C13C14Part III Further Provisions relating to Dealings with Medicinal Products
Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)
Provisions as to sale or supply of medicinal products
F3051 General sale lists.
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F3052 Sale or supply of medicinal products not on general sale list.
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F3053 Sale or supply of medicinal products on general sale list.
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F3054 Sale of medicinal products from automatic machines.
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Exemptions from sections 52 and 53
F3055 Exemptions for doctors and dentists etc
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F3056 Exemptions in respect of herbal remedies.
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F3057 Power to extend or modify exemptions.
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Additional provisions
C2C15C1458C14C1 Medicinal products on prescription only.
C31
F361A
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F561ZA
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F161B
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F382
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F373
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4
Without prejudice to F35 regulation 223(1) of the 2012 Regulations , any order made by the F14 Ministers for the purposes of this section may provide—
a
F24A
An order under this section may provide, in relation to F41an appropriate practitioner, other than a doctor or dentist, that such a person may—
a
give a prescription for a medicinal product falling within a description or class specified in the order;
b
administer any such medicinal product; or
c
give directions for the administration of any such medicinal product,
only where he complies with such conditions as may be specified in the order in respect of the cases or circumstances in which he may do so.
F2 4B
An order under this section may provide, in relation to a condition specified by virtue of subsection (4A), for the condition to have effect subject to such exemptions as may be specified in the order.
F2 4C
Where a condition is specified by virtue of subsection (4A), any prescription or direction given by a person in contravention of the condition is not (subject to such exemptions or modifications as may be specified in the order by virtue of subsection (4)(a) of this section) given by an appropriate practitioner for the purposes of F40 regulation 214(1) or (2) of the 2012 Regulations .
5
C16 6
F327
In subsection (6) “the appropriate committee” means whichever the Ministers consider appropriate of—
a
the Commission; or
b
an expert committee appointed by the Ministers, or by one of them acting alone.
C15C4C5 58A F5F22Requirement to specify certain products as prescription-only products
1
The F17 ... Ministers shall, subject to subsection (4) of this section, so exercise their powers under section 58(1) of this Act as to secure that every product—
F42a
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F42b
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c
to which subsection (2) of this section applies;
F43is specified as a prescription only medicine.
2
This subsection applies to any product which—
a
is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist; or
b
is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or
c
contains substances or preparations of substances of which the activity requires, or the side-effects require, further investigation; or
d
is normally prescribed by a doctor or dentist for parenteral administration.
3
In considering whether subsection (2) of this section applies to a product the F18 ... Ministers shall take into account whether the product—
a
contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or
b
contains a substance which is listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the pro duct is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention); or
c
is likely, if incorrectly used—
i
to present a substantial risk of medicinal abuse, or
ii
to lead to addiction, or
iii
to be used for illegal purposes; or
d
contains a substance which, by reason of its novelty or properties, might fall within paragraph (c) above, but as to which there is insufficient information available to determine whether it does so fall; or
e
by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved for treatments which can only be followed in a hospital; or
f
is used in the treatment of conditions which must be diagnosed in a hospital or in an institution with special diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or
g
is intended for outpatients but may produce very serious sideeffects which would require a prescription drawn up as required by a specialist and special supervision throughout the treatment.
4
Subsection (1) of this section shall not apply in relation to any product if the F19 ... Ministers so determine having regard to—
a
the maximum single dose;
b
the maximum daily dose;
c
the strength of the product;
d
its pharmaceutical form;
e
its packaging; or
f
such other circumstances relating to its use as may be specified in the determination.
5
In this section F20 ...—
“the Narcotic Drugs Convention" means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30th March 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972 X1 ; and
“the Psychotropic Substances Convention" means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971 X2 .
F2158B Requirement to specify certain products for veterinary use as prescription-only products.
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F3159 Special provisions in relation to new medicinal products.
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F3160 Restricted sale, supply and administration of certain medicinal products.
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F3161 Special restrictions on persons to be supplied with medicinal products.
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C7 62 C6 Prohibition of sale or supply, or importation, of medicinal products of specified description F12 ....
1
Subject to the following provisions of this section, the F27 ... Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order—
C8a
prohibit the sale or supply, or the importation, of medicinal products of any description, or falling within any class, specified in the order, or (in such manner as may appear to them to be sufficient to identify the products in question) designate particular medicinal products and prohibit the sale or supply, or the importation, of those particular products;
F28b
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C82
A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order.
C8C173
C84
Where an order is made under this section without prior consultation with the appropriate committee F9 ... in accordance with subsection (3) of this section, the prohibition imposed by the order shall not have effect after the end of such period, not exceeding three months from the date on which it comes into operation, as may be specified in the order, but without prejudice to the making of any further order in accordance with the provisions of this section (including this subsection).
