MEDICINES ORDINANCE

FALKLAND ISLANDS

_____________

Medicines Ordinance 2006

(ORDINANCE No. 13 OF 2006)

ARRANGEMENT OF PROVISIONS

Section

PART 1
PRELIMINARY

Introductory

Section

1. Short title, commencement and application

2. Interpretation: general

3. "Retail sale" and related expressions

4. Regulations: general

PART 2
DEALINGS WITH MEDICINAL PRODUCTS

5. Principles

6. Restrictions on dealing with medicinal products

7. Exemptions

8. General sale of medicinal products

9. Medicinal products on prescription only

10. Regulations under Part 2

11. Application to veterinary medicinal products

PART 3
CONSUMER PROTECTION

12. Adulteration of medicinal products

13. Protection of purchasers of medicinal products

14. Compliance with published standards

15. Misleading descriptions etc

16. Display of information on automatic machines

17. Offences

18. Application to veterinary medicinal products

PART 4
PHARMACIES

19. Register of pharmacies

20. Regulations as to premises

21. Restrictions on use of titles, descriptions and emblems

22. Modification etc of restrictions under section 21

PART 5
POISONS

23. Poisons list

24. Regulation of sale of poisons

25. Exclusion of sales by wholesale and certain other sales

26. Official list of persons entitled to sell certain poisons

27. Supplementary provisions as to official list

28. Poisons rules

29. Offences

PART 6
ENFORCEMENT

30. Enforcement etc

31. Rights of entry

32. Power to inspect, take samples and seize goods and records

33. Application of sampling procedure to substance or article seized under section 32

34. Obstruction etc

35. Analysis of samples in other cases

36. Liability to forfeiture

37. Restrictions on disclosure of information

38. Contravention due to default of other person

39. Warranty as defence

40. Offences in relation to warranties and certificates of analysis

41. Offences by bodies corporate

42. Presumptions

43. Veterinary medicinal products and animal feeding stuffs

PART 7
SUPPLEMENTAL

44. Registration of health professions

45. Medicated animal feeding stuffs

46. Extension of application of Ordinance

47. References to specified publications

Schedule 1 Analysis of samples

Schedule 2 . . .

FALKLAND ISLANDS

_____________

Medicines Ordinance 2006

AN ORDINANCE To make new provision for regulating the import, manufacture, sale and supply of and other dealings with medicinal products and veterinary medicinal products, and the sale and supply of non-medicinal poisons; to amend the Medical Practitioners, Midwives and Dentists Ordinance; and for connected purposes.

[DATE OF COMMENCEMENT: IN ACCORDANCE WITH SECTION 1]

PART 1
PRELIMINARY

[Ord49.6s1]1 Short title, commencement and application

(1) This Ordinance may be cited as the Medicines Ordinance 2006.

[Revision w.e.f. 31/07/2017]

(2) This Ordinance shall come into force on a date or dates to be appointed by the Governor by Notice published in the Gazette, and different dates may be so appointed by one or more such Notices for different provisions and different purposes.

(3) Nothing in this Ordinance applies to the prescription or supply of any medicinal product or veterinary medicinal product by any person acting in the course of his duty as a member of the armed forces of Her Majesty.

[Ord49.6s2]2 Interpretation: general

(1) In this Ordinance -

"advertisement" has the meaning given by subsection (3);

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

"animal" includes any bird, fish or reptile;

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

"authorised person" means -

(a) the Chief Medical Officer, or

(b) an inspector appointed under section 30(2);

"board" (in relation to a body corporate) means the body of persons controlling the body corporate, by whatever name called;

"business" includes a professional practice and any activity carried on by a body of persons, whether corporate or unincorporated;

"Community authorisation" means a marketing authorisation granted under the EC Regulation;

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

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

"contravention" includes failure to comply, and "contravene" has a corresponding meaning;

"dentist" means a person for the time being entered in the register of dentists kept under the Health Professions Ordinance;

"disease" includes any injury, ailment or adverse condition, whether of body or mind;

"doctor" means a person for the time being entered in the register of medical practitioners kept under the Health Professions Ordinance;

"the EC code" means Directive 2001/83/EC on the Community code relating to medicinal products for human use;

"the EC Regulation" (subject to subsection (7)) means Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

"the EC veterinary code" means Directive 2001/82/EC on the Community code relating to veterinary medicinal products;

"hospital" includes a clinic, nursing home or similar institution;

"ingredient" (in relation to the manufacturer or preparation of a substance) includes anything which is the sole active ingredient of that substance as manufactured or prepared;

"label" (in relation to a container or package of a medicinal product or veterinary medicinal product) means a notice describing or otherwise relating to the contents and affixed to or otherwise displayed on the container or package, and "labelling" has a corresponding meaning;

"manufacture" (in relation to a medicinal product or veterinary medicinal product) includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it and does not include the incorporation of the product in any animal feeding stuff;

"manufacturer's licence" means a manufacturer's licence granted in the United Kingdom under section 8(2) of the UK Act;

"medicinal product" means -

(a) any substance or combination of substances presented for treating or preventing disease in human beings; or

(b) any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings.

"medicinal product (or veterinary medicinal product) on general sale" means a medicinal product (or veterinary medicinal product) other than one to which section 8 applies;

"midwife" means a person for the time being entered in the register of midwives kept under the Health Professions Ordinance;

"non-medicinal poison" means a substance which is included in Part I or Part II of the poisons list and is neither -

(a) a medicinal product or veterinary medicinal product; nor

(b) a substance in relation to which, by virtue of regulations under section 44 (and whether, in the case of regulations under section 44(1), it is referred to in the regulations as a substance or as an article), sections 6, 7 and 19 to 22 (whether subject to exceptions and modifications or not and with or without other provisions of this Ordinance) have effect as they have effect in relation to medicinal products or veterinary medicinal products;

"offence under this Ordinance" includes an offence under any regulations made under this Ordinance;

"official analyst" means an analyst approved in writing by the Governor;

"the official list" means the list kept under section 26(1);

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

"pharmacist" means a person for the time being registered in the register of pharmacists kept under the Health Professions Ordinance;

"the poisons list" means the poisons list having effect in the Falkland Islands by virtue of section 23;

"the poisons rules" means the rules mentioned in section 28, as they have effect in the Falkland Islands by virtue of regulations under that section;

"practitioner" means -

(a) in relation to medicinal products -

(i) a doctor,

(ii) a dentist,

(iii) a nurse or midwife holding prescribed qualifications or fulfilling prescribed conditions, or

(iv) any other person holding prescribed qualifications or fulfilling prescribed conditions;

(b) in relation to veterinary medicinal products -

(i) a veterinary surgeon,

(ii) a veterinary practitioner, or

(iii) any other person holding prescribed qualifications or fulfilling prescribed conditions;

"prescribed", except in Part 5, means prescribed by regulations under this Ordinance, and in Part 5 means prescribed by the poisons rules;

"product licence" means a product licence granted in the United Kingdom under section 7 of the UK Act;

"the register" (except in relation to a register kept under the Health Professions Ordinance) means the register kept under section 19;

"nurse" means a person for the time being entered in the register kept under the Health Professions Ordinance;

"registered pharmacy" means premises in respect of which a person is for the time being entered in the register;

"requirement" includes a restriction;

"retail sale" (or selling by retail) has the meaning given by section 3;

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

"supply in circumstances corresponding to retail sale" has the meaning given by section 3;

"treat" (in relation to disease) includes doing or providing anything for alleviating the effects of the disease, whether it is done or provided by way of cure or not, and "treatment" has a corresponding meaning;

