The MinistersF65... 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 this ActF41, 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 of the licensing authority under Part II of this Act or of a Minister under section 75 of this Act, and the validity of any licence or certificate granted or issued or other thing done in pursuance of any such decision, shall not be questioned in any legal proceedings.

Where a decision to grant a licence or certificate is quashed under this section, any licence or certificate granted in pursuance of that decision shall be void, and any proceedings on the application for the grant of the licence or 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 of Justice in Northern Ireland.

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.

Subsection (4) of this section applies to the following bodies, that is to say, the Pharmaceutical Society, any, F1drugs authority the council of any county district which is not a, F1drugs authority and the overseers of the Inner Temple and the Middle Temple.

Regulations made jointly by the Minister of Health and the Minister of Agriculture, Fisheries and Food may provide that, in respect of each area in England or Wales for which there is a food and drugs authority, the Pharmaceutical Society, or the food and drugs authority for that area, or both the Society and that authority, to such extent as, in the case of that Society or authority, the regulations may provide, shall have power concurrently with the appropriate Minister, or shall be under a duty concurrently with him, to enforce the provisions of sections 53 and 54 of this Act.

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

If the appropriate Minister is satisfied, after making such inquiry as he thinks fit, that the Pharmaceutical Society or any other body on whom a duty to enforce any provisions is imposed by or under subsections (4) to (8) of this section have in relation to any matter failed to perform that duty, and that the public interest requires that the provisions in question should be enforced in relation to it, he may determine that he will himself enforce those provisions in relation to that matter.

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 F8“ a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ”

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

Subject to the provisions of subsection (4) of this section, it shall be the duty of the Minister of Health and Social Services for Northern Ireland (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 paragraphs (a) and (b) of subsection (2) of section 108 of this Act in their application as mentioned in those paragraphs, and the provisions and regulations specified in paragraph (c) of that subsection, within the F9district of any F9district council, the Minister may make arrangements or give directions whereby the F9district 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 paragraphs (a) and (b) in their application as so mentioned and the provisions and regulations specified in the said paragraph (c).

For the purpose of performing that duty in relation to the provisions of sections 53 and 54 of this Act and any regulations made under section 66 of this Act within the F9district of any F9district council, the Minister may make arrangements or give directions whereby the F9district 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 those provisions and regulations.

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F10

In this section “ district council ” means a council established under the M3 Local Government Act (Northern Ireland) 1972.

Without prejudice to subsection (1) of this section, any person duly authorised in writing by the licensing authority shall, on production, if required, of his credentials, have a right at any reasonable time to enter any premises occupied by an applicant for a licence or certificate under Part II of this Act for the purpose of verifying any statement contained in the application for the licence or certificate.

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, aircraft, 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, commander or other person in charge of the ship, aircraft, 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.

In the application of this section to Scotland, references to a justice of the peace include references to the sheriff and a magistrate.

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.

Without prejudice to the preceding provisions of this section, any person duly authorised in writing by the licensing authority shall have the rights conferred by those provisions in relation to things belonging to, or any business carried on by, an applicant for a licence or certificate under Part II of this Act, and may exercise those rights for the purpose of verifying any statement contained in the application for the licence or certificate; and, where by virtue of this subsection a person exercises any such right as is specified in subsection (4) of this section, he shall be subject to the duty imposed by subsection (6) of this section.

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 (including that subsection as applied by subsection (7) of that section).

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, aircraft, 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, aircraft, vehicle, stall or place, the master, commander 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 F62 married or a civil partner) the spouse or civil partner of that person.

A person who, not being a person authorised in that behalf by an enforcement authority, has purchased a medicinal product may submit a sample of it for analysis to the public analyst for the area in which the product was purchased, or, if for the time being there is no public analyst for that area, then to the public analyst for some other area.

Paragraphs 2 to 13 of Schedule 3 to this Act shall have effect in relation to a person proposing to submit a sample in pursuance of the preceding subsection, as if in those paragraphs any reference to the sampling officer were a reference to that person.

