法邦网—法律法规查看

(Cap 138, section 29) [1 July 1978] L.N. 145 of 1978 (L.N. 163 of 1975) Cap 138A reg 1 Citation PART I PRELIMINARY These regulations may be cited as the Pharmacy and Poisons Regulations. Cap 138A reg 2 Interpretation (1) In these regulations, unless the context otherwise requires- "antimonial poisons" (含锑毒药) means organic and inorganic compounds of antimony; "arsenical poisons" (含砷毒药) means organic and inorganic compounds of arsenic; "British Pharmaceutical Codex" (英国药学药典), "British Pharmacopoeia" (英国药典), "British National Formulary" (英国国家处方集) and "British Veterinary Codex" (英国兽医药方集) include the supplements thereto; "food" (食物) includes a beverage; "medicine for the internal treatment of human and animal ailments" (用于治疗人类及动物病患的内服药物) includes any medicine to be administered by injection, but does not include any mouth-wash, eye-drops, eye-lotion, ear-drops, nasal drops, douche or similar article; "Tribunal" (审裁处) means the Pharmacy and Poisons Appeal Tribunal established by section 30 of the Ordinance; (L.N. 369 of 1980) "veterinary institution" (兽医机构) means a veterinary hospital, veterinary clinic or other premises where sick animals are treated. (2) In these regulations any reference to an alkaloid shall include a reference to any salt of that alkaloid, and, in a case where the esters of an alkaloid are included in the Poisons List by virtue of the words "its esters", to any esters of that alkaloid. (3) Any reference in the Schedules to these regulations to the percentage of a poison contained in any substance or preparation shall, unless otherwise expressly provided, be construed in the following manner, that is to say, a reference to a substance or preparation containing 1 per cent of any poison means- (a) in the case of a solid, that 1 gramme of the poison is contained in every 100 grammes of the substance or preparation; (b) in the case of a liquid, that 1 millilitre of the poison, or, if the poison itself is a solid, 1 gramme of the poison, is contained in every 100 millilitres of the substance or preparation,and so in proportion for any greater or less percentage. (4) Substances listed under the headings "A" in the Schedules to these regulations are those whose uses are essentially medicinal, whilst substances listed under the headings "B" are not normally used medicinally. (5) Where in these regulations reference is made to a numbered section the reference shall be a reference to that section of the Ordinance. (6) Where functions are conferred on a committee by any provision of these regulations, references in such provision to "the Committee" shall be construed as references to the executive committee established under section 4A of the Ordinance for the purpose of performing such functions. (L.N. 369 of 1980) Cap 138A reg 3 Application of section 22 restricted to the First Schedule Section 22 shall only apply to those poisons included in Part I of the Poisons List as set out in the Schedule to the Poisons List Regulations (Cap 138 sub. leg.) which are also included in the First Schedule but not included in the Third Schedule. (L.N. 202 of 1999) Cap 138A reg 4 Extension of labelling provisions and relaxation with respect to poisons in the Sixth Schedule (1) Subject to paragraph (2), the provisions of section 27 and regulations 12 to 17 (which provisions relate to the labelling of poisons) shall apply to sales exempted by section 32, and shall also apply to the supply of poisons (otherwise than on sale) and references in those provisions to the sale and the seller of poisons shall be deemed to refer to the supply and the supplier of poisons respectively. (2) In the case of the sale or supply of any of the poisons included in the Sixth Schedule to a person who- (a) carries on a business in the course of which poisons are regularly sold by way of wholesale dealing or are regularly used in the manufacture of other articles; and (b) requires the poison for the purpose of that business,if the outside of the package in which the poison is sold or supplied is labelled conspicuously with words indicating the dangerous properties of the poison, it shall be necessary to comply only with regulation 15 and section 27(a) and section 27(d) (as modified by regulation 17). Cap 138A reg 5 Extension of section 22 to sales wholesale etc. and relaxation of the section (1) Section 22 shall apply to sales exempted by section 32, except sales of poisons to be exported to purchasers outside Hong Kong, and shall also apply to the supply in the form of a commercial sample, otherwise than on sale, of any substance included in the First Schedule in like manner as if references in section 22 to the sale and seller of poisons respectively included references to the supply and the supplier of poisons in the form of commercial samples: Provided that section 22 shall not apply to the sale or supply of any article by the manufacturer thereof or by a person carrying on a business in the course of which poisons are regularly sold by way of wholesale dealing, if- (a) the article is sold or supplied to a person carrying on a business in the course of which poisons are regularly sold or are regularly used in the manufacture of other articles; and (b) the seller or supplier is reasonably satisfied that the purchaser requires the article for the purpose of that business.(2) Section 22(1) shall, in its application to sales exempted by section 32 and to the supply in the form of commercial samples of substances included in the First Schedule, be deemed to be satisfied if the person to whom the poison or sample is sold or supplied is known by the person in charge of the department of the business through which the sale or supply is effected to be a person to whom the poison or sample may properly be sold or supplied. (3) Subject to paragraph (4), so much of section 22(3)(b) as requires an entry in the poisons book to be signed by the purchaser of a poison shall not, as respects the sale of a poison to a person for the purpose of his trade, business or profession, apply if the following requirements are satisfied- (a) the seller shall obtain before the completion of the sale an order in writing signed by the purchaser stating his name and address, trade, business or profession, the name and quantity of the article to be purchased, and the purpose for which it is required; (b) the seller shall be reasonably satisfied that the signature is that of the person purporting to have signed the order, and that that person carries on the trade, business or profession stated in the order, being one in which the poison to be purchased is used; and (c) if the article sold is sent by post, it shall be sent by registered post.