ukpga/1968/67 — Medicines Act 1968

Medicines Act 1968 1968 c.67 An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith. [25th October 1968] Part I Administration Ministers responsible for administration of Act. 1 In this Act, “the Ministers” has the meaning given by regulation 6(6) to (8) of the 2012 Regulations (but as if references in that regulation to those Regulations were references to this Act). Establishment of Medicines Commission. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Establishment of the Commission on Human Medicines 2A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Functions of the Commission 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Establishment of committees. 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplementary provisions as to Commission and committees. 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Part II Licences and Certificates Relating to Medicinal Products General provisions and exemptions The licensing authority. 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General provisions as to dealing with medicinal products. 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provisions as to manufacture and wholesale dealing. 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions for doctors and dentists 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions for pharmacists. 10 1 ... The restrictions imposed by regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy, a hospital , a care home service or a health centre and is done there by or under the supervision of a pharmacist and consists of— a preparing or dispensing a medicinal product in accordance with a prescription given by an appropriate practitioner , or b assembling a medicinal product provided that where the assembling takes place in a registered pharmacy— i it shall be in a registered pharmacy at or from which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at or from that registered pharmacy or at or from any other such registered pharmacy ... , and ii the medicinal product has not been the subject of an advertisement ; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where— a the product is prepared or dispensed for administration to that person or to a person under his care, ... b . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Without prejudice to the preceding subsections, the restrictions imposed by regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of— a preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or b preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) or subsection (3) of this section or in paragraph (a) of this subsection provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at or from that registered pharmacy or at or from any other registered pharmacy forming part of the same retail pharmacy business ; and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1)(a) of this section. 5 Without prejudice to the preceding subsections, the restrictions imposed by regulation 46 of the 2012 Regulations do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where— a the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and b the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at or from the registered pharmacy at which it is prepared, and c the medicinal product has not been the subject of an advertisement. 6 Without prejudice to the preceding subsections, the restrictions imposed by regulation 17(1) of the 2012 Regulations do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at or from that registered pharmacy. 6A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7A The ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist. 7B Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed. 7C In any case, compliance with any applicable conditions is sufficient for the thing to be so considered. 8 For the purposes of this section “advertisement" shall have the meaning assigned to it by regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations . 9 In subsection (1) of this section, “care home service" has the meaning given by paragraph 2 of schedule 12 to the Public Services Reform (Scotland) Act 2010 (asp 8) . Exemption for nurses and midwives. 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions in respect of herbal remedies. 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions for imports. 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemption for re-exports. 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provision for extending or modifying exemptions. 15 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 The ... Ministers may by order provide that any of the provisions of section 10 of this Act specified in the order shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be so specified. 4 No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament. Transitional exemptions. 16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Termination of transitional exemptions. 17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applications for, and grant and renewal of, licences Application for licence. 18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Factors relevant to determination of application for licence. 19 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Grant or refusal of licence. 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedure on reference to appropriate committee 21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedure in other cases. 22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hearing before person appointed 22A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special provisions as to effect of manufacturer’s licence. 23 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Duration and renewal of licence. 24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Licences of right Entitlement to licence of right. 25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Scope of licence of right in different cases. 26 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Proceedings on application for licence of right. 27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Suspension, revocation and variation of licences General power to suspend, revoke or vary licences. 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28. 29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Variation of licence on application of holder. 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical trials and medicinal tests on animals Clinical trials. 31 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Medicinal tests on animals. 