Medicines Act 1968

Type Public General Act
Publication 1968-10-25
Last updated 2025-10-01
State In force
Department Statute Law Database
articles Not indexed
Reform history JSON API

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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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

,

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

,

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

.

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

;

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 ;

,

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

(1A) In this Act ' non-medicinal poison' means a substance which is for the time being included in Part I or II of the Poisons Schedule 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 74 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.

23

In Schedule 2 in the proviso to paragraph 1, the word " or " at the end of paragraph (a) and paragraphs (b) and (c) shall cease to have effect, and in paragraph 3 after the words " Part II of this Act " there shall be inserted the words " or Part IV of the Medicines Act 1968 ".

The Pharmacy and Poisons Act (Northern Ireland) 1955 — 1955 c. 31 (N.I.)

24

In sections 1 and 3 there shall be made the amendments to sections 26A and 30 respectively of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 set out above.

25

Section 2 shall cease to have effect.

26

In section 12(1) for paragraphs (a) and (b) there shall be substituted the following words:—

the registrar shall remove from the register required to be kept under section 75 of the Medicines Act 1968 all premises entered in that register in respect of a business carried on by any body corporate of which that person is a director

.

27

Section 14 shall cease to have effect.

The Pharmacy Act (Northern Ireland) 1967 — 1967 c. 12 (N.I.)

28

Section 5 shall cease to have effect.

29

In Schedule 1—

  • (a) the entries amending sections 17 and 27 of the Pharmacy and Poisons Act (Northern Ireland) 1925 shall cease to have effect;
  • (b) the entry amending the proviso to section 14(2) of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 and the entries amending sections 15, 16, 17 and 18 of, and paragraph 1 of Schedule 2 to, that Act shall cease to have effect;
  • (c) in the entry substituting a new subsection for subsection (1) of section 12 of the Pharmacy and Poisons Act (Northern Ireland) 1955 there shall be made the amendment to the said section set out in paragraph 26 above.

The Increase of Fines Act (Northern Ireland) 1967 — 1967 c. 29 (N.l.)

30

In the Schedule—

  • (a) in the entry relating to section 10(2) of the Pharmacy and Poisons Act (Northern Ireland) 1925, for the words " Keeping open shop " there shall be substituted the words " Carrying on a retail pharmacy business ";
  • (b) the entries relating to sections 15(4) and 16(1A) of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 shall cease to have effect.

SCHEDULE 8

Ministers responsible for administration of Act.

41–42
49A

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

58A
  • (1) The ... Ministers shall, subject to subsection (4) of this section, so exercise their powers under section 58(1) of this Act as to secure that every product—
  • (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  • (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  • (c) to which subsection (2) of this section applies;

is specified as a prescription only medicine.

  • (2) This subsection applies to any product which—
  • (a) is likely to present a direct or indirect danger to human health, even when used correctly, if used without the supervision of a doctor or dentist; or
  • (b) is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health; or
  • (c) contains substances or preparations of substances of which the activity requires, or the side-effects require, further investigation; or
  • (d) is normally prescribed by a doctor or dentist for parenteral administration.
  • (3) In considering whether subsection (2) of this section applies to a product the ... Ministers shall take into account whether the product—
  • (a) contains a substance which is listed in any of Schedules I, II or IV to the Narcotic Drugs Convention (where the product is not a preparation listed in Schedule III to that Convention); or
  • (b) contains a substance which is listed in any of Schedules I to IV of the Psychotropic Substances Convention (where the pro duct is not a preparation which may be exempted from measures of control in accordance with paragraphs 2 and 3 of article 3 of that Convention); or
  • (c) is likely, if incorrectly used—
  • (i) to present a substantial risk of medicinal abuse, or
  • (ii) to lead to addiction, or
  • (iii) to be used for illegal purposes; or
  • (d) contains a substance which, by reason of its novelty or properties, might fall within paragraph (c) above, but as to which there is insufficient information available to determine whether it does so fall; or
  • (e) by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved for treatments which can only be followed in a hospital; or
  • (f) is used in the treatment of conditions which must be diagnosed in a hospital or in an institution with special diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or
  • (g) is intended for outpatients but may produce very serious sideeffects which would require a prescription drawn up as required by a specialist and special supervision throughout the treatment.
  • (4) Subsection (1) of this section shall not apply in relation to any product if the ... Ministers so determine having regard to—
  • (a) the maximum single dose;
  • (b) the maximum daily dose;
  • (c) the strength of the product;
  • (d) its pharmaceutical form;
  • (e) its packaging; or
  • (f) such other circumstances relating to its use as may be specified in the determination.
  • (5) In this section ...—

“the Narcotic Drugs Convention" means the Single Convention on Narcotic Drugs signed by the United Kingdom on 30th March 1961 as amended by the Protocol Amending the Single Convention on Narcotic Drugs signed by the United Kingdom on 25th March 1972 ; and

“the Psychotropic Substances Convention" means the Convention on Psychotropic Substances signed by the United Kingdom on 21st February 1971 .