"the UK Act" means the Medicines Act 1968 (an Act of Parliament);

"UK authorisation", in relation to medicinal products, means -

(a) a marketing authorisation granted in the United Kingdom under the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994;

(b) a certificate granted in the United Kingdom under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

(d) a manufacturer's licence;

(e) a clinical trial certificate issued in the United Kingdom under section 31 of the UK Act;

"UK authorisation", in relation to veterinary medicinal products, means -

(a) a marketing authorisation granted in the United Kingdom under the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994;

(b) a product licence;

(d) an animal test certificate issued in the United Kingdom under section 32 of the UK Act;

"UK medicines legislation" means -

(a) any provision of the UK Act,

(b) any provision of any Act of Parliament, or of any statutory instrument, amending, varying, modifying or replacing the UK Act, whether directly or indirectly;

(d) any statutory instrument made under the European Communities Act 1972 (an Act of Parliament) and giving effect to any provision of -

(i) the EC code,

(ii) the EC veterinary code,

(iii) the EC Regulation, or

(iv) any European Community legislation from time to time amending or replacing any of the instruments mentioned in sub-paragraphs (i), (ii) and (iii);

"veterinary medicinal product" means -

(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals; or

(b) any substance or combination of substances that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

"veterinary practitioner" means a person registered in the supplementary veterinary register kept under section 8 of the Veterinary Surgeons Act 1966 (an Act of Parliament) or any equivalent register maintained under a corresponding law in force in Australia or New Zealand; and

"veterinary surgeon" means a person registered in the register of veterinary surgeons kept under section 2 of the said Act of 1966 or any equivalent register maintained under a corresponding law in force in Australia or New Zealand.

(2) The Governor may by regulations amend the definitions of "Community authorisation", "UK authorisation", "veterinary practitioner" and "veterinary surgeon" in subsection (1).

(3) Subject to subsections (4) and (5), in this Ordinance "advertisement" includes every form of advertising, whether -

(a) in a publication, or

(b) by the display of any notice, or

(c) by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other document, or

(d) by words inscribed on any article, or

(e) by means of a photograph, film, sound recording or broadcast, or

(f) in any other way,

and any reference to issuing an advertisement shall be construed accordingly.

(4) "Advertisement" does not include spoken words except words forming part of a sound recording or broadcast.

(5) In subsections (3) and (4) "film", "sound recording" and "broadcast" have the same meanings as in Part I of the Copyright, Designs and Patents Act 1988 (an Act of Parliament).

(6) References in this Ordinance to any legislation of the United Kingdom or the European Community are to that legislation as it may from time to time be amended or replaced.

[Ord49.6s3]3 Retail sale and related expressions

(1) In this Ordinance any reference to selling by retail, or to retail sale, is a reference to selling a substance or article to a person as being a person who buys it for a purpose other than that of -

(a) selling or supplying it; or

(b) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

(2) In this Ordinance any reference to supplying anything in circumstances corresponding to retail sale is a reference to supplying it, otherwise than by way of sale, to a person as being a person who receives it for such a purpose as is mentioned in subsection (1).

(3) For the purposes of this section the provision of services by or on behalf of a public body or public officer shall be treated as the carrying on of a business by that body or officer.

[Ord49.6s4]4 Regulations: general

(1) The Governor may by regulations prescribe anything which is to be prescribed under or for purposes of this Ordinance.

(2) Before making any regulations under this Ordinance the Governor shall consult the Chief Medical Officer and such other person or persons, if any, as the Governor thinks fit.

(3) Regulations under this Ordinance shall be subject to the approval of the Legislative Assembly.

[Revision w.e.f. 31/07/2017]

(4) Regulations under this Ordinance -

(a) may for the purposes of the regulations apply any UK medicines legislation to the Falkland Islands as part of the law of the Falkland Islands, subject to such exceptions, adaptations and modifications as may be specified in the regulations; and

(b) may so apply any order or regulations made under the UK Act which may from time to time be in force in the United Kingdom (that is, any such order or regulations made after as well as before the making of the regulations under this Ordinance).

(5) Regulations under this Ordinance may include provision repealing or amending any provision of an enactment (other than this Ordinance) which appears to the Governor to be inconsistent with, or to be unnecessary or to require modification in consequence of, the order or regulations or any UK medicines legislation thereby applied to the Falkland Islands.

(6) Where regulations under this Ordinance make provision -

(a) under subsection (4), or

(b) corresponding to any UK medicines legislation,

that provision may be made retrospective to such date as may be specified in the regulations, not being earlier than the date from which the relevant UK medicines legislation had effect in England and Wales.

(7) A statement contained in regulations under this Ordinance that any provision of them corresponds to any UK medicines legislation shall be conclusive evidence of that fact.

PART 2
DEALINGS WITH MEDICINAL PRODUCTS

[Ord49.6s5]5 Principles

In exercising his functions under this Part the Governor shall have regard to the systems of control of dealings with medicinal products for the time being operating in the United Kingdom under -

(a) the EC code, and any enactment or instrument giving effect to it;

(b) the EC Regulation;

(d) any instrument or enactment from time to time amending or replacing any of the instruments and enactments mentioned in paragraphs (a), (b) and (c).

[Ord49.6s6]6 Restrictions on dealing with medicinal products

(1) The Governor may by regulations make provision for controlling, restricting, regulating or prohibiting the following activities -

(a) selling, supplying or otherwise placing on the market any medicinal product;

(b) manufacturing or assembling any medicinal product;

(d) procuring the sale, supply or placing on the market otherwise than by sale or supply, manufacture, assembly or distribution of any medicinal product;

(e) the import or export of any medicinal product;

(f) possessing any medicinal product, with a view to selling or supplying it or otherwise placing it on the market;

(g) issuing, sending or delivering any advertisement, or making any representation or recommendation in the course of a business, relating to any medicinal product.

(2) Regulations under subsection (1) may impose such requirements as the Governor considers necessary or expedient for any of the purposes specified in subsection (3) with respect to -

(a) the labelling of containers of medicinal products;

(b) the labelling of packages of medicinal products;

(d) the supply with medicinal products of leaflets;

(e) the strength, materials, shape or other characteristics of containers of medicinal products.

(3) The purposes referred to in subsection (2) are -

(a) securing that medicinal products are correctly described and readily identifiable;

(b) securing that any appropriate warning or other appropriate information or instruction is given, and that false or misleading information is not given, with respect to medicinal products;

(d) in relation to subsection (2)(e), preserving the quality of medicinal products.

(4) Regulations under this section -

(a) may provide for giving effect in the Falkland Islands, in such circumstances and subject to such conditions as may be prescribed, to Community authorisations and UK authorisations; and

(b) may provide for giving effect in the Falkland Islands, subject to such conditions as may be prescribed, to any other authorisation, licence, consent, certificate or other document relating to any activity mentioned in subsection (1) and granted or issued (in the United Kingdom or elsewhere) under any Community instrument.

[Ord49.6s7]7 Exemptions

(1) The Governor may by regulations provide for the exemption, in such circumstances and subject to such conditions as are prescribed, from any control, restriction, regulation or prohibition imposed under section 6(1), for -

(a) prescribed activities in the course of his profession of a practitioner;

(b) prescribed activities in a registered pharmacy or a hospital of, or under the supervision of, a pharmacist or the Chief Medical Officer.

(2) The Governor may by regulations provide for further exemptions, in such circumstances and subject to such conditions as are prescribed, from any such control, restriction, regulation or prohibition.

