ORDER NO. 13 OF 1970
The Medical , Dental and Pharmacy Order 1970
To provide for a medical, Dental and Pharmacy Council; the keeping and sale of poisons and other related matters. [Date of Commencement: see Sec.1]
Made by the Council of Ministers
1. This Order may be cited as the Medical, Dental and Pharmacy
Order 1970, and shall come into operation on a date to be fixed by the Minister in the Gazette, provided that different dates may be fixed for the coming into operation of different sections.
2. In the Order, unless the context otherwise indicates
“Council” means the medical, Dental and Pharmacy Council of Lesotho;
“dental surgeon” means a person registered as such under this Order;
“medical practitioner” means a person registered as such under this Order;
“Minister “means the Minister for the time being responsible for Health;
“paramedical personnel” means persons registered as such under this Order;
“pharmacist” means a person registered as such under this Order;
“practice” shall mean and include doing or performing whether for gain or otherwise, of such acts as specially belong to the calling of a medical practitioner, intern, dental surgeon or pharmacist;
“register” means, when used as a noun, a register kept in accordance with the provisions of this Order, and when used in relation to any class or member of any class of persons in respect of which a register is kept ,means the register kept for that class, and when used as a verb mean to enter in such register; and the words “registered”, ”registrable”, ”registration” and all other words formed with or derived from the word “register” shall have a corresponding meaning;
“this Order” includes any regulation, rule or order made under this Order.
Medical, Dental and Pharmacy Council
3. (1) There shall be established for
Lesotho a council under
Name of the Medical, Dental and Pharmacy Council of Lesotho, whose constitution and functions shall be as in this Order provided.
(2) The Council shall be a corporate body and shall, under the said name, be capable of suing and being sued and, subject to the pro.
He is incapacitated by physical or medical illness; or as an elected member, has notified his resignation in writing to the Council or as an appointed member, has given note in writing to the Minister has accepted his resignation.
(3) Every such vacancy and every vacancy caused by death of a member shall be filled in the following manner—
a)in the case of an elected member, the vacancy shall be filled by election; provided that, if the remainder of the period for which the member whose office has been vacated would otherwise have held office is less than six months, it shall not be necessary to hold an election and the council may, if it deems fit, co-opta person to fill the vacancy;
b)in the case of an appointed member the Minister shall appoint a person to fill the vacancy; and in each case the person so elected ,co-opted- or appointed shall belong to the same procession as the member whose place he fills and shall hold office for the remainder of the period for which that member would otherwise have held office.
(3) If any member of the Council is granted leave of absence by the Council, his place may either be left vacant or the Council may co-opt a person to fill the vacancy during his absence as the Council in its discretion may determine and any person so co-opted shall belong to the same profession as the member whose place be fills.
(4) The council may exercise its powers not withstanding any vacancy in the number of its members.Top
4. (1) At the first meeting of the Council in each three-year
Period the members of the Council shall elect from among themselves a president and a vice-president who shall hold office during that three-year, unless either of them sooner resigns or ceases to be a member, and the vice-president, if the president is absent or unable to act, exercise all the functions of the president.
(2) If the president or vice-president vacated office a new president or a new vice-president shall be elected as the next meeting or as soon thereafter as may be convenient.
(3) A president or vice-president may vacate his office a new president or vice-president without such vacation terminating his membership of the Council.
(4) A president or vice-president shall, not withstanding that his period of membership has expired, continue to hold office as president or vice-president until his successor has been elected.
5. (1) Meetings of the Council shall be held twice a year and
Special meetings may be convened by the president and shall be convened by him if not less than four members of the Council sign a request in writing for such special meeting and such written request clearly states the purpose for which the meeting is to be convened.
(2)At all meetings of the Council the president, or in his absence the vice-president, shall preside; in the absence of both the president and the vice-president the members present may elect one of their number to preside.
(3) In the registers shall be entered the names, addresses, qualifications dates of the first registration thereof and any other particulars relating to registered persons as the Council may time to time prescribe. Top
6. (1) Except as provided in this section no person shall be
Registered who does not at the time of his application for registration reside in Lesotho.
(2) If an applicant for registration does not at the time of his application reside in Lesotho but in good faith intends, if his application is granted, to take up residence therein, his application may be granted on condition that he takes up residence in Lesotho within six months from the date of his application or such other reasonable time as the Council may determine;
Provided that in the event of such conditions not being fulfilled within the prescribed period, such registration shall lapse.