(4) Where a person represents that he urgently requires a poison for the purpose of his trade, business or profession, the seller may, if he is reasonably satisfied that the person so requires the poison and is, by reason of some emergency, unable before delivery either to furnish to the seller an order in writing duly signed or to attend and sign the entry in the book, deliver the poison to the purchaser on an undertaking by the purchaser to furnish such an order within 48 hours next following. (5) Any purchaser by whom an undertaking under paragraph (4) has been given who fails to deliver to the seller a signed order in accordance with the undertaking, or any person who for the purpose of obtaining delivery of any poison makes a statement which is to his knowledge false in any material particular shall be guilty of an offence and shall be liable on conviction to a fine of $10000 and to imprisonment for 12 months. (6) In the case of a sale or the supplying of a poison included in the First Schedule to an institution such of the provisions of this regulation as require the purchaser to state his trade, business or profession and the seller to be satisfied with respect thereto shall not apply and for the reference in paragraph (4) to the purposes of the purchaser's trade, business or profession there shall be substituted in the case of any such sale a reference to the name of the institution and the full name and rank or position held at the institution of the person making the order. Cap 138A reg 6 Relaxation of section 28(3) in the case of certain medicines The requirements of section 28(3) (which requires particulars of medicines supplied or dispensed under that section to be entered in a book) shall be satisfied in respect of medicines included in the First Schedule, but need not be satisfied in respect of other medicines which are supplied by- (a) a registered medical practitioner for the purposes of medical treatment; or (b) an authorized seller of poisons on and in accordance with a prescription given by a registered medical practitioner. Cap 138A reg 7 Exemption from the provisions relating solely to the First Schedule The provisions of these regulations and of the Ordinance (as modified by these regulations) which apply solely to the substances in the First Schedule shall not apply to- (a) machine-spread plasters; (b) surgical dressings; (c) (Repealed L.N. 262 of 1995) (d) corn paints in which the only poison is a poison included in the Poisons List under the heading "Cannabis". Cap 138A reg 8 Complete exemption for articles and substances in the Second Schedule (1) Subject to paragraph (2), nothing in the Ordinance or these regulations shall apply- (a) to any article in Group I of the Second Schedule; or (b) to any of the articles or substances specified in the second column of Group II of the Second Schedule opposite the description of the poison specified in the first column thereof. (L.N. 85 of 1987)(2) Notwithstanding paragraph (1)(b), Parts VII, VIII, VIIIA, IX and X of these regulations shall apply to every article or substance referred to in that paragraph, that is a pharmaceutical product within the meaning of the Ordinance. (L.N. 85 of 1987) Cap 138A reg 9 Additional restriction of sale of poisons in the Third Schedule PART II ADDITIONAL RESTRICTIONS ON THE SALE OF POISONS (1) No person shall sell any poison included in the Third Schedule, except on and in accordance with a prescription given by a registered medical practitioner, registered dentist or registered veterinary surgeon. (L.N. 614 of 1997) (2) This regulation shall apply to the sale of any such poison, including a medicine exempted by section 28, but shall not apply to any sale exempted by section 32. (3) For the purposes of this regulation a prescription shall- (a) be in writing and be signed by the person giving it with his usual signature and be dated by him; (b) specify the address of the person giving it; (c) specify the name and address of the person for whose treatment it is given or, if the prescription is given by a registered veterinary surgeon, of the person to whom the medicine is to be delivered; (L.N. 614 of 1997) (d) have written thereon, if given by a dentist, the words "For dental treatment only 衹限牙科医疗用", or, if given by a registered veterinary surgeon, the words "For animal treatment only 衹限医治禽畜用"; and (L.N. 614 of 1997) (e) indicate the total amount of the medicine to be supplied and the dose to be taken or administered.(4) The person dispensing the prescription shall comply with the following requirements- (a) the prescription shall not be dispensed more than once unless the prescriber has directed either- (i) that it may be dispensed a stated number of times; or (ii) that it may be dispensed at stated intervals;(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals, it shall not be dispensed otherwise than in accordance with the direction; (c) at the time of dispensing there shall be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed; and (d) except in the case of a prescription which may be dispensed again, the prescription shall, for a period of 2 years, be retained and kept on the premises on which it was dispensed in such manner as to be readily available for inspection. Cap 138A reg 10 Restriction of sales by listed sellers of poisons No listed seller of poisons shall sell any poison other than a solution of ammonia, hydrochloric acid, nitric acid, potassium quadroxalate or sulphuric acid, except in a closed container as closed by the manufacturer or other person from whom the poison was obtained. Cap 138A reg 10A Prohibition on dispensing of prescriptions by listed sellers of poisons No listed seller of poisons shall dispense any prescription for medicine. (L.N. 85 of 1987) Cap 138A reg 11 Restriction of sale of strychnine (1) No person shall sell or supply strychnine except as an ingredient in a medicine. (2) This regulation shall extend to transactions exempted by section 32, but shall not apply to the sale of strychnine- (a) by way of wholesale dealing; (b) to be exported to purchasers outside Hong Kong; (c) for the purpose of being compounded in medicines prescribed or administered by a registered medical practitioner or registered veterinary surgeon; or (L.N. 614 of 1997) (d) to a person or institution concerned with education, scientific research or chemical analysis, for the purpose of that education, research or analysis. Cap 138A reg 12 Manner of labelling containers Expanded Cross Reference: 13,14,15,16,17 PART III SUPPLEMENTARY PROVISIONS WITH RESPECT TO LABELLING AND CONTAINERS (1) Subject to paragraphs (2) and (3), the particulars with which the container of a poison is required to be labelled under section 27 and under these regulations, shall appear in a conspicuous position on the container in which the poison is sold and on every box or other covering of whatever nature enclosing the container, and the particulars shall be clearly and distinctly set out and not in any way obscured or obliterated. (2) Where the poison is contained in a cachet or similar article it shall not be necessary to label the article itself, if every box or other covering in which the article is enclosed is labelled in accordance with paragraph (1). (3) Nothing in section 27 or in this regulation or regulations 13 to 17 shall be deemed to require the labelling of any transparent cover or any wrapper, hamper, packing case, crate or other covering used solely for the purposes of transport or delivery. Cap 138A reg 13 Labelling of name of poison (1) For the purposes of section 27(a) and regulation 22(3)(a), the name of a poison shall be the term under which it is included in the Poisons List: Provided that, where the term describes a group of poisons and not the poison specifically, the name of the poison shall be- (a) if the poison is the subject of a monograph in either the British Pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex, one of the names or synonyms or abbreviated names set out at the head of the monograph; or (b) in any other case, the accepted scientific name or the name descriptive of the true nature and origin of the poison.