Medicines Act 1968

• (a) a person who is lawfully conducting a retail pharmacy business; or

• (b) a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at or from the premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

• (4) The General Pharmaceutical Council may make rules in connection with applications under this section.

• (5) Rules under subsection (4) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

• (b) about the information to be provided in respect of applications; and

• (c) about the circumstances in which applications must or, as the case may be, may be refused (including where an application for renewal under this section was not received by the registrar by the time prescribed by the General Pharmaceutical Council in rules under section 74B(2)(b)).

• (6) Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under this section, the registrar must give notice in writing of that restoration to the applicant.

• (7) The notice under subsection (6) must specify—

• (a) the period for which the entry restored to Part 3 of the register is valid;

• (b) any conditions to which that entry is subject by virtue of subsection (2)(c).

• (8) The notice under subsection (6) must be sent—

• (a) where the retail pharmacy business was carried on by an individual, to that individual at that individual’s home address in the register;

• (b) where the retail pharmacy business was carried on by a partnership, to that partnership at its principal office;

• (c) where the retail pharmacy business was carried on by a body corporate, to that body corporate at its registered or principal office.

74D

• (1) The registrar may make the entry of premises entered in Part 3 of the register under section 74A subject to such conditions as the registrar considers it necessary to impose for the purpose of securing the safe and effective practice of pharmacy in the course of the business carried on at or from those premises.

• (2) The power under subsection (1)—

• (a) may be exercised on the making of the entry or subsequently (whether on a renewal of the entry or otherwise);

• (b) includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

• (3) Except as provided in subsection (4), the registrar may not under subsection (1)—

• (a) impose a new condition in respect of premises already entered in Part 3 of the register; or

• (b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on the retail pharmacy business at or from the premises and of the date from which that condition, variation or revocation is to have effect.

• (4) The registrar may, with immediate effect—

• (a) impose a new condition in respect of premises already entered in Part 3 of the register; or

• (b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

if, in the registrar’s opinion, the giving of reasonable notice as required by subsection (3) would prejudice the health, safety or well-being of members of the public.

• (5) The registrar must give notice in writing of any decision under subsection (4) to the person carrying on a retail pharmacy business at or from the premises.

• (6) The notice under subsection (5) must be sent—

• (a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

• (b) where the retail pharmacy business is carried on by a partnership, to that partnership at its principal office; or

• (c) where the retail pharmacy business is carried on by a body corporate, to that body corporate at its registered or principal office.

• (7) Where premises are entered in the register because condition C in section 74B is met by virtue of subsection (4)(a)(ii) of that section, the registrar may, on making the entry of the premises in the register, also make that entry subject to a condition that the applicant for registration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is made.

74E

• (1) Where the entry of premises entered in Part 3 of the register is subject to conditions imposed under section 74D(1), the person carrying on the business at or from the premises may apply to the registrar for any of the conditions imposed to be varied or revoked.

• (2) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

• (3) Rules under subsection (2) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the General Pharmaceutical Council may determine from time to time);

• (b) about the information to be provided in respect of applications;

• (c) about the circumstances in which applications may be refused by the registrar;

• (d) about the giving of notice of the decision in respect of the application to the applicant by the registrar.

• (4) The registrar may vary a condition imposed under section 74D(7) by extending the period within which the applicant for registration must become a person lawfully conducting a retail pharmacy business.

• (5) Where premises are entered in the register subject to a condition imposed under subsection (7) of section 74D, the registrar may remove the entry if the applicant is not a person lawfully conducting a retail pharmacy business at or from the premises within the period determined by the registrar in accordance with that subsection or within such longer period as the registrar may, by virtue of subsection (4), allow.

• (6) Where the registrar—

• (a) varies a condition under subsection (5); or

• (b) removes an entry of premises in Part 3 of the register under subsection (4),

the registrar must send to the person who applied for registration a statement in writing giving that person notice of the decision and the reasons for it.

• (7) The notice under subsection (6) must be sent—

• (a) where the person who applied for registration is an individual, to that individual at that individual’s home address in the register;

• (b) where that person is a partnership, to that partnership at its principal office;

• (c) where that person is a body corporate, to that body corporate at its registered or principal office.

74F

• (1) Where, in pursuance of an application, the registrar enters premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the entry.

