Medicines Act 1968

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

the appropriate Minister shall, in respect of each area for which there is a drugs authority make arrangements or give directions whereby the General Pharmaceutical Council, or the drugs authority for that area, or both the Council and that authority, to such extent as, in the case of that Council or authority, the arrangements or directions may provide, shall have power concurrently with the appropriate Minister, or shall be under a duty concurrently with him, to enforce the provisions specified in paragraph (a) of this subsection, in their application as mentioned in that paragraph....

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) the General Pharmaceutical Council shall be under a duty, concurrently with the appropriate Minister,—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) to enforce the provisions of any regulations made under section 60 ... of this Act in their application to premises in England and Wales at which medicinal products are sold by retail or are supplied in circumstances corresponding to retail sale; and

• (c) to enforce the provisions of section 78 of this Act, and of any regulations made under section 79(2) of this Act, in their application to England and Wales.

• (6A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6B) the General Pharmaceutical Council shall be under a duty to enforce the provisions of sections 72A and 72AA of this Act, and any rules made under section 72A, in their application to England and Wales.

• (6C) The appropriate Minister shall be under no duty to enforce those provisions, or any rules made under section 72A, in their application to England and Wales.

• (6D) Notwithstanding subsection (6C) of this section the appropriate Minister is to be treated for the purposes of sections 111 to 114 of this Act—

• (a) as empowered by this section to enforce those provisions, or any rules made under section 72A, in their application to England and Wales, and

• (b) to that extent as an enforcement authority in relation to those provisions or those rules in their application to England and Wales.

• (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (9) Notwithstanding anything in subsections (2) to (6D) of this section, no duty or power conferred or imposed by or under any of those subsections shall be performed or be exercisable in relation to—

• (a) any hospital (except in relation to so much of the hospital premises as is a registered pharmacy), or

• (b) so much of any premises as is used by a practitioner for carrying on his practice, or

• (c) so much of any premises (not falling within either of the preceding paragraphs) as is used for veterinary medicine or veterinary surgery for the purposes of any institution.

• (10) If the appropriate Minister is satisfied, after making such inquiry as he thinks fit, that the General Pharmaceutical Council has in relation to any matter failed to perform a duty imposed on it by subsection (6B) to enforce any provisions or rules mentioned in that subsection, and that the public interest requires that the provisions or rules in question should be enforced in relation to it, the appropriate Minister may enforce those provisions or rules in relation to that matter.

• (11) In this section “the appropriate Minister”—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) ... means the Secretary of State.

• (12) In this section “ drugs authority ” means—

• (a) in relation to an area in England other than the City of London, the council of a non-metropolitan county, metropolitan district or London borough;

• (b) in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London; and

• (c) in relation to an area in Wales, the council of a county or county borough.

Enforcement in Scotland

109

• (1) Subject to the provisions of section 108(6C) of this Act as applied by subsection (2) of this section, It shall be the duty of the Secretary of State to enforce in Scotland, or to secure the enforcement in Scotland of, the provisions of this Act and of any regulations and orders made under it.

• (2) Subsections (2), (6) to (6D), (9) and (10) of section 108 of this Act shall have effect in relation to Scotland as if—

• (a) any reference to the appropriate Minister ... were a reference to the Secretary of State;

• (b) any reference to England and Wales were a reference to Scotland; and

• (c) references to a food and drugs authority and to the area of any such authority were references respectively to a local authority as defined by section 26(4) of the Food and Drugs (Scotland) Act 1956 and to the area of such an authority; and

• (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (2A) Subsection (12) of section 108 of this Act shall have effect in relation to Scotland as if for paragraphs (a) and (b) there were substituted the words “ a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ”

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) Nothing in this section shall be construed as authorising an enforcement authority to institute proceedings for any offence.

Enforcement in Northern Ireland

110

• (1) Subject to the provisions of subsections (3C) and (4) of this section, it shall be the duty of the Minister for Health, Social Services and Public Safety (in this section referred to as “the Minister”) to enforce in Northern Ireland, or to secure the enforcement in Northern Ireland of, the provisions of this Act and of any regulations and orders made under it.

• (2) For the purpose of performing that duty in relation to the provisions specified in paragraph (a) of subsection (2) of section 108 of this Act in their application as mentioned in that paragraph, within the district of any district council, the Minister may make arrangements or give directions whereby the district council, to such extent as the arrangements or directions may provide, shall have power concurrently with the Minister, or shall be under a duty concurrently with him, to enforce the provisions specified in the said paragraph (a) in their application as so mentioned ....

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3B) The Pharmaceutical Society of Northern Ireland shall be under a duty to enforce the provisions of sections 72A and 72AA of this Act, and any regulations made under section 72A, in their application to Northern Ireland.

• (3C) The Minister shall be under no duty to enforce those provisions, or any regulations made under section 72A, in their application to Northern Ireland.

• (3D) Notwithstanding subsection (3C) of this section the Minister is to be treated for the purposes of sections 111 to 114 of this Act—

• (a) as empowered by this section to enforce those provisions, or any regulations made under section 72A, in their application to Northern Ireland, and

• (b) to that extent as an enforcement authority in relation to those ... provisions or those regulations in their application to Northern Ireland.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) Subsection (9) of section 108 of this Act shall have effect in relation to Northern Ireland as if—

• (a) in the said subsection (9) the reference to subsections (2) to (6D) of that section were a reference to subsections (2) to (3D) of this section; ...

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (8) In this section “district council” means a council established under the Local Government Act (Northern Ireland) 1972.

Rights of entry

111

• (1) Subject to the following provisions of this section, any person duly authorised in writing by an enforcement authority shall, on production, if required, of his credentials, have a right at any reasonable time to enter any premises—

• (a) for the purpose of ascertaining whether there is or has been, on or in connection with those premises, any contravention of any provisions of this Act or of any regulations or order made under this Act which, by or under any provisions of sections 108 to 110 of this Act, that authority is required or empowered to enforce, ...

• (aa) ... or

• (b) generally for the purposes of the performance by the authority of their functions under this Act or under any such regulations or order.

• (2) Any person duly authorised in writing by an enforcement authority shall, on production, if required, of his credentials, have a right at any reasonable time—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) to enter any vehicle other than a hover vehicle, any stall or place other than premises, or any home-going ship, for any purpose for which under subsection (1) of this section the person so authorised would have a right to enter any premises.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) Admission to any premises used only as a private dwelling-house shall not be demanded as of right by virtue of the preceding provisions of this section unless twenty-four hours’ notice of the intended entry has been given to the occupier.

• (5) If a justice of the peace, on sworn information in writing, is satisfied that there are reasonable grounds for entering any premises for any purpose for which a person authorised by an enforcement authority has a right to enter them in accordance with the preceding provisions of this section, and is also satisfied—

• (a) that admission to the premises has been refused, or that a refusal is apprehended, and (in either case) that notice of the intention to apply for a warrant has been given to the occupier, or

• (b) that an application for admission, or the giving of such a notice, would defeat the object of the entry, or

• (c) that the case is one of urgency, or

• (d) that the premises are unoccupied or the occupier is temporarily absent,

the justice may by warrant under his hand authorise the enforcement authority, or any person duly authorised by them, to enter the premises, if need be by force.

• (6) The last preceding subsection shall have effect in relation to entering any ship, ... vehicle, stall or place which may be entered under subsection (2) of this section as it has effect in relation to entering any premises, as if in the last preceding subsection any reference to the occupier were a reference to the master... or other person in charge of the ship, ... vehicle, stall or place.

• (7) Any warrant granted under this section shall continue in force for a period of one month.

• (8) In this section “home-going ship” means a ship plying exclusively in inland waters or engaged exclusively in coastal voyages; and for the purposes of this subsection “inland waters” means any canal, river, lake, loch, navigation or estuary and “coastal voyage” means a voyage which starts and ends in the United Kingdom and does not involve calling at any place outside the United Kingdom.