(2) For the purposes of the proviso to paragraph (1), where- (a) a substance is the subject of a monograph in the British Pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex, or any dilution, concentration or admixture of such substance; or (b) a preparation is contained in the British Pharmacopoeia, the British Pharmaceutical Codex, the British National Formulary or the British Veterinary Codex, or any dilution, concentration or admixture of such preparation; or (c) a surgical dressing of a type for which a standard is prescribed in the British Pharmaceutical Codex,it shall be sufficient to state the name, synonym or abbreviated name used to describe the substance, preparation or surgical dressing with the addition of the letters B.P., B.P.C., B.N.F. or B. Vet.C., as the case may be. Cap 138A reg 14 Labelling of particulars as to proportions of the poison For the purpose of section 27(b) (which requires preparation containing poisons to be labelled with particulars as to the proportion of each poison therein)- (a) in the case of a preparation containing a poison specified in the first column of the Fourth Schedule, it shall be sufficient to state on the label the particulars specified in the second column of that Schedule against the description of the poison; (b) in the case of a substance, preparation or surgical dressing which is named in accordance with regulation 13(2), it shall not be necessary to state on the label the proportion of the poison contained in the substance, preparation or surgical dressing, and in the case of any dilution, concentration or admixture of such substance or preparation it shall be sufficient to state the proportion which the substance or preparation bears to the total ingredients of that dilution, concentration or admixture; (c) where the poison is in tablets, pills, cachets, capsules, lozenges or similar articles, it shall be sufficient to state on the label of the box or other covering in which the articles are enclosed the number of the articles and the amount of the poison, or in the case of a preparation or substance mentioned in paragraph (b), the amount of the preparation or substance, contained in each article; (d) where the poison is in ampoules it shall be sufficient to show the name of the poison contained in it together with, either its concentration (if in solution or in emulsified form), or the quantity (if in solid form); and (e) where any proportion is stated as a percentage, the statement shall indicate whether the percentage is calculated on the basis of weight in weight, weight in volume, or volume in volume. Cap 138A reg 15 "Poison" to be in English and Chinese (1) The word "poison" or other statement as specified in the Fifth Schedule with which a container of a poison is required to be labelled pursuant to section 27(c) shall be printed clearly in both English and Chinese. (2) The container of any article specified in the Fifth Schedule shall, instead of being labelled with the word "Poison 毒药" be labelled with the words specified in that Schedule as applicable to that article. (3) The words referred to in paragraph (2) or the word "Poison 毒药", as the case may be, shall not be modified in meaning by the addition of any other words or marks, and- (a) in the case of a substance included in the First Schedule, shall either be in red lettering or be set against a red background; and (b) in all cases shall either be on a separate label or be surrounded by a line within which there shall be no other words except words with which the container of the poison is required to be labelled under the Ordinance or these regulations. (L.N. 137 of 1978) Cap 138A reg 16 Special precautions in the case of certain articles (1) No person shall sell or supply any poison- (a) in the case of a liquid other than a medicine, in a container of a capacity of not more than 2 litres, unless the container is labelled with the words "Not to be taken 忌食"; and (b) in the case of an embrocation, liniment, lotion, liquid antiseptic, or other liquid medicine for external application, unless the container is labelled with the type of preparation and the words "For external use only 衹供外用". (L.N. 137 of 1978)(2) No person shall sell or supply any compressed hydrocyanic acid, unless the container thereof is labelled with the words "Warning. This container holds poisonous gas and should only be opened and used by persons having expert knowledge of the precautions to be taken in its use. 警告：此容器内载毒气，衹限由具有专门知识而在使用上知所提防之人士开启及使用.". (3) This regulation shall be in addition to the other requirements of the Ordinance and of these regulations with respect to labelling and shall apply to the transactions referred to in sections 28 and 32, but shall not apply to the sale or supply of poisons to be exported to purchasers outside Hong Kong. (L.N. 22 of 1982) Cap 138A reg 17 Name of seller and address of premises (1) Section 27(d) (which requires the container of a poison to be labelled with the name of the seller and the address of the premises on which it was sold) shall apply to the transactions referred to in section 32, but shall not apply- (a) in the case of an article sold for the purpose of being sold again in the same container; or (b) to poisons to be exported to purchasers outside Hong Kong.(2) The requirements of section 27(d) shall be deemed to be satisfied, in the case of a poison supplied from a warehouse or depot, if the container of the poison is labelled with the address of the supplier's principal place of business. (3) Where any poison (other than a substance included in the First Schedule) is sold in a container and outer covering, being the container and covering in which it was obtained by the seller, it shall be sufficient if the name of the seller and the address of the premises on which it was sold appear only on the outer covering. (4) Where the names of more than one person or more than one address appear on any label, there shall also be words on the label indicating clearly which person is the seller and at which of the addresses the poison was sold. Cap 138A reg 18 Form of containers (1) No person shall sell, whether wholesale or retail, or supply any poison unless- (a) it is contained in a container impervious to the poison and sufficiently stout to prevent leakage arising from the ordinary risks of handling and transport; and (b) in the case of a liquid contained in a glass bottle or plastic container containing not more than 2 litres, not being a medicine made up ready to be taken for the internal treatment of human or animal ailments, the outer surface of the bottle or container is fluted vertically with ribs or grooves recognizable by touch. (L.N. 22 of 1982)(2) Paragraph (1)(a) shall apply to the transactions referred to in section 28, and paragraph (1)(b) shall apply to the transactions exempted by section 32 but shall not apply to the sale or supply of poisons to be exported to purchasers outside Hong Kong. Cap 138A reg 19 Storage of poisons PART IV STORAGE AND TRANSPORT (1) No person shall store any poison except in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary risks of handling. (2) No person shall store any substance included in the First Schedule in any retail shop or premises used in connection therewith unless the substance is stored- (a) in a receptacle reserved solely for the storage of poisons, which receptacle shall be locked with an adequate lock the key for which shall be retained by the registered pharmacist; and (L.N. 197 of 1989; L.N. 366 of 1995) (b) in a part of the premises to which customers are not permitted to have access and which is partitioned off or otherwise separated from the remainder of the premises.