- ARRANGEMENT OF SECTIONS.
- INDEPENDENT STATE OF PAPUA NEW GUINEA.
- PART I. – PRELIMINARY
- PART II. – CONTROL AND LICENSING OF PRODUCTS AND DEALERS OF PRODUCTS
- Division 1
- Division 2
- PART III. – STANDARDS
- PART IV. – ADVERTISEMENTS, ETC
- PART V. – PHARMACIES
- Division 1
- Division 2
- 23. REGISTRATION OF PHARMACIES
- 24. APPLICATION FOR REGISTRATION OF A PHARMACY
- 25. GRANT OF PHARMACY REGISTRATION AND LICENCE
- 26. TERM OF PHARMACY LICENCE
- 27. CANCELLATION OR SUSPENSION OF PHARMACY LICENCE
- 28. REGULATION OF PHARMACISTS
- 29. DUTIES OF PHARMACISTS
- 30. SUPPLY OF CERTAIN MEDICINAL PRODUCTS, ETC
- 31. CERTAIN PROHIBITED ADVERTISEMENTS
- 32. INSTITUTION OF PROSECUTIONS
- PART VI. – INSPECTION AND SEIZURE OF PRODUCTS
- 33. APPLICATION OF THIS PART
- 34. APPOINTMENT OF INSPECTORS
- 35. POWERS OF INSPECTORS
- 36. RELEASE OF SEIZED PRODUCTS
- 37. ORDERS THAT SEIZED PRODUCTS BE FORFEITED
- 38. EXPENSES OF SEIZURE, ETC
- 39. STORAGE, ETC., OF SEIZED PRODUCTS
- 40. FORFEITURE OF PRODUCTS BY CONSENT
- 41. DISPOSAL OF FORFEITED PRODUCTS
- 42. OBSTRUCTION OF INSPECTORS
- PART VII. – MISCELLANEOUS
- 43. APPOINTMENT OF ANALYSTS, ETC
- 44. ANALYSIS
- 45. MINISTER MAY REQUIRE INFORMATION AS TO MEDICINAL PRODUCTS, ETC.
- 46. MINISTERIAL ORDERS IN RELATION TO MEDICINAL PRODUCTS AND COSMETICS
- 47. PROHIBITION OF SALE BY AUTOMATIC MACHINES
- 48. HAWKING, ETC., OF MEDICINAL PRODUCTS
- 49. EVIDENCE
- 50. LIABILITY OF EMPLOYERS FOR ACTS OF EMPLOYEES
- 51. OFFENCES BY CORPORATIONS
- 52. APPEALS AGAINST DECISIONS OF LICENSING AUTHORITY
- 53. ADVISORY COMMITTEES
- 54. REGULATIONS
- PART VIII. – REPEAL, SAVINGS AND TRANSITIONAL
Medicines and Cosmetics Act 1999
No. 10 of 1999.
Medicines and Cosmetics Act 1999 .
Certified on: / /20 .
INDEPENDENT STATE OF PAPUA NEW GUINEA.
No. 10 of 1999.
Medicines and Cosmetics Act 1999 .
ARRANGEMENT OF SECTIONS.
