MEDICINES AND RELATED SUBSTANCES: SUBSIDIARY LEGISLATION

INDEX TO SUBSIDIARY LEGISLATION

Medicines and Related Substances (Prohibition of Use of Certain Medicines in Animals) Order

Medicines and Related Substances Regulations

MEDICINES AND RELATED SUBSTANCES REGULATIONS

(section 69)

(27th December, 2019)

ARRANGEMENT OF REGULATIONS

    REGULATION

PART I
Preliminary

    1.    Citation

    2.    Interpretation

PART II
Medicines

    3.    Registration of medicine

    4.    Validity period of registration of medicine

    5.    Renewal of registration

    6.    Exemption from registration of medicines for individual patient

    7.    Import of unregistered medicines for personal use

    8.    Exemption from registration of medicines for wholesale

    9.    Exemption of donated unregistered medicines

    10.    Variations

    11.    Notifications

    12.    Recall of medicines by other institutions outside Botswana

    13.    Recall of medicines by Authority

    14.    Withdrawal of marketing authorisation

    15.    Suspension or revocation of marketing authorisation

PART III
Licensing

    16.    Licensing of pharmaceutical operations

    17.    Licensing of manufacturing facility

    18.    Licensing of pharmacy

    19.    Licensing of pharmaceutical wholesaler

    20.    Licensing of pharmacies within a group practice

    21.    Licensing of dispensaries in surgeries and institutional dispensaries

    22.    Variation of licence

    23.    Suspension or withdrawal of licence

    24.    Renewal of licence

PART IV
Record Keeping and Import of Medicines

    25.    Record keeping

    26.    Import of medicines

    27.    Parallel import of medicines

    28.    Import of samples for registration

    29.    Post-market surveillance

    30.    Adverse medicine reactions

    31.    Counterfeit medicines

    32.    Medicines in transit

    33.    Designation of ports

    34.    Disposal of unwanted medicines

    35.    Classification and description of medicines

    36.    Prescription of medicines

    37.    Contents of prescriptions

    38.    Emergency administration

    39.    General dispensing

    40.    Dispensing of Schedules 1A, 1B and 1C medicines

    41.    Emergency dispensing of Schedules 1A, 1B and 1C medicines

    42.    Dispensing of Schedule 2 medicines

    43.    Dispensing of Schedules 1D and 3 medicines

    44.    Emergency supply of medicines by pharmacist

    45.    Storage of medicines by prescribers

    46.    Dispensing of medicines by healthcare providers other than pharmacists

    47.    Sale and use of precursor chemicals

    48.    Storage of medicines

    49.    Product information

    50.    Import and export of narcotics, psychotropics and precursor chemicals

    51.    Records for narcotics, psychotropics and precursor chemicals

    52.    Correction of records

    53.    Advertising and promotion

    54.    Inspection of premises

PART V
Control of Clinical Trials

    55.    Application for use of medicines for clinical trials

    56.    Monitoring of clinical trial

    57.    Inspection and audit of clinical trials

    58.    Suspension or termination of approval to conduct clinical trials

    59.    Disposal of unused medicines in clinical trials

PART VI
Cosmetics

    60.    Registration of cosmetics

    61.    Exemption for registration of cosmetics

    62.    Publication of list of prohibited ingredients

    63.    Labelling of cosmetics

    64.    Licensing of manufacturing cosmetics

    65.    Import of cosmetics

PART VII
Complementary Medicines

    66.    Registration of complementary medicines

    67.    Validity period of registration of complementary medicines

PART VIII
General

    68.    Harmonisation and collaborative activities of Authority

    69.    Appeals Committee

    70.    Banned medicines

    71.    Offences and penalties

    72.    Revocation of Cap. 63:04 (Sub. Leg.)

        SCHEDULE 1

        SCHEDULE 2

        SCHEDULE 3

        SCHEDULE 4

        SCHEDULE 5

        SCHEDULE 6

S.I. 163, 2019.

PART I
Preliminary (regs 1-2)

1. Citation

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

2. Interpretation

In these Regulations, unless the context otherwise requires—

“Active Pharmaceutical Ingredients (APIs)” means any substance or combination of substances used in a finished pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings;

“authorised person” means any person given the responsibility for ensuring the medicines’ requirements are in compliance with the laws and regulations in force in Botswana;

“bonded warehouse” means a warehouse where goods are stored and held before being cleared to enter the country and these may also be used to store goods in transit;

“complementary medicines” means a labelled substance or mixture of substances manufactured, sold or represented for use as adjuvants to conventional therapy in—

    (a) the mitigation or prevention of an abnormal physical state; or

    (b) restoring, correcting or modifying physical, mental or organic functions in humans, and originate from plant, mineral, animal including micro-organisms, homeopathic preparations, nutritional substances in accepted pharmaceutical dosage forms, a combination of the above or any other such preparations as may be approved by the Authority;

“guidelines” means documents outlining regulatory requirements applied by the Authority in line with these Regulations as listed in Schedule 6;

“notification” means changes that could have minimal or no adverse effects on the overall safety, efficacy and quality of the Finished Pharmaceutical Product (FPP);

“parallel importation” means cross-border importation of a medicine or a product registered by the Authority, without the consent of the patentee, where the medicine has been put on the market by the patentee or by another acting with the patentee’s consent, or having an economic tie to the patentee;

“qualified person” means a person registered with the relevant professional body to undertake work or practise within a specific technical field or area meeting the minimum requirements in the guidelines; and

“variations” means—

    (a) major variations which are changes that could have major effects on the overall safety, efficacy and quality of the FPP; or

    (b) minor variations which are changes that may have minor effects on the overall safety, efficacy and quality of the FPP.