(3) No food shall be stored in the part of the premises where such poison or substance is stored. Cap 138A reg 20 Transport of poisons No person shall consign any poison for transport unless it is sufficiently stoutly packed to avoid leakage arising from the ordinary risks of handling and transport. Cap 138A reg 21 Special provisions with respect to the transport of poisons in the Seventh Schedule (1) No person shall consign for transport by carrier any poison included in the Seventh Schedule unless the outside of the package containing the article is labelled conspicuously with the name or description of the poison as set forth in that Schedule and a notice indicating that it is to be kept separate from food and from empty containers in which food has been contained. (2) No person shall knowingly transport any poison included in the Seventh Schedule, either on his own behalf or for another person, in any vehicle in which food is being transported, unless the food is carried in a part of the vehicle effectively separated from that containing the poison, or is otherwise adequately protected from the risk of contamination. (3) This regulation shall not apply to medicines. Cap 138A reg 22 Supply of medicines to out-patients from certain institutions, etc. PART V SPECIAL PROVISIONS WITH RESPECT TO INSTITUTIONS (1) Nothing in the Ordinance or in these regulations, except regulation 16 and this Part, shall apply with respect to- (L.N. 262 of 1995) (a) any medicine dispensed in an institution where the dispensing is under the supervision of a registered pharmacist or other person as may be approved by the Director of Health; or (L.N. 76 of 1989) (b) any medicine for the treatment of animals supplied from a veterinary institution which is under the superintendence of a registered veterinary surgeon, (L.N. 614 of 1997)if the requirements of this regulation are satisfied in relation thereto. (2) The medicine shall not be supplied except by, or on and in accordance with a prescription of, a duly registered medical practitioner for the purposes of medical treatment, or a registered dentist for the purposes of dental treatment, or a registered veterinary surgeon for the purposes of animal treatment. (L.N. 614 of 1997) (3) In a case where a substance included in the First Schedule is supplied, a record shall be kept on the premises in such a way that there can readily be traced at any time during a period of 2 years after the date on which the substance was supplied the following particulars- (a) the name and quantity of the poison supplied; (b) the date on which the poison was supplied; (c) the name and address of the person to whom the poison was supplied; and (d) the name of the person who supplied the poison or who gave the prescription upon which it was supplied.(4) The container of the medicine shall be labelled- (a) with a designation sufficient to identify the institution or veterinary institution from which it was supplied; (L.N. 137 of 1978) (b) except in the case of a medicine made up ready for treatment, with the word "Poison 毒药"; (c) in the case of a poison supplied from a veterinary institution, with the words "For animal treatment only 只限医治禽畜用".(5) The medicine shall be clearly labelled with instructions for use in English and in Chinese. (6) In the case of a medicine to which regulation 16 applies the requirements of that regulation shall be satisfied in addition to the requirements of this regulation. Cap 138A reg 23 Supply of medicines for use in institutions, etc. (1) In any institution in which medicines are dispensed in a dispensing or pharmaceutical department in charge of a registered pharmacist or any other person approved by the Director of Health for that purpose, no medicine containing a poison shall be supplied from that department, except in cases of emergency, for use in the wards, operating theatres or other sections of the institution, except in accordance with paragraphs (2) and (3). (L.N. 76 of 1989) (2) Subject to paragraph (4), the medicines shall not be supplied except upon a written order signed by a duly registered medical practitioner, registered dentist, or by a person authorized to be in charge of a ward, theatre or other section of the institution. (3) The container of the medicine shall be labelled- (a) with words describing its contents; (b) in the case of substances included in the First Schedule, with a distinguishing mark or other indication indicating that the poison is to be stored in a cupboard reserved solely for the storage of poisons.(4) In the case of an emergency, a medicine containing a poison may be supplied without a written order if the person ordering the medicine undertakes to furnish a written order in respect of that medicine within the next 24 hours. Cap 138A reg 24 Storage of poisons in institutions (1) In any institution in which medicines are dispensed in a dispensing or pharmaceutical department in the charge of a person appointed for the purpose, all poisons other than those issued for use within the institution shall be stored in that department. (2) In any institution to which paragraph (1) does not apply all poisons other than those issued for use within the institution shall be stored- (a) in the charge of a person appointed for the purpose by the governing body or person in control of the institution; and (b) in the case of substances included in the First Schedule either in a cupboard or drawer, or on a shelf, reserved solely for the storage of poisons.(3) No poison shall be stored on an open shelf, unless the container of the poison is distinguishable by touch from the containers of any other substances stored in the same premises. (L.N. 137 of 1978) (4) In every institution, every substance in the First Schedule which is stored in the wards shall be stored in a locked cupboard reserved for the storage of poisons. (L.N. 137 of 1978) (5) All places in which poisons are required by this regulation to be stored shall be inspected at regular intervals of time not exceeding three months by a registered pharmacist or registered medical practitioner appointed for the purpose by the governing body of the institution and a record of all inspections shall be made in a book kept at the institution. Cap 138A reg 24A Applications to be entered on list under section 25 PART VA LISTED SELLERS OF POISONS (1) Any application under section 25(1) shall be made in writing to the Committee and shall be accompanied by the fee specified in the Ninth Schedule. (2) The Committee may grant or refuse any application under this regulation and shall notify the applicant of its decision: Provided that if the Committee intends to refuse an application the Committee shall first notify the applicant and the applicant may, not later than 14 days after the date of such notification, submit representations in writing to the Committee in support of his application. (3) Where the Committee grants an application under this regulation the Committee shall notify the Board of its decision and shall state whether the applicant has paid the prescribed fee. (4) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (Part VA added L.N. 369 of 1980) Cap 138A reg 24B Applications to register premises under section 13 PART VB REGISTRATION OF PREMISES An application to register premises under section 13 shall be- (a) made to the Board in the form prescribed in the Eighth Schedule; and (See Eighth Schedule, Form 15) (b) submitted together with a copy of the certificate of registration of the registered pharmacist in whose presence or under whose supervision the actual sale of poisons will be conducted under section 11(1) of the Ordinance. (L.N. 85 of 1987) Cap 138A reg 24C Certificate of registration under section 13 A certificate of registration under section 13 shall be in the form prescribed in the Eighth Schedule. (See Eighth Schedule, Form 16) (L.N. 85 of 1987) Cap 138A reg 25 Sale and supply of poisons wholesale PART VI WHOLESALE DEALERS No person other than an authorized seller of poisons or a licensed manufacturer selling pharmaceutical products of his own manufacture only shall, by way of wholesale dealing, sell or supply at or from any premises any substance or article consisting of or containing any poison unless he is the holder of a wholesale poisons licence issued to him by the Committee in respect of those premises. (L.N. 137 of 1978) Cap 138A reg 26 Pharmacy and Poisons (Wholesale Licences) Committee (1) There shall be for the purposes of this Part a Committee to be called the Pharmacy and Poisons (Wholesale Licences) Committee. (2) (Repealed L.N. 369 of 1980) (3) The Committee may issue a wholesale poisons licence on payment of the fee prescribed in the Ninth Schedule. (4) The issue of a wholesale poisons licence shall be at the discretion of the Committee and shall be in the form prescribed in the Eighth Schedule. (See Eighth Schedule, Form 1) (5) The Committee may revoke a wholesale poisons licence or suspend it for such period as it thinks fit, if in its opinion the holder has failed to comply with the conditions subject to which the licence was issued or with any of these regulations, or has been convicted of an offence under the Ordinance. (6) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980) (7) (Repealed L.N. 369 of 1980) (8) An applicant for a wholesale poisons licence- (a) shall nominate in writing a responsible person to be in charge of poisons; and (b) may nominate in writing a deputy to act during the temporary absence of the responsible person.