MHRA’s Decentralised Manufacture Designation – Regulatory Framework

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MHRA’s Decentralised Manufacture Designation – Regulatory Framework

An overview of designation criteria, submission steps, and compliance considerations for POC and modular manufacturing

Regulatory Context

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance titled “Decentralised Manufacture: The Designation Step“, effective from 10 June 2025. This guidance supports the implementation of the Human Medicines (Amendment)(Modular Manufacture and Point of Care) Regulations 2025, which come into force on 23 July 2025.

Purpose of the DM Designation

Under SI 2025 No. 87, MHRA mandates a designation step for products manufactured using decentralised approaches, including Point-of-Care (POC) and Modular Manufacture (MM). This step ensures that such models are used only when clinically or technically necessary, and not for routine convenience.

Definition of DM Designation

Decentralised Manufacture (DM) designation is a regulatory requirement for products intended to be manufactured either:

  • At or near the point of care (POC): Often relevant for short shelf-life products, personalised medicines, or products with specific administration timelines.
  • Via modular systems (MM): Involving mobile or prefabricated GMP-compliant units, generally for rapid deployment or public health needs.
When to Seek DM Designation

DM Designation should be obtained at the early development phase and may be required alongside:

  • Initial Clinical Trial Authorisation (CTA)
  • A new Marketing Authorisation Application (MAA)
  • Amendments to existing CTAs or MAAs
  • Applications for unlicensed medicines (“specials”) under a Manufacturer Specials (MS) Licence involving decentralised methods

Applicants must submit a clear justification for decentralised manufacture, supported by relevant quality and, where applicable, clinical data.

Application and Submission Process
  • Use MHRA’s official DM designation template
  • Submit the completed form via email as per MHRA instructions
  • Standard scientific advice fees are applicable
  • MHRA typically issues a response within 30 to 90 days
  • Successful applicants will receive a designation number, which must be cited in all subsequent CTA, MAA, or Specials applications
Ongoing Validity and Reassessment

A designation remains valid unless there is a significant change to: The product itself, Target patient population, Indication, Manufacturing approach.

Any such change may trigger the need for a new designation request.

Reference

MHRA Guidance: Decentralised Manufacture – The Designation Step https://www.gov.uk/guidance/decentralised-manufacture-the-designation-step

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