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STATUTORY INSTRUMENTS
2026 No. 381
MEDICINES
The Human Medicines (Amendment) Regulations 2026
Made - - - - 26th March 2026
Coming into force - - 31st March 2026
The Secretary of State in relation to England and Wales and Scotland, and the Department of Health
in Northern Ireland and the Secretary of State acting jointly in relation to Northern Ireland, make
the following Regulations in exercise of the powers conferred by sections 2(1), 3(1)(a), (c), (d), (h),
(j) and (n), 3(2)(a), (c) and (d) and 43(2) of the Medicines and Medical Devices Act 2021(1).
The Secretary of State and the Department of Health in Northern Ireland have carried out a public
consultation in accordance with section 45(1) of that Act.
In accordance with section 2(2) to (4) of that Act, the overarching objective of the Secretary of
State and the Department of Health in Northern Ireland in making these Regulations is safeguarding
public health. The Secretary of State and the Department of Health in Northern Ireland have had
regard to the matters specified in section 2(3) of that Act and consider that, where these Regulations
may have an impact on the safety of human medicines, the benefits of making these Regulations
outweigh the risks.
In accordance with section 47(3) and (6)(c) of that Act, a draft of this instrument was laid before
Parliament and the Northern Ireland Assembly and approved by a resolution of each House of
Parliament and the Northern Ireland Assembly.
Citation, commencement and extent
1.—(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.
Amendment of the Human Medicines Regulations 2012
2. The Human Medicines Regulations 2012(2) are amended in accordance with regulations 3 to
15.
(1) 2021 c. 3. The powers in section 2(1) of the Medicines and Medical Devices Act 2021, and in the provisions that relate to
it, are exercisable by the “appropriate authority”. See section 2(6) of that Act, which contains the definition of ‘appropriate
authority’ that is relevant to the powers being exercised.
(2) S.I. 2012/1916.Document Generated: 2026-03-31
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Amendment of regulation 3
3.—(1) Regulation 3 (scope of these Regulations: special provisions)(3) 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)”.
Amendment of regulation 3A
4.—(1) Regulation 3A (preparation and assembly of medicinal products used for vaccination or
immunisation against coronavirus or in the reformulation of such products)(4) 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).
Amendment of regulation 8
5. In regulation 8 (general interpretation)(5), 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;”.
Amendment of regulation 19
6.—(1) Regulation 19 (exemptions from requirement for wholesale dealer's licence)(6) is
amended as follows.
(2) In paragraph (4A)—
(a) in the opening words—
(3) Regulation 3 was amended by S.I. 2019/775, 2024/832 and 2025/758.
(4) Regulation 3A was inserted by S.I. 2020/1594 and S.R. 2020/350, and has been amended by S.I. 2024/344 and S.R. 2024/68.
(5) The relevant amending instruments are S.I. 2020/1125 and S.R. 2020/349.
(6) Paragraphs (4A), (4B) and (4D) were inserted by S.I. 2020/1125 and S.R. 2020/349 and paragraph (4D) has been amended
by S.I. 2024/344 and S.R. 2024/68.
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(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.”.
Amendment of regulation 213
7. 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—
(a) is signed by any person who may be required to sign it in the circumstances specified
for its use in regulation 235A; and
(b) 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).”.
Amendment of regulation 233
8. In regulation 233 (exemption for supply etc under a PGD by person conducting a retail
pharmacy business)(7), in paragraph (8), for “vaccination or immunisation against coronavirus or
influenza virus” substitute “vaccination against an infectious disease”.
(7) The relevant amending instruments are S.I. 2020/1594 and S.R. 2020/350
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Insertion of new regulation 235A
9. 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
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(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—
(a) Public Health Scotland in respect of Scotland;
(b) Public Health Wales in respect of Wales;
(c) the UK Health Security Agency in respect of England;
(d) 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—
(a) 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
(b) the actual managing or organising of the whole or a substantial part of those
activities.”.
Omission of regulation 247A
10. Omit regulation 247A (protocols relating to coronavirus and influenza vaccinations and
immunisations)(8).
Amendment of regulation 250
11. In regulation 250 (exceptions to regulation 249)(9), 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”.
Amendment of regulation 346
12. In regulation 346 (review)(10), in paragraph (2)(c)(xxviiiga), for “regulation 247A”
substitute “regulation 235A”.
Amendment to Schedule 16
13. 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”.
(8) Regulation 247A was inserted by S.I. 2020/1125 and S.R. 2020/349 and amended by S.I. 2021/1452, S.I. 2024/344, S.R.
2024/68 and S.I. 2024/832
(9) The relevant amending instruments are S.I. 2020/1125 and S.R. 2020/349.
