DRUGS AND RELATED SUBSTANCES: SUBSIDIARY LEGISLATION(previously “HABIT-FORMING DRUGS”)

Any duly registered medical practitioner, dentist or chemist and druggist, and any duly qualified veterinary surgeon who is desirous of exporting from Botswana any habit-forming drug as defined in the Act (other than prepared opium as defined in the Act), shall-

(a) furnish to the Minister a certificate from the government or administration of the importing country to the effect that such government or administration is satisfied that the consignment of such habit-forming drug is required solely for medicinal or scientific purposes, and that it approves of its importation;

(b) obtain from the Minister a permit under section 4(4) of the Act in the form in the First Schedule hereto.

3. Form of permit

The form of permit to import or acquire habit-forming drugs as provided for in section 5(1) of the Act shall be as contained in the Second Schedule hereto.

FIRST SCHEDULE
PERMIT TO EXPORT OPIUM OR OTHER HABIT-FORMING DRUGS

Permission is hereby granted to …………………… of ………………………………… to export from Botswana to …………………………………………………………… the following habit-forming drugs, to wit: ……………………………………………………………………………………………………………….. for medicinal or scientific purposes only.

This Permit will expire on the ………………………………………………………………………………

Dated this ……………………………. day of ……………………………………….. 20………………..

………………………………………………………….
Minister

This Permit is not transferable.

SECOND SCHEDULE
PERMIT TO IMPORT OR ACQUIRE HABIT-FORMING DRUGS

Mr. ……………………………………………………………………………………. profession/business

address …………………………………………………………………………………………………………… is hereby authorised to import or acquire the undermentioned habit-forming drugs in the quantities specified opposite such item

Drug

Quantity

………………………………………………………………………………………………………………………..
……………………………………………………………………………………………………………………….. It is a condition of this permit that drugs imported or acquired hereunder shall not be used by the person to whom the permit is issued otherwise than for medicinal or scientific purposes or for the purpose of being sold or supplied to some other person in accordance with the provisions of the Habit-forming Drugs Act.

Dated this ………… day of ……………………………………. 20 …………………

Gaborone………………………………………………………….
(Sgd.)

HABIT-FORMING DRUGS (EXEMPTED PREPARATIONS) REGULATIONS

(under section 12)

(10th November, 1937)

ARRANGEMENT OF REGULATIONS

REGULATION

1. Citation

2. Exempted drugs

Schedule

HCN 195, 1937.

1. Citation

These Regulations may be cited as the Habit-forming (Exempted Preparations) Regulations.

2. Exempted drugs

The preparations listed in the Schedule shall be exempted from the provisions of the Act.

SCHEDULE

Cereoli Iodoformi et Morphinae B.P.C. 1923	Iodoform and Morphine Bougies.
Emplastrum Opii B.P. 1898	Opium Plaster.
Linimentum Opii B.P.C.	Liniment of Opium.
Linimentum Opii Ammoniatum B.P.C. 1923	Ammoniated Liniment of Opium.
Pasta Arsenicalis B.P.C.	Arsenical Paste.
Pilulae Hydrargyri cum Opio B.P.C. 1923	Mercury and Opium Pills.
Pilulae Ipecacuanhae cum Scilla B.P.C.	Pills of Ipecacuanha with Squills.
Pilulae Plumbi cum Opio B.P.C.	Lead and Opium Pills.
Pilulae Digitalis et Opii Compositae B.P.C. 1923	Compound Digitalis and Opium Pills.
Pilulae Hydrargyri cum Creta et Opii B.P.C.	Pills of Mercury with Chalk and Opium.
Pulvis Cretae Aromaticus cum Opio B.P.	Aromatic Powder of Chalk and Opium.
Pulvis Ipecacuanhae et Opii B.P.	Dovers Powder.
Pulvis Ipecacuanhae Compositus B.P. 1914.
Pulvis Kino Compositus B.P.C.	Compound Kino Powder.
Suppositoriae Plumbi cum Opio B.P.	Compound Lead Suppositories.
Tablettae Plumbi cum Opio B.P.C. 1923	Lead and Opium Tablets.
Unguentum Gallae cum Opio B.P.C.	Gali and Opium Ointment.
Unguentum Gallae Compositum B.P.C. 1923	Compound Gall Ointment.
Eyedrops for inclusion in first-aid outfits consisting of a solution of 1 in 3,000 Perchloride of Mercury in Castor Oil with 0,5 per centum of Cocaine.
(NOTE. Codeine and its salts are excluded from this list.)

DECLARATION OF HABIT-FORMING DRUGS ORDER

(under section 14)

(2nd April, 1982)

ARRANGEMENT OF PARAGRAPHS

PARAGRAPH

1. Citation

2. Declaration of habit-forming drugs

First Schedule

Second Schedule

S.I. 36, 1982,
S.I. 35, 1987.

1. Citation

This Order may be cited as the Declaration of Habit-forming Drugs Order.

2. Declaration of habit-forming drugs

(1) The substances specified in the First Schedule hereto are hereby declared to be habit-forming drugs.

(2) The substances specified in the Second Schedule are specifically excluded from the list of habit-forming drugs.

FIRST SCHEDULE

Acetorphine

Acetylmethadol

Alfentanil

Allylprodine

Alphameprodine

Alphamethadol

Alphaprodine

Amphetamine

Anileridine

Benzethidine

Benzylmorphine

Betacetylmethadol

Betameprodine

Betamethadol

Betaprodine

Bezitramide

Cannabis (Indian Hemp) and Cannabis resin (Resin of Indian Hemp)

Clonitazene

Coca Leaf

Cocaine

Codoxime

Concentrate of poppy

Desomorphine

Dexamphetamine

Dextromoramide

Diampromide

Diethylthiambutene

Difenoxin

Dihydromorphine

Dimenoxadol

Dimepheptanol

Dimethylthiambutene

Dioxaphetyl butyrate

Diphenoxylate

Dipipanone

Drotebanol

Ecgonine, its esters and derivatives which are convertible to ecgonine and cocaine

Ethylmethylthiambutene

Etonitazene

Etorphine

Etoxeridine

Fentanyl

Furethidine

Heroin

Hydrocodone

Hydromorphinol

Hydromorphone

Hydroxypethidine

Isomethadone

Ketobemidone

Levomethorphan

Levomoramide

Levophenacylmorphan

Levorphanol

Mecloqualone

Metazocine

Methadone

Methadone-Intermediate

Methamphetamine

Methaqualone

Methyldesorphine

Methyldihydromorphine

Methylphenidate

Metopon

Moramide-Intermediate

Morpheridine

Morphine

Morphine-Methobromide and other pentavalent nitrogen morphine derivatives including in particular the morphine-N-oxide derivatives, one of which is Codeine-N-Oxide

Morphine-N-Oxide

Myrophine

Nicomorphine

Noracymethadol

Norlevorphanol

Normethadone

Normorphine

Norpipanone

Opium

Oxycodone

Oxymorphone

Pethidine

Pethidine-Intermediate – A

Pethidine-Intermediate – B

Pethidine-Intermediate – C

Phenadoxone

Phenampromide

Phenazocine

Phencyclidine

Phenmetrazine

Phenomorphan

Phenoperidine

Piminodine

Piritramide

Proheptazine

Properidine

Racemethorphan

Racemoramide

Racemorphan

Sufentanil

Thebacon

Thebaine

Tilidine

Trimeperidine

The isomers, unless specifically excepted, of the drugs in this Schedule whenever the existence of such isomers is possible within the specific chemical designation.

The esters and ethers of the drugs in this Schedule whenever the existence of such esters or ethers is possible.

The salts of the drugs listed in this Schedule, including the salts of esters, ethers and isomers as provided above whenever the existence of such salts is possible.

SECOND SCHEDULE

Dextromethorphan ((+) -3 methoxy-N-methylmorphinan) and dextrophan ((+)-3-hydroxy-N-methylmorphinan) are isomers specifically excluded from the First Schedule.

DRUGS AND RELATED SUBSTANCES REGULATIONS

(under section 21)

(16th April, 1993)

ARRANGEMENT OF REGULATIONS

REGULATION

1. Citation

2. Drugs Advisory Board

3. Registration of drugs

4. Exemption from registration

5. Approval for the manufacture, etc. of drugs

6. Records to be kept by manufacturer of drugs

7. Import, export and distribution of drugs

8. Labelling of drugs

9. Recall of drugs

10. Prescription of drugs

11. Dispensing of Schedule 1A and 1B drugs

12. Dispensing of Schedule 1C drugs

13. Dispensing of Schedule 2 drugs

14. Dispensing of drugs by nurses

15. Dispensing, general

16. Emergency supply of drugs

17. Registers and records

18. Clinical trials

19. Appeals

20. Classification of drugs

21. Prescribed habit-forming drugs

22. Forms

First Schedule

Second Schedule

Third Schedule – Forms

S.I. 46, 1993,
S.I. 105, 2015,
S.I. 141, 2016.

1. Citation

These Regulations may be cited as the Drugs and Related Substances Regulations.

2. Drugs Advisory Board

(1) In accordance with the provisions of section 5 of the Drugs and Related Substances Act, 1992, there is hereby established a Drugs Advisory Board, hereinafter referred to as “the Board”, for the purposes specified in that section.

(2) The Board shall consist of the following persons or their alternates appointed by the Minister-

(a) a hospital pharmacist;

(b) a physician in the service of the Government;

(d) a quality control pharmacist in the service of the Government;

(e) a duly registered medical practitioner from the private sector;

(f) a registered pharmacist from the private retail sector;

(g) a pharmacist from the Drugs Regulatory Unit; and

(h) such other members as the Minister may determine.

(3) Members of the Board shall hold office for a period of three years, but shall be eligible for re-appointment, and the Minister may at any time revoke the appointment of any member, or may grant leave of absence to any member, if he thinks it desirable or expedient to do so.

(4) The appointment, resignation or the revocation of the appointment of any member of the Board shall be notified by the Minister by notice in the Gazette.

(5) The Minister shall appoint a public officer to be the Secretary of the Board.

(6) The Board shall elect from amongst its members a Chairman to preside over meetings of the Board, and a Deputy Chairman to act as Chairman whenever the substantive holder of the post is unable to attend.

(7) The Board shall meet at such times, and as often as may be necessary or expedient for the proper carrying out of its duties under the provisions of the Act:

Provided that intervals between meetings of the Board shall never be greater than three months.

(8) The Board may co-opt one or more persons qualified or able to assist it or advise it in its functions under the Act, to attend any meeting or meetings of the Board, but such person or persons may not vote on any matter before the Board.

(9) The members of the Board and any expert assisting the Board shall observe and preserve the confidentiality of all matters coming before the Board, and such professional discretion shall subsist even after the termination of their terms of office or of their expert mandates .

(10) The Secretary shall keep minutes of each meeting of the Board, which shall be submitted for acceptance at the next meeting of the Board.

(11) Except as is otherwise provided in this regulation, the Board shall be responsible for regulating its own proceedings.

3. Registration of drugs

(1) An application to register a drug, or for the renewal of such registration, shall be made to the Director in Form 1 in the Schedule hereto and shall be accompanied by a fee of P800 for a drug which is imported, P400 for a drug which is partially locally manufactured and P200 for a drug which is totally locally manufactured.

(2) The Director shall submit any such application to the Board, together with his own recommendations and any relevant comments, for consideration by the Board, and he shall abide by any advice tendered by the Board.

(3) Where a drug is approved for registration, or for renewal of registration, the Director shall issue to the applicant a certificate of registration in Form 2 in the Schedule, and if the drug is not approved for registration or renewal of registration, he shall so inform the applicant, giving the reasons for such disapproval, at the same time informing the applicant of his right to appeal against such disapproval.

(4) Where a drug is approved for registration, or re-registration, subject to conditions, the applicant shall be informed of such conditions and shall comply therewith.