32 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions in respect of medicinal tests on animals. 33 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Restrictions as to animals on which medicinal tests have been carried out. 34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplementary provisions as to clinical trials and medicinal tests on animals. 35 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Application for, and issue of, certificate. 36 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transitional provisions as to clinical trials and medicinal tests on animals. 37 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Duration and renewal of certificate. 38 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Suspension, revocation or variation of certificate. 39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Medicated animal feeding stuffs Medicated animal feeding stuffs. 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41–42 Supplementary provisions Extension of s. 7 to certain special circumstances. 43 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provision of information to licensing authority. 44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Offences under Part II. 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special defences under s. 45. 46 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standard provisions for licences 47 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Postponement of restrictions in relation to exports. 48 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special provisions in respect of exporting certain products. 49 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special provisions in respect of exporting certain products to member States 49A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special provisions in respect of exporting certain products to EEA State s 49B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Certificates for exporters of medicinal products. 50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Part III Further Provisions relating to Dealings with Medicinal Products Provisions as to sale or supply of medicinal products General sale lists. 51 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sale or supply of medicinal products not on general sale list. 52 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sale or supply of medicinal products on general sale list. 53 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sale of medicinal products from automatic machines. 54 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions from sections 52 and 53 Exemptions for doctors and dentists etc 55 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Exemptions in respect of herbal remedies. 56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power to extend or modify exemptions. 57 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Additional provisions Medicinal products on prescription only. 58 1 The Ministers may by order specify descriptions or classes of medicinal products as prescription only medicines 1A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1ZA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Without prejudice to regulation 223(1) of the 2012 Regulations , any order made by the Ministers for the purposes of this section may provide— a that regulation 214(1) or (2) of the 2012 Regulations shall have effect subject to such exemptions as may be specified in the order or, in the case of an appropriate practitioner, other than a doctor or dentist, such modifications as may be so specified ; b that, for the purpose of regulation 214(1) of the 2012 Regulations , a medicinal product shall not be taken to be sold or supplied in accordance with a prescription given by an appropriate practitioner unless such conditions as are prescribed by the order are fulfilled. 4A An order under this section may provide, in relation to an 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. 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. 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 regulation 214(1) or (2) of the 2012 Regulations . 5 Any exemption conferred or modification made by an order in accordance with subsection (4)(a) of this section may be conferred or made subject to such conditions or limitations as may be specified in the order. 6 Before making an order under this section the Ministers shall consult the appropriate committee .... 7 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. Requirement to specify certain products as prescription-only products 58A 1 The ... 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— a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c to which subsection (2) of this section applies; is 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 ... 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 ... 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 ...— “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 ; and “the Psychotropic Substances Convention" means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971 . Requirement to specify certain products for veterinary use as prescription-only products. 58B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special provisions in relation to new medicinal products. 59 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Restricted sale, supply and administration of certain medicinal products. 60 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Special restrictions on persons to be supplied with medicinal products. 61 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prohibition of sale or supply, or importation, of medicinal products of specified description .... 62 1 Subject to the following provisions of this section, the ... Ministers, where it appears to them to be necessary to do so in the interests of safety, may by order— a 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; b . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 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. 3 Before making an order under this section the Ministers , unless in their opinion it is essential to make the order with immediate effect to avoid serious danger to health ..., shall consult the appropriate committee .... 4 Where an order is made under this section without prior consultation with the appropriate committee ... 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). 