PART II
Medicines (regs 3-15)

3. Registration of medicine

    (1) An application for registration of medicine shall be in Form 1 set out in Schedule 4 and shall be accompanied by—

    (a) an application fee set out in Schedule 5;

    (b) the Common Technical Document in Form 2 set out in Schedule 4; and

    (c) a sample as described in the guidelines.

    (2) The Authority shall specify conditions for registration for a particular medicine or group of medicines and may—

    (a) amend any conditions for registration;

    (b) specify product labelling requirements; or

    (c) determine what is to be described in the label or packages of medicines.

    (3) Where an application to register medicines is successful, the Authority shall issue the registration certificate to the applicant in Form 3 set out in Schedule 4.

    (4) Where an application to register medicines is unsuccessful, the Authority shall inform the applicant in writing, stating the reasons for the decision not to register the medicine.

    (5) A summary of technical assessment reports for approved and rejected registration may be published and made available to the public.

    (6) A marketing authorisation holder shall be responsible for the importation, advertising and promotion of his or her medicine.

4. Validity period of registration of medicine

A registration certificate issued in terms of regulation 3 shall be valid for five years subject to annual submission of information accompanied by a fee set out in Schedule 5.

5. Renewal of registration

    (1) A person may apply to the Authority for the renewal of registration of medicines.

    (2) An application under subregulation (1) shall be—

    (a) in Form 1 set out in Schedule 4;

    (b) accompanied by a renewal fee set out in Schedule 5; and

    (c) submitted to the Authority not later than six months before the expiry date of registration.

6. Exemption from registration of medicines for individual patient

    (1) A medical practitioner may apply in Form 4, upon payment of an application fee set out in Schedule 5 to the Authority to exempt the registration of medicines from outside Botswana, for his or her patient’s personal use.

    (2) Subject to subregulation (1), the application shall comply with the guidelines and shall be signed by an importing pharmacist residing in Botswana.

    (3) The Authority may, after having considered the application and the supporting documents, grant the exemption.

    (4) The validity period of the exemption from registration shall be six months.

7. Import of unregistered medicines for personal use

    (1) A person who imports medicine from outside Botswana for personal use shall not import more than one month’s supply of medicine.

    (2) Subject to subregulation (1), where a person brings more than one month’s supply, but less than three months’ supply, he or she shall produce, upon request by a competent authority, a certified copy of the prescription from a medical practitioner.

    (3) Subject to regulation 6, a person shall apply to the Authority in writing for an exemption from registration for any subsequent supplies of the imported medicine.

8. Exemption from registration of medicines for wholesale

    (1) An applicant may apply to the Authority to exempt the registration of medicines for wholesale from outside Botswana under special circumstances as determined by the Authority.

    (2) The application shall—

    (a) comply with the guidelines; and

    (b) be accompanied by the application fee in Form 5 set out in Schedule 5.

    (3) The applicant may be required to pay for the inspection of the manufacturing site prior to authorisation.

9. Exemption of donated unregistered medicines

A person may apply to the Authority for exemption from registration of donated medicines in Form 6 as set out in Schedule 4 and he or she shall meet the requirements of the guidelines on donation.

10. Variations

    (1) A marketing authorisation holder shall not make a variation in the particulars of a registered medicine without the prior approval of the Authority, except where the change is a notification.

    (2) A variation application shall be submitted to the Authority and shall be—

    (a) in terms of Form 7 set out in Schedule 4;

    (b) accompanied by a variation fee set out in Schedule 5; and

    (c) accompanied by the supporting documents as specified in the conditions laid down for each type of variation.

    (3) The marketing authorisation holder shall ensure that all the necessary validation has been conducted to demonstrate that the change does not reduce the quality, safety or efficacy of the medicine.

    (4) The Authority may cancel the registration of a medicine where variations are made without prior approval of the Authority.

11. Notifications

    (1) A marketing authorisation holder shall apply to the Authority for a notification of a variation in the particulars of a registered medicine in Form 7 set out in Schedule 4.

    (2) Subject to subregulation (1), the applicant shall pay to the Authority a notification fee set out in Schedule 5.

    (3) An application for immediate notification shall be submitted soon after implementing the variation.

    (4) An application for annual notification shall be submitted within 12 months after implementing the variation.

    (5) The Authority shall ensure that quality, safety and efficacy of a medicine is still maintained.

12. Recall of medicines by other institutions outside Botswana

Where an institution outside Botswana recalls some medicines, a marketing authorisation holder shall provide the Authority with the following—

    (a) information on the batches of medicine involved;

    (b) recall plan and procedure, including the disposal of the recalled medicines;

    (c) distribution list; and

    (d) a report of the investigation, before and after the recall.