(5) A certificate of registration shall be valid for five years or such lesser period as the Director may, in any particular case specify, and provided that an application for the renewal of registration is made at least six months before the date of expiry, such validity shall extend until a decision is made and communicated to the applicant.

(6) When a drug is registered, the following information shall be recorded in the drug register kept by the Director in accordance with section 3(2) of the Act-

(a) the name of the drug approved;

(b) the registration number allocated to the drug;

(c) the approved chemical name or international non-proprietary name (INN) of each active ingredient of the drug, and the quantity thereof contained in a dosage unit or per suitable mass or volume or unit of the drug;

(d) the dosage form of the drug;

(e) the conditions of registration of the drug;

(f) the name of the applicant; and

(g) the date of registration of the drug.

4. Exemption from registration

(1) The following drugs shall be exempted from registration-

(a) any drug manufactured or imported by the Central Medical Stores for specific therapeutic use;

(b) any drug imported through the Central Medical Stores as a donation to the Government or to a Government hospital or to a hospital run by a Mission for use in that hospital;

(c) any drug imported under the authority of the Director, or any person authorised by him, for experimental use in hospitals or for specific therapeutic use or scientific research or tests;

(d) any drug prepared extemporaneously by a pharmacist for use as prescribed by a medical practitioner;

(e) any non-scheduled herb used for traditional medicine and exempted by the Director;

(f) any preparation not containing active ingredients in excess of one millionth part of the preparation’s own weight.

(2) The prior approval by the Director shall be sought in the circumstances specified in paragraphs (a) and (b) of subregulation (1), but where this is not practical such approval shall be sought as soon as is, in the circumstances, reasonably possible thereafter.

(3) The Director shall make records of exempted drugs imported or manufactured under the provisions of paragraphs (a), (b) and (c) of subregulation (1), the quantity imported and the name and address of the person or organisation who imported or manufactured any such drug.

5. Approval for manufacture etc. of drugs

(1) Any person wishing to manufacture, import, export, distribute or sell drugs shall apply to the Director for approval in Form 3 in the Schedule, accompanied by a fee of P50, and the approval of the Director, if given, shall be in Form 4 in the Schedule.

(2) If an application is not approved, the Director shall so inform the applicant, giving the reasons for such refusal.

(3) Any approval shall be valid for a period of five years, or such lesser period as may, in any particular case, be specified by the Director, and provided that an application for the renewal of approval is made at least two months before the date of expiry of such approval, the validity thereof shall extend until a decision is made and communicated to the applicant.

6. Records to be kept by manufacturer of drugs

(1) A manufacturer of drugs shall keep and maintain and hold readily available for inspection, comprehensive records containing details of-

(a) all steps taken in the storage and testing of raw materials;

(b) all steps taken in the manufacture of each batch of drugs;

(d) the sale and distribution of each batch of drugs.

(2) The records required to be kept in accordance with subregulation (1) shall be retained for at least 5 years from the date of manufacture, or for one year from the date of expiry of the relevant batch of drugs, whichever is the longer.

(3) The manufacturer shall, without any undue delay, report in writing to the Director any intention-

(a) to change the process of manufacture, or the method of testing any drug; or

(b) to alter materially the establishment, where such alteration will or is likely to affect the conditions under which approval for the manufacture of drugs was given.

7. Import, export and distribution of drugs

(1) Importers, exporters and distributors of drugs (and for the purpose of this regulation “distributor” includes wholesaler and retailer, and “distribution” shall be construed accordingly) shall keep and maintain records containing all details of the importation, wholesale and distribution of drugs by them, and such records shall be retained and kept available for inspection by a police officer, or by any person so authorised therefor by the Director for a period of at least five years from the date of each relevant entry.

(2) Any person wishing to import or export a Schedule 1A, 1B or 1C drug shall-

(a) in the case of import, apply for the approval of the Director therefor on Form HFD 1 in the Schedule, and any such approval shall be given on Form HFD 2 in the Schedule specifying such quantities of the drug as may be so imported, and any such approval shall be valid for three months, or such lesser period as may be specified therein; or

(b) in the case of export, apply for the approval of the Director on Form HFD 3 in the Schedule, and any such approval shall be given on Form HFD 4 in the Schedule specifying such quantities of the drug as may be exported out of Botswana, and any such approval shall be valid for three months, or such lesser period as may be specified therein.

(3) The export, import and distribution of all drugs other than Schedule 4 drugs shall be-

(a) in a private pharmacy, a referral or district hospital pharmacy, a private hospital pharmacy or in any other place authorised by the Director to sell such drugs, under the control of a pharmacist;

(b) in a private medical practice or surgery or in a Government primary hospital, under the control of a pharmacy technician under the supervision of the medical practitioner concerned or of a medical officer, as the case may be;

(d) in a clinic or health post, under the control of a registered or enrolled nurse approved by the Director.

8. Labelling of drugs

(1) The container of every drug imported, manufactured, processed or packed in Botswana shall bear a label written in English, with the following information clearly indicated thereon-

(a) either the approved name of the drug as used in official pharmacopoeias or formularies, or the international non-proprietary name;

(b) the brand name, if any;

(d) the quantity of active ingredients per dosage unit;

(e) the name of the manufacturer;

(f) the batch identification;

(g) the expiry date;

(h) any special storage conditions that may be necessary or desirable;

(i) any warnings or precautions that may be necessary or desirable;

(j) any directions for use if sold without prescription; and

(k) any appropriate statutory or restrictive direction or label in the Schedule that may be necessary.

(2) In any special circumstances the Director may, where he considers it desirable, exempt any particular consignment of drugs from the requirements of subregulation (1).

(3) The container of every drug dispensed to a patient shall have a label bearing the following information-

(a) the full name of the patient;

(b) the date of dispensing;

(d) all information required for the purposes of subregulation (1) with the exception of paragraphs (b), (e) and (f) thereof.

(4) The container of any drug exempted from registration shall as far as possible bear the information required under subregulation (1).

(5) In respect of those drugs listed in regulation 21, against which a label and a number in parenthesis is indicated, any such drug shall bear a label giving information or instructions in accordance with the following-

Label number	Word Content
(1)	“Contains aspirin” (unless name of product includes word “aspirin”); plus “If symptoms persist, consult your doctor”; plus the recommended dosage; plus “Do not use on children under 12 years except on medical advice.”
(2)	“Contains an aspirin derivate”; plus “If symptoms persist, consult your doctor”; plus the recommended dosage.
(3)	“Contains paracetamol” (unless the name of the product includes the word “paracetamol”); plus “If the symptoms persist, consult your doctor”; plus “Do not exceed the stated dose”; plus the recommended dosage.
(4)	“Warning. Asthmatics should consult their doctor before using this product.”
(5)	“Warning. May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.”
(6)	“Not to be used for babies” or “Not to be administered, except on medical advice, to a child under two years.”
(7)	“Oral Rehydration Therapy is recommended in all forms of diarrhoea.”
(8)	“For external use only.” This cautionary wording should be used if a product is an embrocation, liniment, lotion, liquid antiseptic or other liquid preparation or gel for external application.
(9)	“Warning. Do not exceed the stated dose.” This cautionary wording should be used on pharmacy drugs (P) exempted from POD requirements by reason of the proportion or level in such product of any substance, and which are not for external use.

9. Recall of drugs

Whenever the Director finds that any portion of any batch of drugs does not conform to the standards of identity, strength, quality and purity, or any other requirement specified in the documentation for registration, he may instruct the licensee to discontinue the sale of the remainder of the batch and, so far as is practicable, to recall any portion of the batch already sold.

10. Prescription of drugs

(1) Prescriptions of drugs shall be written in generic or approved international non-proprietary names (INN) except when a particular brand of drug is preferred and clinically acceptable reasons for such preference are communicated to the dispenser.

(2) Where a prescription is written using a generic or approved international non-proprietary name the least expensive drug of that description in the pharmacy shall be sold or dispensed for that prescription.

(3) In granting limited powers of prescription of Schedule 1, 2 and 3 drugs under section 9(2) of the Act, the Director may grant to-

(a) registered nurses in hospitals or Government clinics specialising in medical fields such as ophthalmology, psychiatry, midwifery, or as a registered family nurse practitioner, power to prescribe only those drugs specific to their speciality or training and, where applicable, which are specified for them in the Botswana National Drug Formulary;

(b) registered nurses and enrolled nurses in Government clinics and health posts, power to prescribe only those drugs which are specified for them in the Botswana National Drug Formulary;

(c) dental therapists, power to prescribe only those drugs specified for them in the Botswana National Drug Formulary; and

(d) registered pharmacists power to prescribe drugs only in the circumstances referred to in regulation 12.

11. Dispensing of Schedule 1A and 1B drugs

(1) Schedule 1A and 1B drugs may only be dispensed or sold by a pharmacist upon a written prescription, by a medical practitioner or dentist, presented for dispensing within thirty days of the date of its issue, and for the supply of a quantity not greater than is indicated on the prescription, which shall not in any case exceed thirty days supply, and any such prescription shall be retained in the pharmacy for a period of three years after the date of dispensing.

(2) The dispenser or seller of a Schedule 1A or 1B drug shall enter a record of such sale or dispensing, as the case may be, in an appropriate register, which register shall be kept for a period of five years after the last relevant entry therein.

(3) Separate registers shall be kept for Schedule 1A drugs and for Schedule 1B drugs.

(4) Except when being administered to a patient, every Schedule 1A and Schedule 1B drug shall be kept under safe custody in a lockable cabinet or in a safe.

(5) The destruction of any Schedule 1A or Schedule 1B drug, in part or whole, shall be reported in writing to the Director, and, except where the destruction is accidental, shall be supervised by a pharmacist and witnessed by a police officer.

12. Dispensing of Schedule 1C drugs

Schedule 1C drugs may only be dispensed or sold by a pharmacist upon a written prescription of a medical practitioner or dentist presented for dispensing within thirty days from the date of issue thereof, and for the supply of a quantity of the drug not in excess of that indicated on the prescription, and in any case not exceeding thirty days supply, and any such prescription shall be retained in the pharmacy for a period of not less than three years from the date of the last sale or dispensing:

Provided that where the prescribing medical practitioner or dentist is personally known to the dispensing pharmacist and is confirmed as being a medical practitioner or dentist, and the pharmacist is satisfied that it is impossible or impracticable to obtain a written prescription within a time that is reasonable in all the circumstances, he may dispense a prescription made by telephone or fascimile, in quantities not exceeding those stated above, on condition that a written prescription will be provided within 48 hours.

13. Dispensing of Schedule 2 drugs

Schedule 2 drugs may be dispensed-

(a) in referral hospitals, district hospitals, mission hospitals, mine hospitals or private hospitals by a pharmacist or an intern pharmacist, or by a pharmacy technician under the supervision of a pharmacist, and upon a written prescription issued by a medical practitioner or a dentist;

(b) in a retail pharmacy by a pharmacist, or by a pharmacy technician under the supervision of a pharmacist, and upon a written prescription issued by a medical practitioner or a dentist; or

(c) in a private medical practice or surgery or a Government primary hospital, by a pharmacy technician upon a written prescription issued by a medical practitioner or a medical officer.

14. Dispensing of drugs by nurses

Notwithstanding regulations 11, 12 and 13, registered and enrolled nurses in referral, district, primary, mine, mission and private hospitals, clinics, health posts and mobile clinics, may, in the exercise of their duties, dispense Schedule 1A, 1B, 1C, 2 and 3 drugs to patients, upon written prescription by a medical practitioner or a dentist.

15. Dispensing general

(1) The dispenser of any drug shall not dispense a quantity thereof greater than the amount stated in the prescription.

(2) A prescription may be repeated without further prescription if it is so endorsed by the prescriber.

(3) Except as is otherwise provided in these Regulations or where a shorter period is endorsed thereon, a prescription shall be valid for dispensing for a period not exceeding twelve months from the date of issue.