(10) The relevant amending instruments are S.I. 2013/1855, S.I. 2020/1125 and S.R. 2020/349.
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Amendment to Schedule 17
14.—(1) Schedule 17 (exemption for sale, supply or administration by certain persons)(11) 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)”.
Amendment to Schedule 26
15. In Schedule 26 (packaging requirements: special provisions)(12), in the heading of Part 1,
for “nurses and midwives” substitute “nurses, midwives and pharmacists”.
Signed by authority of the Secretary of State for Health and Social Care
Zubir Ahmed
Parliamentary Under Secretary of State
26th March 2026 Department of Health and Social Care
Sealed with the Official Seal of the Department of Health in Northern Ireland
Cathy Harrison
A senior officer of the Department of Health in
26th March 2026 Northern Ireland
(11) Relevant amendments have been made to Schedule 17 by S.I. 2020/1125 and S.R. 2020/349.
(12) Relevant amendments have been made to Schedule 26 by S.I. 2025/758.
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EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”), which
govern the arrangements across the United Kingdom for the licensing, manufacture, wholesale
dealing and sale or supply of medicines for human use.
Regulation 3 amends regulation 3 of the 2012 Regulations to enable pharmacists to prepare or
assemble medicines for a patient without a manufacturer’s licence. The existing arrangements for
preparation or assembly by pharmacists in regulation 4 of the 2012 Regulations will continue to
apply where someone other than the pharmacist takes the treatment decision to supply or administer
the medicine. Regulation 15 amends Schedule 26 to the 2012 Regulations consequentially to specify
the labelling requirements that would apply in this circumstance.
Regulation 4 amends regulation 3A of the 2012 Regulations, so that it is a permanent provision that
extends to all vaccines against infectious diseases. However, regulation 3A of the 2012 Regulations
is now limited only to assembly by holders of a wholesale dealer’s licences to take account of changes
to shelf life and no longer applies to acts of preparation and assembly undertaken by or under the
supervision of a doctor, nurse or pharmacist.
Regulation 6 amends regulation 19 of the 2012 Regulations, so that it is a permanent provision that
extends to all vaccines against infectious diseases. Regulation 19 of the 2012 Regulations provides
for certain exemptions from the requirement to hold a wholesale dealer’s licence, and paragraphs
(4A) to (4F) of that regulation (which includes new paragraphs added by regulation 6) permit
distribution of stocks of vaccinations between providers of vaccination services without the need
for such a licence. Conditions are imposed to ensure the exceptional use of this exemption, which
include that the situation must be such that there is an urgent public health need, there is no alternative
medicine capable of meeting that need, and there is no alternative route for the patient to receive
the product.
Subject to various exceptions in Part 12 of the 2012 Regulations, prescription only medicines and
pharmacy medicines must be sold or supplied, by or under the supervision of a pharmacist, on
premises that are a registered pharmacy. Regulation 233 of the 2012 Regulations provides that
persons lawfully conducting a retail pharmacy business are exempted from this restriction if the
supply or administration to the patient is in accordance with a patient group direction (amongst other
conditions). Regulation 8 amends regulation 233 of the 2012 Regulations to extend the exemption
to cover all vaccines against infectious diseases.
Regulation 9 introduces a new regulation 235A in the 2012 Regulations, which exempts the supply
or administration of certain vaccines from the requirements relating to the supply of medicines under
regulations 214, 220 and 221, where the administration to the patient is in accordance with a vaccine
group direction produced by a public health agency (as defined in the regulation) and subject to
other pre-conditions as outlined in the regulation. Regulation 7 introduces a new definition for a
vaccine group direction. Regulation 13 makes consequential amendments to Schedule 16 to the 2012
Regulations.
Regulation 10 removes regulation 247A of the 2012 Regulations (as this is replaced by the above
inserted regulation 235A of the 2012 Regulations). Regulations 11 and 12 make consequential
amendments as a result of the removal of regulation 247A of the 2012 Regulations and the insertion
of the new regulation 235A of the 2012 Regulations.
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Regulation 14 amends Schedule 17 to the 2012 Regulations to enable occupational health vaccinators
to administer any vaccine as part of an occupational health scheme (which is not restricted to a
scheme operated by the NHS). Regulation 5 amends the definition of occupational health vaccinator
to align with the classes of individuals specified in Part 4 of Schedule 16 to the 2012 Regulations.
A full impact assessment has not been produced for this instrument as no, or no significant, impact
on the private, voluntary or public sector is foreseen. A de minimis assessment is available from the
Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU and is published with
the explanatory memorandum alongside this instrument on www.legislation.gov.uk.
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