Medicines Act 1968

SCHEDULES

Section 5.

SCHEDULE 1 U.K. Provisions Relating to Medicines Commission and Committees

1 U.K. The Ministers may make provision by regulations with respect to any one or more of the following matters, that is to say—

(a) the terms on which members of the Commission or of committees established under section 4 of this Act shall hold and vacate office, including the terms on which any person appointed as chairman of the Commission or of such a committee shall hold and vacate office as chairman;

(b) the appointment by the Commission of one or more committees consisting wholly or partly of members of the Commission, and the appointment by the Commission of a chairman in respect of each committee so appointed;

(c) the appointment by any committee established under section 4 of this Act, or the appointment jointly by two or more such committees, of one or more sub-committees consisting wholly or partly of members of that committee or those committees, as the case may be, and the appointment by that committee or by those committees, as the case may require, of a chairman in respect of each sub-committee so appointed;

(d) the terms on which members of any such sub-committee shall hold and vacate office, including the terms on which any person appointed as chairman of such a sub-committee shall hold and vacate office as chairman.

2 U.K. The Ministers shall provide the Commission and each committee established under section 4 or appointed under section 60 of this Act with such staff and such accommodation, services and other facilities as appear to the Ministers to be necessary or expedient for the proper performance of their functions.

3 U.K. The validity of any proceedings of the Commission or of any such committee or sub-committee as is mentioned in any of the preceding paragraphs shall not be affected by a vacancy among the members of the Commission, committee or sub-committee or of any defect in the appointment of any member of the Commission, committee or sub-committee.

4 U.K. The Commission and any such committee or sub-committee shall have power to regulate their procedure, including power to determine the quorum at their meetings.

5 U.K. The Ministers may pay to the members of the Commission and of any such committee or sub-committee such remuneration (if any) and such allowances as may be determined by the Ministers with the consent of the Treasury.

6 U.K. The Ministers shall defray any expenses incurred with their approval by the Commission or by any such committee or subcommittee as is mentioned in any of the preceding paragraphs.

7 U.K. Neither the Commission nor any such committee or sub-committee shall be taken to be the servant or agent of the Crown or to enjoy any status or immunity of the Crown.

Section 29.

SCHEDULE 2 U.K. Suspension, Revocation or Variation of Licence

Modifications etc. (not altering text)

C1 Sch. 2 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.

Sch. 2 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

Consultation with appropriate committee or Commission U.K.

1 U.K. Except as provided by paragraph 11 of this Schedule, where the licensing authority propose, in the exercise of their powers under section 28 of this Act,—

(a) to suspend, revoke or vary a product licence on the grounds specified in paragraph (a) or paragraph (c) of subsection (3) of that section, in a case where it appears to the licensing authority that the matters or characteristics in question are such as to affect the safety, efficacy or quality of medicinal products of a description to which the licence relates, or

(b) to suspend, revoke or vary a product licence on any of the grounds specified in paragraph (g) or paragraph (h) of that subsection,

the licensing authority shall not suspend, revoke or vary the licence except after consultation with the appropriate committee or, if for the time being there is no such committee, with the Commission.

2 U.K. Where the appropriate committee or the Commission are consulted under the preceding paragraph, and on any such grounds as are mentioned in that paragraph they have reason to think that they may have to advise the licensing authority that the product licence ought to be suspended, revoked or varied, the committee or Commission shall notify the holder of the licence accordingly, and, before giving any such advice to the licensing authority, shall afford to him an opportunity of appearing before and being heard by them, or of making representations in writing to them with respect to those grounds.

3 U.K. Where the holder of the licence has availed himself of the opportunity of being heard under paragraph 2 of this Schedule, or after considering any representations made by him under that paragraph, the appropriate committee or the Commission, as the case may be, shall report to the licensing authority their findings and advice and the reasons for their advice, and the licensing authority shall take that report into account in making their decision.

4 U.K. Whether the holder of the licence has been heard or has made representations under paragraph 2 of this Schedule or not, if the appropriate committee or the Commisssion advise the licensing authority that the licence ought on any such grounds as are mentioned in paragraph 1 of this Schedule to be suspended or revoked, or to be varied so as to contain provisions specified in their advice, the licensing authority shall serve notice on the holder of the licence stating the advice so given to the authority and the reasons stated by the appropriate committee or the Commission for giving that advice.