(4) The dispenser of a drug shall endorse on the prescription the date when it is dispensed, the quantity dispensed, and shall append his signature thereto.

16. Emergency supply of drugs

(1) In an emergency a Schedule 2 drug can be supplied or dispensed as provided in regulation 13, but without a prescription if-

(a) there is an immediate need for the drug requested to be supplied and it is impracticable in the circumstances to obtain a prescription; or

(b) the treatment with the drug has on a previous occasion been prescribed for the person requesting it.

(2) The quantity of the drug to be supplied in accordance with subregulation (1) shall not exceed five days’ treatment:

Provided that-

(a) where the drug in question is an ointment, a cream or an aerosol for the relief of asthma, which has been made up for sale in a container elsewhere than at the place of supply, the dispenser may supply the smallest pack available;

(b) where the drug in question is an oral contraceptive, the dispenser may supply a sufficient quantity for a full cycle; or

(c) where the drug required is in such a package that it is impractical to split the package, the whole package may be supplied.

17. Registers and records

(1) Separate registers shall be kept for Schedule 1A and Schedule 1B drugs.

(2) Registers to be kept by the manufacturer, seller, importer, exporter or distributor of such drugs shall contain the following information, as appropriate-

(a) the approved name and quantity of the drug concerned;

(b) the name and business address of the supplier;

(d) the import permit number in the case of imports;

(e) the export permit number in the case of exports;

(f) the name and business address of the purchaser;

(g) the date of sale of the drug;

(h) the invoice or reference number of such sale.

(3) Registers to be kept by the dispenser of such drugs in accordance with regulation 11(2) shall contain the following information, as appropriate-

(a) the approved name and quantity of the drug concerned;

(b) the name and business address of the supplier;

(d) the import permit number in the case of imports;

(e) the name and address of the person to whom the drug was dispensed;

(f) the prescription number or reference number upon which the drug was dispensed;

(g) the date of such dispensing;

(h) the name and address of the prescriber.

(4) All invoices for the purchase or supply of Schedule 1A, 1B and 1C drugs shall be kept for a minimum of five years.

(5) All registers or records required to be kept under this regulation must be retained for a period of five years after the date of the last relevant entry, and shall be kept available for inspection by authorised officers.

(6) All registers and records required to be kept under these Regulations shall be balanced at the end of every calendar month.

18. Clinical trials

(1) Clinical trials of drugs means studies in humans or animals in order to systematically generate new or verify existing information about their efficacy and their side effects, and also studies relating to their absorption in, metabolism and excretion from the human or animal body.

(2) Any person wishing to conduct a clinical trial of a drug shall submit to the Director an application signed by the applicant, and if the Director approves he shall issue a written authorisation permitting the applicant to conduct such trial, with or without such conditions or directions as he may specify.

(3) To ensure protection of the general public against any risk or adverse effects from the clinical trial of any drug the Director shall monitor the trial from the beginning to the end so as to satisfy himself that all specific and general conditions or directions subject to which the trial was authorised are being strictly observed by the person conducting the trial, and that to all intents and purposes the trial will achieve its aims and objectives.

(4) If at any stage during the clinical trial of any drug the Director is satisfied that, having due regard to the initial risks, discomforts or other adverse effects caused to persons taking part in the trial, it is in the public interest immediately to stop or suspend the trial, he may, in writing, so notify the person conducting the trial, who shall immediately comply with such notice.

(5) Where a clinical trial is to be conducted in a hospital or other medical institution, the application therefor shall be countersigned by the medical superintendent, or by a senior medical officer of comparable rank of such hospital or medical institution.

(6) Any person who is aggrieved by a decision of the Director not to grant approval for the conduct of a clinical trial may appeal against such decision to the Minister.

19. Appeals

Any appeal lodged in accordance with the provisions of section 14 of the Act or regulation 18(6) shall be lodged within thirty days after the date when the decision appealed against is communicated to the applicant.

20. Classification of drugs

For the purposes of the Act and these Regulations drugs shall be classified in accordance with the lists set out in the First Schedule.

21. Prescribed habit-forming drugs

For the purposes of the definition of “habit-forming drug”, section 3(1)(b) and Part III of the Act the drugs listed in the Second Schedule are declared to be banned habit-forming drugs.

22. Forms

The forms to be used for the purposes of the Act shall be in accordance with the forms set out in the Third Schedule.

FIRST SCHEDULE

(reg. 20)

(1) SCHEDULE 1 DRUGS

Category

Acetorphine; its salts; its esters and ethers; their salts

Acetorphine hydrochloride

Acetyldihydrocodeine; its salts

but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)1D

(b) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)1D

Acetyl-methadol see Methadyl acetate

Alfentanil

Allobarbital

Allylprodine; its salts

Alphacetylmethadol; its salts; its esters and ethers; their salts

Alphameprodine; its salts

Alphaprodine; and its salts

Amferpramone

Amidone see Methadone

Alphamethadol; its salts, its esters and ethers; their salts

Amphetamine; its salts

Amphetamine phosphate

Amphetamine sulphate

Amylobarbitone

Amylobarbitone sodium

Anileridine; its salts

Barbitone

Barbitone sodium

Benzethidine; its salts

Benzphetamine; its salts

Bezphetamine hydrochloride

Benzylmorphine; its salts; its esters and ethers; their salts

Benzylmorphine hydrochloride

Betacetylmethadol; its salts

Betameprodine; its salts

Betamethadol; its salts; its esters and ethers; their salts

Betaminoisopropylbenzene see amphetamine

Betaprodine; its salts

Bezitramide; its salts

Bromazepam

Buprenorphine

Buprenorphine hydrochloride

Butalbital

Butobarbitone

Butobarbitone sodium

Camazepam

Carfentanil; its stereoisomers its salts; its esters and ethers, their salts

Cathine; its salts; its stereoisomers not being phenylpropanolamine; their salts

Chlordiazepoxide

Chlordiazepoxide hydrochloride

Chlorphentamine; its salts

Chlorphentamine hydrochloride

Clobazam

Clonazepam

Clonitazene; its salts

Clorazepate

Clotiazepam

Cloxazolam

Codeine; its salts

but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)

(b) in undivided preparations with ms 1.5% (calculated as base: and not more than 200ml: Schedule 3)

(d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base, and md 10mg: or calculated as base, and not more than 30 tablets: Schedule 3)

Codeine hydrochloride see Codeine

Codeine phosphate see Codeine

Codeine sulphate see Codeine

Codoxime see Dihydrocodeinone O-carboxymethyloxime

4-cyano-2-dimethylamino-4,4-diphenylbutane; its salts

4-cyano-1-methyl-4-phenylpiperidine; its salts

Cyclobarbitone

Delorazepam

Delta-9-tetrahydrocannabinol see Dronabinol

Desomorphine; its salts; its esters and ethers; their salts

Desoxyephedrine see Methylamphetamine

Desoxynorephedrine see Amphetamine

Dexamphetamine; its salts

Dexamphetamine phosphate

Dexamphetamine sulphate

Dextrodiphenopyradine see Dextromoramide

Dextromoramide; its salts

Dextromoramide tartrate

Dextropropoxyphene; its salt; its esters and ethers; their salts

but in a preparation for oral use containing not more than 135mg of dextropropoxyphene (calculated as base, per dosage unit, or with a total concentration of not more than 2.5% calculated as base,

in undivided preparations: Schedule 2)

Diampromide; its salts

Diazepam

Diethylpropion hydrochloride

Diethylthiambutene; its salts

Diethylthiambutene hydrochloride

Difenoxin (1-(3-cyano-3,3-diphenyl-propyl)-4-phenylpiperidine-4-carboxylic acid)1A

(but if in preparation containing, per dosage unit, not more than 0.5mg of difenoxin and a quantity of atropine sulphate equivalent to at least 5% of the dose of difenoxin: Schedule 2)1D

Dihydrocodeine; its salts
but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)1D

(b) in undivided preparations with ms 1.5% (calculated as base) and md 10mg (calculated as base: Schedule 3)1D

(d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 10mg (calculated as base: Schedule 3)1D

Dihydrocodeine phosphate see dihydrocodeine

Dihydrocodeine tartrate see dihydrocodeine

Dihydrocodeinone see hydrocodone

Dihydrocodeinone enolacetate see Thebacon

Dihydrocodeinone O-carboxymethyl-oxime; its salts; its esters and ethers; their salts1A

Dihydrodeoxymorphine see Desomorphine

Dihydrohydroxycodeinone see Oxycodone

Dihydrohydroxymorphinone see Oxymorphine

Dihydromorphine; its salts; its esters and ethers; their salts

Dihydromorphinone see Hydromorphone

Dimenoxadole; its salts

Dimepheptanol; its salts; its esters and ethers; their salts

Dimethylthiambutene; its salts

Dioxaphetyl butyrate; its salts

Diphenoxylate; its salts

but if in preparation with ms per dosage unit 2.5mg of diphenoxylate (calculated as base, and quantity of atropine sulphate equivalent to at least 1% of the dose of diphenoxylate: Schedule 2)1D

Diphenoxylate hydrochloride see diphenoxylate

Dipipanone; its salts

Dipipanone hydrochloride

Dronabinol

Drotebanol; its salts; its esters and ethers; their salts

Ephedrine

Ephedrine hydrochloride

Ephedrine sulphate

Estozolam

Ethchlorvynol

Ethinimate

Ethyl loflazepate

N-Ethylamphetamine; its salts; its stereoisomers; their salts

Ethylmethylthiambutene; its salts

Ethylmorphine; its salts
but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)1D

(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)1D

Ethylmorphine hydrochloride see Ethyl morphine

Etonitazine; its salts

Etorphine; its salts; its esters and ethers; their salts

Etorphine hydrochloride

Etoxeridine; its salts; its esters and ethers; their salts

Fencamfamin; its salts; its stereoisomers; their salts

Fenethylline; its salts; its stereoisomers; their salts

Fenproporex; its salts; its stereoisomers; their salts

Fentanyl; its salts

Fludiazepam

Flunitrazepam

Flurazepam hydrochloride; its salts

Flurazepam monohydrochloride

Furethidine; its salts

Glutethimide; its salts; its stereoisomers; their salts

Halazepam

Haloxazolam

Heptabarbitone

Hexobarbitone

Hexobarbitone sodium

Hydrocodone; its salts

Hydrocodone bitartrate

Hydromorphinol; its salts; its esters and ethers; their salts

Hydromorphone; its salts; its esters and ethers; their salts

Hydroxypethidine; its salts; its esters and ethers; their salts

Isomethadone

Ketazolam

Ketobemidone; its salts; its esters and ethers; their salts

Lefetamine(SPA)

Levamfetamine

Levomethamphetamine

Levomethorphane; its salts

Levomoramide; its salts

Levophenacylmorphan; its salts; its esters and ethers; their salts

Levorphanol tartrate

Lofentanil; its stereoisomers; its salts; its esters and ethers; their salts

Loprazolam mesylate

Lorazepam

Lormetazepam

Mazindol

Mecloqualone

Medazepam

Mefenorex; its salts; its stereoisomers; their salts

Meperedine see Pethidine

Mephentermine; its salts

Mephentermine sulphate

Meprobamate

Metazocine; its salts; its esters and ethers; their salts

Methadone; its salts

Methadone hydrochloride

Methadyl acetate; its salts

Methamphetamine see Methylamphetamine

Methylamphetamine; its salts

Methylamphetamine hydrochloride

Methyldesorphine; its salts; its esters and ethers; their salts

Methyldihydromorphine; its salts; its esters and ethers; their salts

Methyldihydromorphinone see Metopon

2-Methyl-3-morpholino-1,1-diphenyl-propanecarboxylic acid; its salts; its esters and ethers; their salts

alpha-methylphenethylamine see Amphetamine

N-(2-(N-methylphenethylamino)propyl)propionanilide see Diampromide

Methylphenidate; its salts

Methylphenidate hydrochloride

Methylphenobarbitone

1-methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters and ethers; their salts1A

