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The Laws of Zambia REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT
CHAPTER 299 OF THE LAWS OF ZAMBIA
CHAPTER 299 THE PHARMACY AND POISONS ACT
THE PHARMACY AND POISONS ACT ARRANGEMENT OF SECTIONS 2. Interpretation 3. Appointment of Pharmacy and Poisons Board Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Registration of Pharmacists 4. No one to carry on the business of pharmacist unless registered 5. Name and certificate of registration to be exhibited in the premises Registration of Premises 6. All premises in which persons carry on business of pharmacist to be registered 7. Company may carry on business of pharmacist under certain conditions 8. Representatives of deceased or bankrupt pharmacists 9. Qualified medical practitioners and other persons exempted from the provisions 10. Exemption in the case of wholesale dealers and licensed sellers of Part 2 The Poisons List 11. The Poisons List to be prepared by the Board and approved by the Minister Supply of Poisons 12. Sale of poisons in Part 1 of the Poisons List 13. Sale of poisons in Part 2 of the Poisons List 14. Labelling of poisons 15. Medicines supplied by registered medical practitioners and others 16. Special provisions in the case of certain transactions 17. Automatic machines Licensed Sellers of Poisons 18. Certain persons may be licensed to sell poisons in Part 2 of the Poisons List 19. Issue of licences 20. Register of licences to be kept 21. Licensing authority may refuse to grant and may revoke a licence MISCELLANEOUS PROVISIONS Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 22. Powers of search and inspection of books 23. Production of authorisation 24. Examination of premises, drugs, etc.
25. Patent medicines CHAPTER 299
38 of 19403 of 194129 of 1941 PHARMACY AND POISONS ACT 51 of 196349 of 1965 An Act to make better provision for the control of the profession of pharmacy and 58 of 1965
the trade in drugs and poisons.
22 of 197213 of 1994Government Notices [1st July, 1941] 291 of 1964497 of 1964500 of 1964Statutory Instrument 163 of 1965 1. This Act may be cited as the Pharmacy and Poisons Act.
2. In this Act, unless the context otherwise requires-
"arrangement with creditors" means a composition or scheme made in pursuance of the law for the time being in force relating to bankruptcy and includes adeed of arrangement to which the Deeds of Arrangement Act applies; "authorised seller of poisons" means- (a) a registered pharmacist; or (b) a person declared by section seven or eight to be an authorised seller of poisons; "Board" means the Pharmacy and Poisons Board constituted under the provisions of section three; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia "dispensing" means supplying a medicine or a poison on and in accordance with a prescription duly given by a duly qualified medical practitioner or dentist or aveterinary surgeon; "drug" includes any medicine or medicinal preparation or therapeutic substance; "licensed seller of poisons" means a person licensed in accordance with the provisions of section eighteen to sell poisons in Part 2 of the Poisons List; "non-poisonous drug" means a drug which is not included in the Poisons List; "poison" means a poison included in the Poisons List; "wholesale dealing" means sale to a person who buys for the purpose of selling (As amended by No. 58 of 1965) 3. (1) The Minister may appoint a board to be called the Pharmacy and Poisons Appointment of
Board, consisting of not more than six persons, of whom the Director of Medical Services shall be chairman and a registered medical practitioner, two registered pharmacists and such other persons as the Minister shall deem fit to appoint, shall be members.
(2) The Board shall appoint a registrar from among its members, and the powers and duties of the Board may, subject to the directions of the Board, be exercised by theregistrar. Three members of the Board shall form a quorum.
(As amended by No. 3 of 1941, No. 51 of 1963 and Nos. 49 and 58 of 1965) Registration of Pharmacists 4. (1) No person other than a registered pharmacist shall, except as may be No one to carry on the
specifically provided by any of the provisions of sections seven to ten- business ofpharmacist unlessregistered (a) carry on, either on his own behalf or on behalf of another, the business of a Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (b) in the course of any trade or business prepare, mix compound or dispense any drug or supply any poison except under the immediate supervision of aregistered pharmacist; (c) assume, take, exhibit or in any way make use of any title, emblem, description or addition reasonably calculated to suggest that he isregistered as a pharmacist.
(2) For the purpose of paragraph (c) of subsection (1), the use of the word "pharmacist" or "chemist" or "druggist" or any similar word or combination of words shallbe deemed to be reasonably calculated to suggest that the owner of the business and theperson having control of the business on those premises are registered pharmacists.
(3) Nothing in this section shall be deemed to make it unlawful for any person to sell any non-poisonous drug provided such drug is sold in its original condition as received bythe seller or to require such person to be registered as a pharmacist.
(As amended by No. 58 of 1965) 5. It shall not be lawful for any person to carry on the business of a pharmacist Name and certificate
unless the name and certificate of registration of the person having control of the premises of registration to be in which such business is carried on are conspicuously exhibited therein.
exhibited in thepremises Registration of Premises 6. (1) Every person lawfully carrying on the business of a pharmacist shall cause All premises in which
each set of premises where such business is being carried on to be registered.
persons carry onbusiness ofpharmacist to beregistered (2) Application for registration of premises under this section shall be made to the Board in the prescribed form.
(3) The registration of any premises under this section shall become void upon the expiration of thirty days from the date of any change in the ownership of the businesscarried on therein.
(4) The Board may, for good and sufficient reason to be stated in writing, refuse to register or may remove from the register any premises which in its opinion are or havebecome unsuitable for the purpose of carrying on the business of a pharmacist.
(5) The Board shall keep a register in the form prescribed of all premises registered under the provisions of this section.
(As amended by No. 58 of 1965) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 7. (1) Notwithstanding anything contained in the foregoing provisions of this Part-
Company may carryon business ofpharmacist undercertain conditions (a) it shall not be necessary for a company carrying on the business of a pharmacist to be registered provided that- the business is under the personal management and control of aregistered pharmacist; (ii) a copy of the certificate of incorporation of the company is lodged with the Board; and (iii) the other provisions of this Act are complied with; (b) a company carrying on the business of a pharmacist in accordance with the provisions of this section shall be an authorised seller of poisons within themeaning of this Act and may use the description of chemist and druggist orof dispensing chemists or dispensing druggists and may use the description"pharmacy" in connection with the premises.
(2) Any act which if done by an individual would be an offence against this Act shall, if done by a company, be an offence by every director, secretary and manager thereof,unless he proves that the act or omission constituting the offence took place without hisknowledge or consent.
(As amended by No. 58 of 1965) 8. Notwithstanding anything contained in the foregoing provisions of this Part-
Representatives ofdeceased or bankrupt (a) if a registered pharmacist dies, or becomes of unsound mind or is adjudged bankrupt or enters into an arrangement with his creditors, hisrepresentatives may, with the permission of the Board and subject to suchdirections and conditions as the Board may in its discretion deem fit toimpose, carry on the business, and it shall not be necessary for suchrepresentatives to be registered, provided that such business is continuedonly under the personal management and control of a registeredpharmacist, and for such period not exceeding five years as the Board maydecide; (b) the representatives of a registered pharmacist carrying on a business in accordance with the provisions of paragraph (a) shall be authorised sellersof poisons within the meaning of this Act and it shall be lawful for them touse any title, emblem or description which might have been lawfully used bythe pharmacist whose representatives they are.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 9. The provisions of this Part shall not apply to drugs supplied by-
Qualified medicalpractitioners and other (a) a duly qualified medical practitioner or dentist or a veterinary surgeon in the ordinary course of his practice; from the provisions ofPart II (b) any employee of the Government in the course of his duties as such (c) any hospital, dispensary or similar institution exempted by the Minister by statutory order, whether general or special.
(As amended by No. 51 of 1963) 10. Nothing in this Part shall apply to-
Exemption in the caseof wholesale dealers (a) any such transaction as is mentioned in pargraph (a) or (b) of subsection and licensed sellers of (1) of section sixteen; (b) the sale of poisons in Part 2 of the Poisons List by a licensed seller of poisons in accordance with the provisions of section eighteen.
The Poisons List 11. (1) The Board shall, as soon as may be after the commencement of this Act, The Poisons List to be
prepare and submit to the Minister for his approval a list of the substances which are to be prepared by the Board treated as poisons for the purposes of this Act.
and approved by theMinister (2) The list to be prepared under this section shall be ivided into two parts as Part 1 of the list shall consist of those poisons which, subject to the provisions of this Act, are not to be sold except by an authorised seller of poisons.
Part 2 of the list shall consist of those poisons which, subject to the provisions of this Act,are not to be sold except by an authorised seller of poisons or by a person who is licensedunder the provisions of section eighteen to sell poisons in Part 2 of the Poisons List.
(3) In determining the distribution of poisons as between Part 1 and Part 2 of the list, regard shall be had to the desirability of restricting Part 2 to articles which are in commonuse, or likely to come into common use, for purposes other than the treatment of humanailments, and which it is reasonably necessary to include therein if the public are to haveadequate facilities for obtaining them.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (4) The Minister may, by statutory order, confirm the list, with or without modification, and may, upon the recommendation of the Board, from time to time amendor vary the list as he thinks proper.
(5) The said list as in force for the time being is in this Act referred to as the Poisons List, and the expression "poison" means a poison included in the Poisons List.
(As amended by No. 51 of 1963 and G.N. No. 291 of 1964) Supply of Poisons 12. (1) Subject to the provisions of this Part, no person shall sell any poison in Part Sale of poisons in Part
1 of the Poisons List unless- 1 of the Poisons List (a) he is a registered pharmacist; (b) the sale is effected on registered premises; and (c) the person to whom such poison is sold is- certified in writing in the manner prescribed and by a personauthorised by subsection (3) to give a certificate for the purpose; or (ii) known to the seller to be a person to whom the poison may properly (2) The seller of such poison shall not deliver it until- (a) he has made or caused to be made an entry in a book kept for the purpose to be called the Poisons Book stating in the form prescribed the date of thesale, the name and address of the purchaser and of the person, if any, bywhom the certificate required under subsection (1) (c) (i) was given, thename and quantity of the article sold, and the purposes for which it is statedby the purchaser to be required; (b) the purchaser has affixed his signature to the aforesaid entry.
(3) The Board may authorise fit and proper persons to give certificates for the purposes of subsection (1) (c) (i), and shall, from time to time, publish by Gazette notice alist of persons so authorised.
(As amended by No. 51 of 1963 and No. 58 of 1965) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 13. Subject to the provisions of this Part, no person shall sell any poison in Part 2 Sale of poisons in Part
of the Poisons List unless- 2 of the Poisons List (a) he is an authorised seller of poisons; or (b) he is licensed to sell poisons in Part 2 of the Poisons List under the provisions of section eighteen and the sale is effected on premises inrespect of which he is so licensed.
14. It shall not be lawful for a person to supply any poison unless the container of Labelling of poisons
the poison is labelled in the prescribed manner- (a) with the name of the poison; (b) in the case of a preparation which contains a poison as one of the ingredients thereof, with the prescribed particulars as to the proportionwhich the poison contained in the preparation bears to the total ingredients; (c) with the word "poison" or other prescribed indication of the character of the (d) if supplied on sale, with the name of the premises on which it is sold.
15. (1) Nothing in sections twelve to fourteen shall apply-
Medicines supplied byregistered medicalpractitioners andothers (a) to a medicine which is supplied by a duly qualified medical practitioner for the purposes of medical treatment, by a registered dentist for the purposeof dental treatment or by a veterinary surgeon for the purpose of animaltreatment; or (b) to a medicine supplied or dispensed at any institution exempted from the provisions of Part II under the provisions of paragraph (c) of section nine; or (c) to a medicine which is dispensed by an authorised seller of poisons on registered premises; if the provisions of subsections (2) and (3) are satisfied in relation thereto.
(2) The medicine must be distinctly labelled with the name and local address of the person by whom it is supplied or dispensed.
(3) The following particulars shall, within twelve hours after the medicine has been supplied or dispensed, be entered in a book kept for the purpose, to be called the"Prescription Book": (a) the date upon which the medicine was supplied or dispensed; (b) the ingredients of the medicine and the quantity supplied; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (c) if the medicine was dispensed by an authorised seller of poisons, the name and address of the person by whom the prescription was given; (d) the name and address of the person to whom the medicine was supplied.