[Ord49.6s8]8 General sale of medicinal products

(1) This section applies to any medicinal product, except one which under the terms of a Community authorisation or UK authorisation may be sold or supplied otherwise than by, or under the supervision of, a pharmacist.

(a) the product is sold, offered or exposed for sale, or supplied, in a registered pharmacy; and

(b) that person, or, if the transaction is carried out on his behalf by another person, then that other person, is, or acts under the supervision of, a pharmacist.

(3) Subsection (2) is without prejudice to the generality of section 6, and does not preclude the making of any other provision under that section with respect to any medicinal product to which this section applies.

[Ord49.6s9]9 Medicinal products on prescription only

(1) This section applies to medicinal products which under the terms of a Community authorisation or UK authorisation are not to be sold by retail except in accordance with a prescription given by a person holding specified qualifications or complying with specified conditions.

(2) Regulations under section 6 may prohibit, except in such circumstances and subject to such conditions as may be prescribed, any person, in the course of a business carried on by him, selling by retail, offering or exposing for sale by retail, or supplying in circumstances corresponding to retail sale, a medicinal product to which this section applies unless it is sold or supplied in accordance with a prescription given by a person holding such qualifications, and complying with such conditions, as may be prescribed.

[Ord49.6s10]10 Regulations under Part 2

(1) Regulations under this Part may provide that any person contravening a specified requirement of the regulations commits an offence and is liable to a fine not exceeding the maximum of level 4 on the standard scale.

(2) Regulations under this Part may -

(a) require -

(i) as a condition for carrying on any activity to which the regulations relate, or

(ii) as a condition for any exemption conferred under section 7,

any person to be entered in a register kept, or the holder of a licence or certificate issued, by a prescribed person or authority for the purpose of the regulations, or any premises to be entered in a register so kept;

(b) impose conditions in respect of the entry or retention of persons or premises in such a register, or the issue of such a licence or certificate, including conditions requiring the payment of fees;

(i) applications for entry or retention in such a register, or the issue or renewal of such a licence or certificate,

(ii) the making of entries in the register or the issue of such a licence or certificate,

(iii) the duration, renewal, suspension and revocation of registration, licences or certificates;

(iv) reviews of, and appeals to a prescribed authority against, any decision relating to registration, licences or certificates.

(3) Before making any regulations under this Part the Governor shall consult the Chief Medical Officer and such persons or organisations as appear to the Governor to be representative of -

(a) any profession appearing to the Governor to be substantially affected by the regulations, and

(b) other interests likely to be substantially affected by the regulations.

(4) This section is without prejudice to section 4.

[Ord49.6s11]11 Application to veterinary medicinal products

This Part applies to veterinary medicinal products as it applies to medicinal products, with the following modifications -

(a) in section 5(a), for "the EC code" substitute "the EC veterinary code";

(b) in section 10(3), after "Chief Medical Officer" insert ", the Senior Veterinary Officer";

[S. 11(a)/Ord. 11/15/w.e.f. 24/12/15.]

(c) where the veterinary medicinal products referred to above relate to veterinary medicinal products that are administered to livestock or animals slaughtered or killed for human consumption the Livestock and Meat Products Ordinance (No. 14 of 2010) applies.

[S. 11(b)/Ord. 11/15/w.e.f. 24/12/15.]

PART 3
CONSUMER PROTECTION

[Ord49.6s12]12 Adulteration of medicinal products

No person shall -

(a) add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition of the product, with intent that the product shall be sold or supplied in that state; or

(b) sell or supply, or offer or expose for sale or supply, or have in his possession for the purpose of sale or supply, any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.

[Ord49.6s13]13 Protection of purchasers of medicinal products

(1) No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.

(2) No person shall sell or supply, in pursuance of a prescription given by a practitioner, any medicinal product which is not of the nature or quality specified in the prescription.

(3) Subsection (1) or (2) shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.

(4) Subsection (1) or (2) shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that -

(a) the addition or abstraction was not carried out fraudulently, and did not injuriously affect the composition of the product; and

(b) the product was sold having attached to it, or to a container or package in which it was sold, a conspicuous notice of adequate size and legibly printed, specifying the substance added or abstracted.

(5) For the purposes of this section, the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.

[Ord49.6s14]14 Compliance with published standards

(1) No person shall, in the course of a business carried on by him -

(a) sell a medicinal product which has been demanded by the purchaser by, or by express reference to, a particular name; or

(b) sell or supply a medicinal product in pursuance of a prescription given by a practitioner in which the product required is described by, or by express reference to, a particular name,

if that name is, or is an approved synonym for, a name at the head of the relevant monograph and the product does not comply with the standard specified in that monograph.

(2) No person shall, in the course of a business carried on by him, sell or supply a medicinal product which, in the course of that business, has been offered or exposed for sale and has been so offered or exposed for sale by, or by express reference to, a particular name, if that name is, or is an approved synonym for, a name at the head of the relevant monograph and the product does not comply with the standard specified in that monograph.

(3) Where a medicinal product is sold or supplied in the circumstances specified in subsection (1) or (2), and the name in question is the name, not of the product itself, but of an active ingredient of the product, then, for the purposes of the subsection in question, the product shall be taken not to comply with the standard specified in the relevant monograph if, in so far as it consists of that ingredient, it does not comply with the standard so specified.

(4) Subject to subsection (7), in this section -

"publication" means -

(a) the European Pharmacopoeia,

(b) the British Pharmacopoeia,

(d) any compendium published under Part VII of the UK Act;

"the relevant monograph", in relation to the sale or supply of a medicinal product which has been demanded, described in a prescription, or offered or exposed for sale, by or by express reference to a particular name -

(a) if, together with that name, there was specified a particular edition of a particular publication, means the monograph (if any) headed by that name, or by a name for which it is an approved synonym, in that edition of that publication, or, if there is no such monograph in that edition, means the appropriate current monograph (if any) headed by that name;

(b) if, together with that name, there was specified a particular publication, but not a particular edition of that publication, means the monograph (if any) headed by that name in the current edition of that publication, or, if there is no such monograph in that edition, means the appropriate current monograph (if any) headed by that name or by a name for which it is an approved synonym, or, in default of such a monograph, means the monograph headed by that name or by a name for which it is an approved synonym in the latest edition of the specified publication which contained a monograph so headed;

"current" means current at the time when the medicinal product in question is demanded, described in a prescription, or offered or exposed for sale, as mentioned in subsection (1) or (2).

(5) In this section "the appropriate current monograph", in relation to a particular name, means-

(a) the monograph (if any) headed by that name, or by a name for which it is an approved synonym, in the current edition of the European Pharmacopoeia; or

(b) if there is no such monograph, then the monograph (if any) headed by that name in the current edition of the British Pharmacopoeia; or

(c) if there is no such monograph, then the monograph (if any) headed by that name in the current edition of a compendium published under Part VII of the UK Act; or

(d) if there is no such monograph, then the monograph (if any) headed by that name in the current edition of the British Pharmaceutical Codex.

(6) Subject to subsection (7), for the purposes of this section an edition of a publication -

(a) if it is the current edition of that publication, shall be taken as it is for the time being in force (that is to say, together with any amendments, additions and deletions made to it up to the time referred to in subsection (4)); or

(b) if it is an edition previous to the current edition of that publication, shall be taken as it was immediately before the time when it was superseded by a subsequent edition of that publication (that is to say, together with any amendments, additions and deletions made to it up to that time),

and any monograph in an edition of a publication shall be construed in accordance with any general monograph or notice or any appendix, note or other explanatory material which is contained in that edition and is applicable to that monograph, and any reference in this section to compliance with the standard specified in a monograph shall be construed accordingly.