(3) A medical Practitioner, dental surgeon or pharmacist who does not intend to reside permanently in Lesotho but who enters Lesotho for employment, either in the capacity of locum tenes or for a salary or for purposes of private practice, may be granted registration in a separate register, for such period and on such conditions as the Council may determine.
7. (1) Every person who wishes to be registered shall apply in
Writing to the register and shall submit-
(2) The Council or the executive committee of the Council may require any statement in or in connexion with an application to be supported by solemn declaration.
(3) If the register is not satisfied that the degree, diploma or certificate and the facts or documents submitted in support of the application are in accordance with the requirements of this Order he shall submit the application to the Council or the executive committee of the council, whichever meets the sooner, for decision.
(4) The council or the executive committee of the Council, as the case may be, may refuse registration if in its opinion the applicant, notwithstanding that he is otherwise qualified, is not a fit person to be registered by reason of the fact that he is not of good character and reputation or has not an adequate knowledge of the Sesotho or English language.
(5) If the registrar is satisfied that the degree, diploma or certificate and the facts or documents submitted in support of the application are in accordance with the requirements of this Order, he shall, upon payment by the applicant and issue to him a certificate that he is registered in the register applicable to him.
(6)The Council may erase from a register any entry which is proved to have been made in error or though fraudulent representations or conceal of a material fact:
Provision that, whenever practicable, the person whose name it is proposed to erase from the register shall be given an opportunity to show why his name shall not be erased there from.
(7) Whenever an erasure in respect of any person is made from a register in terms of this section, the reasons thereof shall be noted in that register and such person shall, whenever practicable, be notified accordingly. Any certificate issued in respect of any such registration shall be deemed to have been cancelled as from the date of the erasure:Top
Provided that nothing in this section contained shall bar any person from making a new application for registration
8. (1) Any who is aggrieved by
a)the refusal of the Council or the executive committee of the Council, hereinafter in this section referred to as the registering authority, to register him or any degree, diploma, certificate or particular which he wishes to be registered in terms of this Order; or
b) the erasure from a register of his name or of any degree, diploma, certificate or particular which he maintains he is entitled under this order to have enrolled upon that register; may, after notice to the registering authority and within three months after the date on which notice is given to him by the registrar of such refusal or erasure, make application in the manner provided by rules of court to the High Court against such refusal or erasure.
(2) The High Court may dismiss such application, or if it is of opinion that the registering authority has not acted in accordance with the provisions of this order, may make an order for the enrolment on the register of the applicant’s name or of any particulars as aforesaid, or may remit the matter to the registering authority for further consideration and may make such other order as to costs or otherwise as may to it seem just. In any case in which the registering authority has refused to register an applicant on the ground that in the opinion of the registering authority he is not a fit person to registered by reason of his character or reputation or the inadequacy of his knowledge of either the Sesotho or the English language, the High Court may, it thinks fit, notwithstanding the opinion of the registering authority, make an order for the registration of the applicant.
9. Any person who----
a) procures or attempts to procure for himself or
any other person registration under this order or any certificate referred to in this Order by means of false representation whether verbally or in writing, or aids or abets any person in doing so:
10. (1) save as is provided in subsection (2), no person shall
Take or use the title of pharmacist, chemist and druggist, pharmaceutical chemist, druggist or pharmaceutics or take or use in connexion with the sale of goods, whether by wholesale or retail, the title of pharmacist unless the appropriate condition mentioned hereunder is complied with---
(2) No person shall use in connexion with any business any title, emblem or description reasonably calculated to suggest that he or anyone employed in the business possesses any qualification with reference to the selling , dispensing or compounding of medicines or poisons other than the qualification which he in fact possesses. For the purpose of this subsection the use of the description ‘pharmacy’ in connexion with a business carried on in any premises shall be deemed to be reasonably calculated to suggest that the owner of the business and the person having control of the business on those premises are pharmacists.
11. (1) For the purposes of this Order there shall be a
disciplinary committee of the Council ,all of who shall be members of the Council and the membership of which shall be variable in accordance with the provisions of this section and which shall consist of not less than three and not more five members.
(2) The president shall be a permanent member of the disciplinary committee and shall in his discretion appoint the other members on an ad hoc basis save that—
a) in any enquiry into the conduct or condition of a medical practitioner, the member appointed shall be members of the Council who are medical practitioners;
b) in any enquiry into the conduct or condition of a dental surgeon, the members appointed shall be members of the Council who are dental surgeons;
c) in any enquiry into the conduct or condition of a pharmacist, the members appointed shall be members of Council who are pharmacists; and
shall be, as nearly as practicable ,in the form prescribed by the Council and shall be signed by the president or the registrar and shall be served either by registered letter sent tough the post or in the same manner as it would be served if it were a subpoena issued by a magistrate’s court in criminal proceeding.