16. (1) Except as is hereinafter specifically provided, nothing in the foregoing Special provisions in
provisions of this Act shall extend to or interfere with- the case of certaintransactions (a) the sale of poisons by way of wholesale dealing; (b) the sale of an article by a person carrying on a regular business in mining, agricultural or horticultural accessories to a person who requires the articlefor the purpose of his trade or business; or (c) the sale of a poison by an authorised seller of poisons or the sale of poisons in Part 2 of the Poisons List by a licensed seller of poisons to- a duly qualified medical practitioner or dentist or a veterinarysurgeon for the purpose of his profession; (ii) any employee of the Government in the course of his duties as such (iii) any Government institution; or (iv) any hospital, dispensary or similar institution or any person or institution concerned with scientific education or research if theaforesaid hospital, dispensary, institution or person is approved bythe Minister by statutory order, whether general or special; if the requirements contained in the following provisions of this section are complied with.
(2) In the case of sales under paragraphs (a) and (b) of subsection (1), the seller must be in possession of a licence issued by the Board in the prescribed form.
(3) The seller must obtain, before the completion of the sale, an order in writing signed by the purchaser stating his name and address, trade, business or profession, thename and quantity of the article to be purchased and the purpose for which it is required.
(4) The seller must 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 orprofession stated in the order, being one in which the poison to be purchased is used.
(5) If the article sold is sent by post, it must be sent by registered post.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (6) In the case of poisons in Part 1 of the Poisons List, the provisions of subsection (2) (a) of section twelve must be complied with.
(7) The provisions of section fourteen relating to the labelling of poisons must be Provided that where a person represents that he urgently requires a poison for the purpose of his trade, business or profession and satisfies the seller that by reason ofsome emergency he is unable before delivery to furnish an order in writing as required bysubsection (3), the seller may forthwith deliver the poison to the purchaser, and in such acase the purchaser shall, within twenty-four hours of such sale, furnish the required writtenorder to the seller.
(As amended by No. 51 of 1963) 17. No person shall expose or cause to be exposed for sale any poison in or by Automatic machines
means of an automatic machine.
Licensed Sellers of Poisons 18. (1) For the purposes of this Act, there may be licensed certain persons who, not Certain persons may
being registered pharmacists, shall be entitled to sell poisons in Part 2 of the Poisons List.
be licensed to sellpoisons in Part 2 ofthe Poisons List (2) Every Provincial Medical Officer shall be the licensing authority within his Province for the purposes of this Part.
(3) Application for a licence to sell poisons in Part 2 of the Poisons List shall be made to the licensing authority in the manner prescribed.
(As amended by G.N. No. 500 of 1964) 19. (1) If the licensing authority is satisfied that the applicant is a fit and proper Issue of licences
person to sell poisons in Part 2 of the Poisons List and that the premises in which heproposes to carry on such business are suitable, he may, in his discretion and uponpayment of the prescribed fee, issue to the applicant a licence in the prescribed form.
(2) A licence granted under this section shall authorise the licensee to sell poisons in Part 2 of the Poisons List in accordance with the provisions of this Act upon thepremises specified in the licence and shall expire on the 31st December of the year inwhich it is granted.
(3) A licence granted under this section may be renewed upon application.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 20. Every licensing authority shall keep a register in the prescribed form of licences Register of licences to
issued by him under this Part, and shall publish, by Gazette notice, particulars of all such (As amended by No. 51 of 1963) 21. The licensing authority may refuse to issue a licence or may revoke the licence Licensing authority
of any person who in the opinion of the authority is, for sufficient reason relating either to may refuse to grant himself personally or to his premises, not fit to be licensed. In the event of such refusal or and may revoke alicence revocation, an appeal shall lie to the Board whose decision shall be final.
MISCELLANEOUS PROVISIONS 22. (11) Any Government medical officer, any Administrative Officer and any police Powers of search and
officer not under the rank of Sub Inspector and any other person duly authorised in writing inspection of books in that behalf by the Board, in this Part referred to as an authorised officer, may, for thepurpose of securing compliance with this Act, at all reasonable times enter any premiseswhich are on the register of premises or in which a licensed seller of poisons carries onbusiness or in which he has good cause to suspect that a breach of the law in relation tothe sale of drugs or poisons has been committed and may make such examination andinquiry and do such other things, including the taking of samples on payment, as may benecessary for ascertaining whether the provisions aforesaid are being complied with.
(2) Any person who wilfully delays or obstructs a duly authorised officer in the lawful exercise of his powers under this section, or refuses to allow any sample to be taken or togive information which he is duly required to give under this section, is guilty of an offenceand is liable to a fine of one hundred and fifty penalty units.
(3) Every authorised or licensed seller of poisons shall, on the demand of a duly authorised officer, produce for inspection his certificate of registration or licence, as thecase may be.
(4) All books kept by an authorised seller of poisons or a licensed seller of poisons in accordance with the provisions of this Act shall be open to inspection by a dulyauthorised officer at all reasonable times.
(As amended by No. 51 of 1963 and Act No. 13 of 1994) 23. An inspecting officer specially authorised in writing and exercising his powers Production of
under section twenty-two shall produce his authorisation on demand.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 24. Any authorised officer may enter the premises where any registered Examination of
pharmacists carries on business or keeps any drugs or wares used by him and examine premises, drugs, etc.
such premises, drugs and wares.
(As amended by No. 22 of 1972) 25. The Minister, on the recommendation of the Board, may, by statutory order, Patent medicines
prohibit or control the importation, manufacture or sale of any secret, patent, proprietary orhomoeopathic medicine or preparation.
(As amended by No. 51 of 1963 and No. 58 of 1965) 26. (1) The Minister may, by statutory instrument, make rules with respect to any of Rules
the following matters or for any of the following purposes: (a) regulating the sale of poisons in Part 2 of the Poisons List by licensed sellers of poisons or by any class of such persons, or by persons licensedto sell poisons under the provisions of subsection (2) of section sixteen; (b) prohibiting the sale by retail of any specified poison in Part 1 of the Poisons List except on a prescription duly given by a duly qualified medicalpractitioner or dentist or a veterinary surgeon, and for prescribing the formand regulating the use of such prescriptions; (c) exempting from any of the provisions of this Act relating to the sale of poisons, any article or substance containing poison or any class of sucharticles or substances; (d) prohibiting, regulating or restricting the manufacture of drugs, pharmaceutical preparations and therapeutic substances; (e) the safe custody and storage of poisons; the importation, exportation, transport and labelling of poisons; (g) the containers in which poison may be supplied; (h) the addition to poisons of specified ingredients for the purpose of rendering them readily distinguishable as poisons; the compounding and dispensing of poisons; for prescribing the period for which any books or registers required to bekept for the purposes of this Act are to be preserved; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (k) for prescribing the fees to be paid for anything to be done under this Act; for the procedure to be observed by the Board; for prescribing anything which is by this Act to be prescribed by rules.
(2) The power to make rules under this section with respect to poisons or drugs includes the powers to make rules with respect to any class of poison or drug or anyparticular poison or drug.
(As amended by No 51 of 1963, G.N. No. 291 of 1965 and No. 58 of 1965) 27. Any person who contravenes any provision of this Act is guilty of an offence Penalty
and, except as provided by subsection (2) of section twenty-two, is liable on conviction toimprisonment for six months or to a fine of one thousand five hundred penalty units or toboth and, in addition to such penalty as aforesaid, the court before which a person is soconvicted may order any articles in respect of which such offence has been committed tobe forfeited.
(As amended by Act No. 13 of 1994) PHARMACY AND POISONS SECTION 3-APPOINTMENT OF THE PHARMACY AND POISONS BOARD Government Notice106 of 1941 A Board, to be called the Pharmacy and Poisons Board, is hereby appointed.
SECTION 9-EXEMPTIONS FROM PART II Government Notice236 of 1945 It is hereby ordered that Part II of the Act shall not apply to drugs supplied by-
Any mission hospital or mission dispensary at which is employed a trained nurse whose dispensing ability has been approved in writing by the ProvincialMedical Officer.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SECTION 16 (1) (C)-APPROVED INSTITUTIONS Government Notice365 of 1964 Order by the Minister 1. All Government hospitals.
2. All mission hospitals, dispensaries or similar institutions in respect of orders for poisons which have been countersigned by a Provincial Medical Officer.
3. The Bancroft Mine Hospitals.
4. The Chibuluma Mine Hospitals.
5. The Mufulira Mine Hospitals.
6. The Nchanga Mine Hospitals.
7. The Nkana Mine Hospitals.
8. The Roan Mpatamatu Mine Hospitals.
9. The Zambia Broken Hill Development Company Dispensary.
SECTION 11 (4)-THE POISONS LIST Federal GovernmentNotices224 of 1957 Order by the Minister, upon the recommendation of the Pharmacy and Poisons Board 337 of 1962176 of 1963 The following is a list of substances which are to be treated as poisons for the Government Notices
purposes of the Act and the Rules made thereunder.
430 of 1963474 of 1964Gazette Notice846 of 1965Statutory Instruments114 of 1967335 of 1967192 of 197258 of 1980146 of 1981152 of 198188 of 198663 of 198561 of 1985146 of 1981152 of 1981 Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Subject to various exceptions, for which reference must be made to the Act and the Rules, poisons in this Part may only be supplied by registered pharmacists.
Abrus precatorius L.; seed of.
Acetanilide; alkyl acetanilides.
Acetyldihydrocodeine; its salts.
Alkali fluorides other than those specified in Part 2 of this List.
Alkaloids and related substances, the following, their salts, simple or complex, their quaternary compounds: Aconite, alkaloids of; Belladonna, alkaloids of; Calabar bean, alkaloids of; Coca, alkaloids of; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Colchicum, alkaloids of; Curare, alkaloids of; curare bases; Ecgonine; its esters; Ephedra, alkaloids of; Ergot, alkaloids of, whether hydrogenated or not; their homologues; any salt of any substance falling within this item; Gelsemium, alkaloids of; Jaborandi, alkaloids of; Lobelia, alkaloids of; Pomegranate, alkaloids of; Quebracho, alkaloids of, other than the alkaloids of red quebracho; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Rauwolfia, alkaloids of, their salts; derivatives of the alkaloids of rauwolfia; Sabadilla, alkaloids of; Solanaceous alkaloids not otherwise included in this List; Stavesacre, alkaloids of; Veratrum, alkaloids of; Yohimba, alkaloids of.
Allylprodine; its salts.
Alphameprodine; its salts.
Alphaprodine; its salts.
Amidopyrine; its salts; amidopyrine sulphonates; their salts.
Amino-alcohols esterified with benzoic acid, phenylacetic acid, phenylpropionic acid, cinnamic acid or the derivatives of these acids; their salts.
p-Aminobenzenesulphonamide; its salts; derivatives of p-aminobenzenesulphonamide having any of the hydrogen atoms of thep-amino group or of the sulphonamide group substituted by another radical;their salts.
p-Amino-benzoic acid, esters of; their salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia -Aminopropylbenzene and -aminoisopropylbenzene and any compound structurally derived from either of those substances by substitution in theside chain or by ring enclosure therein or both (except ephedrine,N-methylephedrine, N-diethylaminoethylephedrine and prenylamine); theirsalts.
Amitriptyline; its salts.
Amphetamine; its salts and isomers Amyl nitrite.
Ancyclovir triphosphate Androgenic, oestrogenic and progestational substances, the following: Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; Steroid compounds with androgenic or oestrogenic or progestational activity; their esters.
Anileridine; its salts.
Antibiotics, any antimicrobial or antifungal substance synthesised by bacteria, fungi or protozoa, and any substance the chemical properties of which areidentical with or similar to any such antimicrobial or antifungal substancebut which is not produced from living organisms, being a substance which isused in the specific treatment of infections; their salts.
Anti-histamine substances, the following; their salts; their molecular compounds: Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Substances being tetra-substituted N derivatives of ethylenediamine or Antimonial substances, the following: Chlorides of antimony; Oxides of antimony; Sulphides of antimony; Organic compounds of antimony.