• (9) References in this section to a justice of the peace—

• (a) in relation to England, include a reference to a district judge (magistrates’ courts);

• (b) in relation to Scotland, are to be read as references to a sheriff, stipendiary magistrate or justice of the peace, and

• (c) in relation to Northern Ireland, are to be read as references to a lay magistrate or a district judge (magistrates’ courts).

Power to inspect, take samples and seize goods and documents

112

• (1) For the purpose of ascertaining whether there is or has been a contravention of this Act or of any regulations or order made thereunder which, by or under any provisions of sections 108 to 110 of this Act an enforcement authority is required or empowered to enforce, any person duly authorised in writing by that authority shall have a right to inspect—

• (a) any substance or article appearing to him to be a medicinal product;

• (b) any article appearing to him to be a container or package used or intended to be used to contain any medicinal product or to be a label or leaflet used or intended to be used in connection with a medicinal product; or

• (c) any plant or equipment appearing to him to be used or intended to be used in connection with the manufacture or assembly of medicinal products, and any process of manufacture or assembly of any medicinal products and the means employed, at any stage in the processes of manufacture or assembly, for testing the materials after they have been subjected to those processes.

• (2) Where for the purpose specified in the preceding subsection a person authorised as mentioned in that subsection requires a sample of any substance or article appearing to him to be—

• (a) a medicinal product sold or supplied or intended to be sold or supplied, or

• (b) a substance or article used or intended to be used in the manufacture of a medicinal product,

he shall (if he does not obtain the sample by purchase) have a right to take a sample of that substance or article.

• (3) For the purpose specified in subsection (1) of this section, any person authorised as mentioned in that subsection shall have a right—

• (a) to require any person carrying on a business which consists of or includes the manufacture, assembly, sale or supply of medicinal products, and any person employed in connection with such a business, to produce any books or documents relating to the business which are in his possession or under his control;

• (b) to take copies of, or of any entry in, any book or document produced in pursuance of the preceding paragraph.

• (4) Any person so authorised shall have a right to seize and detain any substance or article which he has reasonable cause to believe to be a substance or article in relation to which, or by means of which, an offence under this Act is being or has been committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under this Act.

• (5) For the purpose of exercising any such right as is specified in subsection (4) of this section the person having that right may, so far as is reasonably necessary in order to secure that the provisions of this Act and any regulations or order made thereunder are duly observed, require any person having authority to do so to break open any container or package or open any vending machine, or to permit him to do so.

• (6) Where a person seizes any substance or article (including any document) in the exercise of such a right as is specified in subsection (4) of this section, he shall inform the person from whom it is seized, and, in the case of anything seized from a vending machine, the person whose name and address are stated on the machine as being those of the owner of the machine, or, if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed.

• (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (8) Notwithstanding anything in the preceding provisions of this section, where a person claiming to exercise a right by virtue of this section is required to produce his credentials, the right shall not be exercisable by him except on production of those credentials.

• (9) The provisions of Schedule 3 to this Act shall have effect with respect to samples obtained on behalf of enforcement authorities for the purposes of this Act.

Application of sampling procedure to substance or article seized under s. 112

113

• (1) The provisions of this section shall have effect where a person (in this section referred to as an “authorised officer") seizes a substance or article (other than a document) in the exercise of such a right as is specified in subsection (4) of section 112 of this Act ....

• (2) If any person who in accordance with subsection (6) of that section is entitled to be informed of the seizure so requests, either at the time of the seizure or at any subsequent time, not being later than twenty-one days after he is informed of the seizure, then, subject to the next following subsection, the authorised officer shall either—

• (a) set aside a sample of the substance or article seized, or

• (b) treat that substance or article as a sample,

whichever he considers more appropriate having regard to the nature of that substance or article.

• (3) An authorised officer shall not be required by virtue of subsection (2) of this section to set aside a sample, or to treat a substance or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those things.

• (4) Where in accordance with subsection (2) of this section an authorised officer sets aside a sample, or treats a substance or article as a sample, he shall divide it into three parts, each part to be marked and sealed or fastened up in such manner as its nature will permit, and shall supply one part of it to the person who made the request under subsection (2) of this section.

• (5) Paragraphs 10, 11 and 12 and paragraphs 15 to 27 of Schedule 3 to this Act shall have effect in relation to a sample set aside, or a substance or article treated as a sample, in accordance with subsection (2) of this section as they have effect in relation to a sample obtained as mentioned in paragraph 1 of that Schedule, but as if in those paragraphs—

• (a) any reference to a sampling officer were a reference to an authorised officer;

• (b) any reference to a sample included a reference to a substance or article treated as a sample;

• (c) any reference to the preceding provisions of that Schedule were a reference to the preceding provisions of this section; and

• (d) any reference to the relevant enforcement authority were a reference to the authority by whom the authorised officer is authorised for the purposes of section 112 of this Act,

and as if in paragraph 24(1) of that Schedule the reference to a substance or article obtained as mentioned in paragraph 1 of that Schedule were a reference to a substance or article of which a sample has been set aside, or which has been treated as a sample, in accordance with subsection (2) of this section.

Supplementary provisions as to rights of entry and related rights

114

• (1) Any person entering any property (that is to say, any premises, ship, ... vehicle, stall or place) by virtue of section 111 of this Act (whether in pursuance of a warrant or not) may take with him such other persons and such equipment as may appear to him to be necessary; and on leaving any such property which he has entered in pursuance of a warrant under that section he shall, if the property is unoccupied or the occupier (or, in the case of a ship, ... vehicle, stall or place, the master... or other person in charge of it) is temporarily absent, leave it as effectively secured against trespass as he found it.

• (2) Any person who—

• (a) wilfully obstructs a person acting in pursuance of this Act and duly authorised so to act by an enforcement authority, or

• (b) wilfully fails to comply with any requirement properly made to him by a person so acting under section 112 of this Act, or

• (c) without reasonable cause fails to give to a person so acting any other assistance or information which that person may reasonably require of him for the purpose of the performance of his functions under this Act,

shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding level 3 on the standard scale

• (3) If any person, in giving any such information as is mentioned in subsection (2)(c) of this section, makes any statement which he knows to be false, he shall be guilty of an offence and 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.

• (4) Nothing in this section shall be construed as requiring a person to answer any question or give any information if to do so might incriminate that person or (where that person is married or a civil partner) the spouse or civil partner of that person.

Analysis of samples in other cases

115

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

Liability to forfeiture under Customs and Excise Act 1952

116

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

Special enforcement and sampling provisions relating to animal feeding stuffs

117

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

Restrictions on disclosure of information

118

• (1) If any person discloses to any other person—

• (a) any information with respect to any manufacturing process or trade secret obtained by him in premises which he has entered by virtue of section 111 of this Act, or

• (b) any information obtained by or furnished to him in pursuance of this Act,

he shall, unless the disclosure was made in the performance of his duty, be guilty of an offence.

• (1A) Subsection (1) of this section does not apply if–

• (a) the person making the disclosure is, or is acting on behalf of a person who is, a public authority for the purposes of the Freedom of Information Act 2000or a Scottish public authority for the purposes of the Freedom of Information (Scotland) Act 2002, and

• (b) the information is not held by the authority on behalf of another person.

• (2) Any person guilty of an offence under 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.

Protection for officers of enforcement authorities

119

• (1) An officer of an enforcement authority shall not be personally liable in respect of any act done by him in the execution or purported execution of this Act and within the scope of his employment if he did it in the honest belief that his duty under this Act required or entitled him to do it.

• (2) Where an action has been brought against an officer of an enforcement authority in respect of an act done by him in the execution or purported execution of this Act, and the circumstances are such that he is not legally entitled to require the enforcement authority to indemnify him, the authority may nevertheless indemnify him against the whole or part of the damages and costs or expenses which he may have been ordered to pay or may have incurred, if they are satisfied that he honestly believed that his duty under this Act required or entitled him to do it.

