Importing Human Medicines into the UK: Licensing, Unlicensed Products, and Regulatory Costs

1. Regulatory overview

In the United Kingdom, the importation of human medicines is regulated to ensure that products entering the supply chain meet appropriate standards of quality, safety, and traceability. Any business importing medicines into the UK must hold the correct licence issued by the MHRA, whether the products are licensed or unlicensed. These requirements apply to wholesalers, manufacturers, and other operators involved in supply. Source: Import a human medicine

2. Importing licensed human medicines

To import licensed medicines into the UK for wholesale distribution, a company must hold a Wholesale Dealer’s Licence (WDL). The licence holder is responsible for ensuring:

• Medicines are sourced from appropriately authorised suppliers
• Storage and distribution comply with Good Distribution Practice (GDP)
• Records are maintained to ensure full traceability

Wholesalers importing licensed products from outside the UK are treated as importers and must meet all applicable regulatory obligations. Source: Import a human medicine

3. Importing unlicensed human medicines

The UK allows the importation of unlicensed medicines under tightly controlled conditions, typically to meet specific patient needs. These medicines may be supplied:

• In response to a special clinical requirement
• Where no suitable licensed alternative is available

Importers of unlicensed medicines must ensure that products are supplied only in accordance with UK medicines legislation and that appropriate pharmacovigilance and quality controls are in place. Source: Import a human medicine

4. Manufacturer’s licence for import (MIA)

Where importation involves activities such as batch certification, quality control testing, or release for supply, the business must hold a Manufacturer’s Licence for Import (MIA). This licence is required when:

• Medicines are imported from countries outside the UK
• The importer performs manufacturing or assembly-related activities

An MIA holder must operate in compliance with Good Manufacturing Practice (GMP) and ensure that imported batches are appropriately certified before release. Source: Import a human medicine

5. How to apply for an import licence

Applications for WDLs and MIAs are submitted to the MHRA through the designated application process. Applicants must provide:

• Details of the company, premises, and responsible personnel
• Evidence of appropriate quality systems and compliance with GDP or GMP
• Information on the scope of activities, including importation of licensed or unlicensed medicines

The MHRA may conduct inspections to verify compliance before granting a licence. Source: Import a human medicine

6. Fees and ongoing costs

Import licences are subject to application fees and annual charges. Fees vary depending on:

• The type of licence (WDL or MIA)
• The scope and scale of authorised activities

In addition to application fees, licence holders should budget for ongoing compliance costs, including inspections, quality system maintenance, and regulatory updates. Current fee schedules are published by the MHRA and updated periodically. Source: Import a human medicine

7. Practical compliance considerations

For wholesalers and manufacturers, successful importation of human medicines into the UK requires:

• Early determination of the correct licence type
• Clear procedures for handling licensed versus unlicensed products
• Continuous compliance with GDP or GMP requirements

Proactive engagement with MHRA guidance and timely licence management helps reduce regulatory risk and ensures continuity of supply. Source: Import a human medicine