Apomorphine; its salts.
Arsenical substances, the following, except those specified in Part 2 of this List: Halides of arsenic; Oxides of arsenic; Organic compounds of arsenic.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Azacyclonal; its salts.
Barbituric acid; its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid, its salts, its derivatives, their salts, with any other substance.
Barium, salts of, other than barium sulphate and the salts of barium specified in Part 2 of this List.
Benactyzine; its salts.
Benzethidine; its salts.
Benzhexol; its salts.
Benzoylmorphine; its salts.
Benzphetamine; its salts.
Benztropine and its homologues; their salts.
Benzylmorphine; its salts.
Betameprodine; its salts.
Betaprodine; its salts.
Bis-(1-(2-Isobutyryloxyethl)-2-N(4 amino-2 methyl-5 pyrimidiny) methyl Busulphan; its salts.
Cannabin tannate.
Cannabis (the dried flowering or fruiting tops of Cannabis Sativa Linn).
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia "Dagga", the resin, extract or tinctures thereof.
Captodiame; its salts.
Caramiphen; its salts.
Carperidine; its salts.
Chloral; its addition and its condensation products; their molecular compounds.
Chlordiazepoxide; its salts.
Chlormethiazole; its salts.
Chlorothiazide and other derivatives of benzo-1 : 2 : 4-thiadiazine-7 sulphonamide-1 : 1-dioxide, whether hydrogenated or not.
Chlorphentermine; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Chlorpropamide; its salts.
Chlorprothixene and other derivatives of 9-Methylenethiaxanthen; their salts.
Chlorthalidone and other derivatives of o-chlorobenzene sulphonamide.
Cinchocaine; its salts in injectable form; Clonitazine; its salts.
Creosote obtained from wood.
Croton, oil of.
Cyclizine; its salts; Cycrimine; its salts.
Debnsoquine; its salts; Dehydroemetine; its salts.
Demecarium bromide.
Desipramine; its salts.
Desomorphine; its salts.
Dextromethorphan; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Dextromoramide; its salts.
Dextrorphan; its salts.
Diacetylmorphine; its salts.
Diacetyl-N-allylnormorphine; its salts.
Diamidinodiazoaminobenzene; its salts.
Diampromide; its salts.
Diazepam and other compounds containing the chemical structure of Dihydro-1,4-Benzodiazepine substituted to any degree; their salts.
Diethyl carboinazine; Digitalis, glycosides of; other active principles of digitalis.
Dihydrocodeine; its salts.
Dihydrocodeinone; its salts; its esters; their salts.
Dihydromorphine; its salts; its esters; their salts.
Dimenoxadole; its salts.
Dimepheptanol; its salts.
Dinitrocresols (D.N.O.C.); their compounds with a metal or base (except those specified in Part 2 of this List).
Dioxaphetyl butyrate; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Diperodon; its salts.
Diphenyl sulphone; Diphenoxylate; its salts.
Dipipanone; its salts.
Disopyramide; its salts; Dithienylallylamines; dithienylalkylallylamines; their salts.
Ecothiopate iodide.
Ergot (the sclerotia of any species of Claviceps); extracts of ergot; tinctures of Ethambutol; its salts; Ethacrynic acid; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Ethoheptazine; its salts.
Etonitazene; its salts.
Etoxeridine; its salts.
Fenfluramine; its salts.
Fentanyl; its salts.
Fluphenazine; its salts; Furethidine; its salts.
Gallamine; its salts; its quaternary compounds.
Glutethimide; its salts.
Guanidines, the following: Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Haloperidol and other 4-substituted derivatives of N-(3-fluoro-benzoylpropyl) Hydrazines, bensyl, phenethyl and phenoxyethyl; their a-methyl derivatives; acyl derivatives of any of the foregoing substancescomprised in this item; salts of any compounds comprised in this item.
Hydrocyanic acid; cyanides; double cyanides of mercury and zinc.
Hydromorphinol; its salts.
Hydromorphone; its salts; its esters; their salts.
Hydroxy-N,N-dimethyltryptamines; their esters or esters; any salt of any substance falling within this item.
Hydroxypethidine; its salts.
Hydroxyzine; its salts.
Imipramine; its salts.
Indomethacin; its salts.
Isomethadone (isomidone); its salts.
Ketamine; its salts; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Ketobemidone; its salts.
Ketotifen; its salts; Laudexium; its salts.
Lead acetates; compounds of lead with acids from fixed oils.
Levomethorphan; its salts.
Levomoramide; its salts.
Levophenacylmorphan; its salts.
Levorphanol; its salts.
Lignocaine; its salts infectionable form Lucanthone; its salts.
Lysergide; its salts.
Mannomustine; its salts.
Mebezonium iodide.
Matloquine; its salts Mephenesin; its esters.
Mercaptopurine; its salts; derivatives of mercaptopurine; their salts.
Mercurial substances, the following: Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Oxides of mercury; Nitrates of mercury; Mercuric ammonium chlorides; Organic compounds of mercury which contain a methyl (CH3) group directly linked to the mercury atom; Mercuric oxycyanides; Mescaline; its salts.
Megtaramind; its salts; Metazocine; its salts.
Metformin; its salts.
Methadone (amidone); its salts.
Methadyl acetate; its salts.
Methaqualone; its salts.
Methixene; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Methyldesorphine; its salts.
Methyldihydromorphine; its salts.
Methylpentynol; its esters and other derivatives.
1-Methyl-4-phenylpiperidine-4-carboxylic acid, esters; their salts.
Metopon; its salts.
Monofluoroacetic acid; its salts.
Morpheridine; its salts.
Mustine and any other N-substituted derivative of di-(2-chlorethyl) amine; their Myrophine; its salts.
Nalorphine; it salts.
Neastigmine; its salts Nicocodine; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia m-Nitrophenol; o-nitrophenol; p-nitrophenol.
Nomifensine hydrogen maloate; Noracymethadol; its salts.
Norcodeine; its salts.
Norlevorphanol; its salts.
Normethadone; its salts.
Normorphine; its salts.
Nortriptyline; its salts.
Orphenadrine; its salts.
Orthocaine; its salts.
Oxalic acid.
Oxycinchoninic acid, derivatives of; their salts; their esters.
Oxycodone; its salts; its esters; their salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Oxymorphone; its salts.
Pargyline; its salts Pemoline; its salts.
Pentazocine; its salts.
Phenadoxone; its salts.
Phenampromide; its salts.
Phenanthridinium; its salts, derivatives of phenanthridinium having any of the hydrogen atoms of the phenanthridinium group substituted by anotherradical; molecular compounds of phenanthridinium or of its derivatives; theirsalts.
Phenatine; its salts.
Phenazocine; its salts.
Phencyclidine; its salts.
Phenformin; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Phenols (any member of the series of phenols of which the first member is phenol and of which the molecular composition varies from member to member byone atom of carbon and two atoms of hydrogen) except in substancescontaining less than sixty per centum, weight in weight of phenols;compounds of phenol with a metal, except in substances containing lessthan the equivalent of sixty per centum, weight in weight of phenols.
Phenomorphan; its salts.
Phenothiazine, derivatives of; their salts; except dimethoxanate and its salts.
Phentermine; its salts.
Phenylbutazone; its salts.
Phenylcinchininic acid; salicylcinchoninic acid; their salts; their esters.
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts.
Phenylpropanolamine; its salts.
Phenytoin; its salts.
Pholcodine; its salts.
Phosphorus, yellow.
Pieric acid.
Pilocarpine, its salts (under Alkaloids) Piminodine; its salts.
Pituatary gland, the active principles of.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Pizotiten; its salts.
Pratidoxime; its salts; Procarbazine; its salts.
Procyclindine; its salts.
Proheptazine; its salts.
Propanolor Hydroxide Propoxyphene; its salts.
Propylhexedrine; its salts.
Prothipendyl; its salts.
Protriptyline; its salts.
Psilocin; its salts; its esters and ethers; their salts.
Psilocybin; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Quinapyramine; its salts.
Racemethorphan; its salts.
Racemoramide; its salts.
Racemorphan; its salts.
Sabutamol; its salts.
Savin, oil of.
Strophanthus; glycosides of strophanthus.
Sulphonal; alkyl sulphonals.
Suprarenal gland, the active principles of; their salts and derivatives, whether obtained from natural or synthetic sources.
Suxamethonium; its salts; Tetrabenazine; its salts.
Thalidomide; its salts.
Thallium; salts of.
Thebacon; its salts; its esters; their salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Thyroid gland, the active principles of; their salts.
Timolol; its salts; Trimetnoprim; its salts Tranylcypromine; its salts; Tretamine; its salts.
2:2:2-Trichloroethyl alcohol; its esters; their salts.
Trithioperazine; its salts.
Trimepridine; its salts.
Trimethoprim; its salts Trimipramine; its salts.
Verapamil; its salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Zoxazolamine; its salts.
Any preparation or substance containing a substance specified in any other item of (As amended by S.I. No. 58 of 1980, No 146 of 1981 and No. 88 of 1986) Subject to various exceptions, poisons in this Part may only be supplied by
registered pharmacists and licensed sellers of Part 2 poisons: the latter may
not supply any poisons except those in this Part.
Arsenical substances, the following: Arsenic sulphides; Calcium arsenates; Calcium arsenites; Copper acetoarsenite; Copper arsenates; Copper arsenites; Potassium arsenites; Sodium arsenates; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Sodium arsenites; Barium, salts of, the following: Barium carbonate; Diamines, the following; their salts: phenylene diamines; tolylene diamines; other Dinitrocresols (D.N.O.C.); their compounds with a metal or a base.
Dinosam; its compounds with a metal or a base.
Dinoseb; its compounds with a metal or a base.
Endothal; its salts.
Formic acid.
Hydrochloric acid.
Hydrofluoric acid; potassium fluoride; sodium fluoride; sodium silicofluoride.
Isometamedium Chloride Mercuric chloride; mercuric iodide; organic compounds of mercury except compounds which contain a methyl (CH3) group directly linked to themercury atom.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Metallic oxalates.
Nicotine; its salts.
Nitric acid.
Phenols as defined in Part 1 in substances containing less than sixty per centum, weight in weight, of phenols; compounds of phenol with a metal insubstances containing less than the equivalent of sixty per centum, weightin weight, of phenols.
Phosphoric acid.
Phosphorus compounds, the following: Amiton, azinphos-ethyl, azinphos-methyl, chlorfenvinphos, demeton-O, demeton-S, demeton-O-methyl, demeton-S-methyl, dichlorvos,diethyl 4-methyl-7-coumarinyl phosphorothionate, diethylp-nitrophenyl phosphate, dimefox, disulfoton, ethion, ethylp-nitrophenyl phenylphosphonothionate, mazidox, mecarbam,mevinphos, mipafox, oxydemetonmethyl, parathion, phenkapton,phorate, phosphamidon, schradan, sulfotep, TEPP (HETP),thionazin, triphosphoric pentadimethylamide, vamidothion.
Sodium hydroxide.
Sodium nitrite.
Sulphuric acid.
Zinc phosphide.
Any preparation or substance containing a substance specified in any other item of Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SECTION 25-THE PROPRIETARY PREPARATIONS (PROHIBITION OF IMPORTATION) ORDER Statutory Instrument1 of 1970 Order by the Minister, upon the recommendation of the Pharmacy and Poisons Board 1. This Order may be cited as the Proprietary Preparations (Prohibition of Title
Importation) Order.
2. The importation of the proprietary preparation specified in the Schedule is Prohibition of
hereby prohibited.
importation ofproprietary preparation (Paragraph 2) SPECIFIED PROPRIETARY PREPARATION The proprietary preparation known as "Dublosan Salbe".
SECTION 25-THE PROPRIETARY PREPARATIONS (PROHIBITION OF IMPORTATION OR Order by the Minister, upon the recommendation of the Pharmacy and Poisons Board 1. This Order may be cited as the Proprietary Preparations (Prohibition of Title
Importation or Sale) Order.