(9) An applicant shall at the time of his application submit to the Secretary of the Board the name of the person so nominated and of any deputy, and shall advise the Secretary of any change within 7 days of its occurrence. Cap 138A reg 27 Sales by wholesale dealers No person holding a wholesale poisons licence or a licence to manufacture pharmaceutical products shall sell or supply any poisons except to- (a) another wholesale dealer duly licensed to sell poisons wholesale; (b) an authorized seller of poisons; (c) a registered pharmacist; (d) a registered medical practitioner, a registered dentist or a registered veterinary surgeon; (L.N. 614 of 1997) (e) persons who require the poison for the purpose of their trade or business; (f) a Government department or public officer requiring the article for the purposes of the public service; (g) a person or an establishment concerned with education or scientific research, if the article is required for the purposes of such education or research; (h) an institution; (i) purchasers outside Hong Kong; or (j) a listed seller of poisons: Provided that only such poisons shall be supplied to a listed seller of poisons as are included in the classes of poisons in Part II of the Poisons List that the listed seller is licensed to sell. (L.N. 137 of 1978) Cap 138A reg 28 Records to be kept by wholesale dealer (1) The holder of a wholesale poisons licence or a licence to manufacture pharmaceutical products shall record the following particulars of all transactions whereby poisons included in Part I of the Poisons List are acquired by him whether by way of import, purchase, gift or otherwise- (a) the date of the transaction; (b) the name of the supplier; (c) the name of the poison and unit of quantity; (d) the total quantity of the poison; (e) the nature of the transaction; and (f) a reference to the invoice or other documents supporting the transaction.(2) The holder of a wholesale poisons licence or a licence to manufacture pharmaceutical products shall record the following particulars of all transactions for the disposition of poisons included in Part I of the Poisons List, whether uncompounded or as part of a pharmaceutical product and whether such disposition is by way of export, sale, gift or otherwise- (a) the date of the transaction; (b) the nature of the transaction; (c) the name of the person to whom the poison is supplied; (d) the quantity of the poison or pharmaceutical product, as the case may be; (e) a reference to the invoice or other documents supporting the transaction; (f) the name of the poison or pharmaceutical product, as the case may be, and the unit of quantity; (g) the balance of the poison remaining in his possession after the transaction. (L.N. 137 of 1978)(3) For each poison in Part I of the Poisons List there shall be a separate entry in the records and all transactions involving that poison shall be entered in a part of the records reserved for that poison. (4) Unless the Committee approves another system of recording, all records of transactions involving poisons in Part I of the Poisons List shall be made in the form prescribed in the Eighth Schedule. (See Eighth Schedule, Form 2) (5) Every transaction to which these regulations relate shall be recorded within 72 hours after the time it took place. (6) Records of sales or supplies maintained under this regulation shall be supported by documents signed by the purchaser. (7) In the case of an export transaction the holder of a wholesale poisons licence or a licence to manufacture pharmaceutical products shall retain all shipping and other documents supporting the transaction. (L.N. 137 of 1978) (8) A holder of a wholesale poisons licence or a wholesale dealer in medicines not containing poisons shall set up and maintain a system of control that will enable the rapid and, so far as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N. 137 of 1978) Cap 138A reg 29 Licensing of manufacturers PART VII MANUFACTURERS (1) Subject to paragraph (2), no person shall manufacture any pharmaceutical product on any premises unless he is the holder of a licence to manufacture pharmaceutical products on those premises. (2) Paragraph (1) and regulations 33 and 35 shall not apply to an authorized seller of poisons, who in the course of his retail business, manufactures any pharmaceutical product at any premises registered by him under the Ordinance in quantities which in the opinion of the Board, are consistent with the scope of his business and the nature of the product. (3) The Committee may issue a licence to manufacture pharmaceutical products in such form as it may prescribe on payment of the fee prescribed in the Ninth Schedule. (4) The Committee may revoke the licence or suspend it for such period as it thinks fit, if, in its opinion, the licensee has failed to comply with the conditions subject to which the licence was issued or with any of these regulations. (5) For the purpose of certifying that a manufacturer is licensed under this regulation, the Committee, subject to any conditions it may impose and to the payment of the fee prescribed in the Ninth Schedule, may issue to the manufacturer- (a) a certificate for manufacture; or (b) an interim-certificate for manufacture,in the forms prescribed in the Eighth Schedule. (See Eighth Schedule Forms 3 & 4) (L.N. 137 of 1978) (6) For the purpose of exporting pharmaceutical products manufactured by a manufacturer licensed under this regulation, the Committee may, subject to any conditions it may impose and to the payment of the fee prescribed in the Ninth Schedule, issue to the manufacturer- (a) a free sale certificate of pharmaceutical product; or (b) a certificate of pharmaceutical product,in the forms prescribed in the Eighth Schedule. (see Eighth Schedule, Forms 5 & 5A) (L.N. 449 of 1991) (7) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980) (L.N. 369 of 1980) Cap 138A reg 30 Manufacture to be under supervision of a registered pharmacist (1) In all premises in which pharmaceutical products are manufactured such products shall be manufactured by or under the supervision of- (a) a registered pharmacist; (b) a Fellow or Associate of the Royal Institute of Chemistry; or (c) a person having such other qualifications or sufficient experience as may be approved by the Board.(2) For the purposes of paragraph (1), "supervision" (监督) means the exercise by any of the persons referred to in paragraph (1) of control over the process of manufacture and of the persons engaged therein. (L.N. 137 of 1978) Cap 138A reg 31 Labelling by manufacturers (1) Subject to paragraph (4), a manufacturer or authorized seller of poisons, supplying for distribution under regulation 29(2), shall label or cause to be labelled the container of each pharmaceutical product, with the following particulars- (a) the appropriate designation of- (i) the substance or substances from which the pharmaceutical product was manufactured; (ii) each of the active constituents of the product; or (iii) each of the ingredients from which the product was compounded;(b) in the case where the appropriate designation of each of the active constituents or ingredients of a product is given, the appropriate quantitative particulars of those constituents or ingredients; (c) the name and address of the manufacturer; and (d) the number of the certificate of drug/product registration or the provisional certificate of drug/product registration of the pharmaceutical product issued by the Board.