The United Kingdom’s regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced amendments to the Human Medicines Regulations 2012 that will bring medicines closer to the patient through decentralized manufacturing (DM).
The amendment to the regulation was signed into law through a Statutory Instrument (SI)[i] on 23 January 2025. The amended Human Medicines Regulation and the Medicines for Human Use (Clinical Trials) Regulations 2004 comes into effect from 23 July 2025, supporting the manufacture of medicine at the point of care (POC) as well as modular manufacturing (MM)[ii].
Notably, DM will create flexibility for manufacturers while enabling the maximum number of patients to access the medicines they need when they need them in a safe and timely manner[iii].
The amendment is applicable to a wide range of pharmaceutical dosage forms, including medical gases, biological/biotech/blood small molecule, and advanced therapy medicinal products (ATMPs)).
What is point of care (POC) and modular manufactured (MM)?
Medicines manufactured close to the patient (e.g. at the bedside) for immediate administration are classified as POC. In general, this allows medicinal products (typically with a short shelf-life or highly specialized) to be made and administered at or close to a patient’s location. Manufacturers that intend to obtain a POC license will need to provide evidence to the MHRA that their product “can only be manufactured” at or near the place where the product is to be used or administered[iv]. The MHRA must also agree that the product meets the legislative requirements.
MM can include any activities that are performed away from traditional manufacturing sites (e.g. at clinic or hospital laboratory) to enable deployment to other locations3). The flexibility to move manufacturing facilities allows medicines to be closer to patients and so they can be accessed faster. This can be important when rolling out vaccines or in a military field environment. To qualify for the MM license, the agency has taken a broader approach that is not limited to starting materials or short shelf-life, but the rationale must support scaling out rather than scaling up. The MHRA will be looking for justification based on product deployment (e.g. this can be for pandemic early rollout)[v].
Each product will have a DM Master File (DMMF) that captures the locations, status of manufacturing sites, contact details, product, process, and procedures3.
How can manufacturers obtain POC or MM licenses?
During an MHRA webinar on decentralized manufacturing the agency provided guidance on the designation process3 Applicants are encouraged to apply early or once data indicates their product will meet the relevant DM designation criteria.
The application must provide background about the product and justification as to why the proposed product meets the legal basis. Applicable fees will be based on scientific advice. The MHRA will issue a decision on DM designation within 60 days if no additional information is required or no meeting is required. If a meeting or more information is required, the applicant can expect to receive the designation decision within 90 days4.
Manufacturers that already hold other licenses such as manufacturing and import authorizations (MIA), MIA Investigational Medicinal Products (IMPs) or Manufacturing Specials (MS) can submit a variation to add the POC or MM licenses to their existing license. According to the MHRA, an application will trigger an inspection which will then assess the systems and controls in coordination with the DMMF3.
Manufacturer’s obligations
All DM products are required to have a control site and it is the only site that will be listed on the manufacturer’s authorization. Individual secondary sites will be authorized by being included in the DMMF. Manufacturers are not required to submit a variation to notify the MHRA of new sites or decommissioning of sites; however, they will be required to notify the MHRA of the material alteration to the control site or to modular units2. License holders must maintain the DMMF and keep it up to date with annual reporting of updates and changes.
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- Labeling: Labeling requirements will follow the standard requirements of a marketing authorization. However, there is a labeling exemption for medicines manufactured for immediate administration at the POC with no portion of the medicinal product being retained after administration. In such cases the use of “pre-applied patient identified” on the primary packaging will be recommended2.
- Qualified person (QP) release: Although the QP can nominate an individual who is independent of the manufacturing and clinical team of the patient in question to release a POC product, the license holder will need to demonstrate how they will ensure consistency of the release process and how this process will be reviewed, including how the QP will maintain oversight of the release process4.
- Pharmacovigilance and clinical trial use: Throughout the product’s lifecycle, manufacturers will be expected to demonstrate how they will maintain product/batch traceability. To demonstrate traceability, manufactures need to show the integration of several healthcare settings, particularly those involved or used for the DM product. Manufacturers will be required to have a robust process in place to show how adverse events (AEs) are collected, allocated, and evaluated including contracts and agreements oversight. Decentralized medicines, including the control and manufacturing sites list will be listed in the pharmacovigilance system master file (PSMF). The license holder will also need to demonstrate how the qualified person for pharmacovigilance (QPPV) maintains oversight of the process and sites and how the process is linked to other personnel/departments like the responsible person (RP) or the quality department2. MHRA will focus on the processes and how these are managed, for example, if there is an issue at one of the sites, how will the license holder know whether this is an isolated incident or multiple sites are affected? What processes are in place to manage such situations?
Similarly for clinical trials, there is emphasis on how risks are identified, managed, and mitigated. Manufacturers will need to demonstrate how the investigator maintains oversight of the IMP activities at remote sites and how blinding of treatments are managed2.
Although manufacturers’ obligations are similar when compared to a traditional manufacturing environment, there will be emphasis on risk minimization and whether a manufacturer can demonstrate that they will have oversight of all the processes from manufacturing, product traceability, and AEs.
Conclusion
DM is designed to ensure that patients can access innovative medicines that are not easily deliverable in a traditional centralized manufacturing setup. The development of new guidance underscores MHRA’s commitment to a patient-first approach, allowing access to treatment where and when this is needed without compromising the quality.
As treatment methods continue to evolve and experience is acquired with DM methods it is likely that the guidance will change over time.
How well do you understand the amendments, and how these will affect manufacturing practices, and what will be required to meet DM objectives? We would like to hear what these changes will mean for you.
About the author:
Munyaradzi Japondo is a Senior Specialist in Regulatory Affairs at PharmaLex, with more than 6 years of experience specializing in post-approval lifecycle management. His experience includes managing UK, Ireland, and EU medicinal product portfolios for EU-based clients and providing global regulatory support for multinational consumer healthcare clients.
[i] The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, UK Statutory Instruments, 2025 No. 87. https://www.legislation.gov.uk/uksi/2025/87/contents/made
[ii] Statutory Instrument laid in Parliament provides first regulatory framework of its kind that will transform the manufacture of innovative medicines at the point of patient care. [online] GOV.UK. Available at: https://www.gov.uk/government/news/statutory-instrument-laid-in-parliament-provides-first-regulatory-framework-of-its-kind-that-will-transform-the-manufacture-of-innovative-medicines-at
[iii] Decentralised manufacture hub. GOV.UK. https://www.gov.uk/government/collections/decentralised-manufacture-hub
[iv] Decentralised manufacture: The designation step, MHRA, 10 June 2025. https://www.gov.uk/guidance/decentralised-manufacture-the-designation-step
[v] The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025– GOV.UK. https://www.legislation.gov.uk/uksi/2025/87/made