5 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 Ministers of their desire to be heard under this subsection, or have made representations in writing to the Ministers with respect to that proposal, then before making the order— a if the organisation have given notice of their desire to be heard, the Ministers shall arrange for them to have an opportunity of appearing before, and being heard by, the appropriate committee , or b if they have made representations in writing, the Ministers shall refer those representations to the appropriate committee , 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 Ministers and the Ministers shall take that report into account in determining whether to make the order. 6 Subsection (5) of this section shall not have effect where in the opinion of the ... Ministers it is essential to make the order with immediate effect as mentioned in subsection (3) of this section. 7 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. 8 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. Adulteration of medicinal products. 63 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. Protection of purchasers of medicinal products. 64 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 an 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". Compliance with standards specified in monographs in certain publications. 65 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Further powers to regulate dealings with medicinal products. 66 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Offences, and provision for disqualification Offences under Part III. 67 1 The following provisions of this section shall have effect subject to sections 121 and 122 of this Act. 1A 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 is an appropriate practitioner within the meaning of regulation 214 of the 2012 Regulations ; and 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 Any person who contravenes any of the following provisions of this Part of this Act, that is to say, sections 63 and 64 , or who contravenes ... any order made under section 62 of this Act, shall be guilty of an offence. 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. 3A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Any person guilty of an offence under subsection (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. 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Defence to offence of contravening section 63(a) or (b): product not sold or supplied 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. Defence to offence of contravening section 63(a) or (b): product sold or supplied 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. Defence to offence of contravening section 64 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. Defences under sections 67A, 67B and 67C: evidence etc. 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. Sections 67A to 67D: “adulteration” and “registrant” 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 ); or 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 ... maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ( SI 1976/1213 (NI 22) ). Sections 67A to 67D: “relevant pharmacy service” 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. Disqualification on conviction of certain offences. 68 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Part IV Pharmacies Persons lawfully conducting retail pharmacy business General provisions. 69 1 Subject to the provisions of any order made under section 73 of this Act, a person carrying on a retail pharmacy business shall be taken to be a person lawfully conducting such a business if, not being disqualified by virtue of section 80 of this Act,— a that person (or, if the business is carried on by a partnership, each, or, in Scotland, one or more, of the partners) is a pharmacist and the conditions specified in section 70 of this Act are fulfilled in relation to the business, or b that person is a body corporate and the conditions specified in section 71 of this Act are fulfilled in relation to the business, or c that person is a representative of a pharmacist (as defined by section 72 of this Act) and the conditions specified in subsection (2) of that section are fulfilled in relation to him and in relation to the business and the period applicable in accordance with subsection (3) of that section has not expired. 1ZA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 For the purposes of the application of this Part of this Act to a business which— a is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building, whether it is or is to be also carried on elsewhere or not, or b so far as concerns the retail sale of medicinal products, or the supply of such products in circumstances corresponding to retail sale, is or is to be carried on in one or more separate or distinct parts (but not the whole) of a building, whether it is or is to be carried on elsewhere or not, each such part of that building shall be taken to be separate premises. 3 In this Part of this Act— ... “ the board ”, in relation to a body corporate, means the body of persons controlling the body corporate, by whatever name called; ... “the register” means— in relation to Great Britain, the register established and maintained under article 19 of the Pharmacy Order 2010; and in relation to Northern Ireland, the register kept for the purposes of section 75; “the registrar” means— in relation to Great Britain, the person appointed under article 18 of the Pharmacy Order 2010 as registrar for the purposes of that Order; and in relation to Northern Ireland, the person appointed under Article 9(1) of the Pharmacy (Northern Ireland) Order 1976 as registrar for the purposes of that Order; “the relevant disciplinary committee” means— in relation to Great Britain, the Fitness to Practise Committee established under article 4(6) of the Pharmacy Order 2010; and in relation to Northern Ireland, the Statutory Committee appointed under Article 19 of the Pharmacy (Northern Ireland) Order 1976; “ relevant European State ” means either an EEA State other than the United Kingdom or Switzerland. ... Business carried on by individual pharmacist or by partners. 70 1 The conditions referred to in section 69(1)(a) of this Act are that subsections (2) and (3) of this section are both satisfied as respects each of the premises at or from which the retail pharmacy business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail. 2 This subsection is satisfied if a responsible pharmacist who satisfies the requirement of subsection (4) of this section is in charge of the business carried on at or from those premises, so far as concerns— a the retail sale at or from those premises of medicinal products (whether they are on a general sale list or not), and b the supply at or from those premises of such products in circumstances corresponding to retail sale. 3 This subsection is satisfied if a notice is conspicuously displayed at those premises stating— a the name of the responsible pharmacist for the time being, b the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and c the fact that he is for the time being in charge of the business carried on at or from those premises. 