Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
November 16, 2025
Approximately 5 minutes
UK Export Controls for Medicines: Special Regulatory Rules and Compliance Duties
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
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