2. The importation of the proprietary preparations specified in the Schedule is Prohibition of
hereby prohibited.
3. The sale of the proprietary preparations specified in the Schedule is hereby Prohibition of sale
(Paragraphs 2 and 3) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SPECIFIED PROPRIETARY PREPARATIONS The substance known as Cyclamic Acid or any proprietary preparation containing Cyclamic Acid,or the salts of Cyclamic Acid.
SECTION 26-THE PHARMACY AND POISONS (EQUIVALENTS FOR DEALINGS IN DRUGS) 161 of 1972 Rules by the Minister 1. These Rules may be cited as the Pharmacy and Poisons (Equivalents for Title
Dealings in Drugs) Rules.
2. In these Rules, unless the context otherwise requires-
"ingredient" means a drug which is one constituent of a preparation which is itself a "mixture" means any liquid preparation intended for administration by mouth, which consists of one or more drugs dissolved or suspended in an aqueous orother appropriate vehicle; "Table" means a Table set out in the Schedule; "total quantity" means the total quantity of a drug or of a preparation which is itself a drug other than an ingredient.
3. Any unit of measurement mentioned in column 2 of Table 1 or column 2 of Table Equivalents for
2 shall be treated for the purpose of any dealing with quantities of ingredients as the weights and volumes equivalent of the unit set opposite thereto in column 1 of the Table, and for any fraction of one grain not specifically mentioned in column 1 of Table 1, the equivalent for suchpurpose shall be treated as the corresponding fraction of the equivalent of one grain setout in column 2 of that Table.
4. (1) Where a prescription for any drug states that the quantity of each dose is to Equivalents for doses
be either one fluid drachm (fl dr) or two fluid drachms, the equivalent of that quantity for the purpose of dispensing the prescription shall be treated as five millilitres or ten millilitresrespectively.
(2) Where the prescription for any drug, which is a mixture, states that the quantity of each dose is to be one-half of one fluid ounce (fl oz), the equivalent of that quantity forthe purpose of dispensing that prescription shall be ten millilitres, except as provided for insub-rule (4).
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (3) Where a prescription for any drug, which is a mixture, states that the quantity of each dose is to be two fluid drachms, the equivalent of that quantity for the purpose ofdispensing that prescription shall be ten millilitres.
(4) Where a prescription for liquid paraffin or other fixed oil states the quantity of each dose in terms of fluid ounces, the equivalent of each half of a fluid ounce shall, forthe purpose of that prescription, be treated as fifteen millilitres.
(5) Where any prescription to which this rule refers specifies the quantity of the ingredients of any drug in the total quantity to be dispensed, this rule shall be treated asapplying to the quantity of each such ingredient in each dose.
5. (1) Any unit of measurement mentioned in column 2 of Table 3 or column 2 of Equivalents for total
Table 4 shall be treated for the purpose of any dealing with total quantities of drugs as the quantity prescribed for equivalent of the unit set opposite thereto in column 1 of the Table.
external or bulk oralpreparation (2) Where in a prescription for an external preparation or bulk oral preparation the total quantity to be supplied is expressed in ounces avoirdupois or apothecary, the metricquantity supplied will be on the basis that one ounce avoirdupois or apothecary isequivalent to twenty-five grams.
(3) Where in a prescription for an external preparation or bulk oral preparation the total quantity to be supplied is expressed in fluid ounces (fl oz), the metric quantitysupplied will be on the basis that one fluid ounce (fl oz) is equivalent to twenty-fivemillilitres.
(4) For the purpose of implementing the provisions of the preceding rules, Tables 3 and 4 shall be used.
(5) Where any quantity of an external preparation or bulk oral preparation is expressed in terms of one or more of the units mentioned in column 1 of Table 3 orcolumn 1 of Table 4 and is greater than one pound or one pint, the equivalent, for thepurpose of any dealing with the prescription, shall be treated as the correspondingmultiple of the equivalent for one pound or one pint, as the case may be, plus theequivalent of any residue of less than a pound or pint as ascertained from the appropriateTables.
6. (1) Where any manufacturer, wholesale dealer or retail dealer sells or supplies Control of sale and
any drug on or after the 1st January, 1973, he shall, if the order or prescription relating to such a dealing is expressed in terms of a unit of measurement specified in column 1 ofTables 1, 2, 3 and 4, or of any such fraction as is mentioned in rule 3, carry out suchdealing in terms of the equivalent quantity ascertained in accordance with that rule.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (2) The provisions of rules 4 and 5 shall not apply to imported medicaments that are sold in their original containers as packaged by the manufacturer.
Entries in the above Table expressed Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia as one figure to another are inclusive of both figures Entries in the above Table expressed as one figure to another are inclusive of both figures.
ounces avoirdupois or apothecaries 1 oz or more but less than 11/2oz 11/2 oz or more but less than 3 oz 3 oz or more but less than 51/2oz 51/2 oz or more but less than 9 oz 9 oz or more but less than 141/2 oz 141/2 oz or more but not more than 16 oz or 1 lb avoirdupois 1 fl oz or more but less than 11/2 fl oz 11/2 fl oz or more but less than 3 fl oz 3 fl oz or more but less than 51/2 fl oz 51/2 fl oz or more but less than 9 fl oz 9 fl oz or more but less than 141/2 fl oz 141/2 fl oz or more but not more than 20 fl oz or 1 pint, or 1/8 gallon Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SECTION 26-THE POISONS (PROHIBITION OF EXPORTATION) RULES Statutory Instruments194 of 1972 Rules by the Minister 1. These Rules may be cited as the Poisons (Prohibition of Exportation) Rules, and Title
shall be read as one with the Poisons Rules.
2. The exportation of the poison specified in the Schedule is hereby prohibited.
Abrus Precatorius L., Seed of THE POISONS RULES ARRANGEMENT OF RULES 2. Interpretation 3. Importation of poisons Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 4. Exemption from the provisions of section 12 (1) (c) and 12 (2) (a) and (b) of the 5. Certain articles and substances exempted from Part III of the Act and these 6. Exemption from certain provisions of section 16 of the Act POISONS TO BE SUPPLIED ONLY UPON PRESCRIPTION 7. Certain poisons to be sold only upon prescription 8. Wholesale dealing with Part 1 poisons SALE OF PART 2 POISONS BY LICENSED SELLERS 9. Containers of poisons sold by Part 2 sellers 10. Conditions with respect to sale of certain poisons by Part 2 sellers 11. Entry of certain Part 2 poisons in Poisons Book LABELS AND CONTAINERS 12. Manner of labelling containers 13. Labelling of name of poisons 14. Label to contain particulars as to proportion of poison 15. Labelling of certain substances with indication of character 16. Special precautions as to labels in case of certain articles 17. Form of containers SAFE CUSTODY OF POISONS 18. Safe custody of poisons not exempted under rule 4 TRANSPORT OF POISONS Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 19. Special provisions with respect to the transport of certain poisons COLOURING OF POISONS 20. Colouring of certain poisons 21. Manufacture of pharmaceutical preparations 22. Prescribed fees 23. Prescribed forms 24. Preservation of records FIRST SCHEDULE-Substances exempted by rule 4 from the provisions of section 12 (1) (c) of the Act, which relates to persons to whom poisons may be sold,and section 12 (2) (a) and (b), which relates to the making and signingof entries in the Poisons Book SECOND SCHEDULE-Articles exempted by rule 5 from the provisions of Part III of the Act and of these Rules THIRD SCHEDULE-Statement on label of particulars as to proportion of poison in FOURTH SCHEDULE-Substances required to be sold by retail only upon a prescription given by a duly qualified medical practitioner or dentist or a veterinarysurgeon FIFTH SCHEDULE-Form in which the substances specified are restricted when sold by a licensed seller of Part 2 poisons SIXTH SCHEDULE-Indication of character prescribed by rule 14 for the purposes of section 14 (c) of the Act SEVENTH SCHEDULE-Poisons to which rule 18 (1) applies EIGHTH SCHEDULE-Poisons required to be coloured in certain cases Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia NINTH SCHEDULE-Prescribed forms SECTION 26-THE POISONS RULES Government Notices40 of 1941178 of 1941 Rules by the Minister 107 of 1944216 of 194625 of 1949324 of 1953429 of 1963475 of 1964497 of 1964500 of 1964Federal GovernmentNotices161 of 1954223 of 1957338 of 1962177 of 1963Act51 of 1963Gazette Notice845 of 1965Statutory Instruments163 of 1965115 of 1967336 of 196739 of 1970193 of 1972147 of 1981150 of 1981151 of 198162 of 198564 of 1985143 of 1985Act No.
13 of 1994 1. These Rules may be cited as the Poisons Rules.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 2. (1) In these Rules, unless the context otherwise requires-
"antimonial poisons" means chlorides of antimony, oxides of antimony, sulphides of antimony, antimonates, antimonites, and organic compounds of antimony; "arsenical poisons" means halides of arsenic, oxides of arsenic, sulphides of arsenic, arsenates, arsenites, copper acetoarsenites, sodium thioarsenates,and organic compounds of arsenic; "British Pharmaceutical Codex" and "British Pharmacopoeia" include supplements; "food" includes drink; "medicine for the internal treatment of human ailments" includes any medicine to be administered by hypodermic injection but does not include anymouthwash, eye-drops, eye-lotion, ear-drops, douche or similar article; "Part 1 poison" or "Part 2 poison" means a poison included in Part 1 or Part 2 of the Poisons List, as the case may be; "Poisons List" means the Poisons List for which provision is made in section eleven of the Act.
(2) Any reference to the percentage of a poison contained in any substance shall, unless otherwise expressly provided, be construed in the following manner, that is to say,a reference to a substance containing one per centum of any poison means- (a) in the case of a solid, that one gramme of the poison is contained in every hundred grammes of the substance; (b) in the case of a liquid, that one millilitre of the poison, or, if the poison itself is a solid, one gramme of the poison, is contained in every hundredmillilitres of the substance; and so in proportion for any greater or less percentage.
3. (1) No person, other than a registered pharmacist or a duly qualified medical Importation of poisons
practitioner or dentist or a veterinary surgeon, shall import poisons without a permit inwriting from the Board: such permit may be in general terms: Provided that a licensed seller of Part 2 poisons may import Part 2 poisons without such permit.
(2) The Board may, without assigning any reason therefor, refuse any application for such a permit.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (3) Notwithstanding the provisions of sub-rule (1), no person shall import or export the poisons listed hereunder unless he is in possession of a permit issued to him by theDirector of Medical Services, authorising him either to import or export the said poisons,that is to say: Amphetamine; its salts; Dexamphetamine; its salts; Lysergide; its salts; Mescaline; its salts; Methaqualone hydrochloride and preparations containing methaqualone Methamphetamine; its salts; Methylphenidate; its salts; Phencyclidine; its salts; Phenmetrazine; its salts; Psilocin; its salts; its esters and ethers; Psilocybin; its salts.
Amidopyrine and preparations containing amidopyrine; Clioquinol in preparations for internal use; Hormone pregnancy test preparations containing estrogens and progestrogens; Medroxyprogesterone acetate in injectable form for use as a contraceptive; and Methaqualone hydrochloride and preparations containing methaqualone Lysergide; its salts; Mescaline; its salts; Mafloquine, its salts Psilocin; its salts; its esters and ethers; Psilocybin; its salts.
(As amended by No. 336 of 1967), No. 143 of 1985 and S.I. No. 87 of 1986) (4) Where any poison to which this rule applies is alleged to be in transit through Zambia, the carrier thereof shall, at the points of entry and exit, and at any other timewhen so required, produce documentary evidence to any officer of the Customs andExcise Department, of the Immigration Department, any Police officer or any personauthorised in writing in that behalf by the Board, to show that the export of such poisonfrom the country of its origin or supply and its import into the country of final destinationhas been authorised by the respective drug regulatory authorities, or other relevantauthorities, of the countries concerned.