• (3) In this section any reference to an officer of an enforcement authority shall be construed as including a reference to any person who, not being an officer of the authority, is authorised to act in pursuance of this Act by such an authority; and in relation to any such person any reference in this section to the scope of his employment shall be construed as a reference to the scope of the authorisation under which he acts.

Compensation for loss of employment or loss or diminution of emoluments

120

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

Contravention due to default of other person

121

• (1) Where a contravention by any person of any provision to which this section applies constitutes an offence under this Act, and is due to an act or default of another person, then, whether proceedings are taken against the first-mentioned person or not, that other person may be charged with and convicted of that offence, and shall be liable on conviction to the same punishment as might have been imposed on the first-mentioned person if he had been convicted of the offence.

• (2) Where a person who is charged with an offence under this Act in respect of a contravention of a provision to which this section applies proves to the satisfaction of the court—

• (a) that he exercised all due diligence to secure that the provision in question would not be contravened, and

• (b) that the contravention was due to the act or default of another person,

the first-mentioned person shall, subject to the next following subsection, be acquitted of the offence.

• (3) A person shall not, without the leave of the court, be entitled to rely on the defence provided by subsection (2) of this section unless, not later than seven clear days before the date of the hearing, he has served on the prosecutor a notice in writing giving such information identifying, or assisting in the identification of, the other person in question as was then in his possession.

• (4) This section applies to the following provisions, that is to say, sections 63, 64, 87 and 88, and the provisions of any regulations made under any of those sections.

Warranty as defence

122

• (1) Subject to the following provisions of this section, in any proceedings for an offence under this Act in respect of a contravention of a provision to which this section applies, it shall be a defence for the defendant to prove—

• (a) that he purchased the substance or article to which the contravention relates in the United Kingdom as being a substance or article which could be lawfully sold, supplied, or offered or exposed for sale, or could be lawfully sold, supplied, or offered or exposed for sale under the name or description or for the purpose under or for which he sold, supplied or offered or exposed it for sale, and with a written warranty to that effect;

• (b) that at the time of the commission of the alleged offence he had no reason to believe that it was otherwise; and

• (c) that the substance or article was then in the same state as when he purchased it.

• (2) This section applies to the following provisions, that is to say, sections 63(b), 64, 87 and 88 ... and the provisions of any regulations made under any of those sections.

• (3) A warranty shall not be a defence by virtue of this section unless the defendant has, not later than three clear days before the date of the hearing, sent to the prosecutor a copy of the warranty with a notice stating that he intends to rely on it and specifying the name and address of the person from whom he received it, and has also sent a like notice to that person.

• (4) Where the defendant is a servant of the person who purchased the substance or article under the warranty, he shall be entitled to rely on the provisions of this section in the same way as his employer would have been entitled to do if he had been the defendant.

• (5) The person by whom the warranty is alleged to have been given shall be entitled to appear at the hearing and to give evidence, and the court may, if it thinks fit, adjourn the hearing to enable him to do so.

• (6) For the purposes of this section a name or description entered in an invoice shall be deemed to be a written warranty that the article or substance to which the name or description applies can be sold, supplied, or offered or exposed for sale under that name or description by any person without contravening any provision to which this section applies.

• (7) In the application of this and the next following section to Scotland, any reference to the defendant shall be construed as a reference to the accused.

Offences in relation to warranties and certificates of analysis

123

• (1) If a defendant in any such proceedings as are mentioned in section 122(1) of this Act wilfully applies to any substance or article—

• (a) a warranty given in relation to a different substance or article, or

• (b) a certificate issued under ... paragraph 19 of Schedule 3 to this Act, which relates to a sample of a different substance or article,

he shall be guilty of an offence.

• (2) A person who, in respect of any substance or article sold by him in respect of which a warranty might be pleaded under section 122 of this Act, gives to the purchaser a false warranty in writing shall be guilty of an offence, unless he proves that when he gave the warranty he had reason to believe that the statement or description contained in it was accurate.

• (3) Where the defendant in any such proceedings as are mentioned in section 122(1) of this Act relies successfully on a warranty given to him or to his employer, any proceedings for an offence under subsection (2) of this section in respect of the warranty may, at the option of the prosecutor, be taken either before a court having jurisdiction in the place where a sample of the substance or article to which the warranty relates was procured, or before a court having jurisdiction in the place where the warranty was given.

• (4) Any person guilty of an offence under 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.

Offences by bodies corporate

124

• (1) Where an offence under this Act which is committed by a body corporate is proved to have been committed with the consent and connivance of, or to be attributable to any neglect on the part of, any director, manager, secretary or other similar officer of the body corporate, or any person who was purporting to act in any such capacity, he as well as the body corporate shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

• (2) In relation to a body corporate carrying on a retail pharmacy business as mentioned in subsection (1) of section 71 of this Act, the preceding subsection shall have effect in relation to a person who (not being such an officer of the body corporate as is mentioned in the preceding subsection)—

• (a) is the superintendent referred to in subsection (1) of that section, or

• (b) in respect of any premises at or from which the business is carried on, is the pharmacist referred to in subsection (4)(b) of that section who acts under the directions of the superintendent,

as if he were such an officer of the body corporate as is mentioned in the preceding subsection.

• (3) In this section “director”, in relation to a body corporate established by or under any enactment for the purpose of carrying on under national ownership any industry or part of an industry or undertaking, being a body corporate whose affairs are managed by its members, means a member of that body corporate.

Prosecutions

125

• (1) Notwithstanding anything in section 127(1) of the Magistrates’ Courts Act 1980, a magistrates’ court in England or Wales may try an information for an offence under this Act if the information was laid at any time within twelve months from the commission of the offence.

• (2) Notwithstanding anything in section 331 of the Criminal Procedure (Scotland) Act 1975 (limitation of time for proceedings in statutory offences) summary proceedings in Scotland for an offence under this Act may be commenced at any time within twelve months from the time when the offence was committed, and subsection 3 of the said section 331 shall apply for the purposes of this subsection as it applies for the purposes of that section.

• (3) Notwithstanding anything in section 34 of the Magistrates’ Courts Act (Northern Ireland) 1964Article 19(1) of the Magistrates’ Courts (Northern Ireland) Order 1981, a magistrates’ court in Northern Ireland may hear and determine a complaint for an offence punishable under this Act upon summary conviction other than an offence which is also triable upon indictment if the complaint was made at any time within twelve months from the commission of the offence.

• (4) Neither the General Pharmaceutical Council nor any other body referred to in subsection (2) ... of section 108 of this Act shall institute proceedings for an offence under this Act in respect of a contravention of a provision which, by virtue of that subsection, the Council or body have a power or duty to enforce, unless they have given to the appropriate Minister not less than twenty-eight days’ notice of their intention to institute proceedings, together with a summary of the facts upon which the charges are founded.

• (5) For the purposes of subsection (4) of this section the appropriate Minister, in relation to a contravention of any provision, is the Minister who in accordance with section 108 of this Act has a concurrent duty to enforce that provision.

• (6) A district council (as defined by section 110 of this Act) shall not prosecute for an offence under this Act in respect of a contravention of any provision which, by virtue of subsection (2) of that section, the authority have a power or duty to enforce, unless the authority have given to the Minister for Health, Social Services and Public Safety not less than twenty-eight days’ notice of their intention to begin the prosecution, together with a summary of the facts upon which the charges are founded.

• (7) A certificate of the Minister who is the appropriate Minister for the purposes of subsection (4) of this section that the requirements of that subsection have been complied with in relation to any proceedings, and a certificate of the Minister for Health, Social Services and Public Safety that the requirements of subsection (6) of this section have been complied with in relation to any prosecution, shall be conclusive evidence that those requirements have been so complied with; and any document purporting to be such a certificate and to be signed by or on behalf of that Minister shall be presumed to be such a certificate unless the contrary is proved.