C85
If any organisation consulted in pursuance of section 129(6) of this Act with respect to a proposal to make an order under this section have given notice to the F25Ministers of their desire to be heard under this subsection, or have made representations in writing to F26the Ministers with respect to that proposal, then before making the order—
a
b
and, where the organisation have availed themselves of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report their findings and conclusions to the F25Ministers and F26the Ministers shall take that report into account in determining whether to make the order.
C86
Subsection (5) of this section shall not have effect where in the opinion of the F29 ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section.
C8F117
If an order is made under this section and either—
a
the appropriate committee have not considered the proposal to make the order, or
b
the order is made contrary to the advice of the appropriate committee,
the order shall include a statement of the fact that it has been so made.
F448
In this section “the appropriate committee” means whichever the Ministers consider appropriate of—
a
the Commission; or
b
an expert committee appointed by the Ministers, or by one of them acting alone.
C1063 Adulteration of medicinal products. C9
No person shall—
a
add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition of the product, with intent that the product shall be sold or supplied in that state, or
b
sell or supply, or offer or expose for sale or supply, or have in his possession for the purpose of sale or supply, any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.
64 Protection of purchasers of medicinal products. C11
1
No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.
2
For the purposes of this section the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.
3
Subsection (1) of this section shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.
4
Subsection (1) of this section shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that—
a
the addition or abstraction was not carried out fraudulently, and did not injuriously affect the composition of the product, and
b
the product was sold having attached to it, or to a container or package in which it was sold, a conspicuous notice of adequate size and legibly printed, specifying the substance added or abstracted.
5
Where a medicinal product is sold or supplied in pursuance of a prescription given by F45an appropriate practitioner, the preceding provisions of this section shall have effect as if—
a
in those provisions any reference to sale included a reference to supply and (except as provided by the following paragraph) any reference to the purchaser included a reference to the person (if any) for whom the product was prescribed by the practitioner, and
b
in subsection (1) of this section, for the words “demanded by the purchaser", there were substituted the words “specified in the prescription".
F4665 Compliance with standards specified in monographs in certain publications.
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F4666 Further powers to regulate dealings with medicinal products.
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Offences, and provision for disqualification
67 Offences under Part III. C12
1
The following provisions of this section shall have effect subject to sections 121 and 122 of this Act.
F61A
Any person who gives a prescription or directions or administers a medicinal product in contravention of a condition imposed by an order under section 58 of this Act by virtue of subsection (4A) of that section shall be guilty of an offence.
1B
Any person who—
a
b
gives a prescription or directions in respect of a medicinal product of a description or class in relation to which he is not an appropriate practitioner,
shall be guilty of an offence.
2
3
Where a medicinal product is sold, supplied or imported in contravention of an order made under section 62 of this Act, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other enactment, is in possession of the medicinal product, knowing or having reasonable cause to suspect that it was sold, supplied or imported in contravention of the order, shall be guilty of an offence.
F473A
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4
Any person guilty of an offence under F48subsection (1A), (1B), (2) or (3) of this section shall be liable—
a
on summary conviction, to a fine not exceeding £400;
b
on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.
F525
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F526
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67AF55Defence to offence of contravening section 63(a) or (b): product not sold or supplied
1
This section applies in a case where—
a
a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 63(a) or (b) in respect of a medicinal product; and
b
the product is not sold or supplied in its adulterated state.
2
Where the defendant is charged with contravening section 63(a), it is a defence for the defendant to prove that—
F61a
the adulteration took place—
i
at a registered pharmacy, or
ii
in the course of the provision of a relevant pharmacy service;
b
the defendant—
i
was a registrant acting in the course of his or her profession, or
ii
was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and
c
at the time of the alleged contravention, the defendant did not know that the product was being adulterated.
3
Where the defendant is charged with contravening section 63(b), it is a defence for the defendant to prove that—
F62a
the adulteration took place—
i
at a registered pharmacy, or
ii
in the course of the provision of a relevant pharmacy service;
b
the person who adulterated the product—
i
was a registrant acting in the course of his or her profession, or
ii
was acting under the supervision of a person who was a registrant acting in the course of his or her profession; and
c
at the time of the alleged contravention, the defendant did not know that the product had been adulterated.
67BDefence to offence of contravening section 63(a) or (b): product sold or supplied
1
This section applies in a case where—
a
a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 63(a) or (b) in respect of a medicinal product; and
b
the product was sold or supplied in its adulterated state.