Methyprylone

Metopon; its salts; its esters and ethers; their salts

Midazolam

Morpheridine; its salts

Morphine; its salts; its esters and ethers; their salts; its pentavalent nitrogen derivatives; their esters and ethers1A

Morphine acetate see Morphine

Morphine hydrochloride see Morphine

Morphine methobromide; its esters and ethers

Morphine-N-oxide; its esters and ethers

Morphine sulphate see Morphine

Morphine tartrate see Morphine

Morpholinoethylnorpethidine see Morpheridine

Myrophine; its salts

Nicocodine; its salts

but if for non parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)1D

(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)1D

Nicodicodine; its salts

but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)1D

(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)1D

Nicomorphine; its salts

Nimetazepam

Nitrazepam

Noracymethadol; its salts

Nordazepam

Norcodeine; its salts

but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)1D

(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)1D

Norlevorphanol; its salts; its esters and ethers; their salts

Normethadone; its salts

Normorphine; its salts; its esters and ethers; their salts

Norpipanone; its salts

Opium, medicinal

Oxazepam

Oxazolam

Oxycodone; its salts; its esters and ethers; their salts

Oxymorphone; its salts; its esters and ethers; their salts

Papaveretum see Opium, medicinal

Pemoline

Pentazocine hydrochloride

Pentazocine lactate

Pentobarbitone

Pentobarbitone sodium

Pethidine; its salts

Pethidine hydrochloride

Phenadone see Methadone

Phenadoxone; its salts

Phenampromide; its salts

Phenazocine; its salts; its esters and ethers; their salts

Phenazocine hydrobromide

Phendimetrazine; its salts

Phendimetrazine tartrate

Phenmetrazine; its salts

Phenmetrazine hydrochloride

Phenmetrazine theoclate

Phenobarbitone

Phenobarbitone sodium

Phenomorphan; its salts; its esters and ethers; their salts

Phenoperidine; its salts; its esters and ethers; their salts

Phentermine

Phenylmethylbarbituric acid

4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts

Pholcodine; its salts

but if for non-parenteral use and:

(a) in undivided preparations with ms 2.5%. (calculated as base: Schedule 2)1D

(b) in undivided preparations with ms 1.5% (calculated as base) and md 20mg (calculated as base: Schedule 3)1D

(d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 20mg (calculated as base: Schedule 3)1D

Pholcodine citrate see Pholcodine

Pholcodine tartrate see Pholcodine

Piminodine; its salts

Pinazepam

Pipradrol; its salts

Pipradrol hydrochloride

Piritramide; its salts

Potassium clorazepate

Prazepam

Proheptazine; its salts

Properidine; its salts

Propiram; its salts

but if in preparations containing, per dosage unit, not more than 100mg propiram (calculated as base, and compounded with at least same amount of methylcellulose: Schedule 2)1D

Propylhexedrine; its salts; its stereoisomers; their salts

Pyrovalerone; its salts; its stereoisomers; their salts

Quinalbarbitone

Quinalbarbitone sodium

Racemethorphan; its salts

Racemoramide; its salts

Racemorphan; its salts; its esters and ethers; their salts

Secbutobarbitone

Secbutobarbitone sodium

Secobarbitone see Quinalbarbitone

Sufentanil; its salts; its esters and ethers; their salts

Temazepam

Thebacon; its salts

Thebaine; its salts

Tilidate; its salts; its esters and ethers; their salts

Triazolam

Trimeperidine; its salts

Vinylbital

(2) SCHEDULE 2 DRUGS

Acebutolol

Acepromazine

Acepromazine maleate

Acetanilide

Acetarsol

Acetazolamide

Acetazolamide sodium

Acetohexamide

Acetylcarbromal

Acetylcholine chloride

Acetylcysteine

Acetyldigitoxin

Acetylsalicylic acid label (1)

Acetylstrophanthidin

Acetylsulphafurazole

Acetylsulphamethoxypyridazine

Aconite

Acrosoxacin

Actinomycin C

Actinomycin D

Acyclovir

Adicillin

Adiphenine hydrochloride

Adrenaline

Adrenaline acid tartrate

Adrenaline hydrochloride

Alkomide

Albumin human (immuno)