Presumptions

126

• (1) For the purposes of any proceedings under this Act for an offence consisting of—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) offering a medicinal product for sale in contravention of section 63(b) of this Act,

where it is proved that the ... medicinal product in question was found on a vehicle from which ... medicinal products are sold, it shall be presumed, unless the contrary is proved, that the person in charge of the vehicle offered that ... medicinal product for sale and, in a case falling within paragraph (b) of this subsection, that he offered it for sale by retail.

• (2) For the purposes of any proceedings under this Act for an offence consisting of a contravention of so much of any provision to which this subsection applies as relates to a person’s having any medicinal product ... in his possession for the purpose of sale or supply, where it is proved that the medicinal product ... in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products ..., it shall be presumed, unless the contrary is proved, that he had that medicinal product or animal feeding stuff in his possession for the purpose of sale or supply.

• (3) Subsection (2) of this section applies to the following provisions of this Act, that is to say, section 63(b), ... subsection (2) of section 87 and subsection (3) of section 88... as applied by subsection (1) of section 90, and to subsection (2) of section 90 except in so far as it relates to leaflets.

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Service of documents

127

Any notice or other document required or authorised by any provision of this Act to be served on any person, or to be given or sent to any person, may be served, given or sent—

• (a) by delivering it to him; or

• (b) by sending it by post to him at his usual or last-known residence or place of business in the United Kingdom; or

• (c) in the case of a body corporate, by delivering it to the secretary or clerk of the body corporate at its registered or principal office or sending it by post to the secretary or clerk of that body corporate at that office.

Financial provisions

128

• (1) Any expenses incurred in consequence of this Act by either of the Ministers, other than expenses so incurred exclusively in respect of executing this Act in Northern Ireland, shall be defrayed out of moneys provided by Parliament.

• (2) There shall be defrayed out of moneys provided by Parliament any increase attributable to the provisions of this Act in—

• (a) the sums payable out of moneys so provided in respect of rate support grants to local authorities in England and Wales which may arise from the inclusion, in the expenditure relevant to the fixing of the aggregate amount of those grants, of expenditure under this Act, or

• (b) the sums payable out of moneys so provided under any enactment relating to local government in Scotland.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) Where the General Pharmaceutical Council or (as the case may be) the Pharmaceutical Society of Northern Ireland or any other body enforces any provision of this Act or of any regulations or order made thereunder in the performance of a duty imposed, or the exercise of a power conferred, under section 108(2) or section 110(2) of this Act, the Minister who has a concurrent duty to enforce that provision shall pay to the Society or other body such charges as they may reasonably require to be paid in respect of expenses incurred by them in the enforcement of that provision.

• (5) Where under subsection (10) of section 108 of this Act (or under that subsection as modified in relation to Northern Ireland by section 110(5) of this Act) either of the Ministers makes a determination in respect of the enforcement of any provision in relation to a particular matter, he shall be entitled to recover from the General Pharmaceutical Council or (as the case may be) the Pharmaceutical Society of Northern Ireland or other body who were under a duty to enforce that provision in relation to that matter any expenses reasonably incurred by that Minister in taking steps to enforce that provision in relation to that matter.

• (6) Any fees and other sums received by virtue of this Act by the Secretary of State, shall be paid into the Exchequer.

• (7) Such sums paid out of the Exchequer of the United Kingdom in connection with the execution of this Act as may be determined by the Joint Exchequer Board to be properly payable by the Government of Northern Ireland shall be made good by means of deductions from the Northern Ireland residuary share of reserved taxes.

Orders and regulations

129

• (1) The Ministers may make regulations for any purpose for which regulations are authorised or required to be made under this Act, other than any purpose for which any provision of this Act authorises or requires regulations to be made otherwise than by the Ministers.

• (2) Any power to make orders or regulations under this Act (other than any order made by a court or judge or any order or regulations made in relation to Northern Ireland under section 72A of this Act or paragraph 1... or paragraph 6 of Schedule 4 to this Act ...) shall be exercisable by statutory instrument.

• (3) Any statutory instrument consisting of—

• (a) an order made under any of the following provisions of this Act, that is to say, sections 58, 62, 79 , 84A(5) and 106 and paragraph 27 of Schedule 3, or

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) any regulations made under any provision, other than section 79, of this Act,

shall be subject to annulment in pursuance of a resolution of either House of Parliament.

• (4) Any power to make an order under any provision... of this Act shall include power to revoke or vary the order by a subsequent order made under that provision.

• (5) Any power to make an order or regulations under this Act 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 authority making the order or regulations considers necessary or expedient.

• (6) Before making any regulations under this Act and before making any order under this Act (except an order made in accordance with any provision of this Act under which, in case of urgency, an order can be made with immediate effect) the Ministers proposing to make the regulations or order shall consult such organisations as appear to them to be representative of interests likely to be substantially affected by the regulations or order.

• (6A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) Without prejudice to subsection (6) of this section, where any Ministers propose to make any regulations or order under Part III, ... of this Act, or under section 104 or section 105 of this Act, and they consult an expert committee appointed by themselves, or by one of them acting alone, or the Commission, with respect to that proposal, they shall take the advice of the committee or of the Commission into account before proceeding with those proposals.

Meaning of " medicinal product" and related expressions

130

• (1) In this Act, “medicinal product” has the meaning given by regulation 2 of the 2012 Regulations.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3C) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (9) In this Act “ administer ” means administer to a human being ..., whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act to administering (...) a substance or article is a reference to administering (...) it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle.

• (10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

131

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

General interpretation provisions

132

• (1) In this Act—

• (a) unless the context otherwise requires, any expression defined by any provision of the 2012 Regulations , and not defined in this Act, has the same meaning as it has for the purposes of those Regulations; and

• (b) “the 2012 Regulations ” means the Human Medicines Regulations 2012.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) Any reference in this Act to the holder of a ... certificate shall be construed as a reference to the holder of a ... certificate which is for the time being in force.

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) Except in so far as the context otherwise requires, any reference in this Act to an enactment shall be construed as a reference to that enactment as amended or extended by or under any other enactment, including this Act.

General provisions as to operation of Act

133

• (1) The provisions of this Act, and of any regulations or orders made under it, shall operate cumulatively; and any exemption or exception from any of those provisions shall not be construed as conferring any exemption or exception in relation to any other of those provisions.

• (2) Except in so far as this Act otherwise expressly provides, and subject to the provisions of section 33 of the Interpretation Act 1889 (which relates to offences under two or more laws), the provisions of this Act shall not be construed as—

• (a) conferring a right of action in any civil proceedings (other than proceedings for the recovery of a fine) in respect of any contravention of this Act or of any regulations or order made under this Act, or

• (b) affecting any restriction imposed by or under any other enactment, whether contained in a public general Act or in a local or private Act, or

• (c) derogating from any right of action or other remedy (whether civil or criminal) in proceedings instituted otherwise than under this Act.

• (3) No exemption conferred by or under any provision of this Act shall be construed as derogating from any exemption or immunity of the Crown.

Special provisions as to Northern Ireland

134

• (1) Nothing in this Act shall authorise any department of the Government of Northern Ireland to incur any expenses attributable to the provisions of this Act, which are not expenses falling to be defrayed in accordance with section 128(1) of this Act, until provision has been made by the Parliament of Northern Ireland for those expenses to be defrayed out of moneys provided by that Parliament.

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) The provisions of Schedule 4 to this Act shall have effect with respect to the application of this Act in relation to Northern Ireland.

• (4) In this Act “enactment” includes an enactment of the Parliament of Northern Ireland; and (without prejudice to section 132(6) of this Act) any reference in this Act to such an enactment shall include a reference to any enactment re-enacting it with or without modifications.

• (5) Sections 16(1) and 17(2)(a) of the Interpretation Act 1978 shall have the like operation in relation to any repeal by this Act of an enactment of the Parliament of Northern Ireland as it has in relation to the repeal of an enactment of the Parliament of the United Kingdom.

