- 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 2
- Regulation 23
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This is the original version (as it was originally made).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 170A and 170B (pharmacovigilance requirements: MM and POC medicinal products)
This section has no associated Explanatory Memorandum
23. After regulation 170 (record-keeping requirements) insert—
“MM medicinal products: pharmacovigilance requirements
170A.—(1) Where the sale or supply of an MM medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.
(2) The following information is specified for the purpose of paragraph (1)—
(a)the source from which, and the date on which, the person obtained the product;
(b)the person to whom, and the date on which, the sale or supply was made;
(c)the quantity of the sale or supply;
(d)the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and
(e)details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.
(3) The person must make the record available for inspection by the licensing authority on request.
(4) The person must submit electronically to the licensing authority—
(a)a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and
(b)a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.
(5) The person must ensure that the reports referred to in paragraph (4)—
(a)are in the format and have the content specified in Part 6 of Schedule 12A; and
(b)include the product’s batch number, or other product identifier if no batch number is available.
(6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.
POC medicinal products: pharmacovigilance requirements
170B.—(1) Where the sale or supply of a POC medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.
(2) The following information is specified for the purpose of paragraph (1)—
(a)the source from which, and the date on which, the person obtained the product;
(b)the person to whom, and the date on which, the sale or supply was made;
(c)the quantity of the sale or supply;
(d)the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and
(e)details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.
(3) The person must make the record available for inspection by the licensing authority on request.
(4) The person must submit electronically to the licensing authority—
(a)a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and
(b)a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.
(5) The person must ensure that the reports referred to in paragraph (4)—
(a)are in the format and have the content specified in Part 6 of Schedule 12A; and
(b)include the product’s batch number, or other product identifier if no batch number is available.
(6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the 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.