(3) Every person summoned a s aforesaid shall be found to obey the summons served on him and any person who refuses or fails without sufficient cause to attend and give evidence relevant to the enquiry at the time and place specified in the summons, or who refuses to be sworn when called upon to do so by the president, or to produce any book, record, document or thing which he has been required by summons to produce, shall be guilty of an offence and liable on conviction to a fine not exceeding fifty rands or to imprisonment not exceeding three months or to both such fine imprisonment;
Provided that every person so summon shall be entitled to all the privileges to which a witness subpoenaed to give evidence before the High Court is entitled.
(5) Every witness attends before the disciplinary committee and refuses to answer fully and satisfactory to the best of his knowledge and belief any question lawfully put to him shall be guilty of an offence and liable to a fine not exceeding fifty rands or to imprisonment to exceeding three months or to both such fine and imprisonment.
(6) Any person who gives false evidence on oath at any enquiry, knowing such evidence to be false or not knowing or believing it to be true, shall be guilty of an offence and liable on conviction to a fine not exceeding five hundred rands or to imprisonment for a period not exceeding one year or to both such fine and imprisonment. Top
12. (1) Every registered person who, either before or
after registration, has been convicted of any offence by a court of law shall be liable to be dealt with by the disciplinary committee in accordance with this part if the disciplinary committee is of opinion that such offence constitutes improper or disgraceful conduct, or conduct which, when regard is had to such person’s profession or calling is improper or disgraceful and in every such case the disciplinary committee may, if it thinks fit, on proof before it of such conviction and without hearing further evidence, deal with such person in accordance with this part:
provided that such person shall be afforded an opportunity of tendering an explanation to the disciplinary committee in extenuation of his conduct.
(2) Whenever in the course of any proceedings before any court of law it appears to the court that there is prime facie evidence of improper or disgraceful conduct on the part of the registered person, or conduct which, when regard is had to such person’s profession or calling, is improper or disgraceful, the court shall direct that a copy of the record in such proceedings or such portion thereof as is material to the issue,be transmitted to the register.
13. if any registered person has counseled
or knowingly been a party to the performance of any act in respect of which any unregistered person has been convicted of an offence, his conduct shall for the purpose of this part be improper or disgraced conduct
Any person who is aggrieved by this ,imposed by the disciplinary committed under this section may, within three months after the date of such finding or the imposition of such penalty, appeal to the High Court in manner provided by rules of court against such finding or penalty. The High Court m aside any such finding or penalty or may remit the matter to the disciplinary confirm, vary or set aside any such finding or penalty or may remit the matter to the disciplinary committee for further consideration and may make such other order as to costs or otherwise as army to it seem just:
Provided that a finding shall not be set aside by reason only of any informality in the proceedings of the disciplinary committees which did not embarrass or prejudice the appellant in answering the charge or in the conduct of his defense?
14. (1) The Council may apply to the
High Court for the removal of a registered person’s name from the register.
(2) On any such application the High Court may dismiss the application or may—
a) order that the person’s name be removed from the register; or
b) order him to pay to the Council such penalty as the High Court may think fit; or
c) censure him;
and may make such other order as to costs or otherwise as army to it seem just. In any order for the removal of a name from the register the High Court may order that the Council shall not consider any application for the restoration of that name to the register before the expiry of any period which it may fix or until the Council is satisfied that the conditions imposed by the High Court have been fulfilled.
15. The Minister may, after
considering any recommendation of the Council, make regulations-
i)prescribing standards of accuracy;
ii)providing for inspection, sampling examination and testing;
iii)prescribing the fees payable and the certificates issuable and the methods of marking or labeling in respect of examination and testing;
iv)prescribing the certificates of testing and accordance which may be accepted in lieu of examinination and testing under the regulations;
v)prohibiting the importation into, or the manufacture, sale or use within Lesotho; and providing for the seizure and destruction or requiring re-export fro Lesotho of, any such article or apparatus which is not in accordance with the standard prescribed, or in respect of which any requirement of the regulations has been complied with;
h) prescribing the manner of marking or labeling of any substance or of the container of any substance the name where of is mentioned in the British Pharmacopoeia,or other standard laid down in such formularies for that substance.