1. Compliance with constitutional requirements. 2. Interpretation. 3. Declaration by Minister in case of doubt. 4. Exemptions. 5. Appointed day. 6. Dealing, etc., with products. 7. Manufacture of products. 8. Prescription only, pharmacy only and over the counter products. 9. Application for licence. 10. Consideration of application for licence. 11. Grant of licence. 12. Term of licence. 13. Cancellation or suspension of licence. 14. Standards to which products are to conform. 15. Sale of products not in conformity with standards. 16. Interpretation. 17. Prohibition of certain representations in advertisements. 18. Advertisements to contain name, etc. 19. Order prohibiting false or misleading representation or names. 20. Establishment of pharmacy board. 21. Determination of Pharmacy Board procedural requirements, etc. 22. Functions of the Pharmacy Board. 23. Registration of pharmacies. 24. Application for registration of a pharmacy. 25. Grant of pharmacy registration and licence. 26. Term of pharmacy licence. 27. Cancellation or suspension of pharmacy licence. 28. Regulation of pharmacists. 29. Duties of pharmacists. 30. Supply of certain medicinal products, etc. 31. Certain prohibited advertisements. 32. Institution of prosecutions. 33. Application of this part. 34. Appointment of inspectors. 35. Powers of inspectors. 36. Release of seized products. 37. Orders that seized products be forfeited. 38. Expenses of seizure, etc. 39. Storage, etc., of seized products. 40. Forfeiture of products by consent. 41. Disposal of forfeited products. 42. Obstruction of inspectors. 43. Appointment of analysts, etc. 44. Analysis. 45. Minister may require information as to medicinal products, etc. 46. Ministerial orders in relation to medicinal products and cosmetics. 47. Prohibition of sale by automatic machines. 48. Hawking, etc., of medicinal products. 49. Evidence. 50. Liability of employers for acts of employees. 51. Offences by corporations. 52. Appeals against decisions of licensing authority. 53. Advisory committees. 54. Regulations. 55. Repeal. 56. Saving of existing licences, etc. 57. Actions, etc., not to abate. 58. Application of Acts, etc.
INDEPENDENT STATE OF PAPUA NEW GUINEA.
AN ACT
entitled
Medicines and Cosmetics Act 1999,
Being an Act–
(a) to make provisions with respect to medicinal products and medical advertisements and matters connected therewith; and (b) to repeal the Pharmacy Act (Chapter 94) and the Therapeutic Goods and Cosmetics Act 1984; and (c) to make consequential amendments to the Poisons and Dangerous Substances Act 1952,
and for related purposes.
PART I. – PRELIMINARY.
1. COMPLIANCE WITH CONSTITUTIONAL REQUIREMENTS.
(1) This Act, to the extent that it regulates or restricts the rights or freedoms conferred by Division III.3.C. (Qualified rights) of the Constitution, namely–
(a) the right to freedom from arbitrary search and entry conferred by Section 44 of the Constitution; and (b) the right to freedom of expression conferred by Section 46 of the Constitution; and (c) the right to privacy conferred by Section 49 of the Constitution; and (d) the right to freedom of movement conferred by Section 52 of the Constitution,
is a law that is made for the purpose of giving effect to the public interest in public order and public welfare.
(2) For the purposes of Section 41 of the Organic Law on Provincial Governments and Local-level Governments, it is declared that this Act relates to a matter of national interest.
2. INTERPRETATION.
(1) In this Act, unless the contrary intention appears–
“advertisement”, in relation to any product, means an advertisement published–
(a) in a newspaper, magazine or other publication; or (b) in a circular, handbill, poster or other notice; or (c) orally or by any means of producing or transmitting light or sound; or (d) in any other manner,
for the purposes of promoting, directly or indirectly, the sale or use of that product; “analysis”, in relation to any product, means any bacteriological, biochemical, biological, chemical, electrical, electrochemical, micro-biological, pathological, physical or other examination or test for ascertaining the presence or absence of any substance or organism or the composition or other qualities of that product; “analyst” means a person appointed under Section 43; “animal” includes any bird, fish or reptile; “appointed day”, in relation to a provision of this Act, means the date determined by the Minister under Section 5 to be the appointed day in relation to that provision; “container”, in relation to any product, means the vessel, bottle, tube, tin, box, case, wrapper, cover or other similar receptacle or envelope which immediately covers the product; “cosmetic” means any substance or preparation, other than a medicament, intended to come into contact with the various external parts of the human body such as epidermis, hair system, nails, lips, eyelids, teeth, and mucous membranes, with a view to cleaning, protecting or keeping them in good condition, changing their appearance or perfuming or correcting their odour, but does not include a soap; “dentist” means a person registered as a dentist under the Medical Registration Act 1980; “Departmental Head” means the Departmental Head of the Department responsible for health matters; “device” means any instrument, apparatus or contrivance, and includes any component, part or accessory of that instrument; “expiry date”, in relation to a product, means a day after which they may be expected to cease to conform to any standard applicable to it; “inspector” means a person appointed under Section 34; “label” includes any tag, brand, mark or written statement on, or attached to, or used in connection with, any container or package containing any product; “licence” means a licence granted and issued under this Act and not cancelled or suspended; “licensing authority” means the Departmental Head; “manufacture”, in relation to any product, means the manufacture or preparation of the product and includes–