(7) For the purposes of this section, an edition of the European Pharmacopoeia -

(a) if it is the current edition of that Pharmacopoeia at the time in question, shall be taken as it is for the time being in force in the United Kingdom (that is, together with any amendments, additions and deletions made to it which, by notice published in the London Gazette under section 65(7) of the UK Act before the time referred to in subsection (4), have been declared to have effect for the purposes of the said section 65); and

(b) if it is an edition previous to the current edition of that Pharmacopoeia, shall be taken as it was immediately before the time when it was superseded by a subsequent edition of that Pharmacopoeia in force in the United Kingdom (that is, together with any amendments, additions and deletions made to it which, by notice so published before that time, had been declared so to have effect),

and a name shall be taken to be an approved synonym for a name at the head of a monograph in the European Pharmacopoeia if, by a notice so published and not withdrawn by any subsequent notice so published, it has been declared to be approved by the Medicines Commission in the United Kingdom as a synonym for that name.

[Ord49.6s15]15 Misleading descriptions etc

(1) No person shall, in the course of a business carried on by him, sell or supply, or have in his possession for the purpose of sale or supply, a medicinal product of any description in a container or package which is labelled or marked in such a way that the container or package -

(a) falsely describes the product; or

(b) is likely to mislead as to the nature or quality of the product or as to the uses or effects of medicinal products of that description.

(2) No person shall, in the course of a business carried on by him, supply with a medicinal product of any description, or have in his possession for the purpose of so supplying, a leaflet which -

(a) falsely describes the product; or

(b) is likely to mislead as to the nature or quality of the product or as to the uses or effects of medicinal products of that description.

[Ord49.6s16]16 Display of information on automatic machines

(1) The Governor may by regulations impose such requirements as it considers necessary or expedient with respect to the display on automatic machines of information relating to medicinal products offered or exposed for sale by means of such machines.

(2) No person shall offer or expose for sale any medicinal product by means of an automatic machine in such circumstances as to contravene any requirements imposed by regulations under subsection (1) which are applicable to that product.

[Ord49.6s17]17 Offences

(1) Any person who contravenes section 12, 13(1) or (2), 14(1) or (2) or 15(1) or (2) commits an offence and is liable to a fine not exceeding the maximum of level 5 on the standard scale.

(2) Any person who contravenes section 16(2) commits an offence and is liable to a fine not exceeding the maximum of level 3 on the standard scale.

[Ord49.6s18]18 Application to veterinary medicinal products

18. This Part applies to veterinary medicinal products as it applies to medicinal products, with the substitution, in section 14(4) and (5)(d), of "British Veterinary Codex" for "British Pharmaceutical Codex".

PART 4
PHARMACIES

[Ord49.6s19]19 Register of pharmacies

(1) The Chief Medical Officer shall keep for the purposes of this Part a register ("the register") of persons entitled, on premises in respect of which their names are entered in the register, to sell by retail, or to supply in circumstances corresponding to retail sale, medicinal products or veterinary medicinal products (other than medicinal products or veterinary medicinal products on general sale).

(2) Subject to the provisions of this Part, the Chief Medical Officer shall enter in the register the name of any person who makes an application to the Chief Medical Officer in the prescribed form to have his name entered in the register in respect of the premises mentioned in the application.

(3) The Chief Medical Officer may refuse to enter in, or may remove from, the register the name of any person where it appears to the Chief Medical Officer that -

(a) that person -

(i) is not a pharmacist,

(ii) does not have actual charge of the premises in question, or

(iii) is not present when medicinal products or veterinary medicinal products (other than medicinal products or veterinary medicinal products on general sale) are sold by retail, or supplied in circumstances corresponding to retail sale, on the premises; or

(b) the premises do not comply with regulations under section 20.

(4) If any person is aggrieved by the refusal of the Chief Medical Officer to enter his name in the register or by the removal under this section of his name from that register (otherwise than by virtue of an order under subsection (5)), he may appeal against the refusal or removal to the Supreme Court.

(5) If any person whose name is entered in the register is convicted before any court of an offence under this Ordinance which, in the opinion of the court, renders him, or would if he were a pharmacist render him, unfit to be a pharmacist, the court may, as part of the sentence, order his name to be removed from the register and direct that he shall, for such period as may be specified in the order, be disqualified for having his name entered in the register.

(6) The register shall -

(a) include particulars of the premises in respect of which the name of any person is entered in the register;

(b) subject to paragraph (a), be in such form as may be prescribed; and

(7) The register may be kept otherwise than in documentary form; and where it is so kept, the requirement of subsection (6)(c) is satisfied if the Chief Medical Officer makes any part of which any person wishes to inspect available for inspection in visible and legible form.

[Ord49.6s20]20 Regulations as to premises

(1) This section applies to any premises where medicinal products or veterinary medicinal products (other than medicinal products or veterinary medicinal products on general sale) are sold by retail or supplied in circumstances corresponding to retail sale.

(2) The Governor may by regulations provide for -

(a) the standards of construction, accommodation and equipment to be complied with by premises to which this Part applies;

(b) the precautions to be taken for the safe custody of medicinal products or veterinary medicinal products, or any class of medicinal products or veterinary medicinal products, on such premises;

(c) the keeping of records with respect to medicinal products or veterinary medicinal products, or any class of medicinal products or veterinary medicinal products, on such premises; and

(d) the inspection of any records so kept.

(3) Regulations under this section may provide that any person contravening a specified requirement of the regulations commits an offence and is liable to a fine not exceeding the maximum of level 4 on the standard scale.

[Ord49.6s21]21 Restrictions on use of titles, descriptions and emblems

(1) No person shall -

(a) take or use any of the following titles -

chemist and druggist,

druggist,

dispensing chemist, or

dispensing druggist; or

(b) take or use the title of chemist in connection with the sale of any goods by retail or the supply of any goods in circumstances corresponding to retail sale,

unless the conditions specified in subsection (2) are fulfilled.

(2) Those conditions are -

(a) he is a pharmacist, and

(b) he does not take or use the title in question in connection with any premises at which any goods are sold by retail, or are supplied in circumstances corresponding to retail sale, unless his name is entered in the register in respect of those premises.

(3) No person shall, in connection with a business carried on by him which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, use the description "pharmacy" except in relation to premises in respect of which his name is entered in the register.

(4) No person who is not a pharmacist shall take or use any of the following titles -

pharmaceutical chemist,

pharmaceutist,

pharmacist,

member of the Royal Pharmaceutical Society, and

fellow of the Royal Pharmaceutical Society.

(5) Without prejudice to subsection (4), no person shall take or use any of those titles in connection with a business carried on (whether by him or by some other person) at any premises which consists of or includes the retail sale of any goods, or the supply of any goods in circumstances corresponding to retail sale, unless his name is entered in the register in respect of those premises.

(6) No person shall, in connection with any business, use any title, description or emblem likely to suggest -

(a) that he possesses any qualification with respect to the sale, manufacture or assembly of medicinal products or veterinary medicinal products which he does not in fact possess; or

(b) that any person employed in the business possesses any such qualification which that person does not in fact possess.