2
It is a defence for the defendant to prove that—
F63a
the adulteration took place—
i
at a registered pharmacy, or
ii
in the course of the provision of a relevant pharmacy service;
b
the person who adulterated the product—
i
was a registrant acting in the course of his or her profession, or
ii
was acting under the supervision of a person (“the supervising registrant”) who was a registrant acting in the course of his or her profession;
c
the product was—
i
sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or a patient group direction, or
ii
a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay; and
d
Condition A or B is met.
3
Condition A is that before the defendant was charged—
a
the defendant did not know that the product had been adulterated; and
b
if the defendant is a person within subsection (4), neither the person who adulterated the product nor (in a case within subsection (2)(b)(ii)) the supervising registrant knew that the product had been adulterated.
4
A defendant is a person within this subsection if the defendant is any of the following—
a
the person who adulterated the product;
b
(in a case within subsection (2)(b)(ii)) the supervising registrant;
c
the person carrying on the retail pharmacy business F64, or the relevant pharmacy service, in the course of which the product was sold or supplied.
5
Condition B is that—
a
before the defendant was charged, an appropriate person, on becoming aware that the product had been adulterated—
i
promptly ensured that all reasonable steps were taken to ensure that the person to whom the product was intended to be administered was notified that the product had been adulterated, or
ii
reasonably formed the view that it was not necessary or appropriate to do so, in the circumstances of the case; and
b
the defendant did not know at the time that the product was sold or supplied that it had been adulterated.
6
In subsection (5), “appropriate person” means any of the following—
a
the person who adulterated the product or (in a case within subsection (2)(b)(ii)) the supervising registrant;
b
the person carrying on the retail pharmacy business F65, or the relevant pharmacy service, in the course of which the product was sold or supplied, or any person acting on that person’s behalf.
67CDefence to offence of contravening section 64
1
This section applies in a case where a person (“the defendant”) is charged with an offence under section 67(2) of contravening section 64 in respect of a medicinal product.
2
It is a defence for the defendant to prove that—
F66a
the product was dispensed—
i
at or from a registered pharmacy, or
ii
in the course of the provision of a relevant pharmacy service;
b
the person who dispensed the product—
i
was a registrant acting in the course of his or her profession, or
ii
was acting under the supervision of a person (“the supervising registrant”) who was a registrant acting in the course of his or her profession;
c
the product was—
i
sold or supplied in pursuance of a prescription or directions given by a relevant prescriber or a patient group direction, or
ii
a prescription only medicine that was sold or supplied in circumstances where there was an immediate need for it to be sold or supplied and a prescription could not have been obtained without undue delay; and
d
Condition A or B is met.
3
Condition A is that before the defendant was charged—
a
the defendant did not know that the product was not of the required nature or quality; and
b
if the defendant is a person within subsection (4), neither the person who dispensed the product nor (in a case within subsection (2)(b)(ii)) the supervising registrant knew that the product was not of the required nature or quality.
4
A defendant is a person within this subsection if the defendant is any of the following—
a
the person who dispensed the product;
b
(in a case within subsection (2)(b)(ii)) the supervising registrant;
c
the person carrying on the retail pharmacy business F67, or the relevant pharmacy service, in the course of which the product was sold or supplied.
5
Condition B is that—
a
before the defendant was charged, an appropriate person, on becoming aware that the product was not of the required nature or quality—
i
promptly ensured that all reasonable steps were taken to ensure that the person to whom the product was intended to be administered was notified that the product was not of the required nature or quality, or
ii
reasonably formed the view that it was not necessary or appropriate to do so, in the circumstances of the case; and
b
the defendant did not know at the time the product was sold or supplied that it was not of the required nature or quality.
6
In subsection (5), “appropriate person” means any of the following—
a
the person who dispensed the product or (in a case within subsection (2)(b)(ii)) the supervising registrant;
b
the person carrying on the retail pharmacy business F68, or the relevant pharmacy service, in the course of which the product was sold or supplied, or any person acting on that person’s behalf.
7
In this section, “the required nature or quality”, in relation to a product, means—
a
where the product is sold or supplied in pursuance of a prescription, the nature or quality specified in the prescription; or
b
in any other case, the nature or quality demanded by the purchaser of the product.
67DDefences under sections 67A, 67B and 67C: evidence etc.
1
This section applies for the purposes of sections 67A to 67C.
2
If evidence is adduced that is sufficient to raise an issue with respect to the doing of an act by a person in the course of his or her profession, the court must assume that the person did that act in the course of his or her profession unless the prosecution proves the contrary beyond reasonable doubt.