4 The responsible pharmacist must be— a the person carrying on the business, or b if the business is carried on by a partnership, one of the partners or, in Scotland, one of the partners who is a person registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (pharmacists other than visiting practitioners), or c another pharmacist. 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Business carried on by body corporate 71 1 The conditions referred to in section 69(1)(b) of this Act are— a that there is a superintendent in relation to the retail pharmacy business in respect of whom the requirements specified in subsection (6) are fulfilled, and b that subsections (2) and (3) of this section are both satisfied as respects each of the premises at or from which the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail. 2 This subsection is satisfied if a responsible pharmacist who satisfies the requirement of subsection (4) of this section is in charge of the business carried on at or from the premises mentioned in subsection (1)(b) of this section, so far as concerns— a the retail sale at or from those premises of medicinal products (whether they are on a general sale list or not), and b the supply at or from those premises of such products in circumstances corresponding to retail sale. 3 This subsection is satisfied if a notice is conspicuously displayed at those premises stating— a the name of the responsible pharmacist for the time being, b the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and c the fact that he is for the time being in charge of the business carried on at or from those premises. 4 The responsible pharmacist must be— a the superintendent mentioned in subsection (1)(a) of this section, or b a manager or assistant subject to the directions of the superintendent and who is a pharmacist. 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 The requirements referred to in subsection (1)(a) of this section in relation to a superintendent are that— a he is a pharmacist, aa he is a senior manager of the retail pharmacy business who has the authority to make decisions that affect the running of the retail pharmacy business so far as concerns— i the retail sale of medicinal products (whether they are on a general sale list or not), and ii the supply of such products in circumstances corresponding to retail sale, and b a statement in writing signed by him, and signed on behalf of the body corporate, specifying his name ..., has been sent to the registrar ... c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7A For the purposes of subsection (6)(aa), a person is a senior manager of a retail pharmacy business if the person plays a significant role (irrespective of whether other individuals also do so) in— a the making of decisions about how the whole or a substantial part of its activities are to be managed or organised, or b the actual managing or organising of the whole or a substantial part of those activities. 8 If a person who has been the superintendent in relation to a retail pharmacy business ceases to be the superintendent in relation to the business (otherwise than by reason of death) the person must notify the registrar in writing of that fact within the period of 28 days beginning with the day on which the person ceases to be the superintendent in relation to the business . 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Representative of pharmacist in case of death or disability. 72 1 The provisions of this section shall have effect where a pharmacist carries on a retail pharmacy business and— a he dies, or b he is adjudged bankrupt or enters into a composition or scheme or deed of arrangement with his creditors, or, in Scotland, sequestration of his estate is awarded or he makes a trust deed for behoof of his creditors or a composition contract, or c he becomes a person who lacks capacity (within the meaning of the Mental Capacity Act 2005) to carry on the business , or, in Scotland, a guardian or judicial factor is appointed for him on the ground that he suffers from mental disorder, or, in Northern Ireland, a controller is appointed in his case under the Mental Health (Northern Ireland) Order 1986 , and a representative of his thereafter carries on his business. 1A In subsection (1)(c), the reference to a person who lacks capacity to carry on the business is to a person— a in respect of whom there is a donee of an enduring power of attorney or lasting power of attorney (within the meaning of the Mental Capacity Act 2005), or b for whom a deputy is appointed by the Court of Protection, and in relation to whom the donee or deputy has power for the purposes of this Act. 2 The conditions referred to in section 69(1)(c) of this Act are— a that the name and address of the representative, and the name of the pharmacist whose representative he is, have been notified to the registrar, and b that subsections (2A) and (2B) of this section are both satisfied as respects each of the premises at or from which the business is carried on and medicinal products, other than medicinal products on a general sale list, are sold by retail. 2A This subsection is satisfied if a responsible pharmacist is in charge of the business carried on at or from the premises mentioned in subsection (2)(b) of this section, so far as concerns— a the retail sale at or from those premises of medicinal products (whether they are on a general sale list or not), and b the supply at or from those premises of such products in circumstances corresponding to retail sale. 2B This subsection is satisfied if a notice is conspicuously displayed at those premises stating— a the name of the responsible pharmacist for the time being, b the number of his registration under Part 4 of the Pharmacy Order 2010 or, in relation to Northern Ireland, under the Pharmacy (Northern Ireland) Order 1976, and c the fact that he is for the time being in charge of the business carried on at or from those premises. 