(a) any part of the manufacture or preparation of the product; and (b) the packaging and labelling of the product;
“medical practitioner” means a person registered as a medical practitioner under the Medical Registration Act 1980; “medical device” means any device–
(a) the sole or principal use of which is, or ordinarily is, a therapeutic use; or (b) that is represented to be, or might reasonably be taken to be, for medicinal purposes;
“medicament” means a substance used internally or externally in medical treatment; “medicinal product” means a medicinal substance or a medical device intended for use for medicinal purposes; “medicinal purpose” means a use for the purpose of or in connection with–
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in humans or animals; or (b) influencing, inhibiting or modifying a physiological process in humans or animals; or (c) testing the susceptibility of humans or animals to a disease or ailment; or (d) destroying or inhibiting micro-organisms that may be harmful to humans or animals;
“nurse” means a person registered as a nurse under the Medical Registration Act 1980; “package”, in relation to any product, includes every means by which the product may, for transport or for storage or for sale, be cased, covered, enclosed, contained or packed; “Pharmacy Board” means the Pharmacy Board of Papua New Guinea established by Section 20; “pharmacist” means a person registered as a pharmacist with the Pharmacy Board or any person who had been registered as a pharmacist with the Papua New Guinea Medical Board under the Medical Registration Act 1980 prior to the commencement of this Act; “pharmacy licence” means a licence issued under Section 25; “pharmacy technician” means a person registered as a pharmacy technician with the Pharmacy Board or any person who had been registered as a pharmacy technician with the Papua New Guinea Medical Board under the Medical Registration Act 1980 prior to the commencement of this Act; “premises” includes land, a ship, aeroplane or other vehicle or vessel; “product” means a medicinal product, medical device or a cosmetic declared under Section 3 or 6 to be a medicinal product, medical device or a cosmetic to which this Act applies; “product for animal use only” means, subject to Subsection (2), any product that–
(a) bears any particulars, in accordance with Subsection (2), that constitute, or might reasonably be taken for, a statement that the product is intended for animal use and not to be intended for human use; or (b) is otherwise represented, whether by writing or otherwise, or otherwise purports, to be intended for animal use and not intended for human use;
“product licence” means a product licence granted under Part II; “public institution” means–
(a) a Government Department or a public hospital or a university in the country; or (b) any other institution or establishment which the Minister, by notice in the National Gazette, declares to be a public institution for the purposes of this Act;
“publish” includes cause, allow or permit to be published; “Register of Pharmacists and Pharmacy Technicians” means the register established under Section 22(d); “Register of Pharmacies” means the Register of Pharmacies established under Section 22(c); “sale” includes sale whether by wholesale or retail, and includes dealing in, agreeing to sell, or offering or exposing for sale, or keeping or having in possession for sale, or sending, forwarding, delivering or receiving for sale or on sale, or authorizing, directing, causing, permitting or attempting any of those acts or things; “standards” means the standards referred to in Part III; “substance” includes preparation or a mixture and all salts and derivatives of any substance; “this Act” includes the regulations; “veterinary surgeon” means a person registered as a veterinary surgeon under the Veterinary Surgeons Act 1966; “wholesale dealing”, in relation to any product–
(a) means the sale or supply of the product in the ordinary course of wholesale dealing for the purposes of resale; and (b) includes the sale or supply in wholesale quantities in the ordinary course of wholesale dealing and for use in any public institution or in connection with any prescribed profession, business, trade or industry carried on by any person who satisfies the wholesale dealer that he bona fide requires the product for use, but not for resale, in connection with that profession, business, trade or industry.
