PART 2

Human medicines
CHAPTER 1

Regulations: general

Power to make regulations about human medicines
2
1
The appropriate authority may by regulations make provision specified in sections 3 to 7 amending or supplementing the law relating to human medicines.
2
In making regulations under subsection (1), the appropriate authority's overarching objective must be safeguarding public health.
3
In considering whether regulations under subsection (1) would contribute to this objective, the appropriate authority must have regard to—
a
the safety of human medicines;
b
the availability of human medicines;
c
the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to—
i
carry out research relating to human medicines,
ii
conduct clinical trials, or
iii
manufacture or supply human medicines.
4
Where regulations under subsection (1) may have an impact on the safety of human medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.
5
In subsection (3)(c), “relevant part of the United Kingdom” means—
a
so far as the regulations relate to England and Wales and Scotland, those parts of the United Kingdom, and
b
so far as the regulations relate to Northern Ireland, that part of the United Kingdom.
6
In this Part, “appropriate authority” means—
a
in relation to England and Wales and Scotland, the Secretary of State, and
b
in relation to Northern Ireland—
i
the Department of Health in Northern Ireland, or
ii
the Department of Health in Northern Ireland and the Secretary of State acting jointly.

Manufacture, marketing and supply
3
1
Regulations under section 2(1) may make provision about—
a
authorisations to manufacture human medicines,
b
authorisations to import human medicines,
c
authorisations to distribute human medicines by way of wholesale dealing,
d
marketing authorisations,
e
manufacturing, importing or distributing active substances,
f
brokering in relation to human medicines,
g
the registration of the premises of pharmacy businesses,
h
the recording of information about the supply of human medicines,
i
notification and reporting requirements in relation to human medicines that have been placed on the market,
j
the labelling and packaging of human medicines or the information that must be supplied with them or made available in relation to them,
k
advertising with regard to human medicines,
l
the registration of persons who supply or offer to supply human medicines by means of the internet,
m
the requirements that must be met in relation to a prescription,
n
prohibitions in the provisions mentioned in subsection (2), or
o
the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines.
2
Subsection (1)(n) refers to the following provisions in the Human Medicines Regulations 2012 (S.I. 2012/1916)—
a
regulation 214 and Schedule 13 (sale or supply of prescription only medicines),
b
regulation 215 and Schedule 14 (prescribing and administration by supplementary prescribers),
c
regulation 220 (sale or supply of human medicines not subject to general sale),
d
regulation 221 and Schedule 15 (sale or supply of medicinal products subject to general sale), and
e
regulation 249 and Schedule 22 (restrictions on persons to be supplied with medicinal products).

Falsified medicines
4
1
Regulations under section 2(1) may make provision about—
a
the prevention of the supply of falsified human medicines, or
b
the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.
2
Provision made in reliance on subsection (1)(a) may (among other things) make provision—
a
for human medicines that are subjects of a marketing authorisation to be supplied in packs that—
i
carry unique identifiers associated with the products, and
ii
are protected with anti-tamper devices,
b
for checks to be carried out in relation to packs that have or should have such a unique identifier,
c
about the infrastructure, systems and processes required for the allocation and checking of unique identifiers, including provision about—
i
who is to set up the infrastructure, systems and processes,
ii
who is to maintain them, and
iii
who is to pay for them.
3
In making regulations in reliance on subsection (1), the appropriate authority must have regard to the importance of ensuring that information is retained securely.

Clinical trials
5
1
Regulations under section 2(1) may make provision—
a
corresponding or similar to provision in the EU Clinical Trials Regulation,
b
about authorisations concerning clinical trials in the United Kingdom, including applications for an assessment of the ethics of a proposed clinical trial,
c
about notification and reporting requirements in relation to clinical trials,
d
about requirements that must be met before a clinical trial may be carried out, or
e
relating to the conduct of clinical trials.
2
In subsection (1)(a), “EU Clinical Trials Regulation” means Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

Fees, offences, powers of inspectors
6
1
Regulations under section 2(1) may make provision—
a
about the charging of fees in connection with the exercise of a function conferred by a human medicines provision,
b
creating a criminal offence of failing to comply with a provision made in the regulations, or
c
applying relevant powers of entry or other powers of inspectors with or without modification in relation to a prohibition or requirement in provision made in the regulations.
2
Regulations under section 2(1) may not provide for an offence to be punishable with a sentence of imprisonment of more than two years.
3
In subsection (1), “relevant powers of entry or other powers of inspectors” means powers of entry or powers of inspectors in—
a
Part 8 of the Medicines Act 1968;
b
the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031);
c
Part 16 of the Human Medicines Regulations 2012 (S.I. 2012/1916).
4
In this Part, “human medicines provision” means a provision in—
a
regulations under section 2(1),
b
the Human Medicines Regulations 2012, or
c
the Medicines for Human Use (Clinical Trials) Regulations 2004.