Minor and consequential amendments and repeals

135

• (1) The enactments of the Parliament of the United Kingdom which are specified in Schedule 5 to this Act shall have effect subject to the amendments set out in that Schedule, being minor amendments and amendments consequential upon the preceding provisions of this Act.

• (2) The enactments of that Parliament which are specified in Schedule 6 to this Act are hereby repealed to the extent specified in the third column of that Schedule :

...

• (3) The enactments of the Parliament of Northern Ireland which are specified in Schedule 7 to this Act shall have effect subject to the amendments specified in that Schedule, being minor amendments and amendments consequential upon the preceding provisions of this Act.

• (4) The enactments of the Parliament of Northern Ireland specified in Schedule 8 to this Act are hereby repealed to the extent specified in the third column of that Schedule.

Short title, extent and commencement

136

• (1) This Act may be cited as the Medicines Act 1968.

• (2) Except as provided by section 78(5B), this Act extends to Northern Ireland.

• (3) The following provisions of this Act, that is to say, sections 63 to 65, 77, 85(5), 86(3), 90(2), 93, 97 and 135, shall not come into operation on the passing of this Act but shall come into operation on such day as the Ministers may by order appoint, and different days may be so appointed for, or for different purposes of, any one or more of those provisions (including, in the case of section 135 of this Act, the amendment or repeal of different enactments to which that section is applicable).

• (4) Any order made under this section may make such transitional provision as appears to the Ministers to be necessary or expedient in connection with the provisions of this Act which are thereby brought (wholly or in part) into force, including such adaptations of those provisions or any provision of this Act then in force as appear to them to be necessary or expedient in consequence of the partial operation of this Act (whether before, on or after the day appointed by the order).

SCHEDULE 1

1

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2

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3

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4

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5

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6

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7

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SCHEDULE 2

Procedure on consultation with appropriate committee

1

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2

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3

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4

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5

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6

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7

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Procedure in cases of urgency

8

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9

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Interpretation

10

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11

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12

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13

If, after the suspension has taken effect, it appears to the licensing authority, or (in the case of a product licence) they are advised by the appropriate committee or by the Commission, that it is necessary to consider whether the licence ought to be further suspended, or ought to be revoked or varied, the licensing authority (subject to the next following paragraph) shall proceed in accordance with such of the provisions of paragraphs 1 to 9 of this Schedule as are applicable in the circumstances.

14

Where, in the circumstances specified in paragraph 13 of this Schedule, the licensing authority proceed as mentioned in that paragraph, and any proceedings under paragraphs 1 to 9 of this Schedule relating to a further suspension of the licence have not been finally disposed of before the end of the period for which the licence was suspended under paragraph 11 of this Schedule, or for which it has been further suspended under this paragraph, as the case may be, then, if it appears to the licensing authority to be necessary in the interests of safety to do so, the licensing authority may further suspend the licence for a period which (in the case of each such further suspension) shall not exceed three months.

15

The provisions of section 27(7) of this Act shall, with the necessary modifications, have effect for the purpose of determining the date on which, for the purposes of paragraph 14 of this Schedule, any proceedings are to be taken to be finally disposed of.

Provisions as to hearings

16

Subsection (7) of section 21 of this Act shall have effect in relation to a person appointed by the licensing authority under paragraph 6 or paragraph 9 of this Schedule as it has effect in relation to a person appointed under subsection (5) of that section, as if in the said subsection (7) any reference to the applicant were a reference to the holder of the licence.

SCHEDULE 3

Introductory

1

• (1) The provisions of this Schedule shall have effect where a person authorised in that behalf by an enforcement authority (in this Schedule referred to as a “sampling officer") obtains a sample of any substance or article—

• (a) for the purpose of ascertaining whether there is or has been, in connection with that substance or article, any contravention of any provisions of this Act or of any regulations or order made thereunder which, by or under any provisions of sections 108 to 110 of this Act, that authority (in this Schedule referred to as “the relevant enforcement authority”) is required or empowered to enforce, or

• (b) otherwise for any purpose connected with the performance by that authority of their functions under this Act or under any such regulations or order,

and the sampling officer obtains the sample by purchase or in the exercise of any power conferred by section 112 of this Act.

• (2) In this Schedule “public analyst”, except in relation to Northern Ireland, has the meaning assigned to it by section 27 of the Food Safety Act 1990, and in relation to Northern Ireland has the meaning assigned to it by Article 27(1) of the Food Safety (Northern Ireland) Order 1991.

Division of sample

2

The sampling officer shall forthwith divide the sample into three parts, each part to be marked and sealed or fastened up in such manner as its nature will permit.

3

If the sample was purchased by the sampling officer, otherwise than from an automatic machine, he shall supply one part of the sample to the seller.

4

If the sampling officer obtained the sample from an automatic machine, then—

• (a) if a person’s name, and an address in the United Kingdom, are stated on the machine as being the name and address of the owner of the machine, the sampling officer shall supply one part of the sample to that person;

• (b) in any other case, the sampling officer shall supply one part of the sample to the occupier of the premises on which the machine stands or to which it is affixed.

5

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6

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7

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

8

In any case not falling within any of paragraphs 3 or 4 of this Schedule the sampling officer shall supply one part of the sample to the person appearing to him to be the owner of the substance or article from which the sample was taken.

9

In every case falling within any of paragraphs 3, 4, or 8 of this Schedule the sampling officer shall inform the person to whom the part of the sample in question is supplied that the sample has been obtained for the purpose of analysis or other appropriate examination.

10

Of the remaining parts of the sample into which the sample is divided in accordance with paragraph 2 of this Schedule, the sampling officer, unless he decides not to submit the sample for analysis or other appropriate examination, shall—

• (a) retain one part for future comparison, and

• (b) submit the other part for analysis or examination in accordance with the following provisions of this Schedule.

11

Where a sample consists of substances or articles enclosed in unopened containers, and it appears to the sampling officer that to open the containers and divide the contents into parts—

• (a) is not reasonably practicable, or

• (b) might affect the composition or impede the proper analysis or other examination of the contents,

the sampling officer may divide the sample into parts by dividing the containers into three lots without opening them.

12

Section 127 of this Act shall have effect in relation to supplying any part of a sample in pursuance of the preceding paragraphs as it has effect in relation to the service of a document.

13

If after reasonable inquiry the sampling officer is unable to ascertain the name of a person to whom, or the address at which, a part of a sample ought to be supplied in pursuance of the preceding paragraphs, he may retain that part of the sample instead of supplying it.

Notice to person named on container

14

• (1) Where it appears to the sampling officer that a substance or article of which he has obtained a sample was manufactured or assembled by a person whose name and address in the United Kingdom are stated on its container, and who is not a person to whom a part of the sample is required to be supplied under the preceding provisions of this Schedule, the sampling officer, unless he decides not to submit the sample for analysis or other appropriate examination, shall serve notice on that person—

• (a) stating that the sample has been obtained by the sampling officer, and

• (b) specifying the person from whom the sampling officer purchased it, or, if he obtained it otherwise than by purchase, the place from which he obtained it.

• (2) The notice required to be served under the preceding sub-paragraph shall be served before the end of the period of three days beginning with the day on which the sample was obtained.

Analysis or other examination of sample

15

If the sampling officer decides to submit the sample for analysis or other appropriate examination, he shall—

• (a) submit it for analysis to the public analyst for the area in which the sample was obtained, or, if for the time being there is no public analyst for that area, then to the public analyst for some other area, or

• (b) submit it for other appropriate examination to the person having the management or control of any laboratory available for the purpose in accordance with any arrangements made in that behalf by the relevant enforcement authority.