5 U.K. If, within the time allowed after the service of a notice under paragraph 4 of this Schedule, in a case where the holder of the licence has not been heard by, or made representations to, the Commission under paragraph 2 of this Schedule, the holder of the licence gives notice to the licensing authority of his desire to be heard with respect to the advice given to the authority, or makes representations in writing to the licensing authority with respect to that advice, then, before determining the matter,—

(a) if the holder of the licence has given notice of his desire to be heard, the licensing authority shall arrange for him to have an opportunity of appearing before and being heard by the Commission, or

(b) if he has made representations in writing, the licensing authority shall refer those representations to the Commission,

and, where the holder of the licence has availed himself of the opportunity of being heard, or after considering the representations, as the case may be, the Commission shall report to the licensing authority their findings and advice and the reasons for their advice, and the licensing authority shall take that report into account in making their decision.

6 U.K. If the licensing authority—

(a) propose to determine the matter in a way which differs from the advice of the Commission under paragraph 3 or paragraph 5 of this Schedule, or

(b) where there has been no hearing before, and no representations have been made or referred to, the Commission, propose to determine the matter in a way which differs from the advice of the appropriate committee under paragraph 3 of this Schedule, or

(c) in the absence of any such advice as is mentioned in either of the preceding sub-paragraphs, propose to determine the matter in a way which differs from the advice given by the appropriate committee or the Commission, or

(d) propose to suspend, revoke or vary the licence on grounds not relating to safety, quality or efficacy,

the licensing authority shall notify the holder of the licence accordingly, and, before determining the matter, shall afford to him an opportunity of appearing before, and being heard by, a person appointed for the purpose by the licensing authority, or of making representations in writing to the licensing authority with respect to that proposal.

7 U.K. Any notification given to the holder of the licence under paragraph 6 of this Schedule—

(a) in a case falling within sub-paragraph (a) or sub-paragraph (b) of that paragraph, shall state the advice of the Commission or the appropriate committee and the reasons stated by the Commission or the committee for giving that advice, or

(b) in a case falling within sub-paragraph (c) of that paragraph, shall state the advice given by the appropriate committee or the Commission and the reasons stated by the committee or the Commission for giving that advice,

and in a case falling within sub-paragraph (d) of that paragraph (whether it also falls within any of the other sub-paragraphs of that paragraph or not) the notification shall include a statement of the proposals of the licensing authority and of the reasons for them.

Notification of proposals to holder of licence in other cases U.K.

8 U.K. Except as provided by paragraph 11 of this Schedule, where the licensing authority propose, in the exercise of the powers conferred by section 28 of this Act,—

(a) to suspend, revoke or vary a licence under Part II of this Act, other than a product licence, or

(b) to suspend, revoke or vary a product licence where no notice of that proposal, or of any advice, or grounds for giving advice, which led to that proposal, has been given to the holder of the licence under paragraph 2, paragraph 4 or paragraph 6 of this Schedule,

the licensing authority shall serve on the holder of the licence a notice stating their proposals and the reasons for them and the date (not being earlier than twenty-eight days from the date of service of the notice) on which it is proposed that the suspension, revocation or variation should take effect.

9 U.K. If, before the date specified in a notice under paragraph 8 of this Schedule, the holder of the licence gives notice to the licensing authority of his desire to be heard under this paragraph, or makes representations in writing to the licensing authority with respect to their proposals, then, before determining the matter, the licensing authority shall afford to him an opportunity of appearing before, and being heard by a person appointed for the purpose by the licensing authority, or shall take those representations into account, as the case may be.

Procedure in case of urgency U.K.

10 U.K. The following provisions of this Schedule shall have effect where it appears to the licensing authority that in the interests of safety it is necessary to suspend a licence under Part II of this Act with immediate effect.

11 U.K. In the circumstances specified in paragraph 10 of this Schedule, the licensing authority may, notwithstanding anything in paragraphs 1 to 9 of this Schedule, suspend the licence with immediate effect for a period not exceeding three months.

12 U.K. If the licence is a product licence, the licensing authority shall report the suspension forthwith to the appropriate committee or, if for the time being there is no such committee, to the Commission.

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

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

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

Provisions as to hearings U.K.

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

SCHEDULE 3 U.K. SAMPLING

Modifications etc. (not altering text)

C2 Sch. 3 modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3

Sch. 3 applied (3.10.1994) by S.I. 1994/2328, reg. 11(c)

Sch. 3 applied (with modifications) (1.1.1995) by S.I. 1994/3144, reg.10, Sch. 4

Sch. 3 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

Sch. 3 applied (1.2.2000) by S.I. 2000/7, reg. 5

Introductory U.K.