3 The period referred to in section 69(1)(c) of this Act— a in the case of the death of a pharmacist, is a period of five years from the date of his death; b in the case of the bankruptcy or sequestration of the estate of a pharmacist, is a period of three years from the date on which he is adjudged bankrupt or the date of the award of sequestration, as the case may be; c in the case of a composition or scheme or deed of arrangement, or of a trust deed or composition contract, is a period of three years from the date on which the trustee appointed thereunder becomes entitled to carry on the business; and d in a case falling within subsection (1)(c) of this section, is a period of three years from the date of the appointment of the deputy , curator bonis, judicial factor, committee or guardian or from the date of registration of the instrument appointing the donee , or, in any such case, is such longer period as, on the application of the representative, the relevant disciplinary committee , having regard to all the circumstances of the case, may direct. 4 In this section “ representative ”— a in relation to a pharmacist who has died, means his executor or administrator and, in respect of a period of three months from the date of his death, if he has died leaving no executor who is entitled and willing to carry on the business, includes any person beneficially interested in his estate; b in a case falling within paragraph ( b ) of subsection (1) of this section, means the trustee in bankruptcy or the trustee in the sequestration or any trustee appointed under the composition scheme, deed of arrangement, trust deed or composition contract; and c in a case falling within paragraph ( c ) of that subsection, means the donee, deputy , curator bonis, judicial factor, controller or guardian ; and in paragraph ( b ) above the reference to a trustee appointed under a composition, scheme or deed of arrangement includes a reference to the supervisor of a voluntary arrangement proposed for the purposes of, and approved under, Part VIII of the Insolvency Act 1986 or Chapter II of Part VIII of the Insolvency (Northern Ireland) Order 1989 . The responsible pharmacist 72A A1 Nothing in this Part is to be taken as requiring there to be a responsible pharmacist in respect of premises at or from which a retail pharmacy business is carried on at a time when no medicinal products (whether they are on a general sale list or not) are being— a offered or exposed for sale by retail or supply in circumstances corresponding to retail sale at or from the premises, or b assembled, prepared or dispensed at or from the premises with a view to such sale or supply. 1 It is the duty of the responsible pharmacist mentioned in sections 70, 71 and 72 of this Act to secure the safe and effective running of the pharmacy business carried on at or from the premises in question so far as concerns— a the retail sale at or from those premises of medicinal products (whether they are on a general sale list or not), and b the supply at or from those premises of such products in circumstances corresponding to retail sale. 2 A person may not be the responsible pharmacist in respect of more than one set of premises at the same time, except in circumstances specified by the General Pharmaceutical Council in rules in relation to premises in Great Britain or the Council of the Pharmaceutical Society of Northern Ireland in regulations in relation to premises in Northern Ireland , and then only if such conditions as may be so specified are complied with. 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 The General Pharmaceutical Council may make further provision in rules in relation to the responsible pharmacist in respect of premises in Great Britain, and the Council of the Pharmaceutical Society of Northern Ireland may make further provision in regulations in relation to the responsible pharmacist in respect of premises in Northern Ireland. 6A In making any such provision, the General Pharmaceutical Council and the Council of the Pharmaceutical Society of Northern Ireland must have regard to the principle that the burdens imposed on businesses by rules or regulations should be the minimum necessary to secure the benefits, considered in general terms, which are expected to result from the rules or regulations. 7 The rules and regulations mentioned in subsection (6) may (amongst other things)— a make further provision about the matters mentioned in subsection (1); b make provision about the responsible pharmacist’s absence from the premises. 7A If such rules or regulations make provision about the responsible pharmacist’s absence from the premises, they must also provide that the retail sale of medicinal products on a general sale list may continue at or from the premises during any period in which the responsible pharmacist is absent from the premises. 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The superintendent 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. Sections 72A and 72AA: supplementary 72B 1 The failure by a person to comply with any requirements of section 72A or 72AA of this Act, or of rules or regulations made under section 72A, may constitute misconduct for the purposes of section 80 of this Act, article 51(1)(a) of the Pharmacy Order 2010 and Article 20 of the Pharmacy (Northern Ireland) Order 1976 and the relevant disciplinary committee may deal with such a failure accordingly. 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Subsection (4) of this section applies if a person— a fails to comply with the requirements of subsection (2) of section 72A of this Act, or of rules or regulations made under that subsection, b fails to comply with any requirements as to absence from the premises contained in rules or regulations made by virtue of subsection (7) of that section. 4 If this subsection applies, the person in question is not to be considered while the failure continues as being in charge of the business carried on at or from the premises in question (or in a subsection (3)(a) case at any of them) for the purposes of sections 70 to 72 of this Act. Power to extend or modify conditions. 73 1 The ... Ministers may by order add to, revoke or vary any of the provisions of sections 70 to 72 of this Act, so as either— a to modify, or provide new conditions in substitution for, the conditions referred to in any of the paragraphs of section 69(1) of this Act, or b for the purposes of any of those paragraphs, to provide alternative conditions compliance with which is to have the like effect as compliance with the conditions referred to in that paragraph. 2 Any provision made by an order in accordance with subsection (