(7) For the purposes of subsection (6), the use of the description "pharmacy", in connection with a business carried on at any premises, shall be taken to be likely to suggest that -

(a) the person carrying on the business is a pharmacist, and

(b) any other person, under whose personal control the business (so far as concerns the sale by retail of medicinal products or veterinary medicinal products or the supply of such products in circumstances corresponding to retail sale) is carried on at those premises, is also a pharmacist.

(8) Any person who contravenes this section commits an offence and is liable to a fine not exceeding the maximum of level 5 on the standard scale.

[Ord49.6s22]22 Modification etc. of restrictions under section 21

(1) The Governor may by regulations provide that any of the restrictions imposed by section 21 shall cease to have effect, or shall have effect subject to such exceptions as may be specified in the regulations.

(2) Without prejudice to subsection (1), the Governor may by regulations impose (in addition to the restrictions under section 21) such further restrictions or other requirements with respect to the use of titles, descriptions and emblems as may be specified in the regulations.

(3) Any person who contravenes regulations under subsection (2) commits an offence and is liable to a fine not exceeding the maximum of level 5 on the standard scale.

PART 5
POISONS

[Ord49.6s23]23 Poisons list

The poisons list for the time being in force in Great Britain under section 2 of the Poisons Act 1972 (an Act of Parliament) shall have effect in the Falkland Islands.

[Ord49.6s24]24 Regulation of sale of poisons

(1) Subject to the provisions of this Part, it is not lawful -

(a) for a person to sell any non-medicinal poison which is a substance included in Part I of the poisons list, unless the sale is effected -

(i) in a registered pharmacy, and

(ii) 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) the sale is effected in a registered pharmacy; or

(ii) his name is entered in the official list in respect of the premises on which the poison is sold;

(c) for a person to sell any non-medicinal poison, whether it is a substance included in Part I or in Part II of the poisons list, unless the container of the poison is labelled in the prescribed manner -

(i) with the name of the poison;

(ii) in the case of a preparation which contains a poison as one of its ingredients, with the prescribed particulars as to the proportion which the poison contained in the preparation bears to the total ingredients;

(iii) with the word "poison" or other prescribed indication of the character of the article; and

(iv) with the name of the seller of the poison and the address of the premises on which it is sold.

(2) Subject to the provisions of this Part -

(a) it is not lawful to sell any non-medicinal poison which is a substance included in Part I of the poisons list to any person unless that person is either -

(i) certified in writing in the prescribed manner by a person authorised by the poisons rules to give a certificate for the purposes of this section; or

(ii) known by the seller or by a pharmacist in the employment of the seller at the premises where the sale is effected, to be a person to whom the poison may properly be sold;

(b) the seller of any such poison shall not deliver it until -

(i) he has made or caused to be made an entry in a book to be kept for that purpose stating in the prescribed form the date of the sale, the name and address of the purchaser and of the person (if any) by whom the certificate required under paragraph (a) was given, the name and quantity of the article sold and the purposes for which it is stated by the purchaser to be required; and

(ii) the purchaser has signed the entry.

(3) Subject to the provisions of this Part, it shall not be lawful for a non-medicinal poison to be exposed for sale in, or to be offered for sale by means of, an automatic machine.

[Ord49.6s25]25 Exclusion of sales by wholesale and certain other sales

(1) Except as provided by the poisons rules, nothing in section 24(l) or (2) shall extend to or interfere with -

(a) the sale of poisons by way of wholesale dealing; or

(b) the sale of poisons to be exported to purchasers outside the Falkland Islands; or

(c) the sale of an article to a doctor, dentist, veterinary surgeon or veterinary practitioner for the purpose of his profession; or

(d) the sale of an article for use in or in connection with any hospital; or

(e) the sale of an article by a person carrying on a business in the course of which poisons are regularly sold either by way of wholesale dealing or for use by the purchasers in their trade or business to -

(i) a person who requires the article for the purpose of his trade or business; or

(ii) a person who requires the article for the purpose of enabling him to comply with any requirements made by or in pursuance of any enactment with respect to the medical treatment of persons employed by him in any trade or business carried on by him; or

(iii) a public officer requiring the article in connection with the exercise by him or any other public officer or public authority of his or its functions; or

(iv) a person or institution concerned with scientific education or research, if the article is required for the purposes of that education or research.

(2) In this section "sale by way of wholesale dealing" means sale to a person who buys for the purpose of selling again.

[Ord49.6s26]26 Official list of persons entitled to sell certain poisons

(1) The Chief Medical Officer shall keep for the purposes of this Part a list ("the official list") of persons as being persons entitled, on premises in respect of which their names are entered in the official list, to sell non-medicinal poisons which are substances included in Part II of the poisons list.

(2) Subject to the provisions of this Part, the Chief Medical Officer shall enter in the official list the name of any person who makes an application to the Chief Medical Officer in the prescribed form to have his name entered in the list in respect of the premises mentioned in the application.

(3) The Chief Medical Officer may refuse to enter in, or may remove from, the official list the name of any person who fails to pay the prescribed fees, or who in the opinion of the Governor is, for any sufficient reason relating either to him personally or to his premises, not fit to be on that list.

(4) If any person is aggrieved by the refusal of the Chief Medical Officer to enter his name in the official list or by the removal under this section of his name from that list, he may appeal against the refusal or removal to the Supreme Court.

(5) In this section, "relating to him personally" means, in relation to a body corporate, relating personally to the members of the board, or to the managers or other officers of the body corporate.

[Ord49.6s27]27 Supplementary provisions as to official list

(1) The official list shall -

(a) include particulars of the premises in respect of which the name of any person is entered in that list;

(b) subject to paragraph (a), be in such form as may be prescribed; and

(2) A person whose name is entered in the official list shall pay to the Chief Medical Officer such fees as may be prescribed in respect of -

(a) the entry of his name in that list;

(b) the making of any alteration in that list in relation to the premises in respect of which his name is entered; and

(c) the retention of his name on that list in any year subsequent to the year in which his name is first entered in it (and for this purpose "year" means a period of 12 months beginning on such date as the Governor may from time to time determine).

(3) If any person whose name is entered in the official list is convicted before any court of any offence which, in the opinion of the court, renders him unfit to have his name on the list, the court may, as part of the sentence, order his name to be removed from that list and direct that he shall, for such period as may be specified in the order, be disqualified for having his name entered in the official list.

(4) It shall not be lawful for any person whose name is entered in the official list to use in connection with his business any title, emblem or description reasonably calculated to suggest that he is entitled to sell any poison which he is not entitled to sell.

[Ord49.6s28]28 Poisons rules

The Governor may by regulations apply to the Falkland Islands as part of the law of the Falkland Islands the poisons rules under section 7 of the Poisons Act 1972 (an Act of Parliament), subject to such exceptions, adaptations and modifications as may be specified in the regulations.

[Ord49.6s29]29 Offences

(1) A person who acts in contravention of or fails to comply with any of the preceding provisions of this Part or with the poisons rules commits an offence and is liable to a fine not exceeding the maximum of level 5 on the standard scale.

(2) In the case of proceedings against a person under this section for or in connection with the sale, exposure for sale or supply of a non-medicinal poison effected by an employee -

(a) it shall not be a defence that the employee acted without the authority of the employer; and

(b) any material fact known to the employee shall be deemed to have been known to the employer.

PART 6
ENFORCEMENT

[Ord49.6s30]30 Enforcement etc

(1) It is the duty of the Chief Medical Officer to enforce this Ordinance, any regulations made under it and the poisons rules.