(As amended by S.I. No. 143 of 1985) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 4. The provisions of section twelve (1) (c) and twelve (2) (a) and (b) of the Act Exemption from the
(which make provision as to persons to whom poisons may be sold and to the keeping of provisions of section records of sales) shall not apply- 12 (1) (c) and 12 (2)(a) and (b) of the Act (a) to the substances included in the First Schedule; (b) to the following articles, that is to say- machine-spread plasters; (ii) surgical dressings; (iii) articles containing barium carbonate or zinc phosphide and prepared for the destruction of rats and mice; (iv) any preparation, being a preparation capable of external use only, made from extract or tincture of Cannabis.
(As amended by F.G.N. No. 223 of 1957) 5. Nothing in Part III of the Act or these Rules shall apply to-
Certain articles andsubstances exempted (a) any article in Group I of the Second Schedule; from Part III of the Actand these Rules (b) any poison specified in the first column of Group II of the Second Schedule if contained in or in the form of any of the articles or substances specified inthe second column.
6. (1) The provisions of subsections (3), (4) and (6) of section sixteen of the Act Exemption from
shall not apply to the sale or supply of a poison by the manufacturer thereof or by a certain provisions of person carrying on a business in the course of which poisons are regularly sold by way of section 16 of the Act wholesale dealing if- (a) the poison 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 themanufacture of other articles; and (b) the seller is reasonably satisfied that the purchaser requires the poison for the purpose of that business.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (2) So much of subsection (6) of section sixteen of the Act as requires an entry in the Poisons Book to be signed by the purchaser of a poison shall not apply in respect ofsales made to a person for the purposes of his trade or business if the provisions ofsubsections (3) and (4) of that section are complied with and the seller inserts in the entryin the Poisons Book the words "signed order" and a reference number by which the ordercan be identified.
(No. 115 of 1967) POISONS TO BE SUPPLIED ONLY UPON PRESCRIPTION 7. (1) It shall not be lawful to sell by retail any poison included in the Fourth Certain poisons to be
Schedule except on and in accordance with a prescription given by a duly qualified medical practitioner or dentist or a veterinary surgeon.
(2) This rule shall not apply- (a) to any sale exempted by section sixteen of the Act; or (b) to strychnine or its salts sold- with the permission of the Board for the purpose of poisoningvermin; or (ii) as an ingredient in a medicine which contains not more than 0.2 per centum of strychnine or the equivalent thereof; or (c) to poisons of the sulphonamide group sold on registered premises by an authorised seller of poisons when such poisons are- sold for the treatment of animals; or (ii) present in an amount not exceeding eleven per centum in a preparation visibly marked as intended for external use; or Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (d) to any sale of an anti-histamine preparation for the prevention or treatment of travel sickness to a person for administration to himself or to adependant if the following conditions, in addition to any other requirementsof the Act or of these Rules, are complied with- there shall be written so as to be clearly legible on the container inwhich the preparation is sold, or on a label affixed thereto or, if thepreparation is sold in more than one container, on the innercontainer or a label affixed thereto, or on a direction slip supplied atthe time the preparation is sold- A. the specific purpose for which the preparation is sold; B. the dose and method of administration; C. a warning of any untoward reaction which may occur and of precautions which should be observed in the use of the preparation; (ii) no other purpose for which the preparation may be used shall be indicated on the aforesaid container, label, direction slip or otherliterature supplied with the preparation.
(3) For the purposes of this rule, 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 veterinary surgeon, of the person towhom the medicine is to be delivered; (d) have written thereon, if given by a dentist, the words "for dental treatment only" or, if given by a veterinary surgeon, the words "for animal treatmentonly".
(e) specify the total amount of the medicine to be supplied and the dose to be (4) The person dispensing the prescription shall comply with the following (a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed a stated number oftimes or 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 must not be dispensed otherwisethan in accordance with the direction; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the dateon which the prescription is dispensed; (d) except in the case of a prescription which may be dispensed again, the prescription must, for a period of two years, be retained and kept on thepremises on which it was dispensed in such manner as to be readilyavailable for inspection.
(As amended by No. 216 of 1946, No. 324 of 1953 and F.G.N. No. 223 of 1957) 8. It shall not be lawful to sell by way of wholesale dealings any poison included in Wholesale dealing
Part 1 of the Poisons List to a person carrying on a business of shopkeeping unless the with Part 1 poisons (a) has reasonable grounds for believing that the purchaser is an authorised seller of poisons; or (b) has received a statement signed by the purchaser or by a person authorised by him on his behalf to the effect that the purchaser does notintend to sell the poison on any premises used for or in connection with hisretail business.
(No. 336 of 1967) SALE OF PART 2 POISONS BY LICENSED SELLERS 9. A licensed seller of Part 2 poisons shall not sell any poison other than ammonia, Containers of poisons
hydrochloric acid, nitric acid, potassium quadroxalate and sulphuric acid unless- sold by Part 2 sellers (a) it is in the original container as supplied to such licensed seller; or (b) it is sold in containers in which it has been repacked by a registered (As amended by F.G.N. No. 223 of 1957 and No. 115 of 1967) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 10. No licensed seller of Part 2 poisons shall be entitled by virtue of being Conditions with
authorised to sell poisons listed in Part 2 of the Poisons List, to sell- respect to sale ofcertain poisons by Part (a) any poison included in the first column of the Fifth Schedule unless the article or substance sold is one of the articles or substances specifiedagainst the description of the poison in the second column of that Schedule,and the container of the substance is, in addition to any other direction ofthe Act or of these Rules with respect to labelling, labelled clearly with anotice of the special purpose for which the article or substance is intended,and a warning that it is only to be used for that purpose; (b) any arsenical poison, other than lead arsenates, calcium arsenates and copper acetoarsenites, any mercuric chloride, mercuric iodide, any organiccompound of mercury, unless the purchaser thereof is himself a licensedseller of Part 2 poisons or is engaged in the trade or business of mining,agriculture, horticulture or pest control, or in any industry and requires thepoison for the purpose of that trade, business or industry.
(F.G.N. No. 223 of 1957 as amended by No. 115 of 1967) 11. (1) A licensed seller of Part 2 poisons shall not deliver any poison sold by him Entry of certain Part 2
to which the provisions of this rule apply until- poisons in PoisonsBook (a) he has made or caused to be made an entry in a book kept for the purpose to be called the Poisons Book stating- the date of the sale; (ii) the name and quantity of the poison sold; (iii) the name and address and the business, trade or occupation of the (iv) the purposes for which it is stated by the purchaser to be required; (b) the purchaser has affixed his signature to the aforesaid entry.
(2) The provisions of this rule shall apply to the following poisons and to preparations of them: Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Arsenical substances listed in Part 2 of the Poisons List, except preparations containing less than the equivalent of 0.01 per centum of arsenic trioxide.
Barium carbonate, barium silicofluoride.
Dinosam; its compounds with a metal or base.
Dinoseb; its compounds with a metal or base.
Mercuric chloride, except substances containing less than 1.0 per centum of mercuric chloride.
Mercuric iodide, except substances containing less than 2.0 per centum of mercuric iodide.
Organic compounds of mercury, except substances containing less than the equivalent of 0.2 per centum weight in weight of mercury (Hg).
Nicotine; its salts.
Phosphorus compounds listed in Part 2 of the Poisons List.
Zinc phosphide.
(F.G.N. No. 223 of 1957 as amended by No. 115 of 1967) LABELS AND CONTAINERS 12. (1) The particulars with which the container of a poison is required to be Manner of labelling
labelled by section fourteen of the Act and rules 11 to 15 must appear clearly and distinctly in a conspicuous position on the container in which the poison is supplied and onevery box or other covering of whatever nature enclosing the container.
(2) Where the poison is contained in an ampoule, cachet or similar article, it shall not be necessary to label the article itself if the article is contained in a box or othercovering duly labelled.
(3) If the container is duly labelled, it shall not be necessary to label any outer cover or wrapper used only for the purpose of delivery or transport except as required by rule18.
(4) The word "Poison", or the alternative indication of character prescribed by rule 14, as the case may be, shall- (a) in the case of a poison not exempted from certain provisions by the First Schedule, either be printed in red letters on a contrasting background or inletters of some colour set against a red background; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (b) in all cases be easily legible and either on a separate label or surrounded by a line within which there must be no other words except words withwhich the container of the poison is required to be labelled under the Act orthese Rules.
13. The name with which a poison must be labelled in compliance with section Labelling of name of
fourteen of the Act shall be the term under which it is included in the Poisons List: where the said term describes a group of poisons and not the poisonspecifically, the name of the poison shall be- (a) if the poison is the subject of a monograph in either the British Pharmacopoeia or the British Pharmaceutical Codex, one or other ofthe names or synonyms or abbreviated names set out at the head ofthe monograph; and (b) in any other case, the accepted scientific name or name descriptive of the true nature and origin of the poison; (ii) in the case of a preparation in the British Pharmacopoeia or the Formulary of the British Pharmaceutical Codex, or any dilution or admixture of such apreparation, or any surgical dressing for which a standard is described inthe British Pharmaceutical Codex, it shall be sufficient to state the name,synonym or abbreviated name used to describe the preparation or surgicaldressing in the British Pharmacopoeia or the British Pharmaceutical Codexwith the addition of the letters B.P., or B.P.C., as the case may be.
14. (1) The label of the container of any preparation containing a poison as one of Label to contain
its ingredients shall include a statement of the "proportion" expressed in the form of a particulars as to percentage which the poison bears to the total ingredients of the preparation: proportion of poison in the case of a preparation containing a poison specified in the first columnof the Third Schedule, it shall be sufficient to state on the label theparticulars specified in the second column of that Schedule against thedescription of the poison; (ii) in the case of a preparation or surgical dressing which is named in accordance with proviso (ii) to rule 12, it shall not be necessary to state onthe label the proportion of the poison contained in the preparation, and inthe case of any dilution or admixture of such a preparation, it shall besufficient to state the proportion which the preparation bears to the totalingredients of the dilution or admixture; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (iii) where the poison is in tablets, pills, cachets, capsules, lozenges or similar articles, or in ampoules, it shall be sufficient to state on the label of the boxor other covering in which the articles are enclosed the number of thearticles and the amount of the poison, or in the case of such a preparationas is mentioned in proviso (ii), the amount of the preparation, contained ineach article.
(2) Where any proportion is stated as a percentage, the statement shall indicate how the percentage is calculated.
15. In pursuance of the provisions of paragraph (c) of section fourteen of the Act, Labelling of certain
the container of any article specified in the Sixth Schedule shall, instead of being labelled with the word "Poison", be labelled with the words specified in the said Schedule as indication of character applicable to that article.
(F.G.N. No. 223 of 1957) 16. (1) It shall not be lawful to supply any poison-
Special precautions asto labels in case ofcertain articles (a) in the case of a liquid other than a medicine, contained in a bottle of a capacity of not more than 120 fluid ounces, unless the bottle is labelled withthe words "Not to be taken"; (b) in the case of an embrocation, liniment, lotion, liquid antiseptic, or other liquid medicine for external application, unless the container is labelled withthe name of the article and the words "For external use only".
(2) It shall not be lawful to sell or supply any hydrocyanic acid, or cyanide, unless the container is labelled with the words "Warning. This container holds a poisonoussubstance and should only be opened and used by persons having expert knowledge ofthe precautions to be taken in its use" 17. It shall not be lawful to keep, supply or consign for transport any poison unless- Form of containers
(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 of a capacity of not more than 120 fluid ounces, not being a medicine made up ready to be taken forthe internal treatment of human ailments, or a sterile ophthalmic solution ina single dose sterile bottle enclosed in a sealed container, the outer surfaceof the bottle is fluted vertically with ribs or grooves recognisable by touch.
(As amended by No. 115 of 1967) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SAFE CUSTODY OF POISONS 18. (1) It shall not be lawful for any person knowingly to have in his possession or Safe custody of
under his control on any premises any poison, other than a substance included in the First poisons not exempted Schedule, unless the following conditions are complied with at all times when the poison is not in actual use: (a) The poison shall be kept under lock and key- in a separate room or compartment specially reserved for keepingpoisons and partitioned off from the rest of the premises; or (ii) in a cupboard, box or other receptacle specially reserved for keeping poisons, clearly marked with the words "Poisons Only", and kept in aplace apart from anything containing food or drink.