• (2) The written confirmation under subsection (1) must include—

• (a) the number of the entry;

• (b) the date on which the entry was made;

• (c) the period for which the entry is valid; and

• (d) details of any conditions to which the entry is subject by virtue of section 74D.

• (3) Where, in pursuance of an application, the registrar renews the entry of premises in Part 3 of the register under section 74A, the registrar must give to the applicant a written confirmation of the renewal.

• (4) The written confirmation under subsection (3) must include—

• (a) the number of the entry;

• (b) the date on which the renewal of the entry was made;

• (c) the period for which the renewal of the entry is valid; and

• (d) details of any conditions to which the renewal of the entry is subject by virtue of section 74D.

• (5) Where the registrar refuses an application for the entry of premises in Part 3 of the register under section 74A, or for the renewal of an entry of premises in the register under that section, the registrar must give to the applicant written notice of that refusal and the reasons for it and of the right of appeal to the Appeals Committee under article 40 of the Pharmacy Order 2010.

• (6) Where, under section 74J, the registrar enters premises or a group of premises in Part 3 of the register, the registrar must give written confirmation of the entry to the person who will be carrying on a retail pharmacy business at or from the premises, or at or from each set of premises in the group of premises.

• (7) The written confirmation under subsection (6) must include—

• (a) the number of the entry;

• (b) the date on which the entry was made; and

• (c) details of any conditions to which the entry is subject by virtue of section 74J(4).

74G

• (1) An application may be made to the registrar by the person carrying on a retail pharmacy business at or from any premises entered in Part 3 of the register under section 74A or 74J for the premises to be removed from the register.

• (2) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

• (3) Rules under subsection (2) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

• (b) about the information to be provided by the applicant;

• (c) about the circumstances in which applications may be refused; and

• (d) for written notice of the outcome of the application to be given to the applicant by the registrar.

74H

• (1) Subject to subsection (2), where a change occurs in the ownership of a retail pharmacy business carried on at or from premises entered in Part 3 of the register under section 74A, the entry of the premises in the register ceases to be valid at the end of the relevant period unless the registrar is notified in writing of the change prior to the end of the relevant period by the person who, as a result of the change, will be the person carrying on the business at or from the premises.

• (2) Subsection (1) only applies if the relevant period is shorter than the period for which the entry would otherwise have remained valid under section 74A.

• (3) Where, before the end of the relevant period, the registrar is notified of a change in the ownership of a retail pharmacy business carried on at or from premises entered in Part 3 of the register, the registrar must, on receipt of a fee of the amount prescribed in rules under article 36(1)(c) of the Pharmacy Order 2010, amend the entry relating to the premises in Part 3 of the Register to record the name and address of the person who, as a result of the change, will be the person carrying on the retail pharmacy business at or from the premises.

• (4) For the purposes of subsections (1) to (3), the relevant period—

• (a) if the change occurs on the death of the person carrying on the business or, in the case of a partnership, on the death of one of the partners, means the period of three months beginning with the date of death; and

• (b) in any other case, means the period of 28 days beginning with the date on which the change occurred.

• (5) If the entry of premises entered in Part 3 of the register under section 74A ceases to be valid under this section, the premises are to be treated for all purposes as no longer being entered in the register and accordingly the registrar must remove the entry from the register.

• (6) The registrar must restore the entry of the premises to Part 3 of the register if—

• (a) an application for restoration is made to the registrar in accordance with section 74I(1) and with rules made under section 74I(3);

• (b) a fee of an amount prescribed in rules under article 36(1)(b) of the Pharmacy Order 2010 (fees in connection with entry) is paid; and

• (c) the registrar is satisfied that the standards that are provided for in rules made set under article 7(1) of the Pharmacy Order 2010 are met in connection with the carrying on of a retail pharmacy business at or from the premises.

• (7) Subject to subsection (8), an entry restored to the register under subsection (6)—

• (a) is still to be treated as having been entered in Part 3 of the register under section 74A;

• (b) is subject to the same conditions as those to which the entry was subject immediately before it was removed from Part 3 of the register by virtue of subsection (5);

• (c) is valid for the same period as the period for which the entry would have been valid under section 74A had it not been removed from Part 3 of the register by virtue of subsection (5) of this section.