(2) The Governor may appoint one or more inspectors to assist the Chief Medical Officer in enforcing this Ordinance, regulations made under it and the poisons rules, and may terminate any appointment made under this subsection, and every Government Medical Officer shall be deemed to have been appointed under this subsection.

[Ord49.6s31]31 Rights of entry

(1) Subject to the following provisions of this section, an authorised person an authorised person shall, on production, if required, of his credentials, have a right at any reasonable time to enter any premises -

(a) for the purpose of ascertaining whether there is or has been, on or in connection with those premises, any contravention of any provision of this Ordinance or of any regulations made under this Ordinance; or

(b) generally for the purposes of the performance by the Governor or the Chief Medical Officer of his functions under this Ordinance or under any such regulations.

(2) An authorised person shall, on production, if required, of his credentials, have a right at any reasonable time -

(a) to enter any ship, aircraft or hover vehicle for the purpose of ascertaining whether there is in the ship, aircraft or vehicle any substance or article imported in contravention of any provision of this Ordinance or of any regulations made under this Ordinance;

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

(3) Admission to any premises used only as a private dwelling-house shall not be demanded as of right by virtue of subsections (1) or (2) unless 24 hours notice of the intended entry has been given to the occupier.

(4) If a justice of the peace, on sworn information in writing, is satisfied that there are reasonable grounds for entering any premises for any purpose for which an authorised person has a right to enter them in accordance with subsections (1) to (3), and is also satisfied -

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

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

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

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

(5) Subsection (4) has effect in relation to entering any ship, aircraft, vehicle, stall or place which may be entered under subsection (2) as it has effect in relation to entering any premises as if, in subsection (4) any reference to the occupier were a reference to the master, commander or other person in charge of the ship, aircraft, vehicle, stall or place.

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

(7) Any person entering any property by virtue of this section (whether in pursuance of a warrant or not) -

(a) may take with him such other persons and such equipment as may appear to him to be necessary; and

(b) on leaving any such property which he has entered in pursuance of a warrant under subsection (4) he shall, if the property is unoccupied or the occupier (or, in the case of a ship, aircraft, vehicle, stall or place, the master, commander or other person in charge of it) is temporarily absent, leave it as effectively secured against trespass as he found it.

(8) In this section -

"home-going ship" means a ship engaged exclusively in voyages which start and end in the Falkland Islands and do not involve calling at any place outside the Falkland Islands;

"property" means any premises, ship, aircraft, vehicle, stall or place.

[Ord49.6s32]32 Power to inspect, take samples and seize goods and records

(1) For the purpose of ascertaining whether there is or has been a contravention of this Ordinance, any regulations made under it or the poisons rules, an authorised person shall have a right to inspect -

(a) any substance or article appearing to him to be a medicinal product or a non-medicinal poison;

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

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

(2) Where, for the purpose specified in subsection (1), an authorised person requires a sample of any substance or article appearing to him to be -

(a) a medicinal product sold or supplied or intended to be sold or supplied;

(b) a non-medicinal poison sold or intended to be sold; or

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

(3) For the purpose specified in subsection (1), an authorised person shall have a right -

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

(b) to take copies of, or of any entry in, any record produced in pursuance of paragraph (a).

(4) An authorised person -

(a) is entitled at any reasonable time to have access to, and inspect and check the operation of, any computer and any associated apparatus or material which is or has been in used in connection with the records in question; and

(b) may require the person by whom or on whose behalf the computer is or has been used, or any person having charge of or otherwise concerned with the operation of the computer, apparatus or material, to afford him such assistance as he may reasonably require.

(5) An authorised person has a right to seize and detain -

(a) any substance or article which he has reasonable cause to believe to be a substance or article in relation to which, or by means of which, an offence under this Ordinance is being or has been committed, and

(b) any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under this Ordinance.

(6) For the purpose of exercising any such right as is specified in subsection (5), the person having that right may, so far as is reasonably necessary in order to secure that this Ordinance, any regulations made under it or the poisons rules are duly observed, require any person having authority to do so to break open any container or package or open any vending machine, or to permit him to do so.

(7) Where a person seizes any substance or article (including any record) in the exercise of the power conferred by subsection (5), he shall inform the person from whom it is seized and, in the case of anything seized from a vending machine, the person whose name and address are stated on the machine as being those of the owner of the machine, or, if no name and address are so stated, the occupier of the premises on which the machine stands or to which it is affixed.

(8) Notwithstanding anything in subsections (1) to (7), where a person claiming to exercise a right by virtue of this section is required to produce his credentials, the right shall not be exercisable by him except on production of those credentials.

(9) Schedule 1 has effect with respect to samples obtained for the purposes of this Ordinance.

(10) The Governor shall by regulations prescribe any matter which under Schedule 1 is to be prescribed.

[Ord49.6s33]33 Application of sampling procedure to substance or article seized under section 32

(1) The provisions of this section have effect where an authorised person seizes a substance or article (other than a record) in the exercise of a right specified in section 32(5).

(2) If any person who, in accordance with section 32(7), is entitled to be informed of the seizure so requests, either at the time of the seizure or at any subsequent time, not being later than 21 days after he is informed of the seizure, then, subject to subsection (3), the authorised person shall either -

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

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

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

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

(4) Where, in accordance with subsection (2), an authorised person sets aside a sample, or treats a substance or article as a sample, he shall divide it into 3 parts, each part to be marked and sealed or fastened up in such manner as its nature will permit, and shall supply one part of it to the person who made the request under subsection (2).

(5) Paragraphs 10 to 12 and 15 to 21 of Schedule 1 apply in relation to a sample set aside, or a substance or article treated as a sample, under subsection (2) as if -

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

(b) in paragraph 19(l) the reference to a substance or article obtained as mentioned in paragraph 1 were a reference to a substance or article of which a sample has been set aside, or which has been treated as a sample, under subsection (2).

[Ord49.6s34]34 Obstruction etc

(1) Any person who -

(a) intentionally obstructs an authorised person acting in pursuance of this Ordinance; or

(b) intentionally fails to comply with any requirement properly made to him by an authorised person under section 32 (including that section as modified under section 43(1)); or

(c) without reasonable cause, fails to give to an authorised person any other assistance or information which that person may reasonably require of him for the purpose of the performance of his functions under this Ordinance,

commits an offence and is liable to a fine not exceeding the maximum of level 4 on the standard scale.

(2) If any person, in giving any such information as is mentioned in subsection (1)(c), makes any statement which he knows to be false, he commits an offence and is liable to a fine not exceeding the maximum of level 4 on the standard scale.

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

[Ord49.6s35]35 Analysis of samples in other cases

(1) A person who, not being an authorised person, has purchased a medicinal product or a non-medicinal poison may submit a sample of it for analysis to an official analyst who (subject to sub-paragraph (3)) shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

(2) Paragraphs 2 to 13 and 15 to 18 (except paragraph 15(1)) of Schedule 1 apply in relation a sample submitted under subsection (1) as if any reference to an authorised person were a reference to the person proposing to submit or submitting the sample.

(3) Where a sample is submitted to an official analyst under subsection (1), he may demand payment in advance of -

(a) the prescribed fee, or

(b) in the case of a sample to be sent under paragraph 15(2) of Schedule 1, such sum as may be agreed;

and, if he demands such payment, he shall not be required to analyse the sample or cause or send it to be analysed until the fee or sum has been paid.

[Ord49.6s36]36 Liability to forfeiture

(1) For the purposes of section 42 (forfeiture of goods improperly imported) of the Customs Ordinance 2003 any imported goods shall be deemed to be imported contrary to a restriction for the time being in force with respect to them under this Ordinance if -

(a) they are goods falling within a class specified in regulations made by the Governor for the purposes of this subsection; and

(b) they are imported in such circumstances as are specified in those regulations.