13. Recall of medicines by Authority

    (1) Where the Authority recalls medicines, the Authority shall inform the—

    (a) public of the procedure to be followed through all possible communication media; and

    (b) marketing authorisation holder in writing, of its decision, stating the reasons.

    (2) The marketing authorisation holder shall be responsible for the disposal of the medicines.

14. Withdrawal of marketing authorisation

    (1) A marketing authorisation holder who wishes to withdraw his or her medicines from the market shall provide the Authority with—

    (a) information on the decision to withdraw;

    (b) the effective date of withdrawal;

    (c) reasons for withdrawal; and

    (d) the plan of communication to prescribers and dispensers.

    (2) The Authority shall update the register to indicate the withdrawal.

15. Suspension or revocation of marketing authorisation

    (1) Where the Authority suspends or revokes marketing authorisation for reasons including—

    (a) failure to report adverse reactions to the Authority;

    (b) failure to meet safety, quality, efficacy requirements; or

    (c) implementing variations without approval of the Authority,

the Authority shall communicate to the marketing authorisation holder in writing, the decision to suspend or revoke the market authorisation.

    (2) In the case of a suspension or revocation, the Authority shall, within seven days of taking the decision, communicate to the marketing authorisation holder, conditions of the suspension, the duration and the action the marketing authorisation holder has to take.

    (3) In the case of a revocation, the marketing authorisation holder shall be required to recall his or her medicines from the market in line with the guidelines.

    (4) The Authority shall notify the public of the decision to suspend or revoke the market authorisation.

PART III
Licensing (regs 16-24)

16. Licensing of pharmaceutical operations

    (1) An application for licensing of pharmaceutical operations shall be submitted to the Authority, in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.

    (2) The Authority may, having considered the application, grant the applicant a licence in Form 9 set out in Schedule 4 and the Authority may attach conditions thereto as it may consider necessary.

    (3) The Authority shall inform an unsuccessful applicant in writing, of the decision not to licence the premises and the reasons, in line with the guidelines.

    (4) Where premises are licensed, the premises shall be under the supervision of a qualified person in line with the guidelines.

    (5) Subject to subregulation (4), any change in the person who supervises the premises shall be communicated to the Authority within 30 days.

    (6) The Authority shall keep a database of all licenced manufacturing facilities, pharmacies and pharmaceutical wholesalers.

17. Licensing of manufacturing facility

    (1) An applicant may apply to the Authority for a licence to manufacture medicine in Form 8 set out in Schedule 4 accompanied by an application fee set out in Schedule 5.

    (2) The Authority shall grant a licence in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines.

18. Licensing of pharmacy

    (1) An application for a licence to operate a pharmacy shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

    (2) The Authority shall grant a licence in Form 9 set out in Schedule 4 subject to the submission of all the required documents according to the guidelines.

19. Licensing of pharmaceutical wholesaler

    (1) An application for a licence to operate a pharmaceutical wholesaler shall be made to the Authority in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

    (2) The Authority shall issue a licence in Form 9 set out in Schedule 4, subject to submission of all the required documents according to the guidelines.

20. Licensing of pharmacies within a group practice

    (1) An applicant may apply to the Authority for a licence to operate a pharmacy within a group practice in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

    (2) Subject to subregulation (1), the licence may be under that of a hospital or a pharmacy where the pharmacy services are outsourced.

    (3) The Authority shall issue a licence in Form 9 set out in Schedule 4, subject to submission of a licence or provisional licence of a hospital or a group practice.

21. Licensing of dispensaries in surgeries and institutional dispensaries

    (1) An applicant shall apply to the Authority for a licence to operate dispensaries in surgeries and institutional dispensaries in Form 8 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

    (2) Where the institutions are required to be licensed by other authorities, the Authority shall issue a licence in Form 9 set out in Schedule 4 subject to submission of a licence or provisional licence of a surgery or an institution.

    (3) In its assessment of the application, the Authority shall take into account the scope of practice of the institution in granting the licence.

    (4) The Authority shall issue a licence, subject to submission of a licence or provisional licence of a surgery or institution.

22. Variation of licence

    (1) A licence holder shall apply to the Authority for variation of his or her licence.

    (2) The application for variation shall be in Form 8 set out in Schedule 4 accompanied by a fee set out in Schedule 5.

    (3) The Authority may approve the amendments and where the Authority does not approve, it shall inform the unsuccessful applicant in writing, stating the reasons for the decision.

23. Suspension or withdrawal of licence

    (1) Where the licence holder does not meet the required standards and guidelines, the Authority may suspend or withdraw the licence.

    (2) The Authority shall notify the licence holder of the decision and may indicate the actions to be taken by the licence holder and give the licence holder seven days to respond.

    (3) The facility shall be closed for the duration of the suspension.

    (4) Where a licence is withdrawn the facility shall cease to operate.

24. Renewal of licence

    (1) An application for renewal of a licence made under these Regulations shall be made at least three months before expiry of the licence.

    (2) The application shall be in Form 8 set out in Schedule 4 and shall be in accordance with the guidelines.

    (3) The application shall be accompanied by a fee set out in Schedule 5.

