National Health Service, England Citation, commencement, extent, application and interpretation 1 1 These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) (No. 2) Regulations 2024. 2 These Regulations, apart from this regulation and regulations 2 and 3, come into force on 1st January 2025. 3 This regulation and regulations 2 and 3 come into force on the twenty-eighth day after the day on which these Regulations are laid before Parliament. 4 These Regulations extend to England and Wales and apply in relation to England only . 5 In these Regulations, “ the PLPS Regulations ” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 . Amendment of regulation 91A of the PLPS Regulations 2 1 Regulation 91A of the PLPS Regulations (zero or nominal product reimbursement for vaccines and antivirals) is amended as follows. 2 In paragraph (2)— a omit “or” at the end of sub-paragraph (ab); and b after sub-paragraph (ab) insert— ac a drug or medicine which is used for vaccinating or immunising people against pertussis (whooping cough), if the conditions set out in paragraph (3) are satisfied; or . 3 In paragraph (3A), for “to (ab)” substitute “to (ac)” . Amendment of Schedule 2 to the PLPS Regulations and transitional provisions 3 1 Schedule 2 to the PLPS Regulations (applications in respect of pharmaceutical lists and the procedures to be followed) is amended in accordance with paragraphs (2) and (3). 2 In Part 1 (information to be included in routine and excepted applications), in paragraph 3 (fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list) , omit sub-paragraph (8). 3 In Part 4 (determination and deferral of applications), in paragraph 23 (additional matters for consideration in relation to applications for inclusion in a pharmaceutical list) , in sub-paragraph (1), omit paragraph (c). 4 Where, before the day on which this regulation comes into force, it was necessary to include information in an application for inclusion in a pharmaceutical list by virtue of paragraph 3(8) of Schedule 2 to the PLPS Regulations— a if that information was not provided before that day, or the obligation to provide that information was only partially discharged before that day, it is no longer necessary for the applicant to provide that information, or the rest of that information, pursuant to that paragraph 3(8); but b if the applicant or a referee has provided or does provide information in the form of a reference or details of a referee either prior to or notwithstanding the revocation of paragraphs 3(8) and 23(1)(c) of Schedule 2 to the PLPS Regulations, NHS England may— i have regard to that information for the purposes of its consideration of the application, and ii request further information or documentation from the applicant pursuant to paragraph 11 of Schedule 2 to the PLPS Regulations (relevant information or documentation), which it considers to be missing relevant information or documentation as a consequence of its consideration of that information. Amendment of Schedule 4 to the PLPS Regulations 4 In Part 2 of Schedule 4 to the PLPS Regulations (terms of service of NHS pharmacists – essential services), in paragraph 8 (providing ordered drugs or appliances) , after sub-paragraph (2) insert— 2A Subject to sub-paragraphs (2B) to (2E) and without prejudice to sub-paragraphs (10) and (11), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)— a a different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; and b the provision is otherwise in accordance with the order. 2B In the case of an order for a prescription only medicine, sub-paragraph (2A) only applies if sub-paragraph (8) applies or one of the following applies— a the provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; or b the medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance). 2C In the case of an order for a drug that is not a prescription only medicine, sub-paragraph (2A) only applies if sub-paragraph (8) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where— a the different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; and b the registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber. 2D Where P may, pursuant to sub-paragraph (2A) and sub-paragraph (2B)(a) or (2C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, P must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging. 2E Sub-paragraphs (2B)(a) and (2C)(a) and (b) do not apply to the provision of any drug which is— a for the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); or b a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs). . Amendment of Schedule 7 to the PLPS Regulations 5 In Schedule 7 to the PLPS Regulations (mandatory terms for LPS schemes), in paragraph 6 (providing ordered drugs or appliances) , after sub-paragraph (1) insert— 1A Subject to sub-paragraphs (1B) to (1E) and without prejudice to sub-paragraphs (8) and (9), for the purposes of sub-paragraph (1)(b), a drug is provided in accordance with the order on a prescription form or repeatable prescription if (in addition to where the provision is exactly in accordance with the order)— a a different quantity is provided to that ordered on the prescription form or repeatable prescription in order to allow for the provision of the drug in its manufacturer’s original outer packaging; and b the provision is otherwise in accordance with the order. 1B In the case of an order for a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or one of the following applies— a the provision is in accordance with regulation 217B(1) to (3) of the Human Medicines Regulations 2012 (original pack dispensing), and accordingly, regulation 217B(1) to (3) of those Regulations is expressly applied to such supplies; or b the medicine must be provided in the manufacturer’s original outer packaging in order to comply with regulation 217C of the Human Medicines Regulations 2012 (original pack dispensing: medicinal products containing a relevant substance). 1C In the case of an order for a drug that is not a prescription only medicine, sub-paragraph (1A) only applies if sub-paragraph (6) applies or the provision of a different quantity to that ordered on the prescription is in circumstances where— a the different quantity is no more than 10% greater or no more than 10% less than the quantity ordered; and b the registered pharmacist carrying out or directly supervising the provision does not consider, in the exercise of their professional skill and judgement, that the provision of a different quantity to that ordered may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber. 1D Where C may, pursuant to sub-paragraph (1A) and sub-paragraph (1B)(a) or (1C)(a) and (b), provide a different quantity of a drug to that ordered on a prescription form or a repeatable prescription, C must consider, in the exercise of their professional skill and judgement, whether it is reasonable and appropriate to do so, having regard to the benefits to patients where they are provided with drugs in their manufacturer’s original outer packaging. 1E Sub-paragraphs (1B)(a) and (1C)(a) and (b) do not apply to the provision of any drug which is— a for the time being specified in Schedules 2 to 4 of the Misuse of Drugs Regulations 2001 (which relate to controlled drugs excepted from certain provisions under the Regulations); or b a special medicinal product for the purposes of regulation 167 of the Human Medicines Regulations 2012 (supply to fulfil special patient needs). . Signed by authority of the Secretary of State for Health and Social Care Stephen Kinnock Minister of State Department of Health and Social Care 2nd September 2024