58B

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

Business carried on by individual pharmacist or by partners.

Scope of Part VI.

New editions of British Pharmacopoeia, and other compendia.

Supplementary provisions as to Commission and committees.

115A

A drugs authority or the council of a non-metropolitan district may provide facilities for microbiological examinations of drugs.

Special provisions as to Northern Ireland.

Provisions as to manufacture and wholesale dealing.

2

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

14

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

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

Editorial notes

1

References to Ministers of Northern Ireland to be construed as references to heads of Northern Ireland departments: Northern Ireland Constitution Act 1973 (c. 36), Sch. 5 para. 7

2

Functions of Ministry of Home Affairs for Northern Ireland transferred to Department of Health and Social Services for Northern Ireland by S.R. & O. (N.I.) 1973 No. 504, art. 5, Sch. 2 Pt. I

3

Functions exercisable by Ministers jointly under this Act (except s. 108(4)(7) now exercisable by those Ministers and Secretary of State for Wales jointly: S.I. 1978/272, art. 2(3), Sch. 1; references to Minister of Agriculture, Fisheries and Food amended (W.): ibid., art. 11(6)

4

Act restricted by S.I. 1985/273, reg. 3(3)

6

Certain provisions of the Act extended and modified (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4

7

Act excluded in part (6.5.1998) by S.I. 1998/1046, reg. 43 Act excluded in part (6.5.1998) by S.I. 1998/1047, reg. 74 Act excluded in part (2.8.1999) by S.I. 1999/1871, reg. 92(1)

8

Act: functions transferred (27.12.1999) by S.I. 1999/3142, art. 2(1)(2) (with art. 4) Act: functions transferred (27.3.2002) by S.I. 2002/794, art. 3(1)(c)(2)(7) (with art. 6)

9

Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2

10

S. 1 extended (3.4.1992) by S.I. 1992/605, regs. 2(4), 3

11

Pt. I (ss. 1-5) modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3

12

Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

13

S. 10 amended (E.W.S.) (prosp) by 1954 c. 61, s. 13I(1)(b) (as inserted (prosp.) by 1997 c. 19, ss. 1, 2(1), Sch. para. 2)

14

Words in s. 10(1) inserted (S.) (1.4.2002) by 2001 asp 8, s. 79, Sch. 3 para. 5(a); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

15

Words added by S.I. 1971/1445, art. 3(a)

16

Words added by S.I. 1971/1445, art. 3(b)

17

S. 10(5)–(8) added by S.I. 1971/1445, art. 3(c)

18

S. 10(9) added (S.) (1.4.2002) by 2001 asp 8, ss. 79, Sch. 3 para. 5(b); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

19

Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403 , art. 3(1)

21

Ss. 57, 58, 61 extended by S.I. 1984/187, art. 2 S. 58 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch. 5

22

S. 58 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2) S. 58 modified (1.1.1995) by S.I. 1994/3144, reg. 9(10)

23

S. 58(1) restricted (1.1.1995) by S.I. 1994/3144, reg. 8(4)

24

Words in s. 58(4)(a) inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(2); S.I. 1994/2408, art. 2

25

S. 58(4A)-(4C) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(5); S.I. 2002/1095, art. 2(1)

26

Words in s. 58(5) inserted (3.10.1994) by Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), s. 1(3)(a); S.I. 1994/2408, art. 2

27

Words in s. 58(5) inserted (3.10.1994) by Medicinal Products: Prescripion by Nurses etc. Act 1992 (c. 28), s. 1(3)(b); S.I. 1994/2408, art. 2

28

S. 58A inserted (1.1.1993) by S.I. 1992/3271 , regs. 1(1) , 2

29

S. 58A extended (with modifications) (14.2.1994) by S.I. 1994/105 , reg. 19 , Sch. 4

30

S. 58A modified (1.1.1995) by S.I. 1994/3144 , reg. 9(4)(10) S. 58A applied (1.1.1995) by 1994/3142, reg. 18

31

The Convention, as amended by the Protocol, is published as Cmnd. 7466.

32

Cmnd. 7330.

