MHRA: GB Licensed Manufacturer Specials Register for Compliance

• The Medicines and Healthcare products Regulatory Agency (MHRA) maintains a register of licensed manufacturing sites for human (MS) and veterinary (MANSA) "specials" in the UK.
• These sites are licensed by both the Department of Health and Social Care and the MHRA, covering GB human and veterinary medicine manufacturing sites.
• A separate "Key for MS and MANSA files" (5.32 KB CSV) explains specific authorization reference numbers, such as "Reference 1.1.1.1" for sterile aseptically prepared large volume liquids.
• The register is updated monthly, with separate CSV files for MS (e.g., 268 KB for September 2026) and MANSA (e.g., 10.6 KB for September 2026).
• Lawyers and compliance officers must consult this MHRA register to verify UK pharmaceutical manufacturing licenses for "specials" and ensure due diligence.

Lawyers and compliance officers must consult this MHRA register to ensure robust compliance checks and thorough due diligence processes are conducted.

The Medicines and Healthcare products Regulatory Agency (MHRA) maintains a critical public register detailing licensed manufacturing sites across the United Kingdom. This essential resource specifically focuses on facilities authorized to produce "specials" – custom-made medicines for individual patient needs. The register differentiates between "manufacturer specials - human" (MS) and "manufacturer specials authorisation - veterinary" (MANSA), covering both GB human medicine manufacturing sites and GB veterinary medicine manufacturing sites.

These listed sites hold licenses issued jointly by the Department of Health and Social Care and the MHRA, signifying their compliance with stringent regulatory standards for the production of these specialized pharmaceutical products within the UK. The register serves as a central point of reference for understanding the scope of these unique manufacturing authorizations.

Access to the MHRA licensed manufacturer specials register is provided through distinct documents, with separate listings for human (MS) and veterinary (MANSA) manufacturing sites. To aid in interpretation, a dedicated "Key for MS and MANSA files" is available as a 5.32 KB CSV document. This key is indispensable for deciphering the specific reference numbers used throughout the main registers.

For instance, the key clarifies that a site marked with "Reference 1.1.1.1" possesses the specific authorization to produce "sterile aseptically prepared large volume liquids." The individual registers themselves are also provided in CSV format; the "Register of licensed manufacturing sites - manufacturer specials authorisation, veterinary (MANSA) - September 2026" file, for example, is 10.6 KB, while its human counterpart, the "Register of licensed manufacturing sites - manufacturer specials, human (MS) - September 2026," is significantly larger at 268 KB.

For legal and compliance professionals operating within the pharmaceutical and veterinary sectors, this MHRA register is an indispensable tool. It provides the definitive record for verifying the licensing status of manufacturing sites involved in the production of "specials" (MS) and "manufacturer specials authorisation - veterinary" (MANSA) products. Lawyers and compliance officers must consult this MHRA register to ensure robust compliance checks and thorough due diligence processes are conducted.

The detailed information contained within these documents is crucial for understanding the specific capabilities and regulatory approvals held by various UK pharmaceutical manufacturing licenses. This oversight is vital for maintaining product safety, efficacy, and adherence to the strict regulatory framework governing specialized medicines.

The MHRA demonstrates a commitment to keeping this vital information current through regular updates. The registers are updated on a monthly basis, with specific versions cited for September, August, July, June, April, March, January, December 2025, November 2025, and May 2025. This consistent refresh cycle ensures that stakeholders have access to the most recent licensing data for both MS and MANSA sites.

It is important to note, however, that the CSV files containing these registers may present accessibility challenges. The MHRA explicitly states that these files "may not be suitable for users of assistive technology," a consideration for those relying on such tools to access digital information.

Lawyers and compliance officers in the pharmaceutical and veterinary sectors must consult this MHRA register to verify the licensing status of manufacturing sites for 'specials' (MS) and 'manufacturer specials authorisation - veterinary' (MANSA) products, crucial for compliance checks and due diligence.

Source: Original reporting via GOV.UK