(2) For the purposes of the definition of “product for animal use only” in Subsection (1), a product is deemed to bear any particulars where those particulars are set out on–
(a) the product or any part of the product; or (b) a container or package of the product or any part of the product; or (c) a label attached to the product or any part of the product; or (d) a label attached to a container or package of the product or any part of the product.
3. DECLARATION BY MINISTER IN CASE OF DOUBT.
The Minister may, by notice in the National Gazette, declare any product–
(a) to be–
(i) a medicinal product; or (ii) a medical device; or (iii) a cosmetic; or
(b) not to be–
(i) a medicinal product; or (ii) a medical device; or (iii) a cosmetic,
to which this Act applies where he is of the opinion that, but for the declaration, doubt would exist whether or not the product is a medicinal product, a medical device or a cosmetic, as the case may be, to which this Act applies.
4. EXEMPTIONS.
(1) The Minister may, by notice in the National Gazette, exempt a person or class of persons, or any product or class of products specified or described in the notice, from all of the provisions of this Act or such of the provisions of this Act as are specified or described in the notice.
(2) An exemption under this section may be made unconditionally or subject to such conditions as are specified or described in the notice.
(3) The licensing authority may permit the importation of any medicinal product–
(a) by a person for the purpose of administering the medicinal product to himself or to any member of his family; or (b) by a doctor, dentist or veterinary surgeon for the purpose of administering the medicinal product to a patient under his care; or (c) by a pharmacist pursuant to any prescription given by a doctor, dentist or veterinary surgeon,
without a product licence where the quantity of the medicinal product does not exceed three months’ supply based on the dosage recommended by the manufacturer or supplier of the product.
5. APPOINTED DAY.
(1) The Minister may, by notice in the National Gazette, fix a date to be an appointed day for the purposes of this Act.
(2) A date fixed by the Minister as an appointed day under Subsection (1) shall be the date on which–
(a) a provision of this Act specified in the notice shall come into operation; and (b) the repeal of a provision of an Act repealed by Section 55 and specified in the notice shall come into effect; and (c) the repeal of a provision of the Poisons and Dangerous Substances Act 1952 and specified in the notice shall come into effect.
PART II. – CONTROL AND LICENSING OF PRODUCTS AND DEALERS OF PRODUCTS.
Division 1.
General.
6. DEALING, ETC., WITH PRODUCTS.
(1) The Minister may, by notice in the National Gazette, declare a medicinal product, a medical device or a cosmetic to be a product to which this Part applies.
(2) Subject to Subsection (3), a person, who, with effect from the appointed day, imports, manufactures, sells, supplies or otherwise deals with a product without a licence granted under this Part, is guilty of an offence.
Penalty: A fine of not exceeding K5,000.00 or imprisonment for a term not exceeding 12 months, or both.
(3) The Minister may, in relation to any medicinal product which was available for sale in Papua New Guinea immediately before the coming into operation of this Part, exempt by notice in the National Gazette such medicinal product from the application of Subsection (2) for such period as is specified in the notice.
(4) The licensing authority may, on application in accordance with Division 2 by a person who is not the holder of a product licence, grant an import licence in accordance with Division 2 to that person to import, for sale or supply, a medicinal product that is not otherwise declared under Subsection (1) where the licensing authority is satisfied that the product is, in all respects, the same as a medicinal product registered under product licence.
7. MANUFACTURE OF PRODUCTS.
(1) Subject to Subsection (3), a person shall not, with effect from the appointed day, on any premises, manufacture for sale a product to which this Part applies unless the manufacture by him of that product is authorized by a licence granted under this Part.
(2) A person, who contravenes Subsection (1), is guilty of an offence.
Penalty: A fine not exceeding K5000.00 or imprisonment for a term not exceeding 12 months, or both.