33

S. 62 extended by S.I. 1984/187, art. 2

34

S. 62 extended with modifications by S.I. 1985/1403, art. 3(1) S. 62 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

35

S. 62 (1)(a), (2)–(7) extended by S.I.s 1982/425, art. 3, 1984/187, art. 2 and extended with modifications by S.I. 1985/1403, art. 3(1)

36

Ss. 63–65 extended by S.I. 1984/187, art. 2

37

S. 63 applied (1.1.1995) by S.I 1994/3142, reg. 18(2)

38

Ss. 63–65 extended by S.I. 1984/187 , art. 2

39

S. 67 extended by S.I.s 1982/425, art. 3, 1984/187, art. 2 and extended with modifications by S.I. 1985/1403, art. 3(1) S. 67 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2) S. 67 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch. 5

40

S. 67(1A)(1B) inserted (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(7)(a) (with ss. 64(9), 65(4)); S.I. 2002/1095, art. 2(1) (with transitional provisions in art. 3)

41

Part III (ss.51-68) modified (1.1.1995) by S.I. 1994/3144, reg. 9(9)

42

Definition in s. 69(3) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1 Pt.XII

43

Words in s. 72(1) substituted (S.) (1.4.2002) by 2000 asp 4, s. 88(2), Sch. 5 para. 12(a); S.S.I. 2001/81, art. 3, Sch. 2

44

Words in s. 72(3)(d)(4)(c) repealed (S.) (1.4.2002) by 2000 asp 4, s. 88(2)(3), Sch. 5 para. 12(b), Sch. 6; S.S.I. 2001/81, art. 3, Sch. 2

47

Words in s. 72(4) added (N.I.) (1.10.1991) by S.I. 1989/2405 (N.I. 19), art. 381, Sch. 9 Pt. II para. 24; S.R. 1991/411, art. 2

48

Words in s. 74(1) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1Pt. XII

49

S. 74(2)(4) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1 Pt. XII

50

Functions of Secretary of State in matters only affecting Wales exercisable by Secretary of State for Wales: S.I. 1969/388, art. 2(1)

51

S. 76(4) repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1Pt. XII

52

Words in s. 78 repealed (5.11.1993) by 1993 c. 50, s. 1(1), Sch. 1 Pt. XII

53

S. 80: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

54

S. 81: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

55

s. 82: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

56

S. 83: Power to amend conferred (15.3.2000) by 1999 c. 8, s. 60(1)(2)(4), Sch. 3 para. 2(3)(a); S.I. 2000/779, art. 2(1)

59

Pt. IV: Power to amend conferred (N.I.) (2.4.2001) by 2001 c. 3 (N.I.), s. 60, Sch. 4 para. 2(2); S.R. 2001/128, art. 2(4), Sch.

60

Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

61

Ss. 85–88, 91 extended by S.I. 1984/187, art. 2

62

Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

63

Ss. 85–88, 91 extended by S.I. 1984/187, art. 2

64

Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

65

Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

66

Pt. V (ss. 85–91) extended with modifications by S.I. 1985/1403, art. 3(1)

67

Ss. 85–88, 91 extended by S.I. 1984/187, art. 2

68

S. 91 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.

69

Criminal Justice Act 1982 (c. 48, SIF 39:1), ss. 38 (increase of fines) and 46 (substitution of references to levels on the standard scale) apply (E.W.) and Criminal Procedure (Scotland) Act 1975 (c. 21, SIF 39:1), ss. 289F, 289G (increase of fines and substitution of references to levels on the standard scale) apply (S.) and S.I. 1984/703 (N.I. 3), art. 5 (substitution of references to levels on the standard scale) and art. 6 (increase of fines) apply (N.I.)

71

Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

72

Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

73

Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

74

Commentary missing

75

Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

76

S. 107 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch. S. 107 extended (with modifications)(14.2.1994) by S.I. 1994/105, reg. 19, Sch.4 S. 107 applied (with modifications) (1.1.1995) by s.I. 1994/3144, reg.10, Sch. 4 S. 107 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

77

Power to modify s. 108(8)(W.) conferred by Local Government Act 1972 (c. 70), s. 200(3)

78

Functions of Secretary of State in matters only affecting Wales exercisable by Secretary of State for Wales: S.I. 1969/388, art. 2(1)

79

Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

80

Ss. 108-114 applied (with modifications) (1.7.1992) by S.I. 1992/1520, reg. 12.

81

Ss. 108-115 modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3 Ss. 108-115 applied (3.10.1994) by S.I 1994/2328, reg. 11(c)(ii)(aa)

82

S. 108 modified (30.1.1992) by S.I. 1992/32, reg. 12(1)(2) S. 108 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4 S. 108 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2) s. 108 extended (1.1.1995) by S.I. 1994/3142, reg. 18(7) S. 108 applied (with modifications) (1.1.1995) by S.I. 1994/3144, reg.10, Sch. 4 S. 108 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5 Ss. 108-110 applied (1.2.2000) by S.I. 2000/7, reg. 5

83

S. 108: Functions transferred (W.) (1.7.1999) by virtue of S.I. 1999/672, art. 2, Sch. 1

85

Words substituted by virtue of S.I. 1968/1699, arts. 2, 5(4)(a)

87

Pt. VIII (ss. 104–136) extended by S.I.s 1982/425, art. 3, 1984/187 art. 2; and extended with modifications by S.I. 1985/403, art. 3(1)

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