3
The court must assume that the prosecution has proved the contrary beyond reasonable doubt if the prosecution proves beyond reasonable doubt that, in doing that act—
a
the person used his or her professional skills for an improper purpose; or
b
the person deliberately failed to have due regard for patient safety.
4
Proof that a registrant failed to comply with a procedure established in relation to a registered pharmacy F69or a relevant pharmacy service does not of itself constitute proof that the registrant was not acting in the course of his or her profession.
5
Knowledge acquired after a product is sold or supplied does not count if it is acquired only as a result of an investigation into whether an offence has been committed in respect of a product.
6
If evidence is adduced that is sufficient to raise an issue with respect to doing of an act promptly, the court must assume that the act was done promptly unless the prosecution proves the contrary beyond reasonable doubt.
7
A medicinal product is taken to be sold or supplied to a person in pursuance of a prescription or direction even if that person is not the person for whom it was dispensed in pursuance of the prescription or direction.
67ESections 67A to 67D: F59“adulteration” and “registrant”
In sections 67A to 67D—
“adulteration”, in relation to a medicinal product, means the addition of a substance to, or the abstraction of a substance from, the product, so as to affect injuriously its composition (and related expressions are to be construed accordingly);
“registrant” means—
- a
where it is alleged that the offence in question took place in Great Britain, a person who is entered in Part 1, F57or 2 of the register of pharmacists and pharmacy technicians established and maintained under article 19 of the Pharmacy Order 2010 (SI 2010/231); or
- b
where it is alleged that the offence in question took place in Northern Ireland, a person registered in the register of pharmaceutical chemists for Northern Ireland F58... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 (SI 1976/1213 (NI 22)).
- a
67FF60Sections 67A to 67D: “relevant pharmacy service”
1
For the purposes of sections 67A to 67D a pharmacy service is a relevant pharmacy service if conditions A and B are met in respect of it.
2
Condition A is met in respect of a pharmacy service if—
a
the service is provided in England by a person in the course of carrying on a regulated activity in respect of which the person is registered under Chapter 2 of Part 1 of the Health and Social Care Act 2008;
b
the service is provided in Wales—
i
in the course of the business of a hospital,
ii
in a prison or youth detention accommodation within the meaning of sections 185 to 187 of the Social Services and Well-being (Wales) Act 2014 (anaw 4) (see section 188 of that Act),
iii
in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act),
iv
by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 2 of the Care Standards Act 2000, or
v
by a person in the course of providing a regulated service in respect of which the person is registered under Chapter 2 of Part 1 of the Regulation and Inspection of Social Care (Wales) Act 2016 (anaw 2);
c
the service is provided in Scotland—
i
in the course of the business of a hospital,
ii
in a prison within the meaning of section 49C of the Criminal Law (Consolidation) (Scotland) Act 1995 (see subsection (7) of that section),
iii
in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act),
iv
by a person in the course of providing an independent health care service which is registered under section 10P of the National Health Service (Scotland) Act 1978, or
v
by a person in the course of carrying on a care service which is registered under Chapter 3 of Part 5 of the Public Services Reform (Scotland) Act 2010 (asp 8); or
d
the service is provided in Northern Ireland—
i
in the course of the business of a hospital,
ii
in a prison or other institution for the treatment of offenders, including a place mentioned in section 2 of the Treatment of Offenders Act (Northern Ireland) 1968 (c. 29 (N.I.)) and a juvenile justice centre within the meaning of the Criminal Justice (Children) (Northern Ireland) Order 1998 (S.I. 1998/1504 (N.I. 9)) (see Article 51(1) of that Order),
iii
in a removal centre, short-term holding facility or pre-departure accommodation within the meaning of Part 8 of the Immigration and Asylum Act 1999 (see section 147 of that Act), or
iv
by a person in the course of carrying on or managing an establishment in respect of which the person is registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 (S.I. 2003/431 (N.I. 9)).
3
Condition B is met in respect of a pharmacy service if it has a chief pharmacist.
4
A chief pharmacist, in relation to a pharmacy service, is a pharmacist who—
a
plays a significant role (irrespective of whether other individuals also do so) in—
i
the making of decisions about how the whole or a substantial part of the activities of the pharmacy service are to be managed or organised, or
ii
the actual managing or organising of the whole or a substantial part of those activities,
b
has the authority to make decisions that affect the running of the pharmacy service so far as concerns the sale or supply of medicinal products, and
c
is responsible for securing that the pharmacy service is carried on safely and effectively.
5
For the purposes of subsection (4)(c) a pharmacy service is carried on safely and effectively if it is carried on in ways that ensure its safe and effective running so far as concerns the sale or supply of medicinal products.
F5368 Disqualification on conviction of certain offences.
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Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)