parallel Imports

Following implementation of the Windsor Framework on 1 January 2025, MHRA licenses medicines across the UK, and Parallel Distribution Notices are no longer valid in Northern Ireland.

The framework provides for UK-wide approval and licensing by MHRA and removes EU Falsified Medicines Directive requirements for medicines marketed and supplied in Northern Ireland.

EU Falsified Medicines Directive safety features do not apply to parallel import licences. Licence holders must ensure packs are correctly decommissioned and cannot re-enter the supply chain.

Submitting the Application

Parallel import licence applications are submitted electronically through the MHRA Portal.

Applications must meet the submission requirements and include details of the appropriate UK cross-reference product. Applications that do not meet the requirements may be invalidated and rejected, with reasons provided by MHRA.

Applicants should ensure that all sections of the application form are completed accurately before submission.

Documents, Sample Scans and Packaging

Required documentation includes a cover letter, proposed labelling and patient information leaflet artwork, relevant healthcare professional information, a user testing readability report and the latest approved company functions list.

Applicants must also provide a complete scan of the imported sample pack, including the packaging, patient information leaflet, tablet or capsule markings and braille where applicable.

Packaging and labelling must comply with current requirements. The labelling should include relevant safety information and required product details, while the PIL should follow the UK cross-referenced product wording as closely as possible.

User Testing and Company Functions

Parallel import patient information leaflets must demonstrate readability through user testing. Compliance can be demonstrated through a full user test, bridging studies or evidence relating to the UK-referenced PIL.

Applicants must also provide information about companies performing functions associated with importing the product, including relevant wholesale, manufacturing, import and assembly activities.

UK repackaging sites must be approved for parallel imports, while relevant sites in EEA Member States require evidence of appropriate authorisation.

MHRA Assessment and the One ‘RFI’ Rule

MHRA applies a One ‘RFI’ Rule to parallel import applications and variations.

Where information is missing, or changes are required, MHRA issues one Request for Further Information covering the outstanding issues. Applicants have one opportunity to address them.

If the requested information or changes are not provided within 30 calendar days, MHRA will refuse the application, except in exceptional circumstances.

Variations and Tell and Do

Licence holders must keep their parallel import licences up to date. Changes to the UK marketing authorisation or repackaging arrangements may require a variation.

The Tell and Do (TaD) procedure allows eligible variations to be submitted while repackaging and distribution continue during assessment.

TaD applies only to specified variation codes. No RFIs are permitted for TaD variations. Incorrect applications will be refused and must be resubmitted as non-TaD variations.

Post-Licensing Requirements and Renewal

Parallel import licence holders remain responsible for reporting adverse reactions and defects. Where a product recall is required, the licence holder must arrange the recall and maintain appropriate records. MHRA must be notified immediately when a product is withdrawn for safety reasons.

A parallel import licence is granted for 5 years. Renewal applications should be submitted during the 3 months before expiry through the MHRA Portal.

MHRA Inspections

MHRA may assess parallel import companies through inspections, including checks on leaflet safety updates, current and user-tested leaflets, labels, braille, manufacturer information and packaging requirements.

These inspections help assess whether licence holders continue to meet the applicable regulatory requirements.

What This Means for Parallel Import Licence Holders

The MHRA guidance covers the complete parallel import licence lifecycle, including application, documentation, packaging, assessment, variations, post-licensing requirements, renewal and inspections.

Companies should ensure that licence information, packaging, product information and regulatory submissions remain accurate and up to date throughout the licence lifecycle.

References

• MHRA Guidance: Medicines: apply for a parallel import licence — last updated 26 August 2026.