Subject to the following provisions of this section, a public analyst to whom a sample is submitted under subsection (1) of this section shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

If the public analyst to whom a sample is submitted under subsection (1) of this section 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 (subject to the next following subsection) 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.

A public analyst to whom a sample is submitted or sent under this section may demand payment in advance of the prescribed fee, and, if he demands such payment, he shall not be required to analyse the sample or cause it to be analysed until the fee has been paid.

A public analyst who has analysed a sample or caused a sample to be analysed under this section shall issue a certificate specifying the result of the analysis to the person by whom the sample was originally submitted.

Any certificate issued under subsection (6) of this section shall be in a form prescribed by the Ministers and shall be signed by the public analyst who issues the certificate.

Paragraphs 21 to 23 of Schedule 3 to this Act shall have effect in relation to a certificate issued under subsection (6) of this section as they have effect in relation to a certificate issued under paragraph 19 of that Schedule.

Any regulations prescribing a fee for the purposes of this section shall be made by the Ministers.

In this section “public analyst” has the meaning assigned to it by paragraph 1(2) of Schedule 3 to this Act.

Any class of goods specified in an order under subsection (1) or subsection (2) of this section shall be so specified as to consist exclusively of goods appearing to the Ministers to be goods which are, or normally are, medicinal products F75....

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 63 to 65, F7785 to 89, and 93 to 96, and the provisions of any regulations made under any of those sections.

This section applies to the following provisions, that is to say, section 63(b), sections 64 and 65, sections 85 to 88 F78... 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 F15section 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 F16section 331 of the M4Criminal 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 F16subsection 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 F17section 34 of the M5Magistrates’ Courts Act (Northern Ireland) 1964F17Article 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 F18punishable 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 the Pharmaceutical Society nor any other body referred to in subsection (2) F79... 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 F80that subsection, that Society 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.

F19A 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 of Health and Social Services for Northern Ireland 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 Minister of Health and Social Services for Northern Ireland 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 F84... in his possession for the purpose of sale or supply, where it is proved that the medicinal product F84... 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 F85..., 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), subsections (3) and (5) of section 85, subsection (2) of section 87 and subsection (3) of section 88F86...

For the purposes of any proceedings under this Act for an offence consisting of a contravention of subsection (2) or subsection (3) of section 86 of this ActF87..., where it is proved that the leaflet 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 F88..., it shall be presumed, unless the contrary is proved, that he had the leaflet F89in his possession for the purpose of supplying it with a medicinal product

Any expenses incurred in consequence of this Act by any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act, other than expenses so incurred exclusively in respect of executing this Act in Northern Ireland, shall be defrayed out of moneys provided by Parliament.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F20

Where the Pharmaceutical Society 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) a Minister 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 Pharmaceutical Society 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 any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act, other than Ministers in the Government of Northern Ireland, 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 paragraph 1F90... or paragraph 6 of Schedule 4 to this Act or any regulations made solely by the Minister of Health and Social Services for Northern Ireland under section 120 of this Act) shall be exercisable by statutory instrument.

Any power to make an order under any provision, other than sections 16(1), 17, 25(1), 37(3), 52 and 69(3), of this Act shall include power to revoke or vary the order by a subsequent order made under that provision.

Any power to makeF63 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 theF64 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.

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

Without prejudice to subsection (6) of this section, where any Ministers propose to make any regulations or order under Part III, Part V or Part VI of this Act, or under section 104 or section 105 of this Act, and they consult a committee established under section 4 of this Act, 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.

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

For the purposes of this section, “human blood component” means any of the following constituents of human blood: red cells, white cells, platelets and plasma.