Alclofenac

Alclometasone diproprionate

Alcuronium chloride

Aldosterone

Alfacalcidol

Algestone acetonide

Algestone acetophenide

Allopurinol

Allyloestrenol

Alphadolone acetate

Alphaxalone

Alprenolol

Alprenolol hydrochloride

Alprostadil

Alseroxylon

Altizide

Amantadine hydrochloride

Ambenonium chloride

Ambuside

Ambutonium bromide

Amcinonide

Ametazole hydrochloride

Amethocaine

Amethocaine gentisate

Amethocaine hydrochloride

Amidopyridone

Amikacin sulphate

Amiloride hydrochloride

Aminocaproic acid

Aminodarone hydrochloride

Aminoglutethemide

Aminophylline

Aminopterin sodium

Aminosalicylic acid

Amiphenazole hydrochloride

Amitriptyline

Amitriptyline embonate

Amitriptyline hydrochloride

Ammonium bromide

Amodiaquine hydrochloride

Amoxapine

Amoxycillin

Amoxycillin trihydrate

Amphomycin

Amphotericin

Ampicillin

Ampicillin sodium

Ampicillin trihydrate

Amsacrine

Amylocaine hydrochloride

Ancrod

Androsterone

Angiotensin amide

Anterior pituitary extract

Antimony barium tartrate

Antimony dimercaptosuccinate

Antimony lithium thiomalate

Antimony pentasulphide

Antimony potassium tartrate

Antimony sodium tartrate

Antimony sodium thioglycollate

Antimony sulphate

Antimony trichloride

Antimony trioxide

Antimony trisulphide

Apiol

Apomorphine

Apomorphine hydrochloride

Apramycin

Apramycin sulphate

Aprotinin

Arecoline

Arecoline-acetarsol

Arecoline hydrobromide

Arsanilic acid

Arsenic

Arsenic triiodide

Arsenic trioxide

Arsphenamine

Aspirin see acetylsalicylic acid

Astemizole

Atenolol

Atracurium besylate

Atropine

Atropine methobromide

Atropine methonitrate

Atropine oxide hydrochloride

Atropine sulphate

Azacyclonol

Azacyclonol hydrochloride

Azaperone

Azapropazone

Azothioprine

Azothioprine sodium

Azidocillin potassium

Bacampicillin hydrochloride

Bacitracin

Bacitracin methylene disalicylate

Bacitracin zinc

Baclofen

Barium carbomate

Barium chloride

Barium sulphide

Beclamide

Beclomethasone

Beclomethasone dipropionate

Belladonna herb

Belladonna root

Bemegride

Benactyzine hydrochloride

Benapryzine hydrochloride

Bendrofluazide

Benethamine penicillin

Benoxaprofen

Benperidol

Benserazide

Benzathine penicillin

Benzbromarone

Benzhexol hydrochloride

Benzilonium bromide

Benzocaine

Benzoclamine hydrochloride

Benzoyl peroxide

N-Benzoyl sulphanilamide

Benzquinamide

Benzquinamide hydrochloride

Benzthiazide

Benztropine mesylate

Benzyl penicillin

Benzyl penicillin calcium

Betahistine hydrochloride

Betamethasone

Betamethasone adamantoate

Betamethasone benzoate

Betamethasone dipropiomate

Betamethasone sodium phosphate

Betamethasone valerate

Betaxolol hydrochloride

Bethanecol chloride

Bethanidine sulphate

Biperidine hydrochloride

Biperidine lactate

Bismuth glucollylarsanilate

Bleomycin sulphate

Boldenone undecylenate

Bretylium tosylate

Bromhexine hydrochloride

Bromocriptine mesylate

Bromperidol

Bromvaletone

Budesonide

Bumetadine

Buphenine hydrochloride

Bupivacaine

Bupivacaine hydrochloride

Buspirone hydrochloride

Busulphan

Butacaine sulphate

Butanilicaine phosphate

Butriptyline hydrochloride

Butylchloral hydrate

Calcitonin

Calcitriol

Calcium aminosalicylate

Calcium amphomycin

Calcium benzamidosalicylate

Calcium bromide

Calcium bromidolactobionate

Calcium carbimide

Calcium folinate

Calcium metrizoate

Calcium sulphaloxate

Candicidin

Canrenoic acid

Cantharidin

Capreomycin sulphate

Captopril

Caramiphen hydrochloride

Caramiphen edisylate

Carbachol

Carbamazepine

Carbenicillin sodium

Carbenoxolone sodium

Carbidopa

Carbidopa monohydrate

Carbimazole

Carbocisteine

Carbon tetrachloride

Carboprostrometamol

Carbuterol hydrochloride

Carbromal

Carindacillin sodium

Carisoprodol

Carmustine

Cefaclor

Cefazedone sodium

Cefoxitin sodium

Ceftazidime

Ceftizoxine sodium

Cefuroxime sodium

Cephalexin

Cephalexin sodium

Cephaloridine

Cephalosporin C

Cephalosporin E

Cephalosporin N

Cephalothin sodium

Cephamandole nafate

Cephazolin sodium

Cephradine

Cerium oxalate

Cetirizine

Chenodeoxycholic acid

Chloral antipyrine

Chloral betaine

Chloral formamide

Chloral glycerolate

Chloral hydrate

Chloralose

Chloralurethene

Chlorambucil

Chloramphenicol

Chloramphenicol cinnamate

Chloramphenicol palmitate

Chloramphenicol sodium succinate

Chlorisondamine chloride

Chlormadinone acetate

Chlormerodrin

Chlormethiazole

Chormethiazole edisylate

Chlormezanone

Chloroform

Chloroquine phosphate

Chloroquine sulphate

Chlorothiazide

Chlorotrianisene

Chlorphenoxamine hydrochloride

Chlorpromazine

Chlorpromazine embonate

Chlorpromazine hydrochloride

Chlorpropamide

Chlorprothixene

Chlorprothixene hydrochloride

Chlortetracycline

Chlortetracycline hydrochloride

Chlorthalidone

Chloroxazone

Cholestyramine

Chorionic gonadotrophin

Ciclacillin

Ciclobendazole

Cimetidine

Cimetidine hydrochloride

Cinchocaine

Cinchocaine hydrochloride

Cinchophen

Cinnarizine

Cinoxacin

Ciprofloxacin

Ciprofloxacin hydrochloride

Clavulanic acid

Clenbuterol hydrochloride

Clindinium bromide

Clindamycin

Clindamycin hydrochloride hydrate

Clindamycin palmitate hydrochloride

Clindamycin phosphate

Clioquinol

Clobetasol 17-propionate

Clobetasone butyrate

Clofazimine

Clofibrate

Clomiphene citrate

Clomipramine

Clomipramine hydrochloride

Clomocycline

Clomocycline sodium

Clonidine

Clonidine hydrochloride

Clopenthixol decanoate

Clopenthixol hydrochloride

Cloprostenol sodium

Clorexolone

Clorprenaline hydrochloride

Clostebol acetate

Clotrimazole

Cloxacillin benzathine

Cloxacillin sodium

Cocculus indicus

Co-dergocrine myselate

Colchicine

Colestipol hydrochloride

Colistin sulphate

Colistin sulphomethate

Colistin sulphomethate sodium

Conium leaf

Corticotrophin

Cortisone

Cortisone acetate

Cotarnine chloride

Co-tetroxazine

Co-trimoxazole

Cropropamide

Crotethamide

Croton oil

Croton seed

Curare

Cyclopenthiazide

Cyclopentolate hydrochloride

Cycloghosphamide

Cyclosporin

Cyclothiazide

Cyproterone acetate

Cytarabine

Cytarabine hydrochloride

Dacarbazine

Danazol

Dantrolene sodium

Dapsone

Dapsone ethane ortho sulphonate

Daunorubicin hydrochloride

Deanol salts and esters

Debrisoquine sulphate

Dehydroemetine hydrochloride

Delmadinone acetate

Demecarium bromide

Demeclocycline

Demeclocycline calcium

Demeclocycline hydrochloride

Deoxycortone acetate

Deoxycortone pivalate

Deptropine citrate

Dequalinium chloride

Deserpidine

Desferroxamine mesylate

Desfluorotriamcinolone

Desipramine hydrochloride

Deslanoside

Desmopressin

Desonide

Desoxymethasone

Dexamethasone

Dexamethasone 21-isonicotinate

Dexamethasone phenylpropionate

Dexamethasone pivalate

Dexamethasone sodium phosphate

Dexamethasone sodium m-sulphobenzoate

Dexamethasone trioxaundecanoate

Dextromethorphan hydrobromide

Dextrothyroxine sodium

Diazoxide

Dibenzepin hydrochloride

Dichloralphenazone

Dichlorophernasine hydrochloride

Dichlorphenamide

Diclofenac sodium

Dicyclomine hydrochloride

Dienoestrol

Diethanolamine fusidate

Diethylamine acetarsol

Diflucortolone valerate

Diflunisal

Digitalis leaf

Digitoxin

Digoxin

Dihydrallazine sulphate

Dihydroergotamine mesylate

Dihydrostreptomycin sulphate

Diltiazem hydrochloride

Dimercaprol

Dimethisoquin hydrochloride

Dimethisterone

Dimethothiazine mesylate

Dimethyl sulphoxide

Dimethyltubocurarine bromide

Dimethyltubocurarine chloride

Dimethyltubocurarine iodide

Dinitrodiphenylsulphonylethylenediamine

Dinoprost

Dinoprostone

Diphetarsone

Dipivefrin hydrochloride

Diprenorphine hydrochloride

Dipyridamole

Dipyrone

Disodium etidronate

Disopyramide

Disopyramide phosphate

Distigmine bromide

Disulfiram

Disulphamide

Dithranol

Dobutamine hydrochloride

Dompridone

Dopamine hydrochloride

Dothiepin

Dothiepin hydrochloride

Doxapram hydrochloride

Doxepin hydrochloride

Doxycycline

Doxycycline calcium chelate

Doxycycline hydrochloride

Droperidol

Drostanolone

Drostanolone propionate

Dyaxide

Dydrogesterone

Econazole

Econazole nitrate

Ecthiopate iodide

Edrophonium

Emepromium bromide

Emetine

Emetine bismuth iodide

Emetine hydrochloride

Enalapril maleate

Epicillin

Epirubicin

Epithiazide

Epoprostenol sodium

Ergometrine maleate

Ergometrine tartrate

Ergotamine tartrate

Ergotoxine esylate

Erythromycin

Erythromycin estolate

Erythromycin ethyl carbonate

Erythromycin ethyl succinate

Erythromycin lactobionate

Erythromycin phosphate

Erythromycin stearate

Erythromycin thiocyanate

Estramustine phosphate

Etafedrine hydrochloride

Ethacrynic acid

Ethamsylate

Ethchlorvynol

Ethebenecid

Ethiazide

Ethinyloestradiol

Ethionamide

Ethisterone

Ethoheptazine citrate

Ethopropazine hydrochloride

Ethosuximide

Ethotoin

Ethulose

Ethyl acetanilide

Ethyl biscoumacetate

Ethyloestrenol

Ethynodiol diacetate

Etidronate disodium

Etomidate

Factor XIII concentrate

Fazadinium bromide

Fenbufen

Fenfluramine hydrochloride

Fenoprofen

Fenoprofen calcium

Fenoterol hydrobromide

Fenpipramide hydrochloride

Fenpiprane hydrochloride

Ferrous arsenate

Flavoxate hydrochloride

Flecainide

Fluanisone

Fluclorolone acetonide

Flucloxacillin sodium

Flucytosine

Fludrocortisone acetate

Flufenamic acid

Flugestone

Flugestone acetate

Flumedroxone acetate

Flumethasone

Flumethasone pivalate

Flunisolide

Fluocinolone acetonide

Fluocinonide

Fluocortolone

Fluocortolone hexanoate

Fluocortolone pivalate

Fluopromazine hydrochloride

Fluorouracil

Fluorouracil trometamol

Fluoxymesterone

Flupenthixol decanoate

Flupenthixol dihydrochloride

Fluperolone acetate

Fluphenazine deconoate

Fluphenazine enanthate

Fluphenazine hydrochloride

Fluprednidene acetate

Fluprednisolone

Fluprostenol sodium salt

Flurandrenolone

Flurbiprofen

Fluspirilene

Folic acid

Follicle stimulating hormone

Formosulphathiazole

Fosfestrol tetrasodium

Framycetin sulphate

Frusemide

Fumagillin

Fumagillin bicyclohexylamine

Furazolidone

Fusidic acid

Gallamine triethiodide

Gelsemine

Gelsemium

Gemfibrozil

Gentamicin

Gentamicin sulphate

Gestronol

Gestronol hexanoate

Glibenclamide

Glibornuride

Gliclazide

Glipizide

Glucagon

Glyceryl trinitrate

Glycopyrronium bromide

Glymide

Gonadorelin

Gramicidin

Griseofulvin

Growth hormone

Guanethidine monosulphate

Guanoclor sulphate

Guanoxan sulphate

Hachimycin

Halcinonide

Haloperidol

Heparin

Heparin calcium

Heptaminol hydrochloride

Hexachlorophene

Hexamine phenylcinchoninate

Hexoestrol

Hexoestrol dipropionate

L-Histidine hydrochloride

Homatropine

Homatropine hydrobromide

Homatropine methylbromide

Hydralazine hydrochloride

Hydrargaphen

Hydrobromic acid

Hydrochlorothiazide

Hydrocortamate hydrochloride

Hydrocortisone

Hydrocortisone acetate

Hydrocortisone 17-butyrate

Hydrocortisone caprylate

Hydrocortisone hydrogen succinate

Hydrocortisone sodium phosphate

Hydrocortisone sodium succinate

Hydroflumethiazide

Hydroquinone

Hydroxychloroquine sulphate

1 alpha-Hydroxycalciferol

Hydroxymethylgramicidin

4-Hydroxy-3-nitrophenylarsonic acid

Hydroxyprogesterone

Hydroxyprogesterone enanthate

Hydroxyprogesterone hexanoate

Hydroxyurea

Hydroxyzine embonate

Hydroxyzine hydrochloride

Hyoscine

Hyoscine butylbromide

Hyoscine hydrobromide

Hyoscine methobromide

Hyoscine methonitrate

Hyoscyamine

Hyoscyamine hydrobromide

Hyoscyamine sulphate

Ibuprofen

Idoxuridine

Ignatius bean

Imipramine

Imipramine hydrochloride

Imipramine ion exchange resin

bound salt or complex

Indapamide hemihydrate

Indomethacin

Indoramin hydrochloride

Insulins

Iodamide

Iodamide meglumine

Iodamide sodium

Ipecacuanha see emetine

Iptratropium bromide

Iprindole hydrochloride

Iproniazid phosphate

Iron; its salts

Isoaminile

Isoaminile citrate

Isocarboxazid

Isoconazole nitrate

Isoetharine

Isoetharine hydrochloride

Isoetharine mesylate

Isoniazid

Isoprenaline hydrochloride

Isoprenaline sulphate

Isopropamide iodide

Jaborondi

Kanamycin sulphate

Ketamine hydrochloride

Ketoconazole

Ketoprofen

Ketotifen

Labetolol hydrochloride

Lactogernic hormone

Lanatoside C

Lanatoside complex A, B and C

Latamoxef disodium

Lead arsenate

Levallorphan tartrate

Levodopa

Lidoflazine

Lignocaine

Lignocaine hydrochloride

Lincomycin

Lincomycin hydrochloride

Liothyronine sodium

Lithium carbonate

Lithium sulphate

Lobeline; its salts

Lofepramine

Lofepramine hydrochloride

Lomustine

Loperamide hydrochloride

Loratadine

Loxapine succinate

Luteinising hormone

Lymecycline

Lynoestrenol

Mafenide acetate

Mafenide hydrochloride

Mafenite propionate

Magnesium bromide