Emergencies
7
1
Regulations under section 2(1) may make provision about the disapplication of a human medicines provision in circumstances which give rise to a need to protect the public from a risk of serious harm to health.
2
Regulations made in reliance on subsection (1) may provide for the disapplication to be subject to—
a
conditions set out in the regulations;
b
conditions set out in a protocol published by the appropriate authority.
3
Where regulations made in reliance on subsection (1) provide that the appropriate authority may publish a protocol setting out conditions, the regulations must provide—
a
that the appropriate authority may withdraw or amend the protocol, and
b
that the protocol is to have effect only for a period of time specified in the protocol.
CHAPTER 1A

Regulations: information systems

Information systems
7A
1
The appropriate authority may by regulations make provision about the establishment and operation by
NHS England
of one or more information systems for purposes relating to—
a
the safety of human medicines, including the safety of clinical decisions relating to human medicines;
b
the quality and efficacy of human medicines.
2
The regulations may (among other things) make provision—
a
about the information in relation to human medicines which may or must be entered or retained in an information system established under subsection
(1)
;
b
requiring information to be provided to
NHS England
for the purposes of its functions under the regulations;
c
about the use or disclosure of information contained in an information system established under subsection
(1)
;
d
requiring
NHS England
to have regard to specified matters in exercising its functions under the regulations.
3
The provision mentioned in subsection
(2)(a)
and
(b)
may relate to—
a
information for specified purposes,
b
information that
NHS England
considers it necessary or expedient to have for the purposes of its functions under the regulations,
c
information (including information relating to individuals) which is of a specified description, or
d
information (including information relating to individuals) which is of a description set out in a direction in writing given by the appropriate authority.
4
The provision mentioned in subsection
(2)(b)
may include provision—
a
requiring, or enabling
NHS England
to require, specified persons or descriptions of persons to whom subsection
(5)
applies to provide information to
NHS England
;
b
about the manner in which, and the time at which, those persons must provide information, or for those matters to be determined by
NHS England
;
c
about any procedural steps
NHS England
must follow in requiring a person to provide information to it;
d
requiring specified persons or descriptions of persons to whom subsection
(5)
applies to record or retain information which they are, or may be, required to provide to
NHS England
under the regulations;
e
in relation to the enforcement of any requirement imposed by or under the regulations.
5
This subsection applies to any person who provides services, or exercises any powers or duties, relating to—
a
human medicines,
b
health, or
c
education.
6
The provision mentioned in subsection
(2)(c)
may include provision about—
a
the analysis by
NHS England
of information that is contained in an information system (whether alone or in combination with other information) for the purposes mentioned in subsection
(1)
or for other purposes;
b
the publication by
NHS England
of information that is contained in an information system or has been analysed in combination with such information;
c
the disclosure (other than by way of publication) of information mentioned in paragraph
(b)
to specified persons or descriptions of persons, or for specified purposes;
d
the use or further disclosure by any person of information disclosed to them under the regulations.
7
Regulations conferring on the appropriate authority a power to give a direction by virtue of subsection
(3)(d)
must —
a
provide that the power includes power to vary or revoke the directions by a subsequent direction, and
b
in the case of a power exercisable in relation to Wales or Scotland, require the Secretary of State—
i
where a proposed direction relates to Wales, to consult the Welsh Ministers before giving it, and
ii
where a proposed direction relates to Scotland, to consult the Scottish Ministers before giving it.
8
Where regulations under subsection (1) include provision by virtue of subsection (4)(a) which requires, or enables
NHS England
to require, the provision of individual health information held for the purposes of the health service established under section 1 of the National Health Service (Scotland) Act 1978, the regulations must provide for the information to be collected by the Scottish Ministers, or a person designated by them, on behalf of
NHS England
, subject to specified exceptions.
9
Regulations by virtue of subsection (8) may—
a
confer powers or duties (including discretions) on the Scottish Ministers, a designated person or
NHS England
;
b
provide for powers or duties conferred on the Scottish Ministers to be treated for the purposes of section 2 of the National Health Service (Scotland) Act 1978 as functions relating to the health service (within the meaning of that Act).
10
Where regulations under subsection (1) include provision by virtue of subsection (4)(a) which requires, or enables
NHS England
to require, the provision of individual health information held for the purposes of the health service in Wales, the regulations must provide for the information to be collected by the Welsh Ministers, or a person designated by them, on behalf of
NHS England
, subject to specified exceptions.
11
Regulations by virtue of subsection (10) may confer powers or duties (including discretions) on the Welsh Ministers, a designated person or
NHS England
.
12
Regulations under subsection
(1)
may provide that the disclosure of information by virtue of this section does not breach—
a
an obligation of confidence owed by the person making the disclosure, or
b
any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.
13
In this section—
- “
data protection legislation
” has the meaning given by section 3(9) of the Data Protection Act 2018;
- “
health service
”, in relation to Wales, has the meaning given by section 206(1) of the National Health Service (Wales) Act 2006;
- “
human medicine
” has the same meaning as in Part 2 (see section 9);
- “
individual health information
” means information (however recorded) which relates to—
  1. the physical or mental health or condition of an individual,
  2. the diagnosis of an individual’s condition, or
  3. an individual’s care or treatment,
or is (to any extent) derived directly or indirectly from information relating to any of those matters;
- “
specified
” means specified in regulations under subsection
(1)
.