Where in accordance with the preceding provisions of this section a substance or article is a medicinal product immediately after it has been manufactured, imported or exported as mentioned in subsection (1) F98... of this section, or immediately after the first occasion on which it has been sold or supplied as mentioned in F99that subsection, then . . . F24 it shall not cease to be a medicinal product for the purposes of this Act by reason only that, at any subsequent time, it is sold, supplied, imported or exported for use wholly or mainly in a way other than those specified in F99that subsection .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F25

In this Act “ administer ” means administer to a human being F101..., 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 (F102...) a substance or article is a reference to administering (F102...) 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.

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 F110 the National Health Service Act 2006, the National Health Service (Wales) Act 2006, the National Health Service (Scotland) M6F26Act 1978 or the M7F27Health and Personal Social Services (Northern Ireland) Order 1972 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.

In this Act, except in so far as the context otherwise requires, the following expressions have the meanings hereby assigned to them respectively, that is to say:—

• F51“Advisory Body” has the meaning given to it by paragraph 1 of Schedule 1A to this Act;

• “analysis” includes micro-biological assay but no other form of biological assay, and “analyse” has a corresponding meaning;

• F108...

• F108...

• F108...

• “the appropriate committee” has the meaning assigned to it by section 4(6) of this Act;

• F108...

• “assemble”, in relation to a medicinal product, means enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or, where the product (with or without other medicinal products of the same description) is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied in it, and “assembly” has a corresponding meaning;

• “business” includes a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporate;

• F43...

• F44“the Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004;

• “the Commission” means the F52Commission for Human Medicines established under this Act;

• “composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are contained in it respectively;

• “container”, in relation to a medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle;

• “contravention” includes failure to comply and “contravene” has a corresponding meaning;

• “dentist” means a person registered in the dentists register under the F28Dentists Act 1984 F113...F113...F113...F113...;

• F29. . .

• F108...

• F30 “the 2001 Directive" means Directive 2001/83/ EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use F40 , as amended F58by—

  1. a

     Directive 2002/98/ EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components,

  2. b

     Commission Directive 2003/63/ EC amending Directive 2001/83/ EC on the Community code relating to medicinal products for human use,

  3. c

     Directive 2004/24/ EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/ EC on the Community code relating to medicinal products for human use; and

  4. d

     Directive 2004/27/ EC of the European Parliament and of the Council amending Directive 2001/83/ EC on the Community code relating to medicinal products for human use;

• “disease” includes any injury, ailment or adverse condition, whether of body or mind;

• F31 “ doctor ” means a registered medical practitioner person within the meaning of Schedule 1 to the Interpretation Act 1978

• F32 “ drugs authority ” has the meaning assigned to it by section 108(12) of this Act;

• F57 “ EEA State ” means a Member State, Norway, Iceland or Liechtenstein; and

• “enforcement authority” means any Minister or body on whom a duty or power to enforce any provisions of this Act or of any regulations or order made thereunder is imposed or conferred by or under sections 108 to 110 of this Act;

• F53“Expert Advisory Group” means an Expert Advisory Group established under paragraph 3 or 4 of Schedule 1A to this Act;

• “export” means export from the United Kingdom, whether by land, sea or air, and “import” has a corresponding meaning;

• “the first appointed day” has the meaning assigned to it by section 16(1) of this Act;

• F33 “ food and drugs authority ” has the meaning assigned to it for the purposes of the M8 Food and Drugs Act 1955 by F34 section 198 of the M9 Local Government Act 1972 ;

• “the Gazette” means the London, Edinburgh and Belfast Gazettes;

• “health centre” means a health centre maintained under F111 section 2 or 3 of the National Health Service Act 2006, section 2 or 3 of the National Health Service (Wales) Act 2006, F35section 36 of the M10National Health Service (Scotland) Act 1978 or F36Article 5 of the M11Health and Personal Social Services (Northern Ireland) Order 1972;

• F59“the Herbal Regulations” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005;

• “herbal remedy” means a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance;

• F108...