• (8) Where an entry of premises in Part 3 of the register is restored by the registrar under subsection (6) and the applicant is a person falling within section 74I(2)(b), the registrar may—

• (a) on restoring the entry of the premises to the register, make that entry subject to a condition that the applicant for restoration will be a person lawfully conducting a retail pharmacy business within such period as the registrar reasonably determines beginning with the date on which the entry is restored; and

• (b) subsequently remove the entry of the premises from Part 3 of the register if the applicant is not a person lawfully conducting a retail pharmacy business within the period determined by the registrar in accordance with paragraph (a).

• (9) Where under subsection (8)(b) the registrar removes an entry of premises from Part 3 of the register, the registrar must give to the person who was carrying on a retail pharmacy business at or from the premises immediately prior to the removal written notice of the removal and the reasons for it.

• (10) The notice under subsection (9) must be sent—

• (a) where the retail pharmacy business is carried on by an individual, to that individual at that individual’s home address in the register;

• (b) where the retail pharmacy business is carried on by a partnership, to the principal office of that partnership;

• (c) where the retail pharmacy business is carried on by a body corporate, to the registered or principal office of that body corporate.

74I

• (1) An application may be made to the registrar for the entry of premises removed from Part 3 of the register by virtue of section 74H(5) to be restored to the register.

• (2) An application under subsection (1) must be made by the person who, in consequence of the change of ownership, has become the owner of the business and that person must be—

• (a) a person who is lawfully conducting a retail pharmacy business; or

• (b) a person who, if the entry of the premises is restored to Part 3 of the register and the person begins to carry on a retail pharmacy business at or from those premises, will, from the time the person begins to do so, be a person lawfully conducting a retail pharmacy business.

• (3) The General Pharmaceutical Council may make rules in connection with applications under subsection (1).

• (4) Rules under subsection (3) may, in particular, include provision—

• (a) about the form and manner in which applications are to be made (and the rules may provide that applicants must apply using application forms that are in such form as the Council may determine from time to time);

• (b) about the information to be provided in respect of applications;

• (c) about the circumstances in which an application for restoration under subsection (1) may be treated by the registrar as an application for the renewal of registration under section 74A(4) as well as an application for restoration.

• (5) Where the registrar restores the entry of premises to Part 3 of the register pursuant to an application under subsection (1), the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the restoration.

• (6) The notice given by the registrar under subsection (5) must specify—

• (a) the period for which the entry restored to Part 3 of the register is valid;

• (b) any conditions to which the entry of the premises restored to Part 3 of the register is subject.

• (7) Where the registrar refuses an application under this section for the restoration to Part 3 of the register of an entry relating to any premises, the registrar must send to the applicant for restoration a statement in writing giving the applicant notice of the decision and the reasons for it.

• (8) The notice under subsections (5) and (7) must be sent—

• (a) where the applicant is an individual, to that individual at that individual’s home address in the register;

• (b) where the applicant is a partnership, to the principal office of that partnership;

• (c) where the applicant is a body corporate, to the registered or principal office of that body corporate.

74J

• (1) This section applies in relation to premises in Great Britain.

• (2) If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may under this section enter in Part 3 of the register—

• (a) premises; or

• (b) premises comprising a specified group of premises,

with regard to the emergency.

• (3) The registrar may enter in Part 3 of the register by virtue of subsection (2)(b) all of the premises in a specified group of premises without first identifying each set of premises in the group.

• (4) The registrar may make the entry of premises entered in Part 3 of the register under this section subject to such conditions as the registrar considers necessary to impose for the purpose of securing the safe and effective practice of pharmacy in the course of the business carried on at or from those premises.

• (5) The power in subsection (4)—

• (a) may be exercised on the making of the entry or subsequently;

• (b) includes power to vary the conditions to which the entry of the premises in Part 3 of the register is subject, including by adding to the conditions or revoking any of them.

• (6) The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group may be subject to the same conditions as the entry of the other premises in the group or it may be subject to different conditions.

• (7) The conditions to which the entry of premises entered in Part 3 of the register under this section is subject may include conditions relating to their physical state, safety and security and the conditions in which medicinal products (including controlled drugs) are stored at those premises.

• (8) The registrar may not under subsection (4)—

• (a) impose a new condition in respect of the entry of premises already entered in Part 3 of the register; or

• (b) vary or revoke any conditions to which the entry of premises entered in Part 3 of the register is subject,

unless the registrar has given reasonable notice in writing of the condition to be imposed or, as the case may be, of the variation or revocation of an existing condition, to the person carrying on a retail pharmacy business at or from the premises and of the date from which that condition, variation or revocation is to have effect.