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

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

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

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

(2) In this Schedule “public analyst”, [F1 except in relation to Northern Ireland, has the meaning assigned to it by section 27 of the Food Safety Act 1990], and in relation to Northern Ireland has the meaning assigned to it by [F2 Article 27(1) of the Food Safety (Northern Ireland) Order 1991].

Textual Amendments

F1 Words in Sch. 3 para. 1(2) substituted (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(1), Sch. 3 para. 12

F2 Words in Sch. 3 para. 1(2) substituted (N.I.) (21.5.1991) by S.I. 1991/762, art. 51(1), Sch. 2 para.10; S.R. 1991/175, art. 2(1).

Division of sample U.K.

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

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

4 U.K. If the sampling officer obtained the sample from an automatic machine, then—

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

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

5 U.K. If the sample is of goods consigned from outside the United Kingdom and was taken by the sampling officer before delivery to the consignee, the sampling officer shall supply one part of the sample to the consignee.

6 U.K. If, in a case not falling within any of paragraphs 3 to 5 of this Schedule, the sample was obtained by the sampling officer at the request or with the consent of a purchaser, the sampling officer shall supply one part of the sample to the seller.

7 U.K. If, in a case not falling within any of paragraphs 3 to 6 of this Schedule, the sample was taken in transit, the sampling officer shall supply one part of the sample to the consignor.

8 U.K. In any case not falling within any of paragraphs 3 to 7 of this Schedule the sampling officer shall supply one part of the sample to the person appearing to him to be the owner of the substance or article from which the sample was taken.

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

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

(a) retain one part for future comparison, and

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

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

(a) is not reasonably practicable, or

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

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

12 U.K. 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 U.K. 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 U.K.

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— U.K.

(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 U.K.

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

(a) if they relate exclusively to the examination or analysis of veterinary drugs and are made by an enforcement authority in England and Wales other than the Minister of Agriculture, Fisheries and Food, shall be arrangements approved by that Minister;

(b) if in any other case they are made by an enforcement authority in England and Wales other than [F3 the Secretary of State], shall be arrangements approved by [F3 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 a [F4 district council] in Northern Ireland, shall be arrangements approved by the Minister of Health and Social Services for Northern Ireland.

Textual Amendments

F3 Words substituted by virtue of S.I. 1968/1699, arts. 2, 5(4)(a)

F4 Words substituted by S.R. &O. (N.I.) 1973 No. 211, Sch.

Modifications etc. (not altering text)

C3 Functions of Secretary of State in matters only affecting Wales exercisable by Secretary of State for Wales: S.I. 1969/388, art. 2(1)

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. U.K.

(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. U.K.

(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. U.K.

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

Provisions as to evidence U.K.

21 U.K. 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 U.K. 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. U.K.

(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 U.K.

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— U.K.

(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 U.K. 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 U.K.

26 U.K. In relation to England and Wales section 9 of the M1 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.

Marginal Citations

M1 1967 c. 80.

Power to modify sampling provisions U.K.

27 U.K. 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 U.K.

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. U.K.

(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.

(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 U.K.

29 U.K. 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"

Section 134.

SCHEDULE 4 U.K. Provisions relating to Northern Ireland

Modifications etc. (not altering text)

C4 Sch. 4 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

C5 Paras. 6, 8, 11 extended by Medicines Act 1971 (c. 69), s. 1(3)(c)

1 (1) The Minister of Health and Social Services for Northern Ireland 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. U.K.

(2) In this paragraph “druggist” means a person registered in the register of druggists for Northern Ireland made out and maintained under [F5 Articles 6 and 9 of the M2 Pharmacy (Northern Ireland) Order 1976].

Textual Amendments

F5 Words substituted by S.I. 1976/1213 (N.I. 22), Sch. 5 para. 8

Marginal Citations

M2 S.I. 1976/1213 (N.I. 22)

2 U.K. Where the Minister of Agriculture for Northern Ireland is of the opinion that there are special circumstances which render it expedient that any description or class of veterinary drugs which is proposed to be specified or designated by an order under section 51 of this Act should not be so specified or designated in relation to Northern Ireland, an order under that section may specify or designate that description or class of veterinary drugs for the purposes of the application of this Act in Great Britain but not in Northern Ireland.