• F54“the Homoeopathic Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994

• “hospital” includes a clinic, nursing home or similar institution;

• “hover vehicle” means a vehicle designed to be supported on a cushion of air;

• F57 “import from a third country” means import from any country other than an EEA State ; and

• “ingredient”, in relation to the manufacture or preparation of a substance, includes anything which is the sole active ingredient of that substance as manufactured or prepared;

• “labelling”, in relation to a container or package of medicinal products, means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents, and “label” has a corresponding meaning;

• “leaflet” includes any written information;

• “the licensing authority” has the meaning assigned to it by section 6 of this Act;

• “licence of right” has the meaning assigned to it by section 25(4) of this Act;

• “manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it F107...;

• F55“the Marketing Authorisation Regulations” means the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;

• F106“the Ministers” shall be construed in accordance with section 1(1) of this Act;

• F108...

• “offence under this Act” includes an offence under any regulations or order made under this Act;

• “package”, in relation to any medicinal products, means any box, packet or other article in which one or more containers of the products are or are to be enclosed, and, where any such box, packet or other article is or is to be itself enclosed in one or more other boxes, packets or other articles, includes each of the boxes, packets or articles in question;

• “Pharmaceutical Society” in relation to Great Britain means the Pharmaceutical Society of Great Britain, and in relation to Northern Ireland means the Pharmaceutical Society of Northern Ireland;

• “pharmacist” in relation to Great Britain means a person registered in F109Part 1F112or 3 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007, and in relation to Northern Ireland (subject to any order made under paragraph 1 of Schedule 4 to this Act) means a person registered in the register of pharmaceutical chemists for Northern Ireland F114or the register of visiting pharmaceutical chemists from a relevant European State made out and maintained under F37Articles 6 and 9 of the M12Pharmacy (Northern Ireland) Order 1976;

• “plant” includes any part of a plant;

• F108...

• “practitioner" (except where that word occurs as part of the expression “veterinary practitioner") means a doctor, dentist, veterinary surgeon or veterinary practitioner;

• “prescribed” means prescribed by regulations under this Act;

• “product licence”, “manufacturer’s licence” and “wholesale dealer’s licence” have the meanings assigned to them by sections 7 and 8 of this Act;

• “registered pharmacy” has the meaning assigned to it by section 74 of this Act;

• “retail pharmacy business” means a business (not being a professional practice carried on by a practitioner) which consists of or includes the retail sale of medicinal products other than medicinal products on a general sale list (whether medicinal products on such a list are sold in the course of that business or not);

• “substance” means any natural or artificial substance, whether in solid or liquid form or in the form of a gas or vapour;

• “the time allowed", in Part II of, and Schedule 2 to, this Act has the meaning assigned to it by F56section 21(12) of this Act;

• “treatment”, in relation to disease, includes anything done or provided for alleviating the effects of the disease, whether it is done or provided by way of cure or not;

• F108...

• “veterinary practitioner” means a person registered in the supplementary veterinary register kept under section 8 of the M13Veterinary Surgeons Act 1966;

• “veterinary surgeon” means a person registered in the register of veterinary surgeons kept under section 2 of the M14Veterinary Surgeons Act 1966;

• “writing” includes any form of notation, whether by hand or by printing, typewriting or any similar process, and “written” has a corresponding meaning.

In this Act any reference to doing anything in accordance with a licence under Part II of this Act shall be construed as a reference to doing it in pursuance of such a licence and in compliance with any conditions and any limitations (whether as to area or otherwise) to which the licence is subject, and so as not to fall within any exceptions to which it is subjectF105...F45F105....

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

For the purposes of this Act medicinal products of any description shall be taken to be effectively on the market in the United Kingdom at a particular time if (but only if) during the whole of the period of one month ending with that time adequate stocks of medicinal products of that description were available, or could within a reasonable time be made available, for sale or supply to such persons in the United Kingdom as were likely to require them.

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.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F38

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.

F39Sections 16(1) and 17(2)(a) of the M16Interpretation 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.

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).