• (9) The entry of premises entered in Part 3 of the register under this section may be removed by the registrar, which—

• (a) the registrar must do if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (2) no longer exist;

• (b) the registrar may do for any other reason at any time including where the registrar has grounds for suspecting that there is a failure to comply with any conditions to which the entry of the premises in Part 3 of the register is subject.

• (10) The entry of premises entered in Part 3 of the register under this section by virtue of subsection (2)(b) as one of a specified group of premises may be removed without removing the entries of the other premises in the group, or it may be removed by virtue of a decision to remove the entries of all of the premises in the group.

• (11) In this section, and in section 74K, “emergency” means an emergency of the type described in subsection (1)(a) of section 19 of the Civil Contingencies Act 2004 (meaning of “emergency”), read with subsection (2)(a) and (b) of that section.

74K

• (1) If the Secretary of State advises the registrar that an emergency has occurred, is occurring or is about to occur and that action should be considered under this section, the registrar may annotate—

• (a) the entry of a registered pharmacy entered in Part 3 of the register under section 74J to designate that pharmacy as a pharmacy from which drugs, medicines and appliances may be ordered in a specified capacity; or

• (b) the entries of a specified group of registered pharmacies entered in Part 3 of the register under section 74J to designate that group as a group of pharmacies from which drugs, medicines and appliances may be ordered in a specified capacity.

• (2) The registrar may make an annotation, by virtue of subsection (1), to the entry of a registered pharmacy entered in Part 3 of the register under section 74J in such a way as to distinguish that annotation from an annotation in respect of a registered pharmacy made otherwise than by virtue of subsection (1).

• (3) Annotations made by virtue of subsection (1)—

• (a) must be removed by the registrar if the Secretary of State advises the registrar that the circumstances that led the Secretary of State to advise the registrar as mentioned in subsection (1) no longer exist;

• (b) may be removed by the registrar for any other reason at any time.

• (4) An annotation of the entry of a registered pharmacy made by virtue of subsection (1)(b) as one of a specified group may be removed without removing the annotations of the entries of the other registered pharmacies in the group, or it may be removed by virtue of a decision to remove the annotations of the entries of all the registered pharmacies in the group.

74L

A document purporting to be a certificate signed by the registrar and stating that, on a specified date, specified premises in Great Britain were, or were not, entered in Part 3 of the register (whether under section 74A or section 74J) is admissible in any proceedings as evidence (or in Scotland, as sufficient evidence) that those premises were, or were not, entered in the register on that date.

84A

• (1) The General Pharmaceutical Council may make such provision as it considers appropriate in rules for any purpose for which rules are authorised or required to be made by it under Part 4 of this Act.

• (2) Article 66 of the Pharmacy Order 2010 (rules) applies to the making of rules by the General Pharmaceutical Council under any provision of Part 4 of this Act other than section 72A as it applies to the making of rules by the General Pharmaceutical Council under Part 3 of that Order (registered pharmacies: standards in retail pharmacies).

• (3) The power of the General Pharmaceutical Council to make rules under section 72A may be exercised so as to make different provision for different areas or in relation to different cases or different circumstances to which the power is applicable, and to make any such provision subject to such exceptions, limitations and conditions (if any) as the General Pharmaceutical Council considers necessary or expedient.

• (4) Before making rules under section 72A, the General Pharmaceutical Council must publish draft rules and invite representations to be made to it about the draft by—

• (a) the Secretary of State, the Scottish Ministers and the Welsh Ministers, and

• (b) any other persons appearing to it appropriate to consult about the draft.

• (5) No rules made under section 72A by the General Pharmaceutical Council are to come into force until approved by order of the Privy Council.

• (6) The power vested in the Privy Council to make an order under subsection (5) may be exercised by any two or more members of the Privy Council.

• (7) The making of an order under subsection (5) is sufficiently signified by an instrument signed by the Clerk of the Privy Council.

• (8) Where an order under subsection (5) is signified by an instrument purporting to be signed by the Clerk of the Privy Council, that is evidence and in Scotland sufficient evidence of—

• (a) the fact that the order was duly made, and

• (b) the order’s terms.

Exemption for re-exports.

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).

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

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.)

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

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.

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

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).

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

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.

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

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.

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

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.)

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

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).

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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.

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

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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