16. in any criminal proceedings against any person upon a
Charge of having performed any act which constitutes an offence under this Order if performed by a person who is not registered, the person charged shall be deemed to be unregistered unless he proves the contrary. Top
17. (1) a) as to the registration of blood donor services;
b)prohibiting the operation of blood donor services which are not registered.
c) prohibiting the operation the conditions under which blood donor services shall be operated;
d)providing for the inspection by authorized persons of premises, technical equipment and methods of procuring blood used by blood donor service where any has in connexion with the operation of that service contravened or failed to comply with the provisions of any regulation made under this section.
(2) regulations made under subsection (1) may prescribe penalties for any contravention thereof or failure to comply therewith, not exceeding a fine of one hundred rands.
18. (1) The following formularies shall be the formularies
According t which all medicines mentioned therein shall be prepared unless otherwise directed in writing by a medical practitioner, dental surgeon or veterinary surgeon on whose prescription any medicine is prepared—
Order specifies a quality of the poison in terms of the imperial system and the quality sold, issued or supplied is the equivalent of that amount in the metric system, and the equality of a poison in the metric system which is the equivalent of a particular quantity in the imperial system shall be deemed to be that set out as such in the Table of Equivalent contained in the British Pharmacopoeia 1968. Top
19. (1) It shall not be lawful for any Licensed General Dealer
Or Co-operatives Society registered under the law relating to Co-operative Societies to sell poisons unless authorized thereof by the Permanent Secretary for health by a certificate issued under his hand. Application for such certificate shall be made in the form prescribed in the seventh schedule to this Order.
(2) The permanent Secretary for Health shall maintain a record of all such certificates issued by him in the form prescribed in the seventh schedule to this Order.
20. (1) The substances mentioned or included in part I of the first schedule to this Order may be sold with or without a prescription and only by an authorized seller of poisons.
(2) The substances mentioned or included in part II of the fist schedule to this Order may be sold by authorized sellers of poisons upon a prescription only.
(3) The substances mentioned or included in part III of the first schedule to this Order may be sold by authorized sellers of poisons and subject to the restrictions contained in the Third Schedule, also by listed sellers of poisons.
(4) The Minister may, after considering any recommendation of the Council, by notice in the Gazette amend any of the schedules to this order.
21. (1) Every authorized seller of poisons shall keep a prescription
Book and a poison register in which shall be accurately recorded all the particulars required to be recorded in terms of this order
(2) The prescription book and poisons register shall be open to inspection at all reasonable times by the Permanent Secretary for Health or by any other professional officer so authorized by him in writing.
(3) The prescription book and poisons register shall be retained on the registered premises for a period of not less than two years from the date of the last entry made therein, and each entry shall be made in chronological order on the day on which the sale or supply was affected. Top
22. (1) any person not being an authorized
seller of poisons or a listed seller of poisons who carries on the business of a general dealer in Lesotho may, subject to the provisions of this section, sell patent or proprietary medicines and so called “Dutch “ medicines only if such patent or proprietary or “Dutch” medicines do not co
(2) A prescription shall be in writing and shall be signed by the person giving it and with the date of issue clearly recorded thereon and—
a) specify the address of the person giving it;
b) 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 to whom the medicine is to be delivered.
c)have written there on, if given by a dental surgeon ,the words “For dental treatment only” or ,if given by a veterinary surgeon ,the words “For animal treatment only”;
d) when the medicine is packed otherwise than in ampoules, indicates-
i)the total amount to be supplied, and
ii) except in the case of a preparation which is to be used for external treatment only, the dose to be taken;
i)either the total amount to be supplied or the total amount to be administered or injected ,and
ii) in any case, the amount intended to be administered or injected in each dose.
23. The person dispensing the prescription shall comply with the following requirements;
a)the prescription must not be dispensed more than once unless the prescriber has directed ther on that it may be dispensed a stated number of times or that it may be dispensed at stated intervals;
b) where the prescription contains a a direction that it may be dispensed a stated number of times or at stated intervals it shall not be dispensed otherwise than in accordance with that direction;
c) a prescription which contains a direction that it may be dispensed a stated number of times but no direction as to the intervals at which it may be dispensed shall not be dispensed more often than once in the three days, and a prescription which contains a direction that it is to be dispensed at stated intervals but no direction as to the number of times that it may be dispensed shall not be dispensed more than three times;
d) at the times of dispensing or, where a poison has been delivered in accordance with the proviso to subsection (1) on the subsequent receipt of the prescription there must be noted on the prescription above the signature of the prescriber, the name and address of the seller and the date on which the prescription is dispensed or, as the case may be, the poison was delivered;
e) except in the case of a prescription which may be repeated, the prescription must be retained and kept on the premises. Top
24. (1) The provision of subsection (2) of section 45 shall not
Apply in the case of a substance sold for the purpose of being sold in the same container.