16

Where the relevant enforcement authority is a Minister or the Pharmaceutical Society, and the sampling officer decides to have the sample analysed, he may (instead of submitting it to a public analyst) submit it for analysis to the person having the management or control of any laboratory available for the purpose in accordance with any arrangements made in that behalf by the relevant enforcement authority.

17

Any such arrangements as are mentioned in paragraph 15(b) or paragraph 16 of this Schedule,—

• (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (b) if ... they are made by an enforcement authority in England and Wales other than the Secretary of State, shall be arrangements approved by the Secretary of State;

• (c) if they are made by an enforcement authority in Scotland other than the Secretary of State, shall be arrangements approved by the Secretary of State;

and any such arrangements as are mentioned in paragraph 15(b) of this Schedule, if made by the Pharmaceutical Society of Northern Ireland in Northern Ireland, shall be arrangements approved by the Minister for Health, Social Services and Public Safety.

18

• (1) Subject to the following sub-paragraph, the person to whom the sample is submitted under paragraph 15 or paragraph 16 of this Schedule shall analyse or examine the sample (as the case may be), or cause the sample to be analysed or examined by some other person under his direction, as soon as practicable.

• (2) If the person to whom the sample is so submitted is a public analyst, and that analyst determines that for any reason an effective analysis of the sample cannot be performed by him or under his direction, he shall send it to the public analyst for some other area, and that other public analyst shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

19

• (1) A public analyst who has analysed a sample submitted to him under the preceding provisions of this Schedule, or who has caused such a sample to be analysed by some other person under his direction, shall issue and send to the sampling officer a certificate specifying the result of the analysis.

• (2) A person having the management or control of a laboratory in which a sample submitted to him under the preceding provisions of this Schedule has been analysed or examined, or a person appointed by him for the purpose, shall issue and send to the sampling officer a certificate specifying the result of the analysis or examination.

• (3) Any certificate issued under this paragraph shall be in a form prescribed by the Ministers and shall be signed by the person who issues the certificate.

20

• (1) Any person to whom, in accordance with paragraphs 2 to 8 of this Schedule, a part of the sample is required to be supplied shall, on payment of the prescribed fee to the relevant enforcement authority, be entitled to be supplied with a copy of any certificate as to the result of an analysis or examination which is sent to the sampling officer under paragraph 19 of this Schedule.

• (2) Any regulations prescribing a fee for the purposes of this paragraph shall be made by the Ministers.

Provisions as to evidence

21

In any proceedings for an offence under this Act a document produced by one of the parties to the proceedings and purporting to be a certificate issued under paragraph 19 of this Schedule shall be sufficient evidence of the facts stated in the document, unless the other party requires that the person who issued the certificate shall be called as a witness; and, in any proceedings in Scotland, if that person is called as a witness, his evidence shall be sufficient evidence of those facts.

22

In any proceedings for an offence under this Act a document produced by one of the parties to the proceedings, which has been supplied to him by the other party as being a copy of such a certificate, shall be sufficient evidence of the facts stated in the document.

23

• (1) If in any such proceedings before a magistrates’ court a defendant intends to produce such a certificate, or to require that the person by whom such a certificate was issued shall be called as a witness, a notice of his intention, and (where he intends to produce such a certificate) a copy of the certificate, shall be given to the other party at least three clear days before the day on which the summons is returnable.

• (2) If the preceding sub-paragraph is not complied with, the court may, if it thinks fit, adjourn the hearing on such terms as it thinks proper.

• (3) In Scotland, if in any such proceedings in the sheriff court the accused intends to produce such a certificate, or to require that the person by whom such a certificate was issued shall be called as a witness, notice of his intention, and (where he intends to produce such a certificate) a copy of the certificate, shall be given to the procurator fiscal at least three clear days before the day on which the case proceeds to trial.

• (4) If sub-paragraph (3) of this paragraph is not complied with, the sheriff may, if he thinks fit, adjourn the diet on such terms as he deems proper.

Analysis under direction of court

24

• (1) In any proceedings for an offence under this Act, where the proceedings relate to a substance or article of which a sample has been obtained as mentioned in paragraph 1 of this Schedule, the part of the sample retained in pursuance of paragraph 10(a) of this Schedule shall be produced as evidence; and the court—

• (a) at the request of either party to the proceedings shall, and

• (b) in the absence of any such request may if it thinks fit,

cause that part of the sample to be sent for analysis to the Government Chemist (or, in Northern Ireland, the Government Chemist for Northern Ireland) or to be sent for other appropriate examination to the person having the management or control of a laboratory specified by the court.

• (2) If, in a case where an appeal is brought, no action has been taken under the preceding sub-paragraph, the provisions of that sub-paragraph shall have effect in relation to the court by which the appeal is heard.

• (3) A person to whom a part of a sample is sent under this paragraph for analysis or other examination shall analyse or examine it, or cause it to be analysed or examined on his behalf, and shall transmit to the court a certificate specifying the result of the analysis or examination.

• (4) Any such certificate shall be signed by that person, or signed on his behalf by the person who made the analysis or examination or a person under whose direction it was made.

• (5) Any such certificate shall be evidence (and, in Scotland, shall be sufficient evidence) of the facts stated in the certificate unless any party to the proceedings requires that the person by whom it was signed shall be called as a witness; and, in any proceedings in Scotland, if that person is called as a witness, his evidence shall be sufficient evidence of those facts.

25

The costs of any analysis or examination under paragraph 24 of this Schedule shall be paid by the prosecutor or the defendant (or, in Scotland, the accused) as the court may order.

Proof by written statement

26

In relation to England and Wales section 9 of the Criminal Justice Act 1967, and in relation to Northern Ireland any corresponding enactment which may be passed by the Parliament of Northern Ireland, shall not have effect with respect to any document produced as mentioned in paragraph 21 or paragraph 22 of this Schedule or with respect to any certificate transmitted to a court under paragraph 24 of this Schedule.

Power to modify sampling provisions

27

The Ministers may by order provide that, in relation to substances or articles of any such description as may be specified in the order, the preceding provisions of this Schedule shall have effect subject to such exceptions and modifications as may be specified in the order.

Payment for sample taken under compulsory powers

28

• (1) Where a sampling officer takes a sample in the exercise of any power conferred by section 112 of this Act he shall, if payment is demanded, pay the value of the sample to the person to whom a part of the sample is required under paragraph 5, paragraph 7 or paragraph 8 of this Schedule (as the case may be) to be supplied.

• (2) In default of agreement between the sampling officer and the person mentioned in the preceding sub-paragraph, the value of the sample shall be determined by the arbitration of a single arbitrator appointed by the sampling officer and the other person in question or, if they are unable to agree on the appointment of an arbitrator, shall be determined by the county court for the district (or, in Northern Ireland, the division) in which the sample was taken.

• (2A) For the purposes of this paragraph, England and Wales is to be treated as the district of the county court in England and Wales.

• (3) In the application of this paragraph to Scotland, for references to an arbitrator there shall be substituted references to an arbiter and for the reference to the county court there shall be substituted a reference to the sheriff.

Application of s. 64 to samples

29

Where a medicinal product is taken as a sample by a sampling officer in the exercise of any power conferred by section 112 of this Act, the provisions of subsections (1) to (4) of section 64 of this Act shall have effect as if the taking of the product as a sample were a sale of it to the sampling officer by the person from whom it is taken; and, if the product was prepared in pursuance of a prescription given by a practitioner, those provisions shall so have effect as if, in subsection (1) of that section, for the words “demanded by the purchaser", there were substituted the words “specified in the prescription"

SCHEDULE 4

1

• (1) the Minister for Health, Social Services and Public Safety may by order make provision for the application of this Act in relation to druggists subject to such exceptions and modifications as may be specified in the order.

• (2) In this paragraph “druggist” means a person registered in the register of druggists for Northern Ireland made out and maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976.

2

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3

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4

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5

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6

The appropriate Northern Ireland Minister may in relation to Northern Ireland exercise any power of making an order or regulations which is conferred on the Ministers by any provision of this Act ......... where in his ... opinion there are special circumstances which render it expedient to do so.

