UK Export Controls for Medicines: Special Regulatory Rules and Compliance Duties

1. Purpose and regulatory context

The United Kingdom applies special regulatory rules to the export of drugs and medicines to ensure that exported products meet legal, safety, and international control requirements. These rules apply whether medicines are exported for commercial supply, humanitarian use, or manufacture and processing abroad, and they operate alongside customs and trade controls.
Source: Export drugs and medicines: special rules

2. Medicines exported outside the UK market

Medicines that are manufactured or assembled in the UK solely for export do not require a UK marketing authorisation, provided they are not supplied on the UK market. However, such products must still be manufactured in accordance with UK good manufacturing practice (GMP) and meet the legal requirements of the importing country.
Source: Export drugs and medicines: special rules

3. Licensing and manufacturer responsibilities

Exporters must hold the appropriate manufacturer or wholesale dealer licences, depending on the nature of the activity. This includes ensuring that:

• Manufacturing and batch certification are performed by authorised entities
• Exported medicines are not falsely represented as UK-authorised products
• Records are maintained to demonstrate compliance with export conditions

Failure to hold the correct licence may result in enforcement action by the MHRA.
Source: Export drugs and medicines: special rules

4. Controlled drugs and additional authorisations

Medicines containing controlled drugs are subject to additional export controls. Exporters may need:

• Home Office export licences
• Import permits from the destination country
• Advance notifications or declarations

These requirements apply regardless of whether the product is licensed in the UK.
Source: Export drugs and medicines: special rules

5. Export documentation and labelling considerations

Exported medicines must be accompanied by accurate documentation, including batch certification and shipping records. Labelling and packaging may differ from UK market requirements, but must comply with:

• Legal and regulatory requirements of the importing country
• Any international conventions or bilateral agreements

Export-only labelling must not mislead recipients into assuming UK authorisation where none exists.
Source: Export drugs and medicines: special rules

6. Role of the MHRA and compliance oversight

The Medicines and Healthcare products Regulatory Agency (MHRA) oversees compliance with export rules through licensing, inspection, and enforcement powers. Exporters must be able to demonstrate, upon request, that all exported drugs and medicines comply with UK export regulations and applicable international obligations.
Source: Export drugs and medicines: special rules