Sourcing Medicines for the UK Market: Approved Countries and Northern Ireland

1. Overview of Sourcing Medicines

The UK’s guidance on sourcing medicines for the UK market is aimed at holders of Wholesale Distributor Authorisations (WDA) based in Great Britain. It sets out how authorised medicines can be sourced and supplied into Great Britain either by importing from countries on an approved country for import list or via Northern Ireland under specific regulatory conditions.
Source: Sourcing medicines for the UK market (gov.uk)

This guidance should be read alongside other relevant MHRA requirements covering licences, certifications and quality compliance obligations for supply.
Source: Sourcing medicines for the UK market (gov.uk)

2. Importing from an Approved Country for Import

For importing authorised medicines into Great Britain, the Human Medicines Regulations 2012 establish a list of approved countries for import. Medicines exported from these countries can be imported into Great Britain by a WDA holder, provided each batch is certified by a Qualified Person (QP) in the approved exporting country.
Source: Sourcing medicines for the UK market (gov.uk)

The approved country list includes countries whose regulatory standards are recognised for import certification purposes, such as certain European Economic Area (EEA) states and other jurisdictions confirmed as equivalent under UK law.
Source: List of approved countries - GOV.UK

3. Importation Responsibilities and Certification

When importing from an approved country, the importer must ensure that:

• Each exported batch is QP certified in the approved country before being placed on the UK market.
• For biological products (e.g., vaccines), independent batch release certificates may also be required.
• The importer holds a valid Wholesale Dealer Authorisation (WDA) and has appropriate procedures to verify certification.
  Source: Acting as a Responsible Person (import) (gov.uk)

A Responsible Person (Import) (RPi) may be named on the WDA to undertake the verification of QP certification before the medicine is released for sale or supply in Great Britain.
Source: Acting as a Responsible Person (import) (gov.uk)

4. Northern Ireland Route

Medicines authorised and supplied in or via Northern Ireland can also be sourced for supply to Great Britain, taking into account applicable conditions under the Northern Ireland Protocol and updated arrangements under the Windsor Framework.
Source: Sourcing medicines for the UK market (gov.uk)

Specific rules on regulatory controls, declaration requirements and packaging may apply when moving products between Northern Ireland and Great Britain, reflecting the distinct alignment with EU and UK standards.
Source: Supplying authorised medicines to Northern Ireland (gov.uk)

5. Special Medicinal Products and Parallel Imports

The guidance also covers:

• Importing human medicines for use as special medicinal products from approved countries.
• Parallel importation to the UK market of medicines from a listed country under specific legal bases.
• Export and re-export purposes where sourced medicines are intended for markets outside Great Britain.
  Source: Sourcing medicines for the UK market (gov.uk)

6. Compliance and Regulatory Expectations

Wholesale distributors sourcing medicines for the UK market must ensure adherence to:

• UK regulatory requirements for licensing, certification and quality assurance.
• Record-keeping and traceability obligations for imported batches.
• Verification of certification from approved countries prior to supply.
  Source: Sourcing medicines for the UK market (gov.uk)

Failure to comply may result in regulatory action by the Medicines and Healthcare products Regulatory Agency (MHRA).
Source: Sourcing medicines for the UK market (gov.uk)

Conclusion

Sourcing medicines for the UK market through approved country import channels or via Northern Ireland routes requires clear understanding of the UK’s regulatory framework. Licensed wholesale distributors must meet certification, importation and compliance obligations to ensure that authorised medicines can be legally and safely supplied in Great Britain.
Source: Sourcing medicines for the UK market (gov.uk)