Medicines Act 1968

Business carried on by individual pharmacist or by partners.

False or misleading advertisements and representations.

Rights of entry.

Analysis of samples in other cases.

Prosecutions.

Meaning of “medicinal product" and related expressions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

General interpretation provisions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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Sale of medicinal products from automatic machines.

The responsible pharmacist

Termination of transitional exemptions.

Procedure in other cases.

Enforcement in Northern Ireland.

Power to inspect, take samples and seize goods and documents.

Facilities for microbiological examinations.

Exemption for re-exports.

Section 72A: supplementary

Provision for modifying or extending restrictions under s. 78.

Special provisions as to Northern Ireland.

The Cancer Act 1939 (c. 13.)

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Special provisions as to effect of manufacturer’s licence.

Sale or supply of medicinal products on general sale list.

Requirement to specify certain products as prescription-only products

Business carried on by individual pharmacist or by partners.

Representative of pharmacist in case of death or disability.

Application for licence.

Application for licence.

Offences under Part IV.

False or misleading advertisements and representations.

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Enforcement in Northern Ireland.

Analysis of samples in other cases.

Prosecutions.

Meaning of “medicinal product" and related expressions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

Transitional exemptions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

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Exemption for nurses and midwives.

Hearing before person appointed

Exemptions in respect of herbal remedies.

Entitlement to licence of right.

Requirement to specify certain products for veterinary use as prescription-only products.

Adulteration of medicinal products.

General provisions.

Business carried on by individual pharmacist or by partners.

Business carried on by body corporate

Representative of pharmacist in case of death or disability.

The responsible pharmacist

Revocation of disqualification.

Offences under Part IV.

Scope of Part VI.

False or misleading advertisements and representations.

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Enforcement in Scotland.

Enforcement in Northern Ireland.

Rights of entry.

Analysis of samples in other cases.

Prosecutions.

Meaning of “medicinal product" and related expressions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

General interpretation provisions.

Further powers to regulate dealings with medicinal products.

The Venereal Disease Act 1917 (c. 21).

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Establishment of committees.

Exemption for nurses and midwives.

Exemptions in respect of herbal remedies.

Provision for extending or modifying exemptions.

Termination of transitional exemptions.

Application for licence.

Procedure in other cases.

Hearing before person appointed

Special provisions as to effect of manufacturer’s licence.

Special provisions in respect of exporting certain products to EEA State s

Certificates for exporters of medicinal products.

Requirement to specify certain products as prescription-only products

Scope of Part VI.

Analysis of samples in other cases.

Compliance with standards specified in monographs in certain publications.

Liability to forfeiture under Customs and Excise Act 1952.

Offences under Part III.

Defence to offence of contravening section 63(a) or (b): product sold or supplied

General provisions as to operation of Act.

Business carried on by individual pharmacist or by partners.

Business carried on by body corporate

Representative of pharmacist in case of death or disability.

The responsible pharmacist

Provision for modifying or extending restrictions under s. 78.

Interim measures

Offences under Part IV.

Scope of Part VI.

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New editions of British Pharmacopoeia, and other compendia.

Enforcement in Scotland.

Enforcement in Northern Ireland.

Rights of entry.

Analysis of samples in other cases.

Facilities for microbiological examinations.

Prosecutions.

Presumptions.

Meaning of “medicinal product" and related expressions.

General interpretation provisions.

General interpretation provisions.

Special provisions as to Northern Ireland.

The Cancer Act 1939 (c. 13.)

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67A

• (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—

• (a) 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—

• (a) 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.

67B

• (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—

• (a) 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 , 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 , 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.

67C

• (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—

• (a) 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 , 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 , 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.

67D

• (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 or 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.

67E

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—where it is alleged that the offence in question took place in Great Britain, a person who is entered in Part 1, or 2 of the register of pharmacists and pharmacy technicians established and maintained under article 19 of the Pharmacy Order 2010 (SI 2010/231); orwhere 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 ... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 (SI 1976/1213 (NI 22)).

