The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025
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Change 1
23 Insertion of new regulations 170A and 170B (pharmacovigilance requirements: MM and POC medicinal products)
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. .
23 Insertion of new regulations 170A and 170B (pharmacovigilance requirements: MM and POC medicinal products)
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. .
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