(2) For the purposes of paragraph (1)- (a) the expression "appropriate designation" (适当称号), in relation to a substance, constituent or ingredient, means- (i) in the case of a poison included in the Poisons List, the name with which the container of the poison is for the time being required to be labelled in accordance with regulation 13; (ii) in the case where a substance, constituent or ingredient is not a poison and is described in any of the monographs contained in the edition of the British pharmacopoeia, the British Pharmaceutical Codex or the British Veterinary Codex which was last published before the date on which the article was sold or supplied, the description set out at the head of that monograph; and (iii) in any other case the accepted scientific name or the name descriptive of the true nature and origin of the substance, constituent or ingredient;(b) the expression "appropriate quantitative particulars" (适当数量详情), in relation to the active constituent or ingredient of a pharmaceutical product, means- (i) the percentage or quantity of that constituent or ingredient contained in the pharmaceutical product sold or supplied; or (ii) in the case of a pharmaceutical product which is in pill, capsule, tablet or similar article, either the percentage or quantity of the substance or substances comprising or forming part of the pills, capsules, tablets or similar articles, or the quantity of each constituent or ingredient in each pill, capsule, tablet or article.(3) For the purposes of paragraph (1) the container to be labelled shall, where the pharmaceutical product is packed by the manufacturer in more than one container, be the container which is likely to be sold or distributed to the ultimate user of the product. (4) In the case of a pharmaceutical product intended for export it shall be a sufficient compliance with this regulation if the container of the product is labelled with the following particulars- (a) the name and address of the manufacturer; and (b) such other details as the importing country may require. (L.N. 137 of 1978) Cap 138A reg 32 Manufacturing workers not to infect products A manufacturer shall take adequate steps to ensure that every person engaged in the manufacturing or packing of pharmaceutical products does not contaminate or infect such products. Cap 138A reg 33 Duties of manufacturers (1) Subject to paragraph (1A), a manufacturer shall test each lot or batch of raw or bulk material intended to be used in the manufacture of pharmaceutical products to ensure identity and purity. (1A) Raw or bulk material the identity and purity of which the manufacturer thereof has certified by a certificate of analysis does not require a test by a manufacturer under paragraph (1). (2) A manufacturer shall test each batch of pharmaceutical products in a finished form to ensure identity and potency. (3) Every parenteral product shall be manufactured in accordance with the method of preparation of injections laid down by the British Pharmacopoeia or other Pharmacopoeia with which the particular product is intended to comply. (4) A manufacturer shall maintain a control sample of each batch of finished products under conditions of storage suitable to that product for a period of not less than the normal shelf-life of the product or 2 years after the last transaction in that batch of products whichever is the shorter period. (5) A manufacturer shall set up and maintain a system of control that will enable the rapid and, so far as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N. 137 of 1978) Cap 138A reg 34 Manufacturer's premises (1) No pharmaceutical product shall be manufactured unless the premises and the fittings and machinery therein used in the manufacturing and packaging of such product are of such construction, materials and finish as to- (a) permit the ready and efficient cleaning of all surfaces; and (b) avoid the contamination of the product during manufacture and packing.(2) All premises used in the manufacturing, testing, packing and despatch of pharmaceutical products shall be- (a) suitable for the purpose; and (b) maintained in a clean and orderly condition.(3) The temperature and humidity of the premises shall be controlled as appropriate to the manufacture of the product or the process being carried out therein. (4) All parenteral products shall be manufactured and put into containers in an enclosed area in which aseptic conditions can be maintained. (5) The enclosed area referred to in paragraph (4) shall be separate from the areas used for the manufacture and packing of other pharmaceutical products. Cap 138A reg 35 Records to be kept by manufacturers (1) A manufacturer shall maintain adequate records in respect of each pharmaceutical product prepared by him, showing- (a) the quantities of all substances used in the manufacture of the product; (b) the quantity of the product manufactured; (c) the name and the address of the person to whom the pharmaceutical product was sold or supplied; (d) the nature and results of tests made on each lot or batch of raw or bulk materials used in the product; (e) the nature and results of tests made on each batch of finished product; (f) any complaints received relating to the product and the action taken thereon by him; and (g) the nature and result of any tests made on the samples retained. (L.N. 228 of 1975)(2) The records required to be maintained by paragraph (1) shall be completed within 72 hours from the time the process or test was carried out or the transaction took place. (L.N. 137 of 1978) Cap 138A reg 35A Interpretation (Part VIII) PART VIII REGISTRATION OF PHARMACEUTICAL PRODUCTS AND SUBSTANCES In this Part, unless the context otherwise requires- "additional particulars" (附加详情), in relation to a pharmaceutical product or substance registered before the commencement date, means those registrable particulars of the product or substance not referred to in the repealed regulation 36(3); "commencement date" (生效日期) means the commencement date* of section 4 of the Pharmacy and Poisons (Amendment) (No. 2) Regulation 1995 (L.N. 366 of 1995); "registered particulars" (注册详情) means- (a) in relation to a pharmaceutical product or substance registered before the commencement date- (i) such of its particulars as are registered under the repealed regulation 36(3); and (ii) its additional particulars as contained in or ascertainable from the application form, the relevant literature and supporting documents (if any) submitted to the Committee for the purpose of the registration of the product or substance, or as contained in or ascertainable from the specimen sales packs or samples (or prototypes of the packs and proposed wordings of the labels) made available for inspection by the Committee for the purpose of the registration of the product or substance;(b) in relation to a pharmaceutical product or substance registered on or after the commencement date, its registrable particulars as registered under regulation 36(3), orin either case, where from time to time any subsequent approval has been given by the Board or the Committee to change any of the registrable particulars of the product or substance as from a certain date, then as from that date, its said particulars changed in accordance with such approval;"registered product or substance" (注册制品或物质) means any pharmaceutical product or substance which is the subject of a valid registration certificate issued under regulation 36(5); "registrable particulars" (须注册详情), in relation to a pharmaceutical substance, means the particulars referred to in regulation 36(3)(a), and, in relation