Offence of disclosing information
7B
1
A person to whom information is disclosed under regulations under section
7A
(1)
commits an offence if the person uses or discloses that information in contravention of the regulations.
2
A person guilty of an offence under this section is liable—
a
on summary conviction in England and Wales, to imprisonment for a term not exceeding 51 weeks, to a fine or to both;
b
on summary conviction in Scotland or Northern Ireland, to imprisonment for a term not exceeding 6 months, to a fine not exceeding level 5 on the standard scale or to both.
3
In relation to an offence committed before the coming into force of section 281(5) of the Criminal Justice Act 2003, the reference in subsection
(2)(a)
to 51 weeks is to be read as a reference to 6 months.
CHAPTER 2

International agreements: disclosure of information

Disclosure of information in accordance with international agreements
8
1
This section applies to information which a relevant authority holds in connection with human medicines.
2
The relevant authority may disclose information to a relevant person outside the United Kingdom where—
a
the disclosure is required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines, and
b
the relevant authority considers that the disclosure is in the public interest.
3
The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—
a
considers that it is necessary to do so for the purpose mentioned in that subsection, and
b
is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.
4
Except as provided by subsections (5) and (6), the disclosure of information in accordance with this section does not breach—
a
an obligation of confidence owed by the person making the disclosure, or
b
any other restriction on the disclosure of the information (however imposed).
5
Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.
6
Nothing in this section authorises a disclosure of information which—
a
contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or
b
is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.
7
This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.
8
In this section—
- “commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;
- “data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;
- “patient information” means information (however recorded) which—
  1. relates to—
    1. the physical or mental health or condition of an individual,
    2. the diagnosis of an individual's condition, or
    3. an individual's care or treatment,
or is (to any extent) derived directly or indirectly from information relating to any of those matters, and
  2. identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);
- “relevant authority” means—
  1. the Secretary of State, or
  2. the Department of Health in Northern Ireland;
- “relevant person” means—
  1. the government of a country or territory outside the United Kingdom;
  2. a person who exercises functions on behalf of such a government;
  3. any other person who exercises functions or provides services relating to human medicines in a country or territory outside the United Kingdom;
  4. an international organisation that exercises functions or provides services relating to human medicines.
CHAPTER 3

Interpretation

Interpretation of Part 2
9
In this Part—
- “active substance” has the meaning given by regulation 8 of the Human Medicines Regulations 2012 (S.I. 2012/1916);
- “appropriate authority” has the meaning given by section 2(6);
- “clinical trial” has the meaning given by regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031);
- “EU Clinical Trials Regulation” has the meaning given by section 5(2);
- “falsified human medicine” means a falsified medicinal product within the meaning given by regulation 8 of the Human Medicines Regulations 2012;
- “human medicine” means a medicinal product within the meaning given by regulation 2 of the Human Medicines Regulations 2012;
- “human medicines provision” has the meaning given by section 6(4);
- “law relating to human medicines” means—
  1. sections 10 and 15, and Part 4, and section 131 of the Medicines Act 1968 (which make provision relating to pharmacies),
  2. the Human Medicines Regulations 2012,
  3. the Medicines for Human Use (Clinical Trials) Regulations 2004, and
  4. the Medicines (Products for Human Use) (Fees) Regulations 2016 (S.I. 2016/190);
- “manufacture” includes assembly;
- “marketing authorisation” means an authorisation to market a human medicine in the United Kingdom;
- “pharmacy business” means a business (other than a professional practice carried on by a doctor or dentist) which consists of or includes the sale of medicinal products that are not subject to general sale;
- “supplying” includes administering within the meaning given by regulation 8 of the Human Medicines Regulations 2012 (and related expressions are to be read accordingly).
S. 6(4) in force at 11.2.2021 see s. 50(1)(c)
Pt. 2 Ch. 1 heading substituted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 101(2), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)
Pt. 2 Ch. 1A inserted (1.7.2022) by Health and Care Act 2022 (c. 31), ss. 101(3), 186(6); S.I. 2022/734, reg. 2(a), Sch. (with regs. 13, 29, 30)
Words in s. 7A(1) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 21(2)(a) (with reg. 3)
Words in s. 7A(2)-(4) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 21(2)(b) (with reg. 3)
Words in s. 7A(6) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 21(2)(b) (with reg. 3)
Words in s. 7A(8)-(11) substituted (1.2.2023) by The Health and Social Care Information Centre (Transfer of Functions, Abolition and Transitional Provisions) Regulations 2023 (S.I. 2023/98), reg. 1(2), Sch. para. 21(2)(b) (with reg. 3)