(b) The poison shall be kept in a place ordinarily accessible only to persons lawfully having access thereto.
(c) The key of any room, compartment, cupboard, box or other receptacle in which poisons are kept shall be retained under the control of the person incharge of such poison.
(2) Any person in possession of any receptacle which has been used for containing any such poison, and which is no longer required for that purpose, shall destroy thatreceptacle in such a manner as effectively to prevent its further use or otherwise renderthe receptacle innocuous.
(3) The provisions of sub-rules (1) and (2) shall not apply to wholesalers, educational institutions, laboratories, industrial plants or to poisons kept and maintained atmines and works.
(4) In any hospital or other similar institution all such poisons not in actual use shall be kept under the control of the person in charge of the institution, or some fit and properperson specially detailed by him for the purpose and shall be issued for use as required.
(5) Poisons for use in the treatment of human ailments shall be kept entirely separate from any other poisons.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (6) In any hospital, infirmary, dispensary, clinic, nursing home or other similar institution at which human ailments are treated and at which medicines are dispensed in adispensing or pharmaceutical department in charge of a person appointed for thatpurpose, no medicine containing a poison shall, except in a case of emergency, besupplied from that department for use in the wards, operating theatres or other sections ofthe institution except upon a written order signed by a duly qualified medical or dentalpractitioner or by a sister or nurse in charge of a ward, theatre or other section of theinstitution.
(7) Where in any hospital, infirmary, dispensary, clinic, nursing home or other similar institution at which human ailments are treated, poisons are stored elsewhere than in apharmacy under the direct control and supervision of a registered pharmacist suchstorage places shall be regularly inspected by the pharmacist in charge at intervals of notmore than three months, or if no pharmacist is employed in such institution the Director ofMedical Services shall make suitable arrangements for the periodic inspection of suchstorage places.
(As amended by No. 25 of 1949 and No. 324 of 1953) TRANSPORT OF POISONS 19. (1) It shall not be lawful to consign for transport any of the poisons included in Special provisions with
the Seventh Schedule, not being medicines, unless the outside of the package is labelled conspicuously with the name or description of the poison and a notice indicating that it is transport of certainpoisons to be kept separate from food and from empty food containers.
(2) It shall not be lawful for any person knowingly to transport any such poison in any vehicle in which food is being transported unless the food is carried in a part of thevehicle effectively separated from that containing the poison, or is otherwise adequatelyprotected from the risk of contamination.
(As amended by F.G.N. No. 223 of 1957) COLOURING OF POISONS 20. It shall not be lawful to sell, or to import into Zambia, any poison included in the Colouring of certain
Eighth Schedule which is intended for use as a weed killer or in the prevention or treatment of infestation by animals, plants or other living organisms unless there has beenadded to such poison a dye or other substance which renders it of a distinctive colour,whether the poison is dry, wet or in solution: Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Provided that this rule shall not apply in the case of- poisons which are themselves of a distinctive colour; or (ii) sheep dips which are already of a distinctive colour.
(No. 115 of 1967) 21. In all establishments in which pharmaceutical preparations containing any Manufacture of
poison are manufactured for the purpose of the internal treatment of human ailments, the preparation must be manufactured by, or under the supervision of- (a) a registered pharmacist; or (b) a person having one of the following qualifications in chemistry: the Fellowship of the Institute of Chemistry; (ii) the Associateship of the Institute of Chemistry; (iii) any similar qualification recognised by the Board: Provided that this rule shall not apply to the manufacture by or under the supervision of a duly qualified medical practitioner of preparations containing pituitary, suprarenal orthyroid glands, the active principles of any of those glands, or the salts of the activeprinciples of thyroid gland.
22. The following fees shall be paid in connection with matters arising under the Prescribed fees
(a) For a dealer' licence [section 16 (2)]: Annually K2.
(b) For a licence to sell Part 2 poisons [section 19 (1)]: K2.
(c) For renewal of licence to sell Part 2 poisons [section 19 (3)]: Annually K2.
23. The forms to be used in pursuance of the Act shall be those prescribed in the Prescribed forms
Ninth Schedule.
(As amended by F.G.N. No. 223 of 1957) 24. All books kept for the purposes of Part III of the Act shall be preserved on the Preservation of
premises on which the sales recorded therein were made for a period of two years from the date on which the last entry was made therein.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 25. Any person who contravenes any provision of these Rules is guilty of an Penalty
offence and shall be liable to a fine of one thousand five hundred penalty units or toimprisonment for six months and the court before which a person is convicted may orderany articles in respect of which the offence was committed to be forfeited and disposed ofas it may think fit.
(As amended by Act No. 13 of 1994) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SUBSTANCES EXEMPTED BY RULE 4 FROM THE PROVISIONS OF SECTION 12 (1) (C) OF THE ACT, WHICH RELATES TO PERSONS TO WHOM POISONS MAY BE SOLD, AND SECTION 12 (2) (A) AND (B), WHICH RELATES TO THE MAKING AND SIGNING OF ENTRIES IN THE POISONS BOOK Any substance containing any of the poisons specified in the first column below if the poison content is less than thepercentage specified in the second column.
Percentage of poison content below which substance is exempted Poison Alkali fluorides . . . . . Exempt all percentages Alkaloids and related substances, the following; their salts, simple or complex; their quaternary compounds: Aconite, alkaloids of . . . . . 0.02 per centum Apomorphine . . . . . 0.2 per centum Atropine . . . . . 0.15 per centum Belladonna, alkaloids of . . . . . 0.15 per centum, calculated as Brucine . . . . . 0.2 per centum Coca, alkaloids of . . . . . 0.1 per centum Cocaine . . . . . 0.1 per centum Codeine . . . . . 1.5 per centum Colchicine . . . . . 0.5 per centum Coniine . . . . . 0.1 per centum Cotarnine . . . . . 0.2 per centum Ecgonine and its esters . . . . . 0.1 per centum Emetine . . . . . 1.00 per centum Ephedra, alkaloids of . . . . . Exempt all percentages Ethylmorphine . . . . . 0.2 per centum Gelsemium, alkaloids of . . . . . 0.1 per centum Homatropine . . . . . 0.15 per centum Hyoscine . . . . . 0.15 per centum Hyoscyamine . . . . . 0.15 per centum Jaborandi, alkaloids of . . . . . 0.5 per centum Lobelia, alkaloids of . . . . . 0.5 per centum Morphine . . . . . 0.2 per centum, calculated as anhydrous Papaverine . . . . . 1.00 per centum Pomegranate, alkaloids of. . . . . 0.5 per centum Sabadilla, alkaloids of . . . . . 1.00 per centum Solanaceous alkaloids, not otherwise included in this . . 0.15 per centum, calculated as Schedule. . . . . . hyoscyamine Stavesare, alkaloids of . . . . . 0.2 per centum Strychnine . . . . . 0.2 per centum . . . . . 1.00 per centum Veratrum, alkaloids of . . . . . 1.00 per centum Amino-alcohols, esterified with benzoic acid, phenylacetic acid, . 10.00 per centum of esterified amino- phenylpropionic acid, cinnamic acid or the derivatives of these acids.
Amyl nitrite . . . . . Exempt all percentages Antimonial poisons . . . . . Equivalent of 1.00 per centum of antimony trioxide Arsenical poisons . . . . Equivalent of 0.01 per centum of arsenic trioxide and dentifrices containing less than 0.5 per centum of acetarsol Cantharidin . . . . . 0.01 per centum Cantharidates . . . . . Equivalent of 0.01 per centum of Chloroform . . . . . Exempt all percentages Cresote obtained from wood. . . . . Exempt all percentages Croton, oil of . . . . . Exempt all percentages Dextromethorphan; its salts. . . . . Substances containing less than 1.5 per centum of dextromethorphan Digitalis, glycosides and other active principles of . . One unit of activity (as defined in the British Pharmacopoeia) in two grammes of the Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia ARTICLES EXEMPTED BY RULE 5 FROM THE PROVISIONS OF PART III OF THE ACT AND OF THESE RULES Group I-General Exemptions Adhesives, anti-fouling compositions, builders' materials, ceramics, distempers, electrical valves, enamels, explosives,fillers, fireworks, fluorescent lighting tubes, glazes, glue, inks, lacquer solvents, loading materials, matches, motor fuelsand lubricants, paints other than pharmaceutical paints, photographic paper, pigments, plastics, propellants, rubber,varnishes.
Group II-Special Exemptions Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Poison Substance or Article in which exempted Acetanilide; alkyl acetanilides . . Substances not being preparations for the treatment of human Alkali fluorides . . . Dentifrices containing not more than 0.3 per centum of the alkali salts of hydrofluoric acid.
Alkaloids: Brucine . . . . Surgical spirit containing not more than 0.015 per centum of brucine.
Emetine . . . . Ipecacuanha; extracts and tinctures of ipecacuanha; substances containing less than 0.05 per centum of emetine.
Ephedra, alkaloids of . . Substances containing less than 1 per centum of the alkaloids of Jaborandi, alkaloids of . . Substances containing less than 0.025 per centum of the alkaloids of jaborandi.
Lobelia, alkaloids of . . Preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants; substances containing less than 0.
1 per centum of the alkaloids of lobelia.
Nicotine . . . . Tobacco, preparations with a soap base containing not more than 7.5 per centum of nicotine, weight in weight; aerosols containing not more than 0.2 per centum of nicotine, weight in weight.
Pomegranate, alkaloids of. . . Pomegranate bark.
Solanaceous alkaloids . . Stramonium contained in preparations for the relief of asthma in the form of cigarettes, smoking mixtures or fumigants.
Stavesacre, alkaloids of . . . Soaps; ointments; lotions for external use.
Amino-alcohols, esterified with benzoic acid, . Preparations for the supplementing of animal foodstuffs.
phenylacetic acids, phenylpropionic acid, cinnamic acid or the derivatives of these acids.
p-Aminobenzenesulphonamide; its salts; . Feeding stuffs containing not more than 0.5 per derivatives of p-aminobenzenesulphonamide centum of total sulphonamides; sulphaquinoxaline when having any of the hydrogen atoms of the contained, to a concentration not exceeding 0.5 per centum,p-amino group or of the sulphonamide groups in preparations for the destruction of rats and mice. substituted by another radical; their salts.
-Aminopropylbenzene andáb-aminoisopro- . Appliances for inhalation in which the poison is absorbed in phylbenzene and any compound structurally inert solid material.
derived from either of those by substitution in the side chain or by ring closure therein or both; their salts Ammonia . . . . Substances not being solutions of ammonia or preparations containing solutions of ammonia; substances containing less than 5 per centum, weight in weight, of ammonia (NH3); refrigerators; smelling bottles.
Androgenic, oestrogenic andprogestational . Preparations intended for external application only; feedingsubstances, the following: Benzoestrol.
Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters.
Steroid compounds with androgenic or oestrogenic or progestational activity; their esters.
Antibiotics: any antimicrobial or antifungal . Animal foodstuffs and animal feed supplements.
substance synthesised by bacteria, fungi or protozoa, and any substance the chemical properties of which are identical with or similar to any such antimicrobial or anti- fungal substance, but which is not produced from living organisms, being a substance which is used in the specific treatment of infections; their salts.
Antihistamine substances, the following; their . Preparations intended for external applicationsalts, their molecular compounds: only and preparations containing not more than 1 per centum of antihistamine substances for application in the Bromodiphenhydramine; nose or eye.
Buelizine; Carbinoxamine; Chlorcyclizine; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia STATEMENT ON LABEL OF PARTICULARS AS TO PROPORTION OF POISON IN CERTAIN CASES Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Alkaloids: Aconite, alkaloids of . . The proporation of any one alkaloid of aconite that the preparation would be calculated to contain on the assumption that all the alkaloids of aconite in the preparation were that alkaloid.
Belladonna, alkaloids of . . . The same as above, with the substitutionor the reference Calabar bean, alkaloids of. to aconite of a reference to belladonna, calabar bean or Coca, alkaloids of. or such other of the said poisons as the case may require.