to a pharmaceutical product, means all of the particulars referred to in regulation 36(3)(a) and (b); "repealed regulation 36(3)" (已废除的第36(3)条) means the regulation 36(3) which was in force immediately before the commencement date. (L.N. 366 of 1995)________________________________________________________________________________ Note: * Section 4 of the L.N. 366 of 1995 commenced operation on 28 July 1995. Cap 138A reg 36 Registration of pharmaceutical products and substances (1) Subject to paragraphs (1A), (1B) and (1C), no person shall sell, offer for sale or distribute or possess for the purposes of sale, distribution or other use any pharmaceutical product or substance unless the product or substance is registered with the Board- (L.N. 85 of 1987; L.N. 366 of 1995) (a) by the manufacturer, if the pharmaceutical product or substance is manufactured in Hong Kong; (b) by the importer, if the pharmaceutical product or substance is manufactured outside Hong Kong; or (c) by the local branch, subsidiary, representative, agent or distributor of a manufacturer outside Hong Kong. (L.N. 137 of 1978; 23 of 1998 s. 2)(1A) Nothing in paragraph (1) shall apply in the case of possession or use where the pharmaceutical product or substance- (a) has been imported into Hong Kong- (i) to be exported outside Hong Kong; (ii) by a pharmaceutical manufacturer for the purpose of manufacture or the compounding of pharmaceutical preparations; (iii) for the purpose of treatment by a registered medical practitioner or a registered dentist, of a particular patient or, for the purpose of treatment by a registered veterinary surgeon of a particular animal; or (L.N. 614 of 1997)(b) has been manufactured in Hong Kong to be exported outside Hong Kong. (L.N. 85 of 1987)(1B) For the avoidance of any doubt, a pharmaceutical product or substance is registered with the Board, for the purposes of paragraph (1), if and only if its registrable particulars are those which correspond exactly with the registered particulars of a registered product or substance. (L.N. 366 of 1995) (1C) It shall be a defence to a charge against any person for contravening paragraph (1) if the person proves that he did not know and could not with reasonable diligence have discovered that the product or substance was not registered with the Board. (L.N. 366 of 1995) (2) Application for the initial registration of a pharmaceutical product or substance shall be made in the form prescribed in the Eighth Schedule and shall be accompanied by the fee prescribed in the Ninth Schedule. (See Eighth Schedule Form 6) (2A) In considering an application for registration of a pharmaceutical product which contains as active ingredients any Chinese herbal medicines or proprietary Chinese medicines as defined in section 2 of the Chinese Medicine Ordinance (Cap 549) or other materials of herbal, animal or mineral origin customarily used by the Chinese for medicinal purpose, the Board shall seek advice from the Chinese Medicines Board established under the Chinese Medicine Ordinance (Cap 549). (47 of 1999 s. 175) (3) The particulars to be registered shall- (a) in the case of a product or substance, be- (i) its name; (ii) its specifications; (iii) its label; (iv) its package insert, if any; (v) the name and address of the manufacturer; and (vi) the name and address of the applicant;(b) in the case of a product, further be- (i) its dose form; (ii) the quantity or quantities of the dose form contained in its unit package or unit packages; (iii) the name and quantity of all its active ingredients; (iv) the name and quantity of all its excipients; and (v) its proposed indication, dosage and route of administration. (L.N. 366 of 1995)(3A) For the purposes of paragraph (3)- "active ingredient" (有效成分) means an ingredient of the product which is not an excipient; "excipient" (赋形剂) means an ingredient of the product which does not contribute to its pharmacological action or which so contributes only by regulating the release of an active ingredient; "label" (标签) means any statement forming part of or affixed to the container or package of the product or substance; "package insert" (装附页) means any leaflet, notification or other document supplied with the container or package of the product or substance, but does not include a label. (L.N. 366 of 1995) (4) Representative specimen sales packs of the product or representative samples of the substance shall be made available for inspection by the Committee. In the case of products not yet marketed the Committee may accept prototypes of the packs and proposed wordings of the labels on the understanding that these will be replaced by actual sale packs not later than 6 months after registration of the product or substance. (5) The Committee may issue to an applicant a registration certificate in the form prescribed in the Eighth Schedule valid for a period of 5 years from the date of registration on payment of the fee prescribed in the Ninth Schedule. (See Eighth Schedule Form 7) (6) The Committee shall advise the applicant whether the pharmaceutical product or substance appears in the Poisons List and if so, under which classification. (7) A registration certificate issued under paragraph (5) shall be renewable on payment of the fee prescribed in the Ninth Schedule. (8) The Committee may deregister a pharmaceutical product or substance if it considers it to be in the public interest to do so. (8A) Where the Committee refuses to register or deregisters a pharmaceutical product or substance it shall forward to the applicant or permit holder, as the case may be, a notice of refusal or of deregistration and shall state in such notice its reasons for refusal to register or for deregistration. (L.N. 137 of 1978) (9) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980) (10) (Repealed L.N. 369 of 1980) (11) (Repealed L.N. 366 of 1995) (L.N. 137 of 1978; L.N. 369 of 1980) Cap 138A reg 36A Application for approval to change the registered particulars of a registered product or substance (1) In this regulation- "person responsible for registering a registered product or substance" (负责将注册制品或物质注册的人) means a person who, in relation to the product or substance, belongs to any one of the classes of person described in regulation 36(1)(a), (b) or (c). (2) The person responsible for registering a registered product or substance may apply in writing to the Committee for approval to change any of the registrable particulars of the product or substance except the particulars referred to in regulation 36(3)(a)(i) and (b)(i) and (iii). (3) A person responsible for registering a registered product or substance who proposes to change the particulars referred to in regulation 36(3)(a)(i) or (b)(i) or (iii) may apply under regulation 36 for registering, as a separate product or substance, as the case may be, the product or substance with the particulars changed as proposed. (4) In dealing with an application under paragraph (2)- (a) the Committee shall take into consideration the safety, efficacy and quality of the pharmaceutical product or substance with its particulars changed as proposed, and in considering such safety and efficacy, the Committee shall observe the requirements of regulation 37(2); and (b) regulation 37(3) shall apply to such application as if it were an application for initial registration of the pharmaceutical product or substance with the particulars changed as proposed.