(2) For the purposes of section 60 of the Customs Ordinance 2003 (offences in relation to exportation of prohibited or restricted goods), any goods shall be deemed to be exported contrary to a restriction for the time being in force with respect to them under this Ordinance if -

(a) they are goods falling within a class specified in regulations made by the Governor for the purposes of this subsection; and

(b) they are exported in such circumstances as are specified in those regulations.

(3) Any class of goods specified in regulations under subsection (1) or (2) shall be so specified as to consist exclusively of goods appearing to the Governor to be goods which are, or normally are, medicinal products.

[Ord49.6s37]37 Restrictions on disclosure of information

If any person discloses to any other person -

(a) any information with respect to any manufacturing process or trade secret obtained by him in premises which he has entered by virtue of section 31; or

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

unless the disclosure was made in the performance of his duty, he commits an offence and is liable to a fine not exceeding the maximum of level 5 on the standard scale.

[Ord49.6s38]38 Contravention due to default of other person

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

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

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

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

the first-mentioned person shall, subject to subsection (3), be acquitted of the offence.

(3) A person shall not, without the leave of the court, be entitled to rely on the defence provided by subsection (2), unless, not later than 7 clear days before the date of the hearing, he has served on the prosecutor a notice in writing giving such information identifying, or assisting in the identification of, the other person in question as was then in his possession.

(4) This section applies to sections 13 to 16.

[Ord49.6s39]39 Warranty as defence

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

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

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

(2) This section applies to -

(a) sections 12(b), 13 and 14, and

(b) regulations under section 6(2).

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

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

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

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

[Ord49.6s40]40 Offences in relation to warranties and certificates of analysis

(1) If a defendant in any proceedings mentioned in section 39(1) intentionally applies to any substance or article -

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

(b) a certificate issued under section 35, or under paragraph 15(3) of Schedule 1, which relates to a sample of a different substance or article,

he commits an offence.

(2) A person who, in respect of any substance or article sold by him in respect of which a warranty might be pleaded under section 39, gives to the purchaser a false warranty in writing commits an offence, unless he proves that, when he gave the warranty, he had reason to believe that the statement or description contained in it was accurate.

(3) Any person who commits an offence under this section is liable to a fine not exceeding the maximum of level 5 on the standard scale.

[Ord49.6s41]41 Offences by bodies corporate

Where an offence under this Ordinance which is committed by a body corporate is proved to have been committed with the consent and connivance of, or to be attributable to any neglect on the part of any director, manager, secretary or other similar officer of the body corporate, that person, as well as the body corporate, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

[Ord49.6s42]42 Presumptions

(1) For the purposes of any proceedings under this Ordinance for an offence consisting of offering a medicinal product for sale, or for sale by retail, in contravention of section 12(b) or regulations under section 6, where it is proved that the medicinal product in question was found on a vehicle from which medicinal products are sold, it shall be presumed, unless the contrary is proved, that the person in charge of the vehicle offered that medicinal product for sale, or for sale by retail, as the case may be.

(2) For the purposes of any proceedings under this Ordinance for an offence consisting of having a medicinal product in one's possession for the purpose of sale or supply, in contravention of section 12(b) or regulations under section 6, where it is proved that the medicinal product in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products, it shall be presumed, unless the contrary is proved, that he had that medicinal product in his possession for the purpose of sale or supply.

(3) For the purposes of any proceedings under this Ordinance for an offence consisting of the supply of a leaflet with a medicinal product, where it is proved that the leaflet in question was found on premises at which the person charged with the offence carries on a business consisting of or including the sale or supply of medicinal products, it shall be presumed, unless the contrary is proved, that he had the leaflet in his possession for the purpose of supplying it with a medicinal product.

[Ord49.6s43]43 Veterinary medicinal products and animal feeding stuffs

(1) This Part applies to veterinary medicinal products as it applies to medicinal products.

(2) The Governor may by regulations provide that any of the provisions of this Part shall apply, with or without prescribed modifications, in relation to animal feeding stuffs as they apply (by virtue of subsection (1)) to veterinary medicinal products.

(3) The Governor may by regulations make provision as to the manner in which -

(a) samples may be taken by virtue of section 32 (as applied under subsection (2)),

(b) samples may be set aside, or substances or articles may be treated as samples, by virtue of section 33 (as so applied),

(d) such samples, substances and articles are to be dealt with;

and provision under paragraph (d) may be in substitution for, or by way of modification of or addition to, any of the provisions of Schedule 1.

(4) For the purposes of proceedings for prescribed offences under this Ordinance relating to animal feeding stuffs, the Governor may by regulations -

(a) prescribe a method of analysis to be used in analysing samples of animal feeding stuffs in order to determine what quantity or proportion (if any) of a substance or article of a description or class specified in the regulations has been incorporated in them; and

(b) provide that, on production in the proceedings of such evidence as may be so prescribed of the results of an analysis of a sample performed by the method so prescribed, evidence of the results of any analysis of any part of the sample performed by any other method shall not be admissible in those proceedings.

PART 7
MISCELLANEOUS AND SUPPLEMENTAL

[Ord49.6s44]44 Registration of health professions

(1) The Medical Practitioners, Midwives and Dentists Ordinance -

(a) is renamed "the Health Professions Ordinance", and

(b) . . . .

[Revision w.e.f. 31/07/2017]

(2) Any reference to that Ordinance by its former title in any enactment or other document (whenever enacted or made) shall be read as a reference to it by the title of "the Health Professions Ordinance".

(3) The Governor may by regulations make such transitional provision as appears to him to be necessary or expedient with respect to persons who are registered under that Ordinance immediately before the coming into operation of this section.

[Ord49.6s45]45 Medicated animal feeding stuffs

(1) The Governor may by regulations make provision for controlling, restricting, regulating or prohibiting the following activities -

(a) the incorporation by any person, in the course of a business carried on by him, of a veterinary medicinal product of any description in an animal feeding stuff;

(b) selling, supplying or otherwise placing on the market by any person in the course of a business carried on by him of any animal feeding stuff in which a veterinary medicinal product has been incorporated,

(c) the importation by any person of any animal feeding stuff in which a veterinary medicinal product has been incorporated.

(2) The Governor may by regulations -

(a) prohibit or restrict the sale or supply, or the import, of animal feeding stuffs in which veterinary medicinal products of any description, or falling within any class, specified in the regulations have been incorporated, or

(b) in such manner as may appear to it to be sufficient to identify the feeding stuffs in question, designate particular animal feeding stuffs in which veterinary medicinal products have been incorporated and prohibit or restrict the sale or supply, or the import, of those particular feeding stuffs.

(3) Section 6 applies to any animal feeding stuff in which a veterinary medicinal product of any description has been incorporated as if the references in section 6(2)(a) to (d) (as modified by section 11) to veterinary medicinal products included references to any such animal feeding stuff.

(4) Section 10 applies to regulations under this section as it applies to regulations under Part 2.

[Ord49.6s46]46 Extension of application of Ordinance

(1) The Governor may by regulations -

(a) specify any description or class of articles or substances appearing to it to be articles or substances which are not medicinal products or veterinary medicinal products but are manufactured, sold, supplied, imported or exported for use wholly or partly for a medicinal purpose, and

(b) direct that, subject to such exceptions and modifications as may be specified in the regulations, such provisions of this Ordinance as may be so specified (including provisions so specified which relate to offences or penalties) shall have effect in relation to articles or substances of that description or class as those provisions have effect in relation to medicinal products or veterinary medicinal products, as the case may be.