(2) The requirements of subsection (2) of section 45 shall be deemed to be satisfied, in the case of a poison supplied from a warehouse or depot, if the container is labels with the address of the supplier’s principal place of business or, in the case of a limited company, of the registered office of that company.
(3) where any poison is sold in a container with an outer covering being the container and covering in which it was obtained by the seller, it shall be sufficient if the name of the seller and the address of the premises on which it was sold appear only on the outer covering.
(4) where the names of more than one person or more than one address appear on the label, there must also be words on the label indicating clearly which person is the seller and at which of the addresses it was sold.
25. It shall not be lawful to sell, whether by wholesale or by
Retail, or supply any poison unless—
i)a medicine made up ready for the internal treatment of human or animal ailments, or
ii)a local an aesthetic for injection in the treatment of human or animal ailments, or
iii) a sterile ophthalmic solution in a single dose sterile bottle enclosed in a sealed container, the outer surface of the bottle is fluted vertically with ribs or grooves recognized by touch.
26. It shall not be lawful to store any poison except in a container impervious to the poison and sufficiently stout to prevent leakage from the container arising from the ordinary risks of handling.
i)no food is kept directly under the shelf, and
ii)the container of the substance is distinguishable by touch and in the case of a medicine to which subsection (1) of section 50 applies the requirements of section shall be satisfied in addition to the requirements aforesaid.
27. (1) In any institution in which medicines
are dispensed in a dispensing department in charge of a person appointed for that purpose, no medicine containing a poison shall be issued from that department for use in the wards, operating theatres or other sections of the institution in subsections (3) and (4)
(2) The medicines must not be issued except upon the written order signed by a duly registered medical practitioner, registered dental surgeon, or by a sister or nurse in charge of a ward ,theatre or other sections of the institution;
Provided that in a case of emergency a medicine containing a poison may be issued ,notwithstanding that no such written order is produced, on an undertaking by the person ordering the medicine of furnish such a written order within the next twenty –four hours following.
(3) The container of the medicine must be labeled-
a)with words describing its contents; and
b) in the case of poisons contained in part II of the First Schedule to this Order, with a distinguishing mark or other indication indicating that the poison is to be stored in a cupboard reserved solely for the storage of poisons and other dangerous substances.
(4) In this section “institution” means any hospital, infirmary, health center, dispensary, clinic, nursing home or any other place at which human ailments are treated. Top
28. (1) In any institution in which medicines are dispensed in
a dispensing or pharmaceutical department in the charge of a person appointed for that purpose, all poisons other than those issued for use shall be stored in that department.
(2) in any institution to which the foregoing paragraph of this section does not apply, all poisons other than those issued for the use shall be stored---
a) in the charge of a person appointed for the purpose by the governing body or person in control of the institution;
b)otherwise than on an open shelf, unless the container of the poison is distinguishable by touch from containers of substances other than poison kept on the same premises;
c) in the case of poisons mentioned in Part II of the First Schedule to this Order, either in a cupboard, drawer or cabinet capable of being security locked and reserved solely for the storage of poisons.
(3) In every institution every poison mentioned in Part II of the First Schedule to this Order kept in a ward shall be stored in a cupboard reserved solely for the storage of poisons and other dangerous substances.
Form of entry to be made in the book kept by sellers of poison in accordance with section 43 of the Order.
Date of sale
Name and quality of poison supplied
Name Address Business
Signature of Purchaser
Medical Dental and Pharmacy Order No.13 of 1970
Form of Application
To the permanent Secretary for Health,
I,………………………………………………………..being engaged in the business of………………………..hereby apply for a certificate to sell poisons in terms of Section 20(1) OF MEDICAL,DENTAL AND PHARMACY Order No. 13 of 1970 in respect of the following premises,namely:………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………as a person entitled to sell from these premises poisons included in Part Three of the First Schedule to the Order subject to the provisions of the Third Schedule.Top
Signature of Applicant_______________________
|Import Permit for medicines||Permit obtainable at Ministry of Health||Active||Measure||Goods|
|Export permit for medicines||Permit obtainable at ministry of Health||Active||Measure||Goods|
|Habit forming drugs/psychotropic import/export permit||Habit forming drugs/psychotropic import/export permit||Active||Measure||Goods|