- Latest available (Revised)
- Original (As made)
The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
You are here:
- UK Statutory Instruments
- 2025 No. 87
- PART 3
- Regulation 42
What Version
Opening Options
More Resources
Status:
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
Insertion of new regulations 36A and 36B (manufacture of MM and POC investigational medicinal products)
This section has no associated Explanatory Memorandum
42. After regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) insert—
“Manufacture of MM investigational medicinal products
36A.—(1) No person shall manufacture or assemble an MM investigational medicinal product unless—
(a)the activity and product type is specified in a manufacturing authorisation (MM); and
(b)there is an MM (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file.
(2) Paragraph (1) does not apply to the manufacture or assembly of an MM investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product.
Manufacture of POC investigational medicinal products
36B.—(1) No person shall manufacture or assemble a POC investigational medicinal product unless—
(a)the activity and product type is specified in a manufacturing authorisation (POC); and
(b)there is a POC (IMP) master file relating to the product and the product is manufactured and assembled in accordance with that master file.
(2) Paragraph (1) does not apply to the manufacture or assembly of a POC investigational medicinal product to the extent that the manufacture or assembly is in accordance with the terms and conditions of a UK marketing authorisation or a marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product.”.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Part
PrintThis Section only
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
Explanatory Memorandum
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Impact Assessments
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
- Why the government is proposing to intervene;
- The main options the government is considering, and which one is preferred;
- How and to what extent new policies may impact on them; and,
- The estimated costs and benefits of proposed measures.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.