PART IV
Record Keeping and Import of Medicines (regs 25-54)

25. Record keeping

    (1) A person dealing with the manufacture, import, export, storage, distribution, promotion, advertising and dispensing of medicines shall, according to his or her scope of operation, keep a record as outlined in the guidelines.

    (2) The Authority may at any time in writing, order a person dealing with the manufacture, import, export, storage, distribution, promotion, advertising and dispensing of medicines to produce the record for inspection.

    (3) An inspector may at all reasonable times inspect the records.

26. Import of medicines

    (1) A person shall apply to the Authority for a permit to import medicines, medical products or cosmetics other than narcotics, psychotropics and precursor chemicals in Form 10 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

    (2) An application for an import permit shall be accompanied by authorisation from a market authorisation holder to import medicines to Botswana in line with the guidelines.

    (3) Subject to subsection (1), the Authority shall issue an import permit in Form 11 set out in Schedule 4 and in line with the guidelines.

    (4) Upon assessment the Authority may authorise an entity not licensed as a wholesaler to import medicines, medical products or cosmetics upon payment of a fee set out in Schedule 5.

    (5) Subject to subregulation (1), a person may apply for a permit to import medicines, medical products or cosmetics that have been exempted from registration in line with the guidelines.

    (6) All purchasing orders shall be vetted and authorised by the Authority.

    (7) A person authorised to import medicine shall pay a fee as set out in Schedule 5 for each consignment in line with the guidelines.

    (8) A wholesaler shall notify the Authority and submit an acknowledgment in line with the guidelines, upon receipt of medicines.

27. Parallel import of medicines

An applicant shall apply to the Authority in Form 11 set out in Schedule 4 for parallel import of medicines—

    (a) in the manner outlined in the guidelines;

    (b) accompanied by a fee set out in Schedule 5; and

    (c) the importer shall provide the authorisation from the Ministry responsible for trade.

28. Import of samples for registration

A person shall apply to the Authority for approval to import samples in Form 10 set out in Schedule 4.

29. Post-market surveillance

    (1) A prescriber, pharmacist and a health care professional shall report any safety, quality and efficacy issues to the Authority and to the marketing authorisation holder in line with the guidelines.

    (2) The Authority shall from time to time conduct risk based inspections of pharmaceutical operations and take samples of medicines, medical products or cosmetics on the market for testing and investigation to establish the quality, safety and efficacy in Form 12 set out in Schedule 4.

    (3) The Authority shall, where a sample fails to meet the relevant specifications—

    (a) issue the marketing authorisation holder or importer with a written warning and up to a maximum of 30 days to identify the source or cause of the quality defect and any action to be taken to improve quality; or

    (b) where the failure warrants a recall of the medicines, medical products or cosmetics as set out in the guidelines, the Authority shall order the marketing authorisation holder or importer to recall the medicine, medical product or cosmetic.

    (4) The marketing authorisation holder shall remove from the market and dispose at his or her cost, medicines, medical products or cosmetics that do not meet the required standards which disposals shall be in accordance with regulation 34.

    (5) The marketing authorisation holder shall keep records of the recall and disposal of the medicines, medical products or cosmetic and he or she shall submit a copy of the records to the Authority.

    (6) A person licensed to operate a pharmaceutical operation shall report any suspected problems, regarding the quality, safety or efficacy of the medicines to the Authority.

    (7) A marketing authorisation holder or importer shall carry out investigation to identify the root cause of the problem and develop a risk management plan to prevent recurrence including a comprehensive review of the manufacturing process.

    (8) The Authority shall assess the report of the investigation and risk management plan where a marketing authorisation was earlier suspended, before it can lift the suspension.

    (9) The Authority may investigate and decide on an appropriate action to be taken by either the Authority or the marketing authorisation holder, where any problem is suspected.

    (10) The Authority, the marketing authorisation holder or importer and the manufacturer shall keep the public informed about the findings and any relevant information about the medicines, medical products and cosmetics within a specified time according to the guidelines.

    (11) The marketing authorisation holder or importer shall in accordance with the guidelines, provide a post market surveillance plan for his or her medicine and report to the Authority, any findings from an accredited quality control laboratory.

    (12) All testing shall be done in accredited quality control laboratories.

30. Adverse medicine reactions

    (1) The Board shall appoint a committee to deal with adverse medicines, medical products or cosmetics reactions and to review reports of suspected medicine reactions.

    (2) A marketing authorisation holder of medicines, medical products or cosmetics shall report to the Authority any adverse reactions in line with the guidelines.

    (3) The marketing authorisation holder shall ensure all labels and package inserts are amended to include any new adverse reactions, warning, including precautions within such period as may be determined by the Authority.

    (4) A prescriber, pharmacist or a health care professional shall report to the Authority any adverse reactions in accordance with the guidelines.

31. Counterfeit medicines

    (1) An importer, exporter, marketing authorisation holder, manufacturer, distributor, dispenser, and promoter of medicines, medical products or cosmetics shall have in place, risk management plans to prevent circulation of counterfeit medicines.