Magnesium fluoride

Magnesium metrizoate

Mandragora autumnalis

Mannomustine hydrochloride

Maprotiline hydrochloride

Mebeverine hydrochloride

Mebhydrolin napadisylate

Mecamylamine hydrochloride

Meclofenoxate hydrochloride

Medrogestrone

Medroxyprogesterone acetate

Mefenamic acid

Mefruside

Megestrol

Megestrol acetate

Meglumine iodoxamate

Meglumine ioglycamate

Meglumine iotraxate

Meglumine ioxaglate

Melarsonyl potassium

Melengestrol

Melengestrol acetate

Melphalan

Melphalan hydrochloride

Mepenzolate bromide

Mephenesin

Mephenesin carbamate

Mepivacaine hydrochloride

Meptazinol hydrochloride

Mequitazine

Mercaptopurine

Mercuderamide

Mersalyl

Mersalyl acid

Mesterolone

Metabutethamine hydrochloride

Metaraminol tartrate

Metformin hydrochloride

Methacycline

Methacycline calcium

Methacycline hydrochloride

Methallenoestril

Methandienone

Methandriol

Methcathinone

Methdilazine hydrochloride

Methenolone acetate

Methenolone enanthate

Methicillin sodium

Methimazole

Methindizate hydrochloride

Methixene

Methixene hydrochloride

Methohexitone sodium

Methoserpidine

Methotrexate

Methotrexate sodium

Methotrimeprazine

Methotrimeprazine hydrochloride

Methoxamine hydrochloride

Methylclothiazide

N-Methyl acetanilide

Methyldopa

Methyldopate hydrochloride

Methylephedrine hydrochloride

Methylergotamine maleate

Methylpentynol

Methylpetynol carbamate

Methylprednisolone

Methylprednisolone acetate

Methylprednisolone sodium succinate

Methyltestosterone

Methylyhiouracil

Methysergide maleate

Metoclopramide hydrochloride

Metolazone

Metomidate hydrochloride

Metoprolol tartrate

Metronidazole

Metronidazole benzoate

Mexiletine hydrochloride

Mezlocillin sodium

Mianserin hydrochloride

Miconazole

Miconazole nitrate

Minocycline

Minocycline hydrochloride

Minoxidil

Mithramycin

Mitomycin C

Mitopodozide

Mitozantrone hydrochloride

Molindone hydrochloride

Mustine hydrochloride

Nadolol

Naftidofuryl oxalate

Nalbuphine hydrochloride

Nalidixic acid

Nalorphine hydrobromide

Naloxone hydrochloride

Nandrolone decanoate

Nandrolone laurate

Nandrolone phenylpropionate

Naphazoline hydrochloride

Naphazoline nitrate

Naproxen

Naproxen sodium

Natamycin

Nedocromil sodium

Nefopam hydrochloride

Neoarsephenamine

Neomycin

Neomycin palmitate

Neomycin sulphate

Neomycin undecanoate

Neostigmine bromide

Neostigmine methylsulphate

Netilmicin sulphate

Nialamide

Nicotinaldemyde thio-semicarbazone

Nicoumalone

Nifedipine

Nikethamide

Niridazole

Nitrofurantoin

Nitrofurazone

Nitroxoline

Nomifensine hydrogen maleate

Noradrenaline

Noradrenaline acid tartrate

Norethandrolone

Norethisterone

Northisterone acetate

Northisterone heptanoate

Norethynodrel

Norgestrel

d-Norgestrel

Nortriptyline hydrochloride

Novobiocin calcium

Novobiocin sodium

Nystatin

Oestradiol

Oestradiol benzanoate

Oestradiol cypaionate

Oestradiol dipropionate

Oestradiol diundecanoate

Oestradiol enanthate

Oestradiol phenylpropionate

Oestradiol undecanoate

Oestradiol valerate

Oestriol

Oestriol di-hemisuccinate

Oestrogenic substances, conjugated

Oestrone

Oleandomycin phosphate

Opipramol hydrochloride

Orciprenaline sulphate

Orphenadrine citrate

Orphenadrine hydrochloride

Orthocaine

Ouabain

Ovarin gland, dried

Oxamniquine

Oxandrolone

Oxantel pamoate

Oxatomide

Oxedrine tartrate

Oxolinic acid

Oxophernasine hydrochloride

Oxophernasine tartrate

Oxpentifyline

Oxprenolol hydrochloride

Oxbuprocaine hydrochloride

Oxymeterone

Oxymetholone

Oxypertine

Oxypertine hydrochloride

Oxyphenbutazone

Oxyphencyclamine hydrochloride

Oxyphenonium bromide

Oxytetracycline

Oxytetracycline calcium

Oxytetracycline dihydrate

Oxytetracycline hydrochloride

Oxytocins, natural and synthetic

Pancuronium bromide

Papaverine

Papaverine hydrochloride

Papaveroline

Papaveroline 2-sulphonic acid

Paraldehyde

Paramethadione

Paramethasone acetate

Parathyroid gland

Pargyline hydrochloride

Paromycin sulphate

Pecilocin

Pempidine tartrate

Penbutolol sulphate

Penethamate

Penicillamine

Penicillamine hydrochloride

Penicillin V

Pentamidine

Pentolinium tartrate

Perhexiline hydrogen maleate

Pericyazine

Perphenazine

Phenacaine

Phenacemide

Phernasone sulphoxylate

Phenazone

Phenazone salicylate

Phenbenicillin potassium

Phebutrazate hydrochloride

Phenelzine sulphate

Phenethicillin potassium

Pheneturide

Phenformine hydrochloride

Phenglutarimide hydrochloride

Phenindone

Phenoxybenzamine hydrochloride

Phenoxymethylpenicillin

Phenoxymethylpenicillin calcium

Phenoxymethylpenicillin potassium

Pheprocoumon

Phensuximide

Phentolamine hydrochloride

Phentolamine mesylate

Phenyl aminosalicylate

Phenylbutazone

Phenylbutazone sodium

Phenylephrine hydrochloride

Phenylpropanolamine hydrochloride

Phenytoin

Phenytoin sodium

Phthalylsulphacetamide

Phthalylsulphathiazole

Physostigmine

Physostigmine aminoxide salicylate

Physostigmine salicylate

Physostigmine sulphate

Pilocarpine

Pilocarpine hydrochloride

Pilocarpine nitrate

Pimozide

Pindolol

Pipenzolate bromide

Piperacillin sodium

Piperazine oestrone sulphate

Piperidolate hydrochloride

Pipothiazine palmitate

Piracetam

Pirbuterol acetate

Pirbuterol hydrochloride

Pirenzepine hydrochloride

Pirentanide

Piroxicam

Pituitatry gland (whole dried)

Pituitary powdered (posterior globe)

Pivampicillin hydrochloride

Pivmecillinam

Pivmecillinam hydrochloride

Pizotifen

Pizotifen hydrogen maleate

Plicamycin

Podophyllum indian

Podophyllum resin

Poldine methylsulphate

Polidexide

Polidexide hydrochloride

Polidexide sulphate

Polymyxin B sulphate

Polyoestradiol phosphate

Polythiazide

Potassium aminosalicylate

Potassium arsenite

Potassium bromide

Potassium cancrenoate

Potassium chloride

Potassium citrate

Potassium clavulanate

Potassium perchlorate

Pralidoxime chloride

Pralidoxime iodide

Pralidoxime mesylate

Prazosin hydrochloride

Prednisolone

Prednisolone acetate

Prednisolone butylacetate

Prednisolone hexanoate

Prednisolone pivalate

Prednisolone sodium phosphate

Prednisolone sodium m-sulphobenzoate

Prednisolone 21-steaglate

Prednisolone m-sulphobenzoate

Prednisone

Prednisone acetate

Prenalterol hydrochloride

Prenylamine lactate

Prilocaine hydrochloride

Primaquine phosphate

Primodine

Probenecid

Probucol

Procainamide hydrochloride

Procaine hydrochloride

Procaine penicillin

Procarbazine hydrochloride

Prochlorperazine edisylate

Prochlorperazine maleate

Prochlorperazine mesylate

Procyclidine hydrochloride

Progesterone

Proguanil hydrochloride

Prolintane hydrochloride

Promazine embonate

Promazine hydrochloride

Propanidid

Propantheline bromide

Propicillin potassium

Propiomazine hydrogen maleate

Propranolol hydrochloride

Propylthiouracil

Propylphenazone

Proquamezine fumarate

Proquazone

Prostaglandin F2 alpha tromethamine

Protamine sulphate

Prothionamide

Prothipendyl hydrochloride

Protriptyline hydrochloride

Proxymetacaine hydrochloride

Pseudoephrine hydrochloride

Pseudoephrine sulphate

Pyrantel embonate

Pyrantel tartrate

Pyrazinamide

Pyridostigmine bromide

Pyrimethamine

L-Pyroglutamyl-L-histidyl-L-proline amide

Quinestradiol

Quinestrol

Quinethazone

Quingestanol

Quinidine

Quinidine bisulphate

Quinidine phenylethylbarbiturate

Quinidine polygalacturonate

Quinidine sulphate

Quinine; its salts

Quinuronium sulphate

Racephedrine hydrochloride

Ranitidine hydrochloride

Rauwolfia (serpetina and vomitoria)

Reproterol hydrochloride

Rescinnamide

Reserpine

Rfamide

Rifampicin

Rifamycin

Rimiterol hydrobromide

Ritodrine hydrochloride

Rolitetracycline nitrate

Salazosulphadimidine

Salbutamol

Salbutamol sulphate

Selegiline hydrochloride

Sera and antisera

Serum gonadotrophin

Siver sulphadiazine

Sissomycin sulphate

Sodium aminosalicylate

Sodium antimonylgluconate

Sodium apolate

Sodium arsanilate

Sodium arsenite

Sodium bromate

Sodium bromide

Sodium cacodylate

Sodium cromoglycate

Sodium ethacrynate

Sodium fluoride

Sodium fucidate

Sodium methylarsinate

Sodium metrizoate

Sodium monofluorophosphate

Sodium stibogluconate

Sodium valproate

Sotalol hydrochloride

Spectinomycin

Spiramycin

Spiramycin adipate

Spirinolactone

Stannous fluoride

Stanolone

Stanozolol

Stilboestrol

Stilboestrol dipropionate

Streptodornase

Streptokinase

Streptomycin

Streptomycin sulphate

Strychnine

Strychnine arsenate

Strychnine hydrochloride

Succinylsulphathiozole

Sucralfate

Sulbactam sodium

Sulconazole nitrate

Sulfacytine

Sulfadicramide

Sulfadoxine

Sulfametopyrazine

Sulfamonomethoxine

Sulfapyrazole

Sulfabromethazine

Sulphacetamide

Sulphacetamide sodium

Sulphachlorpyridazine

Sulphadiazine

Sulphadiazine sodium

Sulphadimethoxine

Sulphadimidine

Sulphadimidine sodium

Sulphafurazole

Sulphafurazole diethanolamine

Sulphaguanidine

Sulphaloxic acid

Sulphamerazine

Sulphamerazine sodium

Sulphamethizole

Sulphamethoxazole

Sulphamethoxydiazine

Sulphamethoxypyridazine

Sulphamethoxypyridazine sodium

Sulphamethylphenazole

Sulphamoxole

Sulphanilamide

Sulphaphenazole

Sulphapyridine

Sulphapyridine sodium

Sulphaquinoxaline

Sulphaquinoxaline sodium

Sulpharsphenamine

Sulphasalazine

Sulphasomidine

Sulphasomidine sodium

Sulphathiozole

Sulphathiozole sodium

Sulphathiourea

Sulphatolamide

Sulphaurea

Sulphinpyrazone

Sulphomyxin

Sulpiride

Sulthiame

Suxamethonium bromide

Suxamethonium chloride

Suxethonium bromide

Tacrine hydrochloride

Talampicillin

Talampicillin hydrochloride

Talampicillin napsylate

Tamoxifen

Tamoxifen citrate

Teclothiazide potassium

Terbutaline

Terbutaline sulphate

Testosterone

Testosterone acetate

Testosterone 17B chloral hemiacetal

Testosterone cyclohexylpropionate

Testosterone cypionate

Testosterone decanoate

Testosterone enanthate

Testosterone isocaproate

Testosterone phenylpropionate

Testosterone propionate

Testosterone undecanoate

Tetrabenazine

Tetracosatrin

Tetracosatrin acetate

Tetracycline

Tetracycline hydrochloride

Tetracycline phosphate complex

Thallium acetate

Theophylline

Thiabendazole

Thiethylperazine

Thiethylperazine di-(hydrogen malate)

Thiocarlide

Thioguinine

Thiopentone sodium

Thiopropazate hydrochloride

Thioproperazine mesylate

Thioridazine

Thioridazine hydrochloride

Thiotepa

Thiothexene

Thiouracil

Thymoxamine hydrochloride

Thyroid

Thyrotrophin

Thyrotrophin releasing hormone

Thyroxine sodium

Tianulin hydrogen fumarate

Tiaprofenic acid

Ticarcillin sodium

Tigloidine hydrobromide

Timolol maleate

Tinidazole

Tioconazole

Tobramycin

Tobramycin sulphate

Tocainide hydrochloride

Tofenacin hydrochloride

Tolazamide

Tolazoline hydrochloride

Tolbutamide

Tolbutamide sodium

Tolmetin sodium dihydrate

Tolperisone

Totaquine

Tranexamic acid

Tranylcypromine sulphate

Trazadone

Treosulfan

Tretamine

Treotinon

Triacetyloleandomycin

Triamcinolone

Triamcinolone acetonide

Triamcinolone diacetate

Triamcinolone hexacetonide

Triamterene

Tribromoethyl alcohol

Triclofos sodium

Tricyclamol chloride

Trienbolone acetate

Trientine dihydrochloride

Trifluoperazine

Trifluoperazine hydrochloride

Trifluoperidol

Trifluoperidol hydrochloride

Trilostane

Trimeprazine

Trimeprazine tartrate

Trimetaphan camsylate

Trimetazidine

Trimetazidine hydrochloride

Trimethoprim

Trimipramine maleate

Trimepramine mesylate

Trimustine hydrochloride

Tripolidine

Tropicamide

L-Tryptophan

Tubocurarine chloride

Tybamate

Tylosin

Tylosin phosphate

Tylosin tartrate

Tyrothricin

Uramustine

Urea stibamine

Uridine-5-triphosphoric acid

Urifollitrophin

Urokinase

Ursodeoxycholic acid

Vaccines

Valproic acid

Vancomycin hydrochloride

Vasopressin tannate

Vecuronium bromide

Verapamil hydrochloride

Viloxazine hydrochloride

Vinblastine sulphate

Vincristine sulphate

Vindesin sulphate

Viomycin pantothenate

Viomycin sulphate

Vitamin A

Vitamin A acetate

Vitamin a palmitate

Vitamin D

Vitamins

Warfarin

Warfarin sodium

Xylazine hydrochloride

Yohimbine hydrochloride

Zidovudine

Zinc sulphate in preparations for local

ophthalmic use

Zimeldine hydrochloride

Zomepirec sodium

Zuclopenthixol hydrochloride

(3) SCHEDULE 3 DRUGS

Acertasol in preparations for external use

Acetylsalicylic acid in preparations with md 500mg and not more than 30 doses, (except those intended for children under 12 years: Schedule 2).

label (1)

Aconite in preparations and mixtures of ms 0.02%

Adrenaline, if-

(a) in inhalers

(b) in preparations for external use

Amethocaine in preparations for non-parenteral use (except those intended for local opthalmic use: Schedule 2).