Ephedra, alkaloids of.
Ergo alkaloids of.
Gelsemium, alkaloids of.
Jaborandi, alkaloids of.
Lobelia, alkaloids of.
Pomegranate, alkaloids of.
Quebracho, alkaloids of, other than the alkaloids of red quebracho.
Sabadilla, alkaloids of.
Solanaceous alkaloids not otherwise included in the Poisons List.
Stavesacre, alkaloids of.
Veratrum, alkaloids of.
Yohimba, alkaloids of.
Antimonial poisons . . . The proportion of antimony trioxide (Sb 2 O3) or antimony pentoxide (Sb2 O5) that the preparation would be calculated to contain on the assumption that the antimony (Sb) in the poison had been wholly converted into antimony trioxide or antimony pentoxide as the case may be.
Arsenical poisons. . . . The proportion of arsenic trioxide (As2 O3) or arsenic pentoxide (As2 O5) that the preparation would be calculated to contain on the assumption that the arsenic (As) in the poison had been wholly converted into arsenic trioxide or arsenic pentoxide as the case may be.
Barium, salts of . . . The proportion of one particular barium salt which the preparation would be calculated to contain on the assumption that the barium (Ba) in the poison had been wholly converted into that salt.
Digitalis, glycosides of; other active . . The number of units of activity as defined in the British principles of digitalis. Pharmacopoeia contained in a specified quantity of the preparation.
Hydrocyanic acid; cyanides; doubles cyanides The proportion of hydrocyanic acid (HCN) that the of mercury and zinc preparation would be calculated to contain on the assumption that the cyanides in the poison had been wholly converted into hydrocyanic acid.
Lead, compounds of, with acids from fixed . The proportion of lead oxide (PbO) that the oils. preparation would be calculated to contain on the assumption that the lead in the poison had been wholly converted into lead oxide.
Mercury, organic compounds of . . The proportion of organically combined mercury (Hg) contained in the preparation.
Phenols . . . . The proportion of phenols (added together) contained in the Compounds of phenol with a metal. . . The proportion of phenols (added together) that the preparation would be calculated to contain on the assumption that the compounds of phenols with a metal had been wholly converted into the corresponding phenols.
Pituitary gland, the active principles of; . Either- (a) the number of units of activity as defined in the British Pharmacopoeia contained in a specified quantity of thepreparation; or (b) the proportion of pituitary gland, or of anterior or of posterior lobe of the gland, as the case may be, contained in the preparation;or (c) the amount of pituitary gland, or of anterior or of posterior lobe of the gland, as the case may be, from which a specified quantity ofthe preparation was obtained, together with an indication whetherthe amount relates to fresh or to dried gland substance.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (Rule 7 (1)) SUBSTANCES REQUIRED TO BE SOLD BY RETAIL ONLY UPON A PRESCRIPTION GIVEN BY A DULY QUALIFIED MEDICAL PRACTITIONER OR DENTIST OR A VETERINARY SURGEON Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Abrus precatorius L., seed of.
Acetanilide; alkyl acetanilides.
Acetohexamide.
Acetyl-carbromal.
Alcuronium chloride.
Allylispropylacetylurea.
Amidopyrine; its salts; amidopyrine sulphonates; their salts.
p-Aminobenzenesulphonamide; its salts; derivatives of; p-aminobenzene-sulphonamide having any of the hydrogen atoms of the p-amino group or of the sulphonamide group substituted by another radical; their salts; except when containedin ointments or surgical dressings or in preparations for the prevention and treatment of diseases in poultry.
-Aminopropylbenzene and -aminoisopropylbenzene and any compound structurally derived from either of those substances by substitution in the side chain or by ring closure therein (or by such substitution and such closure),except ephedrine, N-methylephedrine, N-diethylaminoethylephedrine, phenylpropanolamine and prenylamine; anysalt of any substance falling within this item.
Aminophyllin;Amitriptyline; its salts.
Amphetamine;Androgenic, oestrogenic and progestational substances, the following: (i) benzoestrol;(ii) derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters;(iii) steroid compounds with androgenic, oestrogenic or progestationa activity; their esters.
Antibiotics; any antimicrobial or antifungal substances synthesized by bacteria, fungi, or protozoa and any substance the chemical properties of which are identical with or similar to any such antimicrobial or antifungal substance but whichis not produced from living organisms, being a substance which is used in the specific treatment of infections; theirsalts.
Azacyclonal; its salts.
Barbituric acid; its salts; derivatives of barbituric acid, their salts; compounds of barbituric acid, its salts, its derivatives, their salts, with any other substance.
Benactyzine; its salts, molecular compounds, esters and derivatives.
Benzhexol; its salts.
Benztropine and its homologues; its salts.
Bis(1(-2lsobutyry loxyethyl)-2-N-(-4 amino-2 methyl-5 pyrimidinyl tormanindol-l-proplnyldisulplnidesulbutiamineBromvaletone.
Busulphan; its salts.
Captodiame; its salts.
Caramiphen; its salts; except tablets containing not more than the equivalent of 7.5 milligrammes of caramiphen base, or liquid preparations containing not more than the equivalent of 0.1 per centrum of caramiphen base.
carbamazepinecarbimazole;Carbaromal.
Carisoprodol.
Chloral; its addition and its condensation products; their molecular compounds.
Chlorambacil,Chlordiazepoxide; its salts.
Chloromethiazole; its salts.
Chlorothiazide and other derivatives of benzo-1:2:4-thiadiazine-7-sulphonamide 1:1-dioxide, whether hydrogenated or not.
Chlorphenoxamine.
Chlorphentermine; its salts.
Chlorpropamide; its salts.
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts.
Chlorthalidone and other derivatives of o-chlorobenzene sulphonamide.
Cinchocaine its salts in inpectable fromClorexolone.
cimetidineClofazamine;Cyclarbamate.
Cydizine; its saltsCyclophosphamide;Cycrinine (1-cyclopentyl-1-phenyl-3-piperidinopropan-1-ol); its salts.
Debrisoquine; its salts;Demecarium bromide.
Desipramine; its salts.
Diamidinodiazoaminobenzene; its salts.
Diazepam and other compounds containing the chemical structure of dihydro-1,4-benzodiazepine substituted to any degree; their salts.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (Rule 9 (a)) FORM IN WHICH THE SUBSTANCES SPECIFIED ARE RESTRICTED WHEN SOLD BY A LICENSED SELLER OF Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Poison Form to which sale is restricted Arsenical substances- Arsenious oxide. . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Arsenic sulphides . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Calcium arsenates . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Calcium arsenites . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Copper acetoarsenite . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Copper arsenates . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Copper arsenites . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Lead arsenates. . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Potassium arsenites . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Sodium arsenates . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Sodium arsenites . . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Sodium thioarsenates . . Dips and washes for cattle and sheep; agricultural and horticultural insecticides or fungicides; wood preservatives; or weed-killers.
Barium carbonate. . . . Preparations for the destruction of rats and mice.
Dinitrocresols (D.N.O.C.); their compounds . Agricultural and horticultural uses and as orinsecticides orwith a metal base. fungicides.
Dinosam; its compounds with a metal or . Preparations for use in agriculture or horticulture.
base.
Dinoseb; its compounds with a metal or base. Preparations for use in agriculture or horticulture.
Mercurial substances- Mercurie chloride . . . Agricultural and horticultural fungicides, seed and bulb dressings, insecticides. Mercuric iodide. . . . Agricultural and horticultural fungicides, seed and bulb dressings.
Organic compounds of mercury. . Agricultural and horticultural fungicides, seed and bulb dressings; solutions containing not more than 5 per centum, weight, in volume of phenyl mercuric acetate for use in swimming baths.
Metallic oxalates other than potassium . Photographic solutions or materials.
quadroxalate.
Nicotine and its salts . . Agricultural and horticultural insecticides or fungicides, and preparations for the treatment of animals.
Nitrobenzene . . . Agricultural and horticultural insecticides; substances for the treatment of bee disease; ointments for the treatment of animals.
Phosphorus compounds, the following: . Preparations for use in agriculture or horticulture.
Amiton, azinphosethyl, azinphosmethyl, chlorfenvinphos demeton-O, demeton-S, demeton-O-methyl, demeton-S-methyl, dichlorvos, diethyl 4-methyl-7-coumari- nylphosphorothionate, diethyl p-nitro- phenyl phosphate, dimefox, disulfoton, ethion, ethyl p-nitrophenyl phenylphos- phonothionate, mazidox, mecarbam, mevinphos, mipafox, oxydemeton- methyl, parathion, phenkapton, phorate, phosphamidon, schradan, sulfotep, EPP (HETP), thionazin, triphosphoric pentadimethylamide, vamidothion.
Potassium fluoride and sodium silicofluoride.Insecticides.
. . . Insecticides and preparations for the treatment of animals.
Zinc phosphide . . . . Preparations for the destruction of rats and mice.
(F G N No 223 of 1957 as amended by Nos 115 and 336 of 1967) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia INDICATION OF CHARACTER PRESCRIBED BY RULE 14 FOR THE PURPOSES OF SECTION 14 (C) OF THE ACT 1. To be labelled with the words "Caution. It is dangerous to take this preparation except under medical supervision": Medicines made up ready for internal treatment of human ailments if the poison is one of the following: Insulin.
Lucanthone; its salts.
2. To be labelled with the words "Caution. It is dangerous to exceed the stated dose": Medicines (other than medicines mentioned in paragraph 1) made up ready for the internal treatment of humanailments and being substances exempted from certain provisions by rule 4 (b) and the First Schedule.
3. To be labelled with the words "Poison. For animal treatment only" or " Poison. For veterinary use only": Medicines made up ready for the treatment of animals.
4. To be labelled with the words "Caution. This preparation may cause serious inflammation of the skin in certainpersons and should be used only in accordance with expert advice": Preparations for the dyeing of hair containing phenylene diamines, tolylene diamines or other alkylated-benzenediamines or their salts.
5. To be labelled with the words "Caution. This substance is caustic": Potassium hydroxide, sodium hydroxide, and articles containing either of these substances.
6. To be labelled with the words "Caution. This substance is poisonous. This inhalation of its vapour, mist, spray or dustmay have harmful consequences. It may also be dangerous to let it come into contact with the skin or clothing": Dinitrocresols (D.N.O.C.); their compounds with a metal or a base; except preparations for the treatment of humanailments and except winter washes containing not more than the equivalent of 5 per centum of dinitrocresols.
Dinosam; its compounds with a metal or a base.
Dinoseb; its compounds with a metal or a base.
Endosulfan.
Endothal; its salts.
Endrin.
Fluoroacetamide; fluoroacetanilide.
Organic compounds of mercury in aerosols.
Phosphorus compounds, the following: Amiton; Azinphos-ethyl; Azinphos-methyl; Chlorfenvinphos; Demeton-O; Demeton-S; Dichlorvos; Diethyl 4-methyl-7-coumarinyl phosphorothionate; Diethyl p-nitrophenyl phosphate; Dimefox; Disulfoton; Ethion; Ethyl p-nitrophenyl phenylphosphonothionate; Mazidox; Mecarbam; Mavinphos; Mipafox; Oxydemeton-methyl; Parathion; Phenkapton; Phorate; Phosphamidon; Schradan; Sulfotep; TEPP (HETP): Thionazin; Triphosphoric pentadimethylamide; Vamidothion.
7. To be labelled with the words "Caution. This preparation should be administered only under medical supervision. Thevapour is dangerous": Medicines made up ready for internal or external treatment of human ailments and containing di-isopropylfluorophosphonate.
8. To be labelled with the words "Caution. Care is necessary in opening the bottle, owing to pressure of gas" in additionto the word "Poison": Liquid ammonia, containing over 30 per centum of ammonia (NH3).
9. To be labelled with the words "Caution. This substance is poisonous. Inhalation of the powder is dangerous. It isalso dangerous to let the substance come into contact with the skin or clothing": Monofluoroacetic acid; its salts Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia POISONS TO WHICH RULE 18 (1) APPLIES Arsenical poisons.
Barium, salts of.