    (2) The plans under subregulation (1) shall include the following measures—

    (a) to prevent counterfeit medicines, medical products or cosmetics from entering Botswana;

    (b) to prevent the sale and use of counterfeit medicines, medical products or cosmetics;

    (c) to address counterfeit medicines, medical products or cosmetics once detected on the market; and

    (d) to regularly review risk management plans.

    (3) The Authority shall publish the information on circulating counterfeit medicines, medical products or cosmetics as and when the need arises.

32. Medicines in transit

    (1) Any person transiting medicines, medical products or cosmetics through Botswana shall apply to the Authority for a transit permit in line with the guidelines by completing Form 13 set out in Schedule 4 and accompanied by a fee set out in Schedule 5.

    (2) The Authority shall issue a transit permit in Form 14 set out in Schedule 4.

    (3) The importer of medicines shall ensure that medicines, medical products or cosmetics in a bonded warehouse comply with requirements for transit as set out in the guidelines.

    (4) The importer of medicines shall keep records for the medicines, medical products or cosmetics at the bonded warehouse which records shall be open for inspection by the Authority and other relevant authorities.

33. Designation of ports

    (1) The Authority shall recommend designation of ports of import and export to the Minister.

    (2) The Authority shall review the list of designated ports from time to time.

34. Disposal of unwanted medicines

    (1) A person who disposes of medicines shall follow the guidelines and keep disposal certificates issued by the relevant authorities, for the Authority’s inspection.

    (2) The destruction of any Schedule 1A, Schedule 1B, Schedule 1C medicines or precursors, in part or whole, shall be reported to the Authority in accordance with the guidelines and, except where the destruction is accidental, the destruction shall be supervised by a pharmacist and witnessed by a police officer.

    (3) A person shall dispose of unused medicines in a clinical trial in line with the guidelines.

    (4) The Authority may in special circumstances authorise the export of medicines, medical products or cosmetics that do not meet specifications for disposal in line with the guidelines.

35. Classification and description of medicines

    (1) The Authority shall carry out a risk based review of the classification of medicines in consultation with the relevant stakeholders.

    (2) For purposes of the Act and these Regulations, medicines shall be classified in accordance with the lists set out in Schedule 1 and the lists shall be published in the Gazette.

36. Prescription of medicines

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

    (2) The Minister shall draw guidelines on dispensing and prescription of medicines in terms of section 38(3) and section 39(2) of the Act.

    (3) In granting limited powers of prescription of Schedules 1, 2, 3 and 4 medicines under section 39(2) of the Act, the Minister 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 medicines specific to their speciality or training and, where applicable, which are specified for them in the Botswana National Medicines Formulary;

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

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

    (d) registered pharmacists, power to prescribe Schedules 1 and 2 medicines only in the circumstances referred to in regulations 38, 40 and 41;

    (e) optometrists and chiropractors limited prescribing powers according to their scope of practice;

    (f) pharmacists to prescribe Schedule 3 medicines; and

    (g) nurses to give repeat prescriptions for Schedules 1, 2 and 3 medicines for palliative care at hospitals, hospices and at home-based care.

37. Contents of prescriptions

    (1) A valid prescription shall contain the following information—

    (a) particulars of the patient including name, age and gender;

    (b) name of the medicine, dosage form, dosage strength, directions for use, duration of treatment or quantity;

    (c) name, signature and address of prescriber;

    (d) date of prescription; and

    (e) the facility stamp.

    (2) For Schedules 1A, 1B and 1C medicines the quantity shall be written in words and figures.

    (3) A prescriber shall keep a copy of each prescription issued by him or her for a period of one year.

38. Emergency administration

    (1) An emergency medical services provider may under emergency situations administer Schedules 1, 2 and 3 medicines without a written prescription.

    (2) Subject to subregulation (1), in administering such medicines, the emergency medical services provider shall follow his or her scope of practice as determined by the Botswana Health Professions’ Council.

    (3) For medicines which are not within his or her scope, the emergency medical service provider may administer with medical direction and he or she shall keep registers and records of the medicine administered.

39. General dispensing

    (1) A person shall not dispense medicine of a quantity greater than the amount and the stated duration of treatment in the prescription.

    (2) A person dispensing medicine shall endorse on the prescription the date when the medicine is dispensed, the quantity dispensed, and he or she shall append his or her signature thereto.

    (3) A repeat prescription may be dispensed for a maximum of six times from the date of issue.

40. Dispensing of Schedules 1A, 1B and 1C medicines

    (1) Schedules 1A, 1B and 1C medicines may only be dispensed by a pharmacist upon a written prescription by a medical practitioner or dentist, presented for dispensing within 30 days of the date of its issue, and for the supply of a quantity not greater than the quantity indicated on the prescription, which shall not exceed 30 days’ supply.

    (2) The prescription shall be retained in the pharmacy for a period of five years after the date it was dispensed.

    (3) The dispenser of Schedules 1A, 1B and 1C medicine shall enter a record of such dispensing and the register shall be kept for a period of five years after the last entry.

    (4) Separate registers shall be kept for Schedules 1A, 1B and 1C medicines.

    (5) Except when being administered to a patient, every Schedules 1A, 1B and 1C medicines shall be kept under safe custody in a lockable cabinet or in a safe securely fixed in terms of regulation 48(2).