Amethocaine gentisate in preparations for non-parenteral use (except those intended for local opthalmic use: Schedule 2).

Amethocaine hydrochloride in preparations for non-parenteral use (except those intended for local opthalmic use: Schedule 2).

Astemizole in preparations licensed and labelled for the treatment of hay fever in adults and children over 12 years.

label (5)

Atropine in preparations for external use, (except those intended for local opthalmic use: Schedule 2)

Atropine methobromide in preparations for external use, (except those intended for local opthalmic use: Schedule 2)

Atropine methonitrate in preparations for external use, (except those intended for local opthalmic use: Schedule 2)

Atropine oxide hydrochloride in preparations for external use, (except those for local opthalmic use: Schedule 2)

Azatadine maleate

label (5)

Benzocaine in preparations for non-parenteral use (except those for local opthalmic use: Schedule 2)

Benzoyl peroxide in preparations for external use with ms 10%

Boric acid

Brompheniramine maleate

Bupivacaine in preparations for non-parenteral use, (except those intended for local opthalmic use: Schedule 2)

Bupivacaine hydrochloride in preparations for non-parenteral use, (except those intended for local opthalmic use: Schedule 2)

Butacaine sulphate in preparations for non-parenteral use, (except those intended for local opthalmic use: Schedule 2)

Butanilicaine phosphate in preparations for non-parenteral use, (except preparations intended for local ophthalmic use: Schedule 2)

Caffeine

Cantharidin in preparations for external use and ms 0.01 %

Caramiphen edisylate in:

(a) tablet preparations and ms 7.5mg (calculated as base)

(b) liquid preparations and ms 0.1% (calculated as base)Carbenoxolone sodium in preparations for external use ms 2%ChlorhexidineChloroquine phosphate for prophylaxis of malaria. Labelling for malaria prophylaxis

Chloroquine sulphate for prophylaxis of malaria.

Labelling for malaria prophylaxis

Chlorpherinamine maleate, label (5)

(But in preparations for parenteral use: Schedule 2)

Cinchocaine in preparations for non-parenteral use and ms 3%, (except preparations for local ophthalmic use: Schedule 2)

Cinchocaine hydrochloride in preparations for non-parenteral use ms 3%, (except preparations for local ophthalmic use: Schedule 2)

Clemastine, label (5)

Clioquinol in preparations for external use

Clotrimazole in preparations for external use

Cyclizine hydrochloride in preparations for non-parenteral use

Dequalinium chloride in:

(a) throat lozenges or throat pastilles and ms 0.25mg

(b) external paint preparations and ms 1%Dextromethorphan hydrobromide in preparations for internal use with md 15mg (calculated as base)Diclofenac in preparations for external useDicyclomine hydrochloride in non-parenteral preparations, label (6)Dimenhydrinate in preparations for non-parenteral use label (5)Dimethindine maleate, label (5)Dimethisoquin hydrochloride in preparations for non-parenteral use, (except preparations for local ophthalmic use: Schedule 2)Diphenhydramine hydrochloride in preparations for non-parenteral use, label (5)Diphenylpyraline hydrochloride, label (5)Econazole in preparations for external use, (except for vaginal use: Schedule 2)Econazole nitrate in preparations for external use, (except for vaginal use: Schedule 2)Emetine in preparations for internal or external use and ms 1%Emetine hydrochloride in preparations for internal or external use and ms 1% (calculated as base)Ephedrine in:

(a) preparations for internal use (except nasal sprays or nasal drops) with md 30mg and mdd 60mg, label (4)

(b) nasal sprays or nasal drops and ms 2% label (4)Ephedrine hydrochloride in:

(a) preparations for internal use (except nasal sprays and nasal drops) with md 30mg (calculated as base) and mdd 60mg (calculated as base) label (4)

(b) nasal sprays or nasal drops and ms 2% (calculated as base), label (4)
Folic acid (schedule 2) in preparations for internal use and mdd 500 micrograms,Gramicidin in preparations for external use and ms 0.02%Hexachlorophene in preparations for external use and:

(a) in soaps with ms more than 0.1 % but not more than 2% label (6)

(b) in products other than soaps or aerosols with ms more than 0.1% but not more than 0.75% label (6)L-Histidine hydrochloride used as an ingredient in dietary or nutritional products as an amino acid

Homatropine in preparations for external use (except preparations for local ophthalmic use: Schedule 2))

Hydroxychloroquine sulphate for the prophylaxis of malaria

Labelling for malaria prophylaxis

Hydrocortisone in preparations for external use and ms 1%

Hydroxymethylgramicidin in throat lozenges or throat pastilles

Ibuprofen in preparation for internal use with ms 200mg and not more than 30 doses

Idoxuridine in preparations for external use (except preparations for local ophthalmic use: Schedule 2))

Indomethacin in preparations for external use

Isoconazole nitrate for external use, (except preparations intended for vaginal use: Schedule 2)

Lignocaine in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Lignocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Mebendazole

Mepivacaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Metabutethamine hydrochloridein preparations for non-parenteral use, (except preparations for local ophthalmic use)

Methylephedrine hydrochloride in preparations for internal use with md 30mg and mdd 60mg

Miconazole for external use (except vaginal use: Schedule 2))

Naphazoline hydrochloride:

(a) in nasal sprays or nasal drops not containing liquid paraffin as vehicle and ms 0.05%

(b) in eye drops and ms 0.015%

Naphazoline nitrate in nasal sprays or nasal drops not containing liquid paraffin as vehicle and ms 0.05%

Nitrofurazone in preparations for external use

Orthocaine in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Oxybuprocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Paracetamol

label (3)

Phenacaine in preparations for non-parenteral use, (except those intended for local ophthalmic use)

Phenindamine tartrate

Pheniramine maleate

Phenolphthalein

Phenylephrine hydrochloride but if in eye drops with ms 10%

Phenylpropanolamine hydrochloride:

(a) in preparations for internal use (except controlled release capsules, nasal sprays or nasal drops) with md 25mg and mdd 100mg

(b) in controlled release capsules with md 50mg and mdd 100mg

Piperazine

Podophyllum resin in ointments or impregnated plasters for external use with ms 20%

Prilocaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Procaine hydrochloride in preparations for non-parenteral use, (except those intended for local ophthalmic use: Schedule 2)

Proguanil hydrochloride for prophylaxis of malaria

Labelling for malaria prophylaxis

Proxymetacaine hydrochloride in preparations for non-parenteral use (except those intended for local ophthalmic use: Schedule 2)

Pseudophedrine hydrochloride in preparations for internal use with md 60mg and mdd 180mg

Pseodophedrine sulphate in preparations for internal use with md 60mg and mdd 180mg

Quinine in preparations for internal use md 100mg (calculated as base) and mdd 300mg (calculated as base)

Sodium apolate in preparations for external use

Sodium arsenite in preparations for internal and external use and ms 0.013%

Sodium cromoglycate in preparations for use by being administered through the nose

Sodium fluoride:

(a) in preparations for use in the prevention of dental caries, other than dentifrices, in the form of:

(i) tablets or drops and mdd 2.2mg

(ii) mouth rinses other than those for daily use and ms 0.2%

(iii) mouth rinses for daily use and ms 0.05%

Streptodornase in preparations for external use

Streptokinase in preparations for external use

Sulconazole in preparations for external use, (except vaginal use Schedule 2)

Terfenadine

Thiabendazole in preparations for external use

Tioconazole in preparations for external use (except vaginal use: Schedule 2) with ms 2%

Tyrothricin in throat lozenges or throat pastilles

Zinc sulphate in non-parenteral preparations (except in preparations for local ophthalmic use: Schedule 2)

(4) SCHEDULE 4 DRUGS

Aluminium compounds

Ascorbic acid in preparations for non-parenteral use

Benzocaine in preparations for external use and ms 1% (except preparations for local ophthalmic use: Schedule 2))

Carbon tetrachloride

N.B. if the unlicensed product is sold for non-medical purposes e.g. cleaning, there are no restrictions on its sale

Cetrimide

Chlorhexidine:

(a) for external use (except vaginal use: Schedule 3)

(b) in preparations for mouth wash and for use in the prevention of dental caries

Chloroform in liquid preparations for internal use and ms 0.5%

Folic acid in preparations for internal use and mdd 200 micrograms

Glycerol

Hexachlorophene:

in preparations for external use and:

(a) in soaps with ms 0.1%

label (6)

(b) in aerosols with ms 0.1%

label (6)

Iron in preparations for internal use and mdd 100mg (calculated as iron)

Lignocaine in preparations for external use and ms 0.6% (except preparations for local ophthalmic use: Schedule 2)

Lignocaine hydrochloride in preparations for external use and ms 0.7% (except preparations for local ophthalmic use: Schedule 2)

Magnesium trisilicate

Paracetamol in tablet preparations with ms 500mg and not more than 30 tablets

label (3)

Sodium fluoride in dentifrices and ms 0.33%

Sodium monofluorophosphate in dentifrices and ms 1.14%

Stannous fluoride in dentifrices and ms 0.62%

Vitamin A in:

(a) preparations for internal use with mdd 7500 iu Vitamin A (2250 mcg Retinol equivalent)

(b) preparations for external use

Vitamin A acetate in:

(a) preparations for internal use with mdd equivalent to 7500 iu Vitamin A (2250 mcg Retinol equivalent)

(b) preparations for external use

Vitamin A palmitate in:

(a) preparations for internal use with mdd equivalent to 7500 iu Vitamin A (2250 mcg Retinol equivalent)

(b) preparations for external use

Vitamin D in:

(a) preparations for internal use with mdd 10 mcg

(b) preparations for external use

Vitamins, mixed in non-parenteral preparations

NOTES

Explanation of abbreviations and other phrases used in lists of drugs

md:

(maximum dose) i.e. the maximum quantity of the drug or substance that is contained in the amount of a medicinal product which is recommended to be taken or administered at any one time.

mdd:

(maximum daily dose) i.e. the maximum quantity of the substance that is contained in the amount of a medicinal product which is recommended to be taken or administered in any period of 24 hours.

ms:

(maximum strength) i.e. either or, if so specified, both of the following:

(a) the maximum quantity of the substance by weight or volume that is contained in the dosage unit of a medicinal product; or

(b) the maximum percentage of the substance contained in a medicinal product calculated in terms of w/w, w/v, v/w or v/v, as appropriate.

external use:

means for application to the skin, teeth, mucosa of the mouth, throat, nose, eye, ear, vagina or anal canal when a local action only is necessary and extensive systemic absorption is unlikely to occur.
N.B. The following are not regarded as for external use: throat sprays, throat pastilles, throat lozenges, throat tablets, nasal drops, nasal sprays, nasal inhalations or teething preparations.

oral use:

means administration through the mouth.

parenteral administration:

means administration by breach of the skin or mucous membrane.

SECOND SCHEDULE

(reg. 21)

Amphetamine

Brolamphetamine (DOB, Bromo-STP)

Bufotenine (N,N-Dimethylserotonin)

Cannabis

Cocaine

Coca Leaf

Cathinone

DET or 3-[2-(diethylamino)ethyl]indole

Dexamphetamine

DMA or (+ or -)-2,5-dimethoxy-alpha-methylphenethylamine

DMT or 3-[2-(dimethylamino)ethyl]indole

DOET or (+ or -)-4-ethyl-2,5-dimethoxy-alpha-phenethylamine

Ecgonine

Eticyclidine (PCE)

Fentanyl analogues (unless listed in another Schedule):

acetyl-alpha-methyl-fentanyl

alpha-methyl-fentanyl

alpha-methyl-fentanyl-acetanilide

alpha-methyl-thiofentanyl

beta-hydroxy-fentanyl

3-methyl-thiofentanyl

3-methyl-fentanyl and its cis- and trans- isomeric forms

thiofentanyl

para-flurofentanyl

Harmaline

Harmine

Heroin (diacetylmorphine)

(+)-lysergide (LSD, LSD-25)

MDMA or (+ or -)-N, alpha-dimethyl-3,4-(methylenedioxy)-phenethylamine

Mecloqualone

Mescaline

Methaqualone

4-methylaminorex

MMDA or 2-methoxy-alpha-methyl-4,5(methylenedioxy)phenethylamine

N-ethyl MDA or (+ or -)-N-ethyl-alpha-methyl-3,4- (methylenedioxy)phenethylamine

N-hydroxy MDA or (+ or -)-N-[alpha-methyl-3,4(methylene-dioxy)phenethyl]hydroxylamine

Opium

Parahexyl

Pethidine analogues:

1-methyl-4-phenyl-4-propionoxy-piperidine (MPPP)

1-methyl-4-phenyl-2,5,6-tetrahydropieridine (MPTP)

1-phenylethyl-4-phenyl-4-acetyloxy-piperidine (PEPAP)

PMA

Poppy straw concentrate

Psilocine or psilotsin

Psilocybine

Rolicyclidine (PHP, PCPY)

STP, DOM or 2,5-dimethoxy-alpha,4-dimethylphenelhylamine

Tenamfetamine (MDA)

Tenocyclidine (TCP)

Tetrahydrocannabinol

TMA or (+ or -)-3,4,5-trimethoxy-alpha-methylphenethylamine

All preparations and mixtures of the following unless specifically excluded or unless listed in another Schedule:

(i) the isomers of substances above, where existence of such isomers is possible;

(ii) the esters and ethers of such substances and of the isomers referred to above or isomers of such esters and ethers, where the existence of such esters, ethers and isomers is possible;

(iii) the salts of such substances and of the isomers referred to in (i), and the salts of the esters, ethers and isomers referred to in (ii), where the existence of such salts is possible;

(iv) the isomers of any of the salts referred to in (iii), where the existence of such isomers is possible.

THIRD SCHEDULE
FORMS

(reg. 22)

Form 1

Application for Registration of a Drug

Form 2

Approval for Registration of a Drug

Form 3

Application for Licensing to Import, Export, Manufacture and Sell Drugs

Form 4

Approval for Licensing as per Form 3

Form HFD 1

Application for Permit to Import Habit-Forming Drug

Form HFD 2

Import Permit for Habit-Forming Drug

Form HFD 3

Application for Permit to Export Habit-Forming Drug

Form HFD 4

Export Permit for Habit-Forming Drug

Form 1
APPLICATION FOR REGISTRATION OF A DRUG

(All documents in English)

REPUBLIC OF BOTSWANA
MINISTRY OF HEALTH

Page 1 of 7

Application to be sent to:
Permanent Secretary
Ministry of Health
Private Bag 0038
GABORONE
Attention: Chief Pharmacist

APPLICATION
Number:

APPLICATION FOR REGISTRATION OF A DRUG
(All documents in English)N.B.: Please study the notes on the reverse of each side.APPLICANT:Name:Postal Address:Business Address:Telephone/Telefax Number:THE DRUG:Name (Trade and INN-name)(The strength to be per dosage unit. Where no dosage unit exists other suitable unit of mass or volume of the drug.(2):Colour Country of Origin:Manufacturer:The undersigned hereby declares that all information contained herein and in the appendices is correct and true.

Date: ……………………………………….Signature: …………………………………………..Name (block letters): ……………………………………………………………………………………………Official and Professional Designation function a7(msg) { myWindow=window.open(”,”,’width=400,height=150,left=400 ,scrollbars=1,top=400,screenX=400,screenY=100′);myWindow.document.write(msg);} (a) British Pharmacopoeia; (b) European Pharmacopoeia; (c) United States Pharmacopoeia; (d) International Pharmacopoeia; and of (e) any such reference that the Director may approve.(2) of any raw material used in manufacturing whether or not present in final dosage product;

(d) chemical details of the active ingredients showing the approved name, solubility, storage requirements, etc.ACTIVE INGREDIENTSApproved nameChemical name (i) Data indicative of at least 24 months shelf-life derived from the product in the packaging material specified in Appendix III. Where the products contain inherently unstable ingredients this requirement shall not apply. (ii) Temperatures in Botswana can be as low as 0 degrees C and as high as 40 degrees C. Extremes of these shall be specified and tested. (iii) The preserving ability of any antibacterial agents or preservatives in the formulation shall be specified and tested. (iv) Data to include normal degradation products storage conditions required to maintain raw material integrity and results of qualitative results of tests carried out. (v) Date of manufacture and batch number of samples studied for stability (minimum of two batches).(3);

(f) Manufacturing procedures Refused (date):Deferred (date):Conditionally approved
(date, conditions):
Final approval (date):Schedule:Approved indications:SPECIAL CONDITIONS ETC:

Form 2
APPROVAL OF REGISTRATION OF A DRUG

REPUBLIC OF BOTSWANA
MINISTRY OF HEALTH Subject to due compliance with the requirement of the Drugs and Related Substances Act, 1992, and Regulations thereto, the Director of Health Services has approved the following drug to be marketed in Botswana and entered it into the Drug Register as follows:Registration Number:Name of Drug:
Active ingredient(s), approved name and quantity per dosage unit or per suitable mass or volume of the drug:Dosage Form:Strength:Manufacturer:
Manufacturing Country:
Package size(s):
Packaging Material:
Approved Indication(s):
Schedule:
Special Conditions:
Date granted:Valid until:Authorisation (name and stamp):Signature
(Dir. Health Serv.):

Form 3
APPLICATION FOR APPROVAL TO IMPORT OR EXPORT DRUGS

REPUBLIC OF BOTSWANA
MINISTRY OF HEALTHApplication to be sent to:
Permanent Secretary
Ministry of Health
Private Bag 0038
GABORONE
Attention: Chief Pharmacist

APPLICATION
Number:

_______________

APPLICATION FOR APPROVAL TO:[ ] import drugs[ ] export drugs

[ ] as wholesaler[ ] Schedule 1, 2, 3 and 4

[ ] Schedule 4 only

[ ] as retailer[ ] Schedule 1, 2, 3 and 4

[ ] as agent[ ] Schedule 1, 2, 3 and 4[ ] manufacture drugs (see also reverse page)[ ] sell drugs

[ ] as wholesaler[ ] Schedule 1, 2, 3 and 4

[ ] Schedule 4 only

[ ] as retailer[ ] Schedule 1, 2, 3 and 4 (pharmacy)

[ ] Schedule 4 onlyName of applicant ………………………………………………………………………………………………..

(of person representing the company)Address ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………My qualifications are (profession/education) …………………………………………………………………………………………………………………………………………………………………………………………The premises are located (address) …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..
Date

……………………………………………
Signature of applicant

ADDITIONAL INFORMATION NEEDED FOR APPLICATION TO MANUFACTURE DRUGS

1. The following shall be the key personnel in the manufacturing plant:

NAME

QUALIFICATION

EXPERIENCESupervising
pharmacist

Production
pharmacist

Quality assurance
pharmacist

Other

2. The following are products intended to be manufactured (attach list showing name of product, active ingredient, strength and dosage form, include formulations and manufacturing process):
………………………………………………………………………………………………………………….

3. The following are the equipment to be used (attach list showing the name, type and capacity of equipment):

……………………………………………………………………………………………………………………
……………………………………………………………………………………………………………………

Form 4
APPROVAL FOR LICENSING

REPUBLIC OF BOTSWANA
MINISTRY OF HEALTH

Approval No: Subject to due compliance with the requirements of the Drugs and Related Substances Act, 1992 and Regulations thereto, the Director of Health Services, Ministry of Health, hereby approve for licensing:Name of Applicant: ………………………………………………………………………………………………Address …………………………………………………………………………………………………………….[ ] to import drugs[ ] to export

[ ] as wholesaler[ ] Schedule 1, 2, 3 and 4

[ ] Schedule 4

[ ] as retailer[ ] Schedule 1, 2, 3 and 4

[ ] as agent[ ] Schedule 1, 2, 3 and 4[ ] to manufacture drugs[ ] to sell drugs

[ ] as wholesaler[ ] Schedule 1, 2, 3 and 4

[ ] Schedule 4

[ ] as retailer[ ] Schedule 1, 2, 3 and 4

[ ] Schedule 4at ……………………………………………………………………………………………………………………

(premises)Special conditions: ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Date

…………………………………………………..
Valid until (date) ……………………………………………
Stamp and signature
Dir. of Health Services

Form HFD 1
APPLICATION FOR PERMIT TO IMPORT
HABIT- FORMIMG DRUGS AND/OR PSYCHOTROPIC SUBSTANCES

(Drugs and Related Substances Act, 1992)

REPUBLIC OF BOTSWANA
MINISTRY OF HEALTHApplication to be sent to:
Permanent Secretary
Ministry of Health
Private Bag 0038
GABORONE
Attention: Chief Pharmacist In accordance with the Drugs and Related Substances Act, 1992, the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971:I, ……………………………………………………………………………………………………………………..

(Name of Applicant)registered as ………………………………………………………………………………………………………

(Qualification and Registration Number)of ……………………………………………………………………………………………………………………..

(Company and Address)……………………………………………………………………………………………………………………….hereby apply for permit to import the following habit-forming drugs and/or psychotropic substances:Item No.Approved
name of drug/substance and strengthQuantity and presentation of drug substance drug or substancePurpose: medicinal, manufacture, research scientific other (specify)Stock will last (number of days if applicable)

Total number of items: ………………………………………………………………………………………….From (name and address of exporting firm):Route of supply (by):Port of entry (at):

Date: ………………………………………………………………………………..
Signature of applicantNOTES: To be accompanied by a completed order from the importing firm specifying the exporting firm.

Form HFD 2
IMPORT PERMIT FOR HABIT-FORMING DRUGS
AND/OR PSYCHOTROPIC SUBSTANCES

REPUBLIC OF BOTSWANA
MINISTRY OF HEALTH
Import Permit No_____________

In accordance with the Drugs and Related Substances Act, 1992, the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971, authority is here granted to:………………………………………………………………………………………………………………………..

(name, location and postal address of importing firm)………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….to import or acquire the Habit-Forming Drugs and/or Psychotropic substances specified hereunder from:………………………………………………………………………………………………………………………..

(name, location and postal address of exporting firm)………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….Item No.Approved
name of drug/substance and strengthQuantity and presentation of preparationApproved name and quantity of controlled drug/substance as base in kilogramsPurpose: medicinal, manufacture, scientific and others (specify)

Total Number of Items: …………………………………………………………………………………….. It is a condition of this permit that drugs/substances imported or acquired hereunder shall not be used by the person to whom this permit is issued, otherwise than for or in accordance with the Drugs and Related Substances Act, 1992. This authority expires on …………………………………………………………………………………. Drugs/substances ordered on this authority must be consigned by registered mail/road/air/ sea. Import Permit No ……………………………………..Dated ……………………………………….Route of supply (by) …………………………………………………………………………………………….Port of entry (at) …………………………………………………………………………………………………..Date …………………………………..

…………………………………..
Signature and stamp
Dir. of Health Services

NOTESTo be completed in quintuplicate:

1. Original to accompany consignment.

2. Duplicate to be endorsed in accordance with the requirements of the Single Convention on Narcotic Drugs, 1961 and the Convention on Psychotropic Substances, 1971, and returned to the Chief Pharmacist, Ministry of Health P/Bag 0038, Gaborone.

3. Triplicate to be certified by the exporter and returned to the Chief Pharmacist, Ministry of Health, as soon as possible after the date of despatch.

4. Quadruplicate to be retained by the exporter for their records.

5. Quintuplicate to be retained by the export authorising office.