3 U.K. A product licence, in so far as it is applicable to veterinary drugs of any description, or contains provisions relating to the incorporation of substances or articles in animal feeding stuffs, or an animal test certificate, except where it is issued by the Minister of Agriculture for Northern Ireland (whether acting with or without any one or more than one of the other Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act), shall not authorise the doing of anything in or in relation to Northern Ireland except to the extent (if any) to which the licence or certificate is expressed to do so.

4 U.K. Notwithstanding anything contained in section 28(3) or section 39(2) of this Act, the powers conferred by sections 28 and 30 and by section 39 of this Act to vary the provisions of a product licence and an animal test certificate respectively shall include power for the Minister of Agriculture for Northern Ireland (whether acting with or without any one or more than one of the other Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act) to extend to Northern Ireland any product licence or, as the case may be, any animal test certificate, or any provision of such a licence or certificate, which by virtue of paragraph 3 of this Schedule does not extend to Northern Ireland.

5 U.K. Where by virtue of paragraph 3 of this Schedule a product licence or animal test certificate, in so far as it is applicable to veterinary drugs of any description or contains provisions relating to the incorporation of substances or articles in animal feeding stuffs, does not extend to Northern Ireland, the Minister of Agriculture for Northern Ireland may by order prohibit (subject to such exceptions as may be provided for by or under the order) any person from landing in Northern Ireland, or having in his possession in Northern Ireland, a veterinary drug of that description or any animal feeding stuffs in which a substance or article to which those provisions relate has been incorporated, and may by the order provide for the imposition of penalties, not exceeding on summary conviction a fine of [F6 level 5 on the standard scale], for contravention of any provision of the order.

Textual Amendments

F6 Words substituted by virtue of (E.W.) Criminal Justice Act 1982 (c. 48, SIF 39:1), ss. 38, 46 and (S.) Criminal Procedure (Scotland) Act 1975 (c.21, SIF 39:1), ss. 289F, 289G and (N.I.) S.I. 1984/703 (N.I. 3), arts. 5, 6

6 U.K. The appropriate Northern Ireland Minister or Ministers may in relation to Northern Ireland exercise any power of making an order or regulations which is conferred on the appropriate Ministers by any provision of this Act (except a provision contained in section 15(3), section 35, . . . F7 or section 57(3) of this Act) where in his or their opinion there are special circumstances which render it expedient to do so.

Textual Amendments

F7 Words repealed by Animal Health and Welfare Act 1984 (c. 40, SIF 2:8), s. 16, Sch. 1 para. 3(11), Sch. 2

7 U.K. Where an order is made by virtue of paragraph 6 of this Schedule prohibiting or restricting the sale, supply or administration in, or the importation into, Northern Ireland of veterinary drugs of any description or class or any particular veterinary drugs or animal feeding stuffs in which medicinal products of any description or class have been incorporated or any particular animal feeding stuffs in which medicinal products have been incorporated, the order may also contain provisions for prohibiting (subject to such exceptions as may be provided for by or under the order) any person from landing in Northern Ireland or having in his possession in Northern Ireland any veterinary drug, or animal feeding stuffs containing medicinal products, of that description or class or, as the case may require, any such particular veterinary drugs or animal feeding stuffs.

8 U.K. Every order or regulation under this Act made by the Minister of Health and Social Services for Northern Ireland, or the Minister of Agriculture for Northern Ireland, or both those Ministers, by virtue of the power conferred by paragraph 1, paragraph 5 or paragraph 6 of this Schedule, and every regulation made solely by the Minister of Health and Social Services for Northern Ireland under section 120 of this Act, shall be subject to negative resolution within the meaning of section 41(6) of the M3 Interpretation Act (Northern Ireland) 1954 as if it were a statutory instrument within the meaning of that Act.

Marginal Citations

M3 1954 c. 33 (N.I.)

9 U.K. In this Schedule “the appropriate Northern Ireland Minister or Ministers”—

(a) for the purpose of making any order or regulations relating exclusively to matters other than veterinary drugs and the treatment of diseases of animals, means the Minister of Health and Social Services for Northern Ireland;

(b) for the purpose of making any order containing provisions such as are mentioned in paragraph 7 of this Schedule, means the Minister of Agriculture for Northern Ireland; and

(c) in any other case, means the Minister of Health and Social Services for Northern Ireland and the Minister of Agriculture for Northern Ireland acting jointly,

and “landing”, in relation to any medicinal product or any feeding stuffs, means landing it or them from a vessel, aircraft or vehicle or otherwise introducing it or them into Northern Ireland.