41. Emergency dispensing of Schedules 1A, 1B and 1C medicines

    (1) Emergency dispensing of Schedules 1A, 1B and 1C medicines may be done where—

    (a) there is a repeat prescription for a patient known by both the prescriber and pharmacist;

    (b) the pharmacist has contacted the prescriber and the prescriber is confirmed as being a medical practitioner or dentist; and

    (c) the pharmacist is satisfied that it is impossible or impracticable to obtain a written prescription.

    (2) The prescription may be made by telephone, email or facsimile, in quantities not exceeding those stated in regulation 40(1), on condition that a written prescription shall be provided within 48 hours.

42. Dispensing of Schedule 2 medicines

Schedule 2 medicines may be dispensed in-—

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

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

    (c) a Government clinic, by a pharmacy technician under the supervision of a pharmacist upon a written prescription issued by an authorised prescriber; or

    (d) a private health facility by an authorised dispenser.

43. Dispensing of Schedules 1D and 3 medicines

Schedules 1D and 3 medicines shall only be dispensed by a pharmacist or any authorised dispenser upon a prescription.

44. Emergency supply of medicines by pharmacist

    (1) Notwithstanding regulation 42, in an emergency Schedule 2 medicines may be supplied or dispensed without a prescription by a pharmacist, where—

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

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

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

Provided that—

    (a) where the medicine 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 a place of supply, the dispenser may supply the smallest pack available;

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

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

45. Storage of medicines by prescribers

    (1) A prescriber may, in line with the guidelines store some medicines to administer to his or her patients.

    (2) Subject to subregulation (1), the type and quantities of the medicines administered shall be determined by the scope of the prescriber’s practice and the prescriber shall fulfil other requirements set out in the guidelines.

46. Dispensing of medicines by healthcare providers other than pharmacists

    (1) A healthcare provider shall apply to the Director of Health Services for an approval to dispense medicines.

    (2) An approval shall be given to a medical practitioner, dentist, pharmacy technician and any other health personnel on condition that he or she has competency in dispensing medicines.

    (3) A dispensary, clinic, health post and mobile clinic shall meet the standards set out in the guidelines.

47. Sale and use of precursor chemicals

    (1) Precursor chemicals at Schedule 2 of these Regulations shall be sold by authorised dealers.

    (2) The use of the precursor chemicals that require import permits shall be authorised by the Authority.

    (3) Registers of the sale and use of chemicals shall be maintained by the authorised dealers and the register shall capture information as determined by the Authority.

48. Storage of medicines

    (1) Medicines shall be stored in secure, well ventilated rooms, with adequate lighting and controlled temperatures.

    (2) Schedule 1 medicines shall be kept in bolted locked steel cabinets or rooms with controlled access.

    (3) The storage facilities shall be protected from pests, harsh weather and shall meet building codes.

    (4) The guidelines relating to the storage of medicines shall be updated as the Authority determines.

49. Product information

    (1) Any product information shall be provided in line with the guidelines.

    (2) The container of every medicine 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 medicine as used in official pharmacopoeias or formularies, or the international non-proprietary name;

    (b) the brand name, if any;

    (c) the contents of the container;

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

    (e) the name of the manufacturer or applicant;

    (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 terms of subregulation (6);

    (l) any conditions of registration stipulated by the Authority during registration; and

    (m) manufacture date.

    (3) In any special circumstances the Authority may exempt any particular consignment of medicines from the requirements of subregulation (1).

    (4) The container of every medicine dispensed to a patient shall have a label bearing the following information—

    (a) full name of the patient;

    (b) date of dispensing;

    (c) pack size;

    (d) name and signature of the dispenser; and

    (e) all information required for the purposes of subregulation (1).

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

    (6) The containers of pre-packed medicines shall bear the label with the following—

    (a) name, strength and quantity of the medicine;

    (b) batch number;

    (c) date of manufacture;

    (d) expiry date; and

    (e) manufacturer.

    (7) If the medicine contains any ingredient that is known to cause any allergic reaction, there shall be a warning to that effect.

    (8) For medicines which require caution, such medicine shall bear a label giving information and instructions in accordance with the following—

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.”

        The label shall include name of the applicant, Botswana registration number and the Schedule.

        (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 shall 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 shall 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 shall be used on pharmacy medicines (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.

50. Import and export of narcotics, psychotropics and precursor chemicals

    (1) An application for import of narcotics, psychotropics and precursor chemicals shall be made to the Authority by a pharmacist in Form 15 set out in Schedule 4 accompanied by a fee set out in Schedule 5.

    (2) Upon assessment the Authority shall issue an import permit in Form 16 set out in Schedule 4, to the applicant, which permit shall be valid for six months.

    (3) After receipt of the medicines the pharmacist shall notify the Authority and submit an acknowledgment in Form 17 set out in Schedule 4 and a copy of export permit from the relevant country, within seven days.

    (4) An application for export of narcotics, psychotropics and precursor chemicals shall be made by a pharmacist in Form 15 set out in Schedule 4 accompanied by a fee set out in Schedule 5.

    (5) The Authority shall issue an export permit in Form 18 set out in Schedule 4, valid for six months prior to exportation of the medicines.