(3) The provisions of Subsection (2) do not apply to the manufacture of a medicinal product to which this Part applies–
(a) by a medical practitioner or dentist for use in the treatment of a patient under his care; or (b) by a pharmacist on the premises on which the business of the pharmacist is carried out in open shop; or (c) on the premises of a public health institution for sale (otherwise than by wholesale) on or from those premises.
8. PRESCRIPTION ONLY, PHARMACY ONLY AND OVER THE COUNTER PRODUCTS.
(1) The licensing authority shall establish, maintain and publish–
(a) a list of medicinal products that can only be dispensed or supplied by a pharmacist on a prescription given by a medical practitioner, dentist or veterinary surgeon; and (b) a list of medicinal products that can be sold or supplied without prescription issued by a medical practitioner, dentist or veterinary surgeon, but under the supervision of a pharmacist; and (c) a list of medicinal products that can generally be sold over the counter without the supervision of a pharmacist.
(2) A person, other than a medical practitioner, dentist, veterinary surgeon, pharmacist or a person licensed under this Act to do so, who sells or supplies a product specified in–
(a) the list of prescription only medicinal products referred to in Subsection (1)(a); or (b) a pharmacy only medicinal product referred to in Subsection (1)(b),
is guilty of an offence.
Penalty: A fine not exceeding K5,000.00 or imprisonment for a term not exceeding 12 months, or both.
(3) Notwithstanding Subsection (2), the supply of a medicinal product by a medical practitioner, dentist or veterinary surgeon shall be for treatment of his patients only.
Division 2.
Licences.
9. APPLICATION FOR LICENCE.
(1) A person may apply to the licensing authority for a product licence or a licence authorizing him–
(a) to manufacture on specified premises a medicinal product or a cosmetic or a medicinal device; or (b) to sell by wholesale or retail a medicinal product or a cosmetic or a medicinal device; or (c) to import a medicinal product or a cosmetic or a medicinal device for sale or distribution; or (d) to sell by retail a medical device or a cosmetic or a medicinal device,
to which this Part applies.
(2) An application for a licence shall be–
(a) in the prescribed form; and (b) lodged with the licensing authority; and (c) accompanied by the prescribed non-refundable application fee.
10. CONSIDERATION OF APPLICATION FOR LICENCE.
(1) In considering an application for a licence, the licensing authority shall take into consideration–
(a) the safety, efficacy and quality of the product before granting a product licence; and (b) in relation to an imported product and in addition to Paragraph (a) the fact that the product is registered with the relevant licensing authority of the country from which it is to be imported and that it is manufactured in a factory approved for its manufacture by the licensing authority of that country; and (c) in relation to the premises in which manufacturing operation is to be carried out–
(i) the availability of manufacturing equipment; and (ii) the qualifications of the person supervising the manufacturing operation; and (iii) the storage and safekeeping of manufactured products; and (iv) adequate record keeping; and
(d) the premises and the conditions for storage and safe keeping of the product, the availability of equipment and facilities for distribution and adequate record keeping before granting a wholesaler’s licence or a licence for retailing.
(2) In considering an application under this section, the licensing authority may request the applicant to provide such further and better information as he considers necessary.
11. GRANT OF LICENCE.
(1) Where the licensing authority has considered an application under Section 10, he may–
(a) grant the application and issue the licence; or (b) refuse the application and notify the applicant forthwith giving the reasons for the refusal.
(2) A product licence granted under Subsection (1)(a)–
(a) shall be in the prescribed form; and (b) shall contain such conditions as are determined by the licensing authority and specified in the licence; and (c) is subject to the conditions specified in the licence; and (d) subject to Subsection (3), comes into force on the date specified in the licence, or, where a date is not specified, on the date on which it is granted; and (e) is subject to the payment of the prescribed licence fee; and (f) is not transferable.
(3) Notwithstanding Subsection (2)(d), a product licence shall not come into force unless the prescribed licence fee has been paid.
12.