The Human Medicines (Amendment) Regulations 2026

• Citation: S.I. 2026/381
• Sections: 15

Section 1 Citation, commencement and extent

(1) These Regulations may be cited as the Human Medicines (Amendment) Regulations 2026.

(2) These Regulations come into force on 31st March 2026.

(3) These Regulations extend to England and Wales, Scotland and Northern Ireland.

Section 2 Amendment of the Human Medicines Regulations 2012

The Human Medicines Regulations 2012 are amended in accordance with regulations 3 to 15.

Section 3 Amendment of regulation 3

(1) Regulation 3 (scope of these Regulations: special provisions) is amended as follows.

(2) In paragraph (2), after “paragraph (5A)” , insert “, (5B)” .

(3) After paragraph (5A), insert—

(5B) This paragraph applies where a medicinal product is manufactured or assembled by a pharmacist—

(a) who is acting in the course of his or her profession; and

(b) where—

(i) the conditions in paragraphs (8) and (9) are met, and

(ii) treatment of the patient with the medicinal product is a treatment decision of the pharmacist.

(4) In paragraph (11), after “paragraph (5)” , insert “, (5B)” .

(5) In paragraph (12), in sub-paragraph (b), for “or (5A)” substitute “, (5A) or (5B)” .

Section 4 Amendment of regulation 3A

(1) Regulation 3A (preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products) is amended as follows.

(2) In the heading, for “vaccination or immunisation against coronavirus” substitute “vaccination against an infectious disease” .

(3) Omit paragraphs (1) and (2).

(4) In paragraph (3), for “for vaccination or immunisation against coronavirus” substitute “under relevant arrangements for vaccination against an infectious disease” .

(5) In paragraph (4), omit sub-paragraph (a).

(6) In paragraph (5), omit the definition of “authorised”.

(7) Omit paragraph (6).

Section 5 Amendment of regulation 8

In regulation 8 (general interpretation) , in paragraph (1), for the definition of “occupational health vaccinator” substitute—

“ occupational health vaccinator ” means a person who is employed or engaged by a person operating an occupational health scheme, who is an individual belonging to one of the classes of individuals specified in Part 4 of Schedule 16;

Section 6 Amendment of regulation 19

(1) Regulation 19 (exemptions from requirement for wholesale dealer's licence) is amended as follows.

(2) In paragraph (4A)—

(a) in the opening words—

(i) for “vaccination or immunisation against coronavirus or influenza virus” substitute “vaccination against an infectious disease” , and

(ii) after “the person distributing the medicinal product” , insert “(Person A)” ;

(b) in sub-paragraph (b)—

(i) after “relevant arrangements” insert “(Person B)” , and

(ii) at the end, omit “and” ;

(c) at the end of sub-paragraph (c), insert “and” ; and

(d) after sub-paragraph (c), insert—

(d) conditions A and B in paragraphs (4E) and (4F) are met.

(3) Omit paragraph (4B).

(4) For paragraph (4D), substitute—

(4E) Condition A is that supply between Person A and Person B is agreed with the body making the arrangements to supply the medicinal product and the distribution occurs in exceptional circumstances, which are such that Person A and Person B are satisfied, having made appropriate enquiries, that—

(a) there is an urgent public health need for a patient to have administered to them the medicinal product on a particular occasion that the distribution would facilitate;

(b) there is no other way that the patient could receive treatment with the medicinal product without undue delay; and

(c) there is no suitable alternative medicinal product that the patient could receive treatment with without undue delay.

(4F) Condition B is that the medicinal product remains in its manufacturer’s original outer packaging, and is stored and transported, in accordance with the terms of its marketing authorisation.

Section 7 Amendment of regulation 213

In regulation 213 (interpretation), in paragraph (1), after the definition of “unit preparation” , insert—

“ vaccine group direction ” means a written direction that relates to the supply and administration of a vaccine and that—

is signed by any person who may be required to sign it in the circumstances specified for its use in regulation 235A; and

relates to supply and to administration to eligible persons in accordance with regulation 235A (subject to any exclusions that may be specified in the vaccine group direction).

Section 8 Amendment of regulation 233

In regulation 233 (exemption for supply etc under a PGD by person conducting a retail pharmacy business) , in paragraph (8), for “vaccination or immunisation against coronavirus or influenza virus” substitute “vaccination against an infectious disease” .

Section 9 Insertion of new regulation 235A

After regulation 235 (exemption for sale, supply or administration by certain persons), insert—

Exemption for supply or administration of certain medicines used for vaccination

(235A)

(1) Regulations 214, 220 and 221 do not apply to the supply or administration of a medicinal product used for vaccination in accordance with conditions A to F by—

(a) a public health agency;

(b) a health authority or special health authority;

(c) an NHS Trust;

(d) an NHS Foundation Trust;

(e) a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); or

(f) a person under relevant arrangements.