    (6) After dispatch of the medicines, the pharmacist shall notify the Authority and submit an acknowledgment in Form 17 set out in Schedule 4 within seven days.

51. Records for narcotics, psychotropics and precursor chemicals

    (1) Separate registers shall be kept for Schedules 1A, 1B, 1C medicines and precursor chemicals.

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

    (a) quantities received, issued, spoiled, disposed of and the balance of the medicine concerned;

    (b) name and business address of the supplier;

    (c) date on which the medicine was received;

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

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

    (f) name and business address of the purchaser;

    (g) date of sale of the medicine; and

    (h) invoice or reference number of such sale.

    (3) Registers kept by the dispenser of medicines under subregulation (1) shall contain the following information where appropriate, the—

    (a) quantities received, issued, spoiled, disposed of and the balance of the medicines concerned;

    (b) name and business address of the supplier;

    (c) date on which the medicine was received;

    (d) name and address of the patient to whom the medicine was dispensed;

    (e) prescription number or reference number upon which the medicine was dispensed;

    (f) date of such dispensing; and

    (g) name and address of the prescriber.

    (4) All invoices for the purchase or supply of Schedules 1A, 1B, 1C medicines or precursor chemicals shall be kept for a minimum of five years.

    (5) All registers or records required to be kept under this regulation shall 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 within seven days.

    (7) A register shall be a bound book with serially numbered pages.

    (8) A register shall not transferable without the Authority’s approval.

52. Correction of records

    (1) A person who keeps a register under the Act shall make corrections to the register by drawing a line through the entry being corrected and shall insert his or her initials on the corrected entry.

    (2) A correction to a register shall not be marked or done with correction fluid and there shall be no overwriting.

53. Advertising and promotion

    (1) A market authorisation holder shall submit advertising and promotional materials to the Authority for approval before use.

    (2) The Authority shall assess advertising and promotional materials according to set guidelines and issue a written approval to the market authorisation holder.

    (3) Schedules 1, 2 and 3 medicines shall not be advertised directly to the public.

    (4) Subject to subregulation (3), only registered medicines may be advertised or promoted.

    (5) Medicines may be advertised to the professionals or in professional journals and publications.

    (6) Schedule 4 medicines may be advertised to the public.

    (7) Any advertising shall not mislead, compare medicines from other manufacturers and shall not include illustrations or pictures which may offend.

    (8) The adverts shall not contain promises that have not been scientifically proven and shall not make reference to symptoms in a manner likely to mislead the public.

54. Inspection of premises

    (1) The Authority shall ensure all premises are inspected to assess compliance to set guidelines.

    (2) An inspector shall present proof of authorisation and identification to the pharmaceutical operator before the inspection under subregulation (1) is carried out.

    (3) The inspections shall be done at all reasonable times and where samples are collected during inspections, the inspectors shall provide the pharmaceutical operator with a list of samples taken in Form 24 set out in Schedule 4.

    (4) The form under subregulation (3) shall be signed by both the inspector and the person in authority of the inspected premises.

    (5) Where an inspector seizes medicines in terms of section 47(3) of the Act, he or she shall complete Form 24 set out in Schedule 4.

PART V
Control of Clinical Trials (regs 55-59)

55. Application for use of medicines for clinical trials

    (1) The applicant shall apply to the Authority in Form 19 set out in Schedule 4 accompanied by a fee set out in Schedule 5.

    (2) The Authority shall issue an applicant a written approval for use of medicines regulated under the Act.

    (3) The Authority shall keep registers of—

    (a) medicines and sites approved for clinical trials; and

    (b) all authorised and rejected clinical trials.

    (4) The clinical trials shall be conducted according to the set standards and guidelines.

    (5) All applications for clinical trials shall be registered with a World Health Organisation recognised clinical trials registry.

    (6) A detailed report on the results of the clinical trial shall be submitted to the Authority at the completion of the trial.

56. Monitoring of clinical trial

The reporting of adverse events in clinical trials shall be in line with set guidelines and shall meet international standards.

57. Inspection and audit of clinical trials

The Authority shall inspect clinical trial sites for readiness and compliance with good clinical practices.

58. Suspension or termination of approval to conduct clinical trials

    (1) The Authority may suspend or terminate an approval to conduct clinical trials where the Authority determines that the use of the medicines under trial is not safe or the anticipated benefits cannot be realised.

    (2) The trials may also be suspended or terminated if the conduct is not according to the approval issued under these Regulations.

59. Disposal of unused medicines in clinical trials

A person who disposes of unused medicines in a clinical trial shall notify the Authority in terms of regulation 34.

PART VI
Cosmetics (regs 60-65)

60. Registration of cosmetics

    (1) A person shall apply to the Authority for registration of cosmetics in Form 20 Part A set out in Schedule 4 and accompanied by a—

    (a) payment of a fee in Schedule 5; and

    (b) sample as described in the guidelines.

    (2) The registration procedure for cosmetics shall be as outlined in the guidelines.

    (3) The Authority shall, upon assessment issue an approval in Form 23 set out in Schedule 4 and in line with the guidelines.

    (4) The Authority shall collaborate with other institutions and authorities in any harmonisation and collaborative activities in order to benchmark and facilitate developments of requirements and guidelines for efficient operations and prudent use of cosmetics.

