Medicines Citation, commencement and extent 1 1 These Regulations may be cited as the Human Medicines (Amendment Relating to Original Pack Dispensing) (England and Wales and Scotland) Regulations 2023. 2 These Regulations come into force on the 28th day after the day on which they are made. 3 These Regulations extend to England and Wales, and Scotland. New regulations 217B and 217C of the Human Medicines Regulations 2012 2 1 The Human Medicines Regulations 2012 are amended as follows. 2 After regulation 217A (requirements for prescriptions to be dispensed in an EEA state) insert— Original pack dispensing 217B 1 Subject to paragraphs (2) to (4) and regulation 217C, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where— a a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and b the sale or supply is otherwise in accordance with the prescription. 2 Paragraph (1) does not apply— a to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or b in circumstances where a pharmacist is carrying out or supervising the sale or supply and the pharmacist considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber. 3 Paragraph (2) does not apply to— a a medicine in a form that makes it not practicable to dispense in the exact quantity ordered; b a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity; c a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine. 4 Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to— a in England, paragraph 8(1)(b) of Schedule 4, or paragraph 6(1)(b) of Schedule 7, to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 , b in Wales, paragraph 9(1)(b) of Schedule 5 to the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 , until those Regulations expressly apply paragraphs (1) to (3) to those supplies. Original pack dispensing: medicinal products containing a relevant substance 217C 1 Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless— a it is sold or supplied in its manufacturer’s original outer packaging; and b if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription. 2 Paragraph (1) does not apply where— a the sale or supply is by or under the supervision of a pharmacist; and b the pharmacist is satisfied that— i a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and ii unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet. 3 In this regulation, “ relevant substance ” means any of the following— a sodium valproate; b valproic acid; c valproate semisodium. . Signed by authority of the Secretary of State for Health and Social Care Maria Caulfield Parliamentary Under Secretary of State, Department of Health and Social Care 13th September 2023