(2) The Governor may by regulations -

(a) specify any substance appearing to the Governor to be a substance which is not itself a medicinal product or veterinary medicinal product but -

(i) is used as an ingredient in the manufacture of medicinal products or veterinary medicinal products; or

(ii) if used without proper safeguards, is capable of causing danger to the health of the community, or of causing danger to the health of animals generally or of one or more species of animals, and

(b) direct that, subject to such exceptions and modifications as may be specified in the regulations, such provisions of this Ordinance as may be so specified (including any provisions so specified which relate to offences or penalties) shall have effect in relation to that substance as those provisions have effect in relation to medicinal products or veterinary medicinal products, as the case may be.

(3) The power conferred by subsection (2) may be exercised in relation to a class of substances if it appears to the Governor that the conditions specified in subsection (2)(a)(i) or (ii) are fulfilled in relation to all substances falling within that class.

[Ord49.6s47]47 References to specified publications

(1) In this section "specified publication" means -

(a) the European Pharmacopoeia;

(b) the British Pharmacopoeia;

(d) the British Veterinary Codex;

(e) the British National Formulary;

(f) the Dental Practitioners' Formulary;

(g) any compendium prepared and published under section 99(3) and (6) of the UK Act;

(h) any list of names prepared and published under section 100 of the UK Act.

(2) Where any authorisation, licence or certificate refers to a specified publication, but not to a particular edition of that publication, then, for the purpose of determining whether anything done, at a time when the licence or certificate is in force, is done in accordance with the licence or certificate, the reference shall, unless the licence or certificate otherwise expressly provides, be construed as a reference to the current edition of that publication as in force at that time.

(3) In this section -

(a) any reference to the current edition of a specified publication as in force at any particular time is a reference to the edition of that publication in force at that time together with any amendments, additions or deletions made to it up to that time; and

(b) any reference to making an instrument in the exercise of a power conferred by a statutory provision includes a reference to issuing, approving or varying such an instrument.

SCHEDULE 1
SAMPLING

1. Introductory

This Schedule has effect where an authorised person obtains a sample of any substance or article -

(a) for the purpose of ascertaining whether there is or has been, in connection with that substance or article, any contravention of any provisions of this Ordinance or of any regulations made under it; or

(b) otherwise for any purpose connected with the performance by the Governor of his functions under this Ordinance or under any such regulations,

and the authorised person obtains the sample by purchase or in the exercise of any power conferred by section 35.

2. Division of sample

The authorised person shall forthwith divide the sample into 3 parts, each part to be marked and sealed or fastened up in such manner as its nature will permit.

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

4. If the authorised person obtained the sample from a automatic machine, then -

(a) if a person's name, and an address in the Falkland Islands, are stated on the machine as being the name and address of the owner of the machine, the authorised person shall supply one part of the sample to that person;

(b) in any other case, the authorised person 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. If the sample is of goods consigned from outside the Falkland Islands and was taken by the authorised person before delivery to the consignee, the authorised person shall supply one part of the sample to the consignee.

6. If, in a case not falling within paragraphs 3 to 5, the sample was obtained by the authorised person at the request or with the consent of a purchaser, the authorised person shall supply one part of the sample to the seller.

7. If, in a case not falling within paragraphs 3 to 6, the sample was taken in transit, the authorised person shall supply one part of the sample to the consignor.

8. In any case not falling within paragraphs 3 to 7, the authorised person shall supply one part of the sample to the person appearing to him to be the owner of the substance or article from which the sample was taken.

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

10. Of the remaining parts of the sample into which the sample is divided in accordance with paragraph 2, the authorised person, unless he decides not to submit the sample for analysis or other appropriate examination, shall -

(a) retain one part for future comparison; and

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

11. Where a sample consists of substances or articles enclosed in unopened containers, and it appears to the authorised person that to open the containers and divide the containers 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 authorised person may divide the sample into parts by dividing the containers into 3 lots without opening them.

12. Any part of a sample to be supplied to any person in pursuance of the preceding paragraphs of this Schedule may be supplied by post; and section 9 of the Interpretation and General Clauses Ordinance applies to supplying a part of a sample as it applies to the service of a document.

13. If, after reasonable inquiry, the authorised person 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 paragraphs 1 to 12, he may retain that part of the sample instead of supplying it.

14. Notice to person named on container

(1) Where it appears to the authorised person 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 Falkland Islands are stated on the 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 authorised person, 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 authorised person; and

(b) specifying the person from whom the authorised person 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 paragraph (1) shall be served before the end of the period of 3 days beginning with the day on which the sample was obtained.

15. Analysis or other examination of sample

(1) If the authorised person decides to submit the sample for analysis, he shall submit it to an official analyst, who (subject to sub-paragraph (2)) shall as soon as practicable analyse the sample or cause.

(2) An official analyst who has analysed a sample under this paragraph shall issue to the authorised person a certificate specifying the result of the analysis.

(3) Where a sample taken or purchased by an authorised person has been analysed by an official analyst, any person to whom a part of the sample was given in accordance with paragraphs 2 to 8 is entitled, on paying the prescribed fee to the Chief Medical Officer, to be supplied with a copy of the certificate given by the analyst under sub-paragraph (3).

(4) A certificate under sub-paragraph (3) shall be in a prescribed form and signed by the official analyst who issues it.

16. Provisions as to evidence

In any proceedings for an offence under this Ordinance, a document produced by one of the parties to the proceedings and purporting to be a certificate issued under paragraph 15 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.

17. In any proceedings for an offence under this Ordinance, 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.

18. (1) If, in any such proceedings, 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 3 clear days before the day on which the summons is returnable.

(2) If sub-paragraph (1) is not complied with, the court may, if it thinks fit, adjourn the hearing on such terms as it thinks proper.

19. Analysis under direction of court

(1) In any proceedings for an offence under this Ordinance, where the proceedings relate to a substance or article of which a sample has been obtained as mentioned in paragraph 1, the part of the sample retained in pursuance of paragraph 10(a) 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 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 sub-paragraph (1), 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 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.

20. The costs of any analysis or examination under paragraph 19 shall be paid by the prosecutor or the defendant, as the court may order.

21. Power to modify sampling provisions

The Governor may by regulations provide that, in relation to substances or articles of any prescribed description, paragraphs 1 to 20 shall have effect subject to such exceptions and modifications as may be prescribed.

22. Payment for sample taken under compulsory powers

(1) Where an authorised person takes a sample in the exercise of any power conferred by section 35, 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, 7 or 8, as the case may be, to be supplied.

(2) In default of agreement between the authorised person and the person mentioned in sub-paragraph (1), the value of the sample shall be determined by the arbitration of a single arbitrator appointed by the authorised person and the other person in question or, if they are unable to agree on the appointment of an arbitrator, shall be determined by the Summary Court.

23. Application of section 13 to samples

Where a medicinal product is taken as a sample by an authorised person in the exercise of any power conferred by section 35, section 13(1) to (4) applies as if the taking of the product as a sample were a sale of it to the authorised person by the person from whom it is taken; and, if the product was prepared in pursuance of a prescription given by a practitioner, section 13(1) to (4) shall so apply as if, in section 13(1), for "demanded by the purchaser" there were substituted "specified in the prescription".

SCHEDULE 2 . . .

[Revision w.e.f. 31/07/2017]