    (5) An approval issued in terms of subregulation (3) shall be valid for five years subject to annual submission of information accompanied by the annual fee in Schedule 5.

    (6) Any cosmetic product awarded marketing authorisation shall maintain information regarding safety, manufacturing and any other necessary information as detailed in the guidelines and shall be accessible to the Authority.

    (7) Regulations 5, 6, 7, 10, 11, 12, 13, 14 and 15 shall apply with the necessary modifications.

61. Exemption for registration of cosmetics

    (1) An applicant may apply in Form 20 Part B set out in Schedule 4 upon payment of a fee set out in Schedule 5 to the Authority to exempt the registration of cosmetics from outside Botswana under special circumstances.

    (2) The Authority may, after having considered the application and the supporting documents, grant the exemption in line with the guidelines.

62. Publication of list of prohibited ingredients

The Authority shall determine and publish a list of prohibited ingredients according to the guidelines.

63. Labelling of cosmetics

The container for cosmetics shall be labelled in English with the following information—

    (a) the name of the product;

    (b) list of ingredients;

    (c) manufacturer’s details;

    (d) shelf life, expiry date or period of use after opening;

    (e) batch identification;

    (f) storage conditions;

    (g) directions for use; and

    (h) any warnings or precautions.

64. Licensing of manufacturing cosmetics

A person shall apply to the Authority for a manufacturing licence of cosmetics in Form 8 set out in Schedule 4 accompanied by a fee set out in Schedule 5.

65. Import of cosmetics

    (1) A person shall apply to the Authority to import cosmetics in Form 10 set out in Schedule 4 accompanied by a fee set out in Schedule 5.

    (2) Upon assessment the Authority shall issue an import permit in Form 11 set out in Schedule 4 and in line with the guidelines.

    (3) Only registered or exempted cosmetics may be imported.

    (4) The marketing authorisation holder shall submit advertising and promotional materials to the Authority for authorisation before use.

    (5) The Authority shall assess advertising and promotional materials according to set guidelines and issue a written authorisation to the marketing authorisation holder.

    (6) A person authorised to import cosmetics shall pay a fee set out in Schedule 5 for each consignment in line with the guidelines.

PART VII
Complementary Medicines (regs 66-67)

66. Registration of complementary medicines

    (1) An application for registration of complementary medicines shall be submitted in Form 21 set out in Schedule 4 and accompanied by—

    (a) an application fee set out in Schedule 5; and

    (b) a sample as described in the guidelines.

    (2) The Authority shall specify conditions for registration for a particular complementary medicine and may—

    (c) amend any conditions for registration;

    (b) specify product labelling requirement; or

    (c) determine what is to be described in the labels or packages of complementary medicines.

    (3) Scientific evidence of safety and efficacy data shall be required for the registration of any therapeutic claim.

    (4) Where an application to register a complementary medicine is successful, the Authority shall issue a written approval for registration to the applicant in Form 22 set out in Schedule 4.

    (5) Where an application to register complementary medicines is unsuccessful, the Authority shall inform the applicant in writing stating the reason for the decision not to register the medicine.

    (6) No application for a complementary medicine shall be made to the Authority for an injectable and eye preparations.

    (7) The container for complementary medicines shall be labelled in English with the following information—

    (a) the botanical or INN name of the product;

    (b) the brand name of the product;

    (c) list of ingredients;

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

    (e) name and address of manufacturers;

    (f) shelf life, expiry date;

    (g) batch identification;

    (h) storage conditions;

    (i) directions for use;

    (j) any warnings or precautions;

    (k) any contraindications;

    (l) manufacturing date; and

    (m) the statement that “there are no approved therapeutic claims”, where applicable.

    (8) The Authority shall review allowable indication and functional claims from time to time and shall publish the claims in the Gazette.

    (9) A person may apply to the Authority for the renewal of registration of complementary medicines in Form 4 set out in Schedule 4.

    (10) Regulations 5, 6, 7, 10, 11, 12, 13, 14 and 15 shall apply with the necessary modifications.

67. Validity period of registration of complementary medicines

An approval issued in terms of regulation 66 shall be valid for five years subject to annual submission of information accompanied by the annual fee in Schedule 5.

PART VIII
General (regs 68-72)

68. Harmonisation and collaborative activities of Authority

The Authority shall collaborate with other institutions and authorities in any harmonisation and collaborative activities in order to benchmark and facilitate developments of requirements and guidelines for efficient operations and prudent use of resources.

69. Appeals Committee

Any person aggrieved by the decision of the Authority may appeal to the Appeals Committee.

70. Banned medicines

The Minister shall, in consultation with the Authority publish a list of banned medicines in Schedule 3.

71. Offences and penalties

A person who—

    (a) contravenes the provisions of these Regulations, for which no penalty is provided;

    (b) fails to comply with any direction given or request made by the Authority or any competent authority under these Regulations; or

    (c) fails to comply with any condition of a licence,

commits an offence and is liable to the penalties provided for under section 66 of the Act.

72. Revocation of Cap. 63:04 (Sub. Leg.)

The Drugs and Related Substances Regulations are hereby revoked.

SCHEