The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025

Amendments to Schedule 26

12.—(1) Schedule 26 (packaging requirements: special provisions) is amended as follows.

(2) In Part 1 (supply by doctors, dentists, nurses and midwives), after paragraph 4 insert—

“4A.   Where a product is to be sold or supplied in accordance with an order submitted as mentioned in regulation 222A(1)(a), for the purposes of—

(a) paragraph 2, B1, as defined in regulation 222A(1)(b), is the person who sells or supplies the product; and

(b) paragraph 3, the date is instead the date on which the product is ready for sale or supply to or for the patient for whom it is dispensed.”.

(3) In Part 2 (pharmacy exceptions), after paragraph 10 insert—

“10A.   Where a product is to be sold or supplied in accordance with an order submitted as mentioned in regulation 222A(1)(a), for the purposes of—

(a) paragraph 6, B1, as defined in regulation 222A(1)(b), is the person who sells or supplies the product;

(b) paragraph 7, the date is instead the date on which the product is ready for sale or supply to or for the patient for whom it is dispensed; and

(c) paragraphs 8 to 10, the final form of the particulars to be included for the final sale or supply to or for the use of a patient is to be determined by a pharmacist acting on behalf of B1, even if—

(i) the inclusion of the particulars was done by or under the supervision of a pharmacist acting on behalf of B2, as defined in regulation 222A(1)(b), and

(ii) the determination by the pharmacist acting on behalf of B1 is by way of a confirmation of what was done by or under the supervision of a pharmacist acting on behalf of B2.”.