10 U.K. In this Act any reference to the Minister of Health and Social Services for Northern Ireland or to the Minister of Agriculture for Northern Ireland, and any reference which is to be construed as including a reference to either or both of those Ministers, shall include a reference to the Ministry of Health and Social Services for Northern Ireland or, as the case may require, the Ministry of Agriculture for Northern Ireland, or both those Ministries.

11 U.K. [F8 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 [F8 under that Order]), shall not apply to any orders or regulations made under this Act by statutory instrument.

Textual Amendments

F8 Words substituted by S.I. 1979/1573, Sch. 4 para. 10

Section 135(1)

SCHEDULE 5 U.K. Amendments of Enactments of Parliament of United Kingdom.

The Venereal Disease Act 1917 (c. 21). U.K.

1 In the proviso to section 2 (restriction on advertisments relating to treatment for venereal disease), for the words “announcement, recommendation, or holding out" there shall be substituted the words “or announcement".

Modifications etc. (not altering text)

C6 The text of Sch. 5 paras. 1, 10, 13, 16, 7, Schs. 6, 8 is in the form in which it was originally enacted: it was not reproduced in Statutes in Force and does not reflect any amendments or repeals which may have been made prior to 1.2.1991.

2, 9. U.K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F9

Textual Amendments

F9 Sch. 5 paras. 2–9 repealed by Poisons Act 1972 (c. 66), Sch. 2

The Cancer Act 1939 (c. 13.) U.K.

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".

Modifications etc. (not altering text)

C7 The text of Sch. 5 paras. 1, 10, 13, 16, 7, Schs. 6, 8 is in the form in which it was originally enacted: it was not reproduced in Statutes in Force and does not reflect any amendments or repeals which may have been made prior to 1.2.1991.

11 U.K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F10

Textual Amendments

F10 Sch. 5 para. 11 repealed by National Health Service Act 1977 (c. 49), Sch. 16

12 U.K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F11

Textual Amendments

F11 Sch. 5 para. 12 repealed by National Health Service (Scotland) Act 1978 (c. 29), Sch. 17

The Purchase Tax Act 1963 (c. 9). U.K.

13 In Part II of Schedule 1, in paragraph 5(1)(a)(i), 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".

Modifications etc. (not altering text)

C8 The text of Sch. 5 paras. 1, 10, 13, 16, 7, Schs. 6, 8 is in the form in which it was originally enacted: it was not reproduced in Statutes in Force and does not reflect any amendments or repeals which may have been made prior to 1.2.1991.

14, 15. U.K. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F12

Textual Amendments

F12 Sch. 5 paras. 14, 15 repealed by Misuse of Drugs Act 1971 (c. 38), Sch. 6

The Trade Descriptions Act 1968 (c. 29). U.K.

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.”

Modifications etc. (not altering text)

C9 The text of Sch. 5 paras. 1, 10, 13, 16, 7, Schs. 6, 8 is in the form in which it was originally enacted: it was not reproduced in Statutes in Force and does not reflect any amendments or repeals which may have been made prior to 1.2.1991.

[F13 17 U.K. In section 22, in subsection (2), after the words “the Food and Drugs Act (Northern Ireland) 1958 M4 " 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,”

at the end of the subsection there shall be inserted the words “or paragraph 27 of Schedule 3 to the said Act of 1968".]

Textual Amendments

F13 Sch. 5 para. 17 repealed (E.W.S.) by Food Safety Act 1990 (c. 16, SIF 53:1, 2), ss. 54, 59(4), Sch. 5

Marginal Citations

M4 1958 c. 27 (N.I.)

Section 135(2)

SCHEDULE 6 U.K. Enactments of Parliament of United Kingdom Repealed.

Modifications etc. (not altering text)

C10 The text of Sch. 6 is in the form in which it was originally enacted: it was not reproduced in Statutes in Force and does not reflect any amendments or repeals which may have been made prior to 1.2.1991

F14 F14 SCHEDULE 7 U.K.

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

Textual Amendments

F14 Sch. 7 repealed by S.I. 1976/1213 (N.I. 22), Sch. 6 and 1976/1214 (N.I. 23), Sch. 3

Section 135(4)

SCHEDULE 8 U.K. Enactments of Parliament of Northern Ireland Repealed.

Modifications etc. (not altering text)

C11 The text of Sch. 8 is in the form in which it was originally enacted: it was not reproduced in Statutes in Force and does not reflect any amendments or repeals which may have been made prior to 1.2.1991