Exporting Medicines From the UK: The Compliance Basics

The UK is a respected source of medicines worldwide, thanks to its strong regulator and well-controlled supply chain. Exporting medicines, however, involves more than packing a parcel. Here are the basics every overseas buyer and UK exporter should understand.

The UK side

• The exporter must hold an appropriate wholesale dealer's licence from the MHRA.

• Each product must be checked against the Department of Health and Social Care list of medicines that cannot be exported or hoarded.

• Controlled drugs need specific export licences from the Home Office.

• Good Distribution Practice applies throughout, including transport.

The destination side

Every country sets its own rules for importing medicines. The buyer may need an import licence, a local marketing authorisation, or a named-patient or special-access approval. Some countries restrict certain categories entirely.

Documentation

Typical paperwork includes commercial invoices, certificates of analysis or conformity, packing lists, temperature records for cold-chain products, and any permits required by the importing country.

Common pitfalls

• Assuming a product licensed in the UK is automatically allowed in the destination.

• Underestimating customs timelines for temperature-sensitive goods.

• Missing local labelling or language requirements.

Getting it right

A good exporter will ask the right questions before quoting. Acorn Pharmaceuticals works through compliance with every international customer, so supply is legal at both ends.