Dinitrocresols (D.N.O.C.); their compounds with a metal or a base.
Dinosam; its compounds with a metal or a base.zDinoseb; its compounds with a metal or a base.
Hydrocyanic acid; cyanides.
Nicotine.
Phosphorus compounds, the following: Diethyl thiophosphate of ethyl-mercapto-ethanol, dimefox, ethylparanitropheny1-benzene thiophosphonate,hexaethyl tetraphosphate (HETP), 4-methyl-hydroxy-coumarin-diethyl thiophosphate, mipafox,paranitrophenyl-diethyl phosphate, parathion, schradan, sulphotepp, tetraethyl pyrophosphate (TEPP), triphosphoricpentadimethylamide.
Thallium, salts of.
(F.G.N. No. 223 of 1957) POISONS REQUIRED TO BE COLOURED IN CERTAIN CASES Arsenical poisons, fluoroacetamide; fluoroacetanilide, monofluoroacetic acid; its salts, phosphorus compounds, thefollowing: (No. 115 of 1967 as amended by No. 336 of 1967) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 1. Application for registration of premises. (Section 6 (2).) 2. Register of premises. (Section 6 (5).) 3. Certificate for purchase of poison. (Section 12.) 4. Poisons Book. (Section 12 (2).) 5. Dealer's licence. (Section 16 (2).) 6. Application for licence to sell Part 2 poisons. (Section 18.) 7. Licence to sell Part 2 poisons. (Section 19.) 8. Register of licences issued to sellers of Part 2 poisons. (Section 20.) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 6 (2)) APPLICATION FOR REGISTRATION OF PREMISES The Registrar,Pharmacy and Poisons Board,P. O. Box 205, Lusaka In accordance with the provisions of section 6 of the Pharmacy and Poisons Act, I, . being duly registered as a Pharmacist, do hereby apply for registration of premises situated at (give full address ofpremises) .
.
Signature of Applicant Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 6 (5)) REGISTER OF PREMISES Name of Pharmacist Address of Premises under whose control Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 12) CERTIFICATE FOR PURCHASE OF POISON For the purpose of subsection (1) (c) (i) of section 12 the Pharmacy and Poisons Act, I, the undersigned, hereby certifyfrom my knowledge of (a) . of (b) .
he is a person to whom (c) .
may properly be supplied.
I further certify that (d) .
is the signature of the said (a) .
Signature and designation of person giving certificate (a) Insert full name of intending purchaser.
(b) Insert full postal address.
(c) Insert name of poison (d) Intending purchaser to sign his name here.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 16(2)) Messrs . of . carrying on business in . at . are hereby authorised to sell poisons by way of wholesale dealing, or* .
.
NOTE.-This licence exempts the holder from certain provisions of the Pharmacy and Poisons Act-see section 16.
(*State the nature of the transaction which the licensee is permitted to conduct in accordance with paragraph (b) ofsubsection (1) of section 16.) Registrar, Pharmacy and Poisons Board Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 18) APPLICATION FOR LICENCE TO SELL PART 2 POISONS To the Provincial Medical Officer, I, . being engaged in the business of . hereby apply for a licence to sell poisons in Part 2 of the Poisons List on the following premises .
Signature of Applicant Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 19) LICENCE TO SELL PART 2 POISONS . of . carrying on the business of . at . is hereby licensed to sell and keep open for the sale of poisons in Part 2 of the Poisons List, at the following premises: .
.
This licence is in force until the 31st December, 19 .
Provincial Medical OfficerFee: K2 Renewals .
.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia GOVERNMENT OF THE REPUBLIC OF ZAMBIA THE PHARMACY AND POISONS ACT (Section 20) REGISTER OF LICENCES ISSUED TO SELLERS OF PART 2 POISONS (F.G.N. No. 223 of 1957 as amended by Act No. 51 of 1963, No. 500 of 1964 and No. 163 of 1965) Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia SECTION 26-THE POISONS (PROHIBITION) RULES Statutory Instrument166 of 1983 1. These Rules may be cited as the Poisons (Prohibition) Rules.
2. No person shall sell, prescribe or use any substance referred to in the Schedule Sale of certain poisons
hereto for the purpose specified therein.
3. Any person who contravenes any provision of these Rules is guilty of an offence Penalty
and shall be liable upon conviction to a fine of two hundred and fifty penalty units or toimprisonment for a term not exceeding six months, or to both penalty units and the courtbefore which such person is convicted may order any article in respect of which theoffence was committed to be forfeited.
(As amended by Act No. 13 of 1994) THE PHARMACY AND POISONS (ISSUE AND CONTROL OF WHOLESALE LICENCES) RULES Statutory Instrument14 of 1977 Rules by the Minister 1. These Rules may be cited as the Pharmacy and Poisons (Issue and Control of Title
Wholesale Licences) Rules.
2. The Board may, without assigning any reason therefore, refuse any application Refusal of application
for a licence to carry out wholesale dealing in poisons.
for wholesale licence 3. The Board may, after consultation with the Minister, revoke any wholesale Revocation of
licence of any person without assigning any reason therefore.
wholesale licence SECTION 26-THE PHARMACY AND POISONS (FEES) ORDER Statutory Instrument46 of 1993Act No.
13 of 1994 1. This Order may be cited as the Pharmacy and Poisons (Fees) Order.
2. In this Order, unless the context otherwise requires "medicine" means any Interpretation
medicine and includes any secret, patent, proprietary, generic or homoeopathic medicineor preparation.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 3. The fees set out in the Schedule hereto shall be payable to the Pharmacy and Fees
Poisons Board for the purposes therein specified.
(Paragraph 2) 1. Application for a licence to import or manufacture medicines 2. Issue of a licence to manufacture medicines 6,000 3. Annual retention of a licence to manufacture medicines 2,000 4. Issue of a licence to import medicines 4,000 5. Annual retention of a licence to import medicines 2,000 6. Application for a product licence 400 7. Issue of a product licence 600 8. Annual retention of a product licence 300 9. Application for a dealer's licence under subsection (2) of section sixteen of the Act 600 10. Issue of a dealer's licence, under section (2) of section sixteen 11. Annual retention of a dealer's licence issued under subsection (2) of section sixteen of the Act 1,400 12. Application for a licence to sell poisons in Part 2 of the Poisons List under subsection (1) of section nineteen of the Act 200 13. Issue of a licence to sell poisons in Part 2 of the Poisons List under subsection (1) of section nineteen of the Act 1,000 14. Annual retention of a licence to sell poisons in Part 2 of the Poisons List issued under subsection (2) of section nineteen of the Act 500 15. Application for registration of premises to be used as a retail 16. Registration of premises to be used as a retail pharmacy 1,600 17. Annual retention of registration of premises to be used as a (As amended by Act No. of of 1994) SECTIONS 25 & 26-THE PHARMACY AND POISONS (MEDICINES) (IMPORTATION, MANUFACTURE AND SALE) ORDER.
47 of 1993 1. This Order may be cited as the Proprietary Medicines (Importation and Title
Manufacture) Order.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia 2. In this Order, unless the context otherwise requires-
"medicines" means all medicines including any secret, patent, proprietary, generic or homoeopathic medicine or preparation; "Board" means the Pharmacy and Poisons Board.
3. (1) No person shall import or manufacture any medicine without an appropriate Import or manufacture
licence, and a product licence from the Board.
(2) An application for an importation, a manufacturing or licence under this paragraph shall contain the following information: (a) the name and address of the application; (b) the name of the medicine; (c) the dosage form of the medicine, (d) the active constituents of the medicine; (e) the indications and method of use; the contra-indications, warnings, precautions; (g) the composition; (h) the shelf life; the containers and packaging; (k) the method of sale, that is to say, whether it is to be prescription sale only; (ii) pharmacy sale only; or (iii) general sale; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia the manufacturer's name and address; the distributors name and address; (n) the World Health Organisation (WHO) pharmaceutical certificate of quality and free sale certificate; (o) the name of designation of the person signing the application; and (p) any other information which may be requested by the Board.
(3) Where the medicine to be imported or manufactured is to be marketed in Zambia for the first time, the application shall, in addition to the information submitted undersub-paragraph (2), contain the following: (a) the chemistry of the medicine; (b) the pharmacological data; (c) the toxological data; (d) the teratology; (e) the clinical studies; and the countries in which the sale of the medicine has been authorised.
(4) This regulation shall not apply to- (a) person importing medicine for his own use or use by members of his family where the quantity imported is not more than a year's supply; (b) a person importing medicine to the order of a physician, dentist or veterinary surgeon for administration to an individually named person oranimal; (c) an authorised seller who manufactures medicine for sale in his own Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (d) medicine manufactured in a hospital; and (e) medicine donated charitably for which no charge is made to the patient.
4. (1) No person shall advertise medicine unless the advertisement conforms with Advertising
the information submitted to obtain a licence.
(2) Medicine which is sold by prescription only shall not be advertised to the general public without prior written authority of the Board.
5. (1) Every package or container of medicine shall be labelled to show-
(a) the name of the medicine; (b) the pharmacological properties; (c) the names and quantities of active ingredients; (d) the quality of the medicine; (e) the directions for use; the contra-indications, warnings and precautions; (g) the storage instructions, when necessary; (h) the expiry date; the batch number; the date of manufacture; (k) the licence number; the name and address of the manufacturer; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia the method of sale, that is to say, if it is to be by- prescription only; (ii) pharmacy sale only; or (iii) general sale.
(2) When the space on the container of medicine is not adequate to accommodate the information specified in sub-paragraph (1), the container shall be labelled to indicatethe particulars specified under paragraphs (a), (c), (d), (h) and (n) of sub-paragraph (1): Provided that the particulars specified under paragraph (b), (e), (f), (g), (i), (j), (k) and (l) of sub-paragraph (1) shall be set out on the package.
(3) Where the container of medicine is in the form of a blister or strip packet, the container shall be labelled to indicate the particulars specified in paragraphs (a) and (m) ofsub-paragraph (1) and the other particulars specified in that sub-paragraph shall be setout on the package.
(4) The provisions of this paragraph shall not apply to dispensed medicine: 6. (1) Every package or container of dispensed medicine shall be labelled to Dispensed medicine
(a) the name of the person to whom the medicine is to be administered; (b) the dosage or where the medicine is to be used; (c) the date on which the medicine is dispensed; and (d) any other information necessary to ensure the correct use of the medicine.
(2) A package or container of dispensed medicine may indicate the name and address of suppliers of the medicine.
(3) Where a package or container of dispensed medicine is to be administered to an animal, the package or container shall be labelled to indicate- (a) the name and address of the person in control of the animal; (b) name and address of the suppliers of medicine; Copyright Ministry of Legal Affairs, Government of the Republic of Zambia The Laws of Zambia (c) the date on which the medicine is dispensed; and (d) any other information necessary to ensure the correct use of the medicine.
7. (1) No person shall sell by retail or otherwise supply medicine in a place other Sale of medicine
than a pharmacy except with the written authority of the Board.
(2) Where the medicine is to be sold, under sub-paragraph (1) in a place other than (a) it shall be sold in the original package labelled with- full instructions for use; (ii) contra-indications, warnings and precautions; and (b) the package shall be marked in a conspicuous way with the letters "G S" that is, for general sale.
(3) No physician, dentist or veterinary surgeon shall sell medicine unless it is in a package for an individual patient's use only.
(4) No wholesaler, manufacturer, or importer shall sell medicine to any person other than a pharmacist unless the medicine is for general use.
(5) Except for herbal or traditional medicine containing poison, this paragraph shall not apply to herbal or traditional medicine.
8. (1) No person shall supply medicine which is administered by parenteral injection Parenteral injection of
to the general public without prescription except- (a) in cases of diabetic conditions; or (b) where specified written authority has been obtained from the Board.
(2) In this regulation "parenteral injection" means injection by breach of skin or Revocation of S.I. No.
mucous membrane.
Copyright Ministry of Legal Affairs, Government of the Republic of Zambia

Source: http://www.parliament.gov.zm/sites/default/files/documents/acts/Pharmacy%20and%20Poisons%20Act.pdf