(5) The Committee shall advise the applicant in writing whether the change is approved, and where the Committee refuses to approve a change it shall state its reasons for such refusal. (6) Where the change is approved, it shall be approved to take effect from a certain date, and the following provisions shall apply- (a) as from that date, and without limiting the generality of regulation 36(1B), the product or substance having as its registrable particulars the registered particulars which are to be changed (hereinafter referred to as the "product or substance to be replaced") shall not be regarded as registered with the Board; (b) the applicant shall, prior to that date, recall or cause to be recalled any product or substance to be replaced which may still be in the possession of any person to whom he supplied the product or substance; (c) where the product or substance to be replaced is to be recalled, the applicant shall, as soon as reasonably possible, replace or cause to be replaced such product or substance with the product or substance having the particulars changed as approved, or make such alternative arrangements as are agreed with the person to whom he supplied the product or substance.(7) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 366 of 1995) Cap 138A reg 36B Clinical trials and medicinal tests (1) For the purpose of conducting a clinical trial on human beings or a medicinal test on animals application shall be made in writing to the Committee and shall be accompanied by the fee prescribed in the Ninth Schedule. (2) A sample of the product or substance and a copy of the protocol for the trial or test shall accompany the application. (3) The Committee may issue a clinical trial certificate or medicinal test certificate in the form prescribed in the Eighth Schedule valid for a period not exceeding 2 years on payments of the fee prescribed in the Ninth Schedule. (See Eighth Schedule Form 12) (4) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980) (L.N. 137 of 1978; L.N. 360 of 1980) Cap 138A reg 36C Definition of "pharmaceutical product" and "substance" for the purposes of this Part For the purposes of this Part "pharmaceutical product" (药剂制品) and "substance" (物质) have the meaning assigned to "pharmaceutical product" and "medicine" in the Ordinance. (L.N. 137 of 1978) Cap 138A reg 36D Duplicate certificates (1) The Committee may issue a duplicate of any certificate issued under this Part if the Committee is satisfied that the original certificate has been lost or destroyed or that for other good reason such duplicate ought to be issued. (2) A duplicate certificate issued under this regulation shall be certified in such manner as the Committee may determine. (3) There shall be payable in respect of any duplicate certificate issued under this regulation the fee prescribed in respect thereof in the Ninth Schedule. (L.N. 369 of 1980) Cap 138A reg 37 Factors relevant to determination of application for registration (1) In dealing with an application for initial registration of a pharmaceutical product or substance the Committee shall in particular take into consideration- (a) the safety of the pharmaceutical product or substance to which the application relates; (b) the efficacy of the pharmaceutical product or substance for the purposes for which the product or substance is proposed to be administered; and (c) the quality of the pharmaceutical product or substance according to the specification and the method or proposed method of manufacture of the product or substance, and the provisions proposed for securing that the product or substance as sold or supplied will be of that quality.(2) In taking into consideration the efficacy for a particular purpose of a pharmaceutical product or substance to which such an application relates, the Committee shall leave out of account any question whether a pharmaceutical product or substance of another description would or might be equally or more efficacious for that purpose: Provided that nothing in the paragraph shall be construed as requiring the Committee, in considering the safety of a pharmaceutical product or substance of a particular description, in relation to a purpose for which it is proposed to be administered, to leave out of account any question whether a pharmaceutical product or substance of another description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose. (3) In dealing with an application by an importer the Committee shall also take into consideration in particular the methods, standards and conditions of manufacture of the pharmaceutical product or substance in respect of which application is made and may, if it thinks fit, require the production by the applicant of one or both of the following- (a) an undertaking, given by the manufacturer of any such products or substances, to permit the premises where they are to be manufactured, and the operations carried on or to be carried on in the course of manufacturing them, to be inspected by or on behalf of the Committee; (b) a declaration, given by or on behalf of the manufacturer of any such products or substances, that, in relation to the manufacture of these products any requirements imposed by or under the law of the country in which they are or are to be manufactured have been or will be complied with.(4) The Committee shall make arrangements for the separate processing of an application for the registration of a new pharmaceutical product or new substance so that its registration shall not be unduly delayed. (L.N. 137 of 1978) (5) For the purposes of paragraph (4) "new pharmaceutical product" (新药剂制品) and "new substance" (新物质) mean a medicine containing an active ingredient, or a substance, having a chemical formula which has not previously been marketed or registered in Hong Kong under some other name or description. (L.N. 137 of 1978; L.N. 235 of 1996) (L.N. 369 of 1980) Cap 138A reg 37A Application for registration under section 28A PART VIIIA REGISTRATION OF IMPORTERS AND EXPORTERS (1) Any application for registration under section 28A as an importer or exporter of pharmaceutical products shall be made to the Committee in Form 13 in the Eighth Schedule and shall be accompanied by the fee specified in the Ninth Schedule. (2) The Committee may require any applicant under this regulation to furnish such information and to permit such inspection of premises and storage facilities used by the applicant for the purposes of his business as the Committee may specify by notice to the applicant. (3) The Committee may grant or refuse any application under this regulation as the Committee may deem fit. (4) The Committee shall furnish any person whose application is granted with a certificate in Form 14 in the Eighth Schedule. (5) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (Part VIIIA added L.N. 369 of 1980) Cap 138A reg 38 Disclosure of composition of medicines PART IX SALE OF MEDICINES (1) Subject to these regulations, no person shall- (a) sell any article consisting of or comprising a substance recommended as a medicine; or (b) supply any such article as a sample for the purpose of inducing persons to buy the substances of which it consists or which it comprises,unless- (i) the article is labelled as required under regulation 31; or (ii) the particulars specified under regulation 31(1) are printed so as to be clearly legible in English or Chinese on the article or a label affixed thereto. (L.N. 137 of 1978)(2) Nothing in this regulation shall apply to any article- (a) made up and supplied for the use of a particular person, being an article prescribed by reference to the needs of that person; or (b) consisting wholly of either- (i) a product resulting solely from the pharmaceutical treatment of natural products as referred to by the Chinese Herbal Materia Medica; (ii) a mixture the sole ingredients of which are two or more of such products; or (iii) a natural mineral water or an artificial imitation thereof.(3) For the purposes of this regulation- "advertisement" (广告) includes any notice, circular, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound; "proprietary designation" (所有人称号), in relation to the sale of an article consisting of or comprising a substance recommended as a medicine, means words used or proposed to be u