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UK MHRA Guidance: Regulatory Framework for Licensing, Importing, and Supplying Medicines in the UK

Writer's picture: Sharan MuruganSharan Murugan

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued several guidance documents detailing the licensing, importation, and supply of both licensed and unlicensed medicinal products. These regulatory measures are essential for maintaining patient safety, compliance, and transparency in the UK pharmaceutical supply chain.


1. UK-wide licensing for Human Medicines (Full Guidance Here)

The UK-wide licensing system allows pharmaceutical companies to apply for a single marketing authorization that covers England, Scotland, Wales, and Northern Ireland. This aligns with the UK’s regulatory framework post-Brexit and is crucial for maintaining a consistent medicine supply across the country.

Key Features of UK-Wide Licensing

  • Simplified Regulatory Process: One application covers all four nations.

  • Mutual Recognition: Ensures harmonized access to medicines within the UK.

  • Application Submission: Companies must apply via the MHRA Submission Portal.

  • Types of Applications: Includes new marketing authorizations, variations, and renewals.

This streamlined approach ensures greater regulatory efficiency while upholding stringent safety and efficacy standards.


2. Notification of Intent to Import an Unlicensed Medicinal Product (Full Guidance Here)

Unlicensed medicines may be imported into the UK when no suitable licensed alternative is available. However, strict regulatory oversight is in place to ensure their safe use.

Steps for Importing an Unlicensed Medicine

  1. Notification to the MHRA: Importers must submit a Notification of Intent at least 28 days before the first import.

  2. Justification for Use: A registered UK healthcare professional must confirm that the medicine is needed for patient treatment.

  3. Good Distribution Practices (GDP) Compliance: The imported product must be stored and transported safely under GDP guidelines.

  4. Pharmacovigilance Requirements: Adverse effects and safety concerns must be monitored and reported.

This regulatory framework ensures that patients can access critical medicines while preventing unauthorized imports.


3. Supply of Unlicensed Medicinal Products (Specials) (Full Guidance Here)

"Specials" are unlicensed medicinal products prepared when no licensed equivalent is available. These medicines are usually manufactured for individual patient needs and must comply with strict quality controls.

Key Considerations for Supplying Specials

  • Prescriber’s Justification: A doctor, pharmacist, or healthcare professional must confirm the need for a special medicine.

  • Manufacturing Standards: Specials must be produced under GMP-compliant facilities.

  • Record-Keeping: Suppliers must document all transactions to ensure traceability.

  • Labeling and Packaging: Must clearly state that the product is unlicensed.

  • No Promotional Activities: Specials cannot be marketed or promoted.

This guidance ensures patient safety while allowing flexibility for unique medical needs.


4. Importing Human Medicine into the UK (Full Guidance Here)

Who Needs an Import License?

  • Pharmaceutical wholesalers

  • Hospitals and NHS Trusts

  • Pharmacy chains

Types of Importation

  1. Licensed Medicines:

    • Must comply with UK marketing authorization regulations.

    • Requires a Wholesale Dealer’s License (WDA(H)).

  2. Unlicensed Medicines:

    • Requires prior MHRA notification and approval.

    • Can only be supplied when no alternative is available.

Regulatory Requirements

  • GDP and GMP Compliance: Medicines must meet storage and distribution standards.

  • Import License Application: Submitted via the MHRA portal.

  • Batch Testing and Verification: Imported medicines must undergo quality control testing before distribution.

This system ensures that all medicines imported into the UK meet regulatory standards, protecting public health while facilitating global pharmaceutical trade. The UK pharmaceutical regulatory framework ensures that medicines—both licensed and unlicensed—are safely manufactured, imported, and supplied. The MHRA’s comprehensive guidelines help maintain strict oversight while enabling patient access to essential medicines.


For full details, refer to the respective guidelines:🔹 UK-Wide Licensing🔹 Importing Unlicensed Medicines🔹 Supplying Specials🔹 Importing Medicines

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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