(2) Condition A is that the medicinal product is used for vaccination—

(a) for the purpose of providing protection against an infectious disease; and

(b) as part of a vaccination programme that has been approved by the Secretary of State, the Scottish Ministers, the Welsh Ministers or the Minister of Health in Northern Ireland.

(3) Condition B is that the medicinal product is supplied for the purpose of being administered to a person in accordance with the requirements of a vaccine group direction which has been produced by a public health agency.

(4) Condition C is that the vaccine group direction—

(a) is signed by or on behalf of—

(i) in the case of supply or administration by a body listed in paragraph (1)(a) to (e), a senior manager of that body, or

(ii) in the case of supply or administration by a person as mentioned in paragraph (1)(f), a senior manager of the body that enters into the relevant arrangements with that person; and

(b) has effect at the time at which the medicinal product is administered.

(5) Condition D is that the individual who administers the medicinal product is either at the same location and under the supervision of an individual who, or is an individual who—

(a) has—

(i) assessed and determined that the person who is to receive the medicinal product is eligible for the treatment, and

(ii) obtained and recorded the informed consent of, or in respect of, the person who is to receive the medicinal product; and

(b) belongs to one of the classes of individuals specified in Part 4 of Schedule 16.

(6) Condition E is that the vaccine group direction contains the particulars specified in Part 1 of Schedule 16, and specifies—

(a) the classes of persons permitted to administer medicinal products under the direction;

(b) the process by which a person of a specified class is designated, and by whom, as a person permitted to administer medicinal products under the direction; and

(c) requirements, where appropriate, for the supervision of a person who, on any particular occasion, administers a medicinal product under the direction.

(7) Condition F is that, when the medicinal product is administered, there is in force in relation to it—

(a) a UK marketing authorisation; or

(b) an authorisation by the licensing authority on a temporary basis under regulation 174.

(8) In this regulation—

“ a public health agency ” means—

Public Health Scotland in respect of Scotland;

Public Health Wales in respect of Wales;

the UK Health Security Agency in respect of England;

the Public Health Agency in respect of Northern Ireland;

“ relevant arrangements ” has the meaning given in regulation 19(4C) (exemptions from requirement for wholesale dealer’s licence);

“ senior manager ” means a person who plays a significant role (irrespective of whether other individuals also do so) in—

the making of decisions about how the whole or a substantial part of the activities of the body in question are to be managed or organised, or

the actual managing or organising of the whole or a substantial part of those activities.

Section 10 Omission of regulation 247A

Omit regulation 247A (protocols relating to coronavirus and influenza vaccinations and immunisations) .

Section 11 Amendment of regulation 250

In regulation 250 (exceptions to regulation 249) , in paragraph (4A)—

(a) for “regulation 247 or 247A” substitute “regulation 235A or 247” ; and

(b) for “protocol of the types” substitute “direction or protocol of the type” .

Section 12 Amendment of regulation 346

In regulation 346 (review) , in paragraph (2)(c)(xxviiiga), for “regulation 247A” substitute “regulation 235A” .

Section 13 Amendment to Schedule 16

In Schedule 16 (patient group directions)—

(a) in the heading, after “directions” insert “and vaccine group directions” ; and

(b) in the heading of Part 1, after “direction” insert “and a vaccine group direction” .

Section 14 Amendment to Schedule 17

(1) Schedule 17 (exemption for sale, supply or administration by certain persons) is amended as follows.

(2) In the table in Part 2 (exemption from the restriction on supply of prescription only medicines)—

(a) in entry 6a, in column 1, for “An NHS body or a local authority” substitute “Persons” ; and

(b) in entry 6b, in column 2, omit “against coronavirus or influenza virus (of any type)” .

(3) In the table in Part 3 (exemptions from the restriction on administration of prescription only medicines)—

(a) in entry 5a, in column 1, for “An NHS body or a local authority” substitute “Persons” ; and

(b) in entry 5b, in column 2, omit “against coronavirus or influenza virus (of any type)” .

(4) In the table in Part 5 (exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products)—

(a) in entry 10a, in column 1, for “An NHS body or a local authority” substitute “Persons” ; and

(b) in entry 10b, in column 2, omit “against coronavirus or influenza virus (of any type)” .

Section 15 Amendment to Schedule 26

In Schedule 26 (packaging requirements: special provisions) , in the heading of Part 1, for “nurses and midwives” substitute “nurses, midwives and pharmacists” .