Guide to Applying for a Parallel Import Licence for Medicines in the UK

1. What is a Parallel Import Licence

In the UK, a parallel import licence (PLPI) permits a medicine that is 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 equivalent UK-licensed product. The UK licensing scheme enables continued supply of such medicines post-Brexit under MHRA regulation. Source: Medicines: apply for a parallel import licence (gov.uk) ([GOV.UK][1])

2. Eligibility and key requirements

To obtain a PLPI, you must demonstrate that the imported medicine:

• is manufactured to good manufacturing practice (GMP) standards, and
• matches the reference UK product in composition and therapeutic effect.

You must also hold an appropriate wholesale dealer’s licence covering importation, storage and sale for each product. If you assemble or repackage the product, a manufacturer’s licence is required. For products controlled by the Misuse of Drugs Act, a Home Office import licence may also be necessary. Source: Medicines: apply for a parallel import licence (gov.uk) ([GOV.UK][1])

3. Categories of PLPI applications

Applications for a parallel import licence fall into different categories based on the relationship between the UK and imported product’s marketing authorisation holders:

• Simple: same marketing authorisation holders or within the same corporate group, or where a licensing agreement exists.
• Complex: where there is no common origin, or where the imported product differs in excipients, manufacturing route, sterility, or container material from the UK product. Source: Medicines: apply for a parallel import licence (gov.uk) ([GOV.UK][1])

4. Submitting your application

Applications must be submitted to the MHRA with all required documentation detailing the product, licences held, manufacturing practices and evidence of equivalence. The MHRA assesses whether the product meets the criteria for parallel import and may request additional information or clarification where necessary. Source: Medicines: apply for a parallel import licence (gov.uk) ([GOV.UK][1])

5. Labelling and packaging

Parallel imported medicines must comply with UK labelling and packaging standards. Following implementation of the Windsor Framework and related guidance, UK-wide authorised products must display the ‘UK Only’ statement to indicate they are for the UK market and prevent onward movement into the EU. Source: UK parallel import licences following agreement of the Windsor Framework (gov.uk) ([GOV.UK][2])

6. Pharmacovigilance and compliance

Once granted, PLPI holders must comply with pharmacovigilance requirements, including reporting adverse reactions and defects under UK law. MAHs remain responsible for recalls and notifying the MHRA of withdrawals or safety issues. Source: Medicines: apply for a parallel import licence (gov.uk) ([GOV.UK][1])

7. Maintaining and varying your licence

Parallel import licences are typically valid for a set period and may be renewed in advance of expiry. Changes to the licence (e.g., adding new products or changing territory) require a variation application to the MHRA. The licence holder must also maintain appropriate records and meet inspection requirements. Source: Medicines: apply for a parallel import licence (gov.uk) ([GOV.UK][1])

8. Legislative basis

Under the Human Medicines Regulations 2012, a PLPI authorises the holder to place the specified medicinal product on the UK market and overrides the usual requirement for a separate marketing authorisation for that imported batch. Source: Human Medicines Regulations 2012 ([Legislation.gov.uk][3])