The MinistersF32... may by order specify any description or class of articles or substances appearing to them to be articles or substances which are not medicinal products but are manufactured, sold, supplied, imported or exported for use wholly or partly for a medicinal purpose, and may by the order direct that, subject to such exceptions and modifications as may be specified in the order, such provisions of F69the 2012 RegulationsF21, or the Clinical Trials Regulations, as may be so specified (including provisions so specified which relate to offences or penalties) shall have effect in relation to articles or substances of that description or class as those provisions have effect in relation to medicinal products.

No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.

The power conferred by the preceding subsection may be exercised in relation to a class of substances if it appears to the Ministers that the conditions specified in paragraph (a) or paragraph (b) of that subsection are fulfilled in relation to all substances falling within that class.

The Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if in those provisions any reference to a business included a reference to an activity (other than a business) of a description specified in the order.

Without prejudice to the preceding subsection, the Ministers may by order direct that such provisions of this Act as may be specified in the order, in so far as they relate to things done by a person in the course of a business carried on by him, shall have effect, subject to such exceptions and modifications as may be specified in the order, as if, in such circumstances as may be so specified, a business carried on by a person’s employer were a business carried on by that person.

Except as provided by the following provisions of this section, the validity of any decision F72... of a Minister under section 75 of this Act, and the validity of any F73certificate issued or other thing done in pursuance of any such decision, shall not be questioned in any legal proceedings.

Where a decision to F74issue a certificate is quashed under this section, any F75certificate issued in pursuance of that decision shall be void, and any proceedings on the application for the F76issue of the certificate may be continued as if no such decision had been made.

In the application of this section to Scotland, any reference to the High Court shall be construed as a reference to the Court of Session.

In the application of this section to Northern Ireland, any reference to the High Court shall be construed as a reference to a judge of the High Court F77... in Northern Ireland.

F58Subject to the provisions of subsection (6C) of this section, it shall be the duty of the appropriate Minister to enforce in England and Wales, or to secure the enforcement in England and Wales of, the provisions of this Act and any regulations and orders made under it.

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F86the General Pharmaceutical Council shall be under a duty to enforce F150the provisions of sections 72A and 72AA of this Act, and any rules made under section 72A, in their application to England and Wales.

The appropriate Minister shall be under no duty to enforce F151those provisions, or any rules made under section 72A, in their application to England and Wales.

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If the appropriate Minister is satisfied, after making such inquiry as he thinks fit, that F81the General Pharmaceutical CouncilF82has in relation to any matter failed to perform a duty imposed on it byF154subsection (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.

F60 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.

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 F7 “ a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ”

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

Subject to the provisions of F62subsections (3C) and (4) of this section, it shall be the duty of the F99Minister 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.

For the purpose of performing that duty in relation to the provisions specified in F106paragraph (a) of subsection (2) of section 108 of this Act in their application as mentioned in F107that paragraph, within the F146district of any F147district council, the Minister may make arrangements or give directions whereby the F147district 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 F106paragraph (a) in their application as so mentioned F108....

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The Pharmaceutical Society F100of Northern Ireland shall be under a duty to enforce F156the provisions of sections 72A and 72AA of this Act, and any regulations made under section 72A, in their application to Northern Ireland.

The Minister shall be under no duty to enforce F157those provisions, or any regulations made under section 72A, in their application to Northern Ireland.

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

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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.

The last preceding subsection shall have effect in relation to entering any ship, F112... 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 masterF113... or other person in charge of the ship, F112... vehicle, stall or place.

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

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.

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.

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.

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.

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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.

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.

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 F116....

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.

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.

Any person entering any property (that is to say, any premises, ship, F117... 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, F117... vehicle, stall or place, the masterF118... or other person in charge of it) is temporarily absent, leave it as effectively secured against trespass as he found it.

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 F29 married or a civil partner) the spouse or civil partner of that person.

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.

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.

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.

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.

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.

This section applies to the following provisions, that is to say, sections F11963, 64, 87 and 88, and the provisions of any regulations made under any of those sections.

This section applies to the following provisions, that is to say, F120sections 63(b), 64, 87 and 88F41... and the provisions of any regulations made under any of those sections.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Notwithstanding anything in F10section 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.

Notwithstanding anything in F11section 331 of the M2Criminal 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 F11subsection 3 of the said section 331 shall apply for the purposes of this subsection as it applies for the purposes of that section.

Notwithstanding anything in F12section 34 of the M3Magistrates’ Courts Act (Northern Ireland) 1964F12Article 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 F13punishable 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.

Neither F122the General Pharmaceutical Council nor any other body referred to in subsection (2) F42... 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 F43that subsection, F123the 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.

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.

F14A 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 F124Minister 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.

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 F124Minister 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.

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 F47... in his possession for the purpose of sale or supply, where it is proved that the medicinal product F47... 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 F48..., 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.

Subsection (2) of this section applies to the following provisions of this Act, that is to say, section 63(b), F125... subsection (2) of section 87 and subsection (3) of section 88F49... as applied by subsection (1) of section 90, and to subsection (2) of section 90 except in so far as it relates to leaflets.

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Any expenses incurred in consequence of this Act by F128either 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.

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Where F129the 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.

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) F130either 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 F129the 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.

Any fees and other sums received by virtue of this Act by F131the Secretary of State, shall be paid into the Exchequer.

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.

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.

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 F161section 72A of this Act or paragraph 1F50... or paragraph 6 of Schedule 4 to this Act F132...) shall be exercisable by statutory instrument.

Any power to make an order under any provisionF135... of this Act shall include power to revoke or vary the order by a subsequent order made under that provision.

Any power to makeF30 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 theF31 order or regulations considers necessary or expedient.

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.

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Without prejudice to subsection (6) of this section, where any Ministers propose to make any regulations or order under Part III, F136... of this Act, or under section 104 or section 105 of this Act, and they consult F137an 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.

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

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In this Act “ administer ” means administer to a human being F53..., 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 (F54...) a substance or article is a reference to administering (F54...) 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.

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In this Act any reference to selling anything by way of wholesale dealing is a reference to selling it to a person as being a person who buys it for one or more of the purposes specified in subsection (2) of this section, except that it does not include any such sale by the person who manufactured it.

In this Act any reference to selling by retail, or to retail sale, is a reference to selling a substance or article to a person as being a person who buys it otherwise than for a purpose specified in subsection (2) of this section.

For the purposes of this section the provision of services by or on behalf of the Minister of Health, the Secretary of State or the Ministry of Health and Social Services for Northern Ireland under F55 the National Health Service Act 2006, the National Health Service (Wales) Act 2006, the National Health Service (Scotland) M4F18Act 1978F141, the Health and Personal Social Services (Northern Ireland) Order 1972 or the Health and Social Care (Reform) Act (Northern Ireland) 2009 shall be treated as the carrying on of a business by that Minister, the Secretary of State or that Ministry, as the case may be.

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Any reference in this Act to the holder of a F143... certificate shall be construed as a reference to the holder of a F143... certificate which is for the time being in force.

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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.

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.

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

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.

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

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.

F20Sections 16(1) and 17(2)(a) of the M6Interpretation 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.

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.

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 :

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.

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.

This Act may be cited as the Medicines Act 1968.

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

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).

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).