7

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8

Every order or regulation under this Act made by the Minister for Health, Social Services and Public Safety... by virtue of the power conferred by paragraph 1... or paragraph 6 of this Schedule... shall be subject to negative resolution within the meaning of section 41(6) of the Interpretation Act (Northern Ireland) 1954 as if it were a statutory instrument within the meaning of that Act.

9

In this Schedule “the appropriate Northern Ireland Minister”—

• (a) ... means the Minister for Health, Social Services and Public Safety;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

...

10

In this Act any reference to the Department of Health, Social Services and Public Safety ..., and any reference which is to be construed as including a reference to that Minister, shall include a reference to the Ministry of Health and Social Services for Northern Ireland ....

11

The Statutory Rules (Northern Ireland) Order 1979, except article 5(2)(a) of that Order (which requires the responsible officer of each rule-making authority making any statutory rules to send copies of them, and certain information, to the Ministry of Finance for Northern Ireland for registration under that Order), shall not apply to any orders or regulations made under this Act by statutory instrument.

SCHEDULE 5

The Venereal Disease Act 1917 (c. 21)

1

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The Pharmacy and Poisons Act 1933 (c. 25)

2

In section 17(2), for the words from "those poisons" to " authorised seller of poisons ", in each place where those words occur, there shall be substituted the words " those substances which, where they are non-medicinal poisons, are by virtue and subject to the provisions of this Act prohibited from being sold except by a person lawfully conducting a retail pharmacy business ".

3

In section 18, in subsection (1), for paragraphs (a) and (b) there shall be substituted the following paragraphs :—

(a) for a person to sell any non-medicinal poison which is a substance included in Part I of the Poisons List unless— (i) he is a person lawfully conducting a retail pharmacy business ; and (ii) the sale is effected on premises which are a registered pharmacy; and (iii) the sale is effected by, or under the supervision of, a pharmacist; (b) for a person to sell any non-medicinal poison which is a substance included in Part II of the Poisons List unless— (i) he is a person lawfully conducting a retail pharmacy business and the sale is effected on premises which are a registered pharmacy ; or (ii) his name is entered in a local authority's list in respect of the premises on which the poison is sold

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and in paragraph (c), for the words "poison, whether" there shall be substituted the words " non-medicinal poison, whether it is a substance ; and in subsection (2), for the word " poison ", in the first place where it occurs, there shall be substituted the words " non-medicinal poison which is a substance "

4

In section 21, in subsection (1), for the words from "who, not being entitled to sell poisons included in Part I" to " such poisons on those premises", there shall be substituted the words " as being persons entitled, on premises in respect of which their names are entered in the list, to sell non-medicinal poisons which are substances included in Part II of the Poisons List, and shall enter in the list the name of any person who, having premises in the area of the authority, makes an application to the local authority in the form prescribed by rules to have his name entered in the list in respect of those premises " ; and in subsection (3), for the words from " on which " to " the said Part II" there shall be substituted the words " in respect of which the name of any person is entered in the list ".

5

In section 22, before the word " poison " there shall be inserted the word " non-medicinal ".

6

In section 23, in subsections (1) and (2), before the word " poisons " in each place where it occurs (except where the reference is to the " Poisons Board " or " the Poisons List") there shall be inserted the word " non-medicinal ".

7

In section 24, in subsection (2), before the word " poison " there shall be inserted the word " non-medicinal ".

8

In section 25, in subsection (1), for the words " registered pharmacists and authorised sellers of poisons " there shall be substituted the words " pharmacists and persons carrying on a retail pharmacy business " ; in subsection (4), for the words " registered pharmacists and authorised sellers of poisons " there shall be substituted the words " pharmacists and persons carrying on a retail pharmacy business ", for the words " premises which are on the register of premises " there shall be substituted the words " registered pharmacy ", and for the word " poisons ", in the second and fourth places where it occurs, there shall be substituted the word " substances " ; in subsection (5), after the word " steps " there shall be inserted " (a) ", for the words " authorised sellers of poisons " there shall be substituted the words " persons lawfully conducting a retail pharmacy business ", for the word " poisons ", in the second place where it occurs, there shall be substituted the word " substances ", and for the words " for that purpose " there shall be substituted the words—

(b) to secure compliance with those provisions and rules by persons lawfully conducting a retail pharmacy business, in so far as that business is carried on at premises which are not a registered pharmacy,

and for those purposes ; and in subsection (6), for the word " poisons ", in the first place where it occurs, there shall be substituted the word " substances ".

9

In section 29, for the definition of "pharmacist" there shall be substituted the following:—

• ' person lawfully conducting a retail pharmacy business ' shall be construed in accordance with section 69 of the Medicines Act 1968 ;
• ' pharmacist ' has the meaning assigned to it in relation to Great Britain by section 132(1) of the Medicines Act 1968

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after the definition of "registered dentist" there shall be inserted the words " 'registered pharmacy' has the meaning assigned to it by section 74 of the Medicines Act 1968 ; ' retail pharmacy business ' has the meaning assigned to it by section 132(1) of that Act, " and at the end of section 29 there shall be inserted the following subsection:—

(2) In this Act ' non-medicinal poison' means a substance which is for the time being included in Part I or Part II of the Poisons List and is neither— (a) a medicinal product as defined by section 130 of the Medicines Act 1968, nor (b) a substance in relation to which, by virtue of an order under section 104 or section 105 of that Act for the time being in force (and whether, in the case of an order under section 104 of that Act, it is referred to in the order as a substance or as an article), the provisions of sections 51 to 54 and sections 69 to 77 of that Act (whether subject to exceptions and modifications or not and with or without other provisions of that Act) have effect as they have effect in relation to medicinal products as so defined.

The Cancer Act 1939 (c. 13)

10

In section 4, in subsection (4)(a)(v), for the words “authorised sellers of poisons" there shall be substituted the words “persons lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968".

The National Health Service Act 1946 (c. 81)

11

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The National Health Service (Scotland) Act 1947 (c. 27)

12

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The Purchase Tax Act 1963 (c. 9)

13

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The Drugs (Prevention of Misuse) Act 1964 (c. 64)

14

In section 1, in subsection (2), in paragraph (f), for the words " an authorised seller of poisons" there shall be substituted the words " a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 ", and in paragraph (k), for the words " the said Act of 1955 " there shall be substituted the words " Schedule 3 to the Medicines Act 1968 "; and in subsection (6), for paragraph (a) there shall be substituted the following paragraph:—

(a) for the reference in paragraph (j) of subsection (2) to section 89 of the Food and Drugs Act 1955 there shall be substituted a reference to section 27 of the Food and Drugs (Scotland) Act 1956

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The Dangerous Drugs Act 1965 (c.15)

15

In section 11, in subsection (2), for the words from "carrying on business " to " authorised seller of poisons " there shall be substituted the words " conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 ", and for the words " duly registered under Part I" there shall be substituted the words " which are a registered pharmacy as defined by section 74 "; in subsection (3), for the words from " the sale by retail" to the end of the subsection there shall be substituted the words " any contravention of the Pharmacy and Poisons Act 1933 or of the Medicines Act 1968 or any rules, regulations or order made under either of those Acts " ; and in subsection (4), for the words from " subsections (2) and (3)" to the end of the subsection there shall be substituted the words " the reference in subsection (2) to the Pharmaceutical Society of Great Britain, of a reference to the Pharmaceutical Society of Northern Ireland, for the reference in subsection (3) to the Pharmacy and Poisons Act 1933, of a reference to the Pharmacy and Poisons Acts (Northern Ireland) 1925 to 1967, and as if in subsection (2) the reference to a person lawfully conducting a retail pharmacy business included a reference to a person deemed to be a person lawfully conducting such a business by virtue of an order made under paragraph 1 of Schedule 4 to the said Act of 1968 ".