82A

• (1) Subsection (2) applies where—

• (a) the relevant disciplinary committee have given a direction (“the principal direction”) under section 80(1), (1A) or (2) in relation to a body corporate, pharmacist or partnership; and

• (b) the direction has not yet taken effect.

• (2) Where the committee are satisfied that to do so is necessary for the protection of members of the public or is otherwise in the public interest, the committee may direct the registrar to suspend from the register, until the principal direction takes effect or an appeal under section 82(3) against the principal direction is successful—

• (a) all entries of premises entered in the register as premises at or from which the body corporate, pharmacist or partnership carries on a retail pharmacy business; or

• (b) entries of such of those premises as may be specified in the direction under this subsection.

• (3) Where the committee give a direction under subsection (2), the registrar must send to the body corporate, pharmacist or partnership to whom the direction relates a statement in writing giving that person notice of—

• (a) the contents of the direction; and

• (b) the right of appeal under subsection (5).

• (4) The statement must be sent—

• (a) in the case of a body corporate, to the body corporate at its registered or principal office;

• (b) in the case of a pharmacist, to the pharmacist at the pharmacist’s home address in the register;

• (c) in the case of a partnership, to the partnership at its principal office.

• (5) A body corporate, pharmacist or partnership to whom a direction under subsection (2) relates may appeal against the direction to the High Court.

• (6) Subsections (4) to (6) of section 82 apply in relation to an appeal under subsection (5) as they apply in relation to an appeal under section 82(3).

• (7) Subsections (7) and (8) of section 82 apply in the application of this section to Scotland or Northern Ireland as they apply in the application of section 82 to Scotland or Northern Ireland.

The Venereal Disease Act 1917 (c. 21).

The responsible pharmacist

Section 72A: supplementary

Enforcement in Scotland.

Enforcement in Northern Ireland.

Rights of entry.

Power to inspect, take samples and seize goods and documents.

Liability to forfeiture under Customs and Excise Act 1952.

Meaning of “medicinal product" and related expressions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exemption for nurses and midwives.

Exemptions in respect of herbal remedies.

Procedure in other cases.

Hearing before person appointed

Special provisions in respect of exporting certain products to EEA State s

Requirement to specify certain products as prescription-only products

Requirement to specify certain products for veterinary use as prescription-only products.

Adulteration of medicinal products.

Compliance with standards specified in monographs in certain publications.

Offences under Part III.

Defence to offence of contravening section 63(a) or (b): product not sold or supplied

67F

• (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.

General provisions.

Business carried on by individual pharmacist or by partners.

Business carried on by body corporate

Offences under Part IV.

72AA

It is the duty of the superintendent in relation to a retail pharmacy business to secure that the business is at all times carried on in ways that ensure its safe and effective running so far as concerns—

• (a) the retail sale of medicinal products (whether they are on a general sale list or not), and

• (b) the supply of such products in circumstances corresponding to retail sale.

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Scope of Part VI.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Enforcement in Scotland.

Enforcement in Northern Ireland.

Power to inspect, take samples and seize goods and documents.

Meaning of “medicinal product" and related expressions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

General interpretation provisions.

General provisions as to operation of Act.

The Venereal Disease Act 1917 (c. 21).

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exemptions for imports.

Special provisions as to effect of manufacturer’s licence.

Requirement to specify certain products as prescription-only products

Requirement to specify certain products for veterinary use as prescription-only products.

Adulteration of medicinal products.

Compliance with standards specified in monographs in certain publications.

Further powers to regulate dealings with medicinal products.

Offences under Part III.

Defence to offence of contravening section 63(a) or (b): product not sold or supplied

General provisions.

Business carried on by individual pharmacist or by partners.

Business carried on by body corporate

Representative of pharmacist in case of death or disability.

Interim measures

Enforcement in Scotland.

Enforcement in Northern Ireland.

Power to inspect, take samples and seize goods and documents.

Liability to forfeiture under Customs and Excise Act 1952.

Meaning of “medicinal product" and related expressions.

Meaning of “wholesale dealing", “retail sale" and related expressions.

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