The Trade Descriptions Act 1968 (c. 29)

16

In section 2, in subsection 5, after the word “section" there shall be inserted “(a)", and at the end of the subsection there shall be inserted the following paragraph:—

(b) where by virtue of any provision made under Part V of the Medicines Act 1968 (or made under any provisions of the said Part V as applied by an order made under section 104 or section 105 of that Act) anything which, in accordance with this Act, constitutes the application of a trade description to goods is subject to any requirements or restrictions imposed by that provision, any particular description specified in that provision, when applied to goods in circumstances to which those requirements or restrictions are applicable, shall be deemed not to be a trade description.

17

In section 22, in subsection (2), after the words “the Food and Drugs Act (Northern Ireland) 1958 " there shall be inserted the words “or the Medicines Act 1968" ; in paragraph (b) the word “and", where it occurs at the end of that pargraph, shall be omitted ; and at the end of paragraph (c) there shall be inserted the words

and (d) in relation to the said Act of 1968, so much of Schedule 3 to that Act as is applicable to the circumstances in which the sample was procured,

SCHEDULE 6

SCHEDULE 7

The Pharmacy and Poisons Act (Northern Ireland) 1925 c. 8 (N.I.)

1

In section 10(2) for the words " open shop is kept for any of the purposes mentioned in paragraphs (a) and (b) of subsection (1) of section 15 of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 " there shall be substituted the words " a retail pharmacy business is carried on ", for the words " such shop " (twice) and " the shop " there shall be substituted the words " the business ", and for the words " keep open shop for any of the purposes mentioned in paragraphs (a) and (b) of subsection (1) of the said section 15 " there shall be substituted the words " carry on a retail pharmacy business " : and after the said subsection (2) there shall be inserted the following subsection:—

(3) In subsection (2) of this section the " expression ' retail pharmacy business' has the meaning assigned to it by section 132(1) of the Medicines Act 1968.

2

Sections 17 and 18 shall cease to have effect.

3

In section 25 for the word " poisons " there shall be substituted the words " non-medicinal poisons ".

4

In section 27(2) for the words from the beginning to the words " such portion " there shall be substituted the following words:—

The fees paid to the registrar under section 75(1) of the Medicines Act 1968 on the entry of premises in the register required to be kept under that section and the retention or other fees, or any other sums, paid to him under section 76 of that Act shall be paid by him to the Ministry of Health and Social Services. Of the fees so paid to the Ministry of Health and Social Services such portion

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and after the words "under this Act" there shall be inserted the words " and any expenses attributable to the functions of the registrar under Part IV of the Medicines Act 1968 ".

5

In section 30 for the definition of " poison" there shall be substituted the following definition—

• The expression ' non-medicinal poison ' has the meaning assigned to it by section 38(1A) of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945.

6

Schedule 3 shall cease to have effect.

The Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 — 1945 c. 9 (N.I.)

7

Part I shall cease to have effect.

8

In section 14(1) the words " if he is a registered person " and the words from " and, if he is a representative " onwards, and in section 14(2) the proviso, shall cease to have effect.

9

In section 14(6) for the words ", or in respect of any annual licence under section seventeen of the Act of 1925," there shall be substituted the words " , and in the register of premises required to be kept under section 75 of the Medicines Act 1968, ".

10

Sections 15 to 18 shall cease to have effect.

11

In section 19 in subsection (1) for the words "carry on the business of " there shall be substituted the words " be registered as a " ; and in that subsection the words " or to be an authorised seller of poisons " and the words from ", or if the owner is a body corporate " to " employee of the body corporate," in subsection (2) in paragraph (a) the words from " or, if the owner " onwards and in paragraph (b) the words from " or, if the owner is a body corporate " to " employee of the body corporate," and subsection (3) shall cease to have effect.

12

In section 26A(3) for the words from " those poisons" to " authorised sellers of poisons " in each place where those words occur, there shall be substituted the words " those substances which, where they are non-medicinal poisons, are by virtue of and subject to the provisions of this Act prohibited from being sold except by a person lawfully conducting a retail pharmacy business " and for the words "and those persons who are authorised by the local authority " there shall be substituted the words " or a person whose name is entered in a register kept under this Part of this Act by a local authority (in this Act referred to as a. ' local authority's register'). "

13

In section 27, in subsection (1) for paragraphs (a) and (b) there shall be substituted the following paragraphs:—

(a) for a person to sell any non-medicinal poison which is a substance included in Part I of the Poisons Schedule unless— (i) he is a person lawfully conducting a retail pharmacy business ; and (ii) the sale is effected on premises which are a registered pharmacy ; and (iii) the sale is effected by, or under a personal control of, a pharmacist; (b) for a person to sell any non-medicinal poison which is a substance included in Part II of the Poisons Schedule unless— (i) he is a person lawfully conducting a retail pharmacy business and the sale is effected on premises which are a registered pharmacy ; or (ii) his name is entered in a local authority's register in respect of the premises on which the poison is sold,

and in paragraph (d) for the words "poison, whether" there shall be substituted the words " non-medicinal poison, whether it is a substance ; and in subsection (2) for the word " poisons " where it first occurs there shall be substituted the words " non-medicinal poison which is a substance " and in paragraph (a)(ii) of that subsection for the words " duly registered person" there shall be substituted the word " pharmacist ".

14

Section 28 shall cease to have effect.

15

In section 30, in subsection (1), for the words from " who, not being entitled to sell poisons included in Part I" to "such poisons on those premises " there shall be substituted the words " as being persons entitled, on premises in respect of which their names are entered in the register, to sell non-medicinal poisons which are substances included in Part II of the Poisons Schedule, and shall enter in the register the name of any person who, having premises in the area of the authority, makes an application to the local authority in the prescribed form to have his name entered in the register in respect of those premises " ; and in subsection (3), for the words from " on which " to " the said Part II " there shall be substituted the words " in respect of which the name of any person is entered in the register ".

16

In section 31, before the word "poison" there shall be inserted the word " non-medicinal ".

17

In section 32, in subsection (1) and (2), before the word " poison" or " poisons" in each place where it occurs (except as part of the expression "the Poisons Board"), there shall be inserted the word " non-medicinal " ; and in subsection (1) paragraphs (a), (b)(ii) and (i) shall cease to have effect, and, in subsection (3), the references to paragraphs (a) and (i) of subsection (1), shall be omitted.

18

In section 33(2) before the word "poison" there shall be inserted the word " non-medicinal ".

19

In section 35(3) the words " section four, section five or " shall cease to have effect.

20

In section 36 in subsections (2) and (3) for the word " Parts " there shall be substituted the word " Part " and the words " I and " shall cease to have effect, in subsection (2) for the words " registered persons, authorised sellers of poisons " there shall be substituted the words " pharmacists, persons carrying on a retail pharmacy business and "; and in subsection (3) for the words " premises having an annual licence or registered under section 30 of this Act" there shall be substituted the words " registered pharmacy or any premises in respect of which a person's name is entered in a local authority's register, " and for the word " poisons" there shall be substituted the words " substances included in Part I or Part II of the Poisons Schedule ".

21

Section 37 shall cease to have effect.

22

In section 38, in subsection (1), the definitions of " authorised seller of poisons ", " poison ", " premises having an annual licence " and "retailing" shall cease to have effect, and the following definitions shall be inserted at the appropriate points in alphabetical order—

• ' person lawfully conducting a retail pharmacy business ' shall be construed in accordance with section 69 of the Medicines Act 1968 ;
• ' pharmacist ' means a person who is, or is deemed to be, a pharmacist for the purposes of any provision of the Medicines Act 1968 ;
• ' registered pharmacy ' has the meaning assigned to it by section 74 of the Medicines Act 1968 ;
• ' retail pharmacy business ' has the meaning assigned to it by section 132(1) of the Medicines Act 1968 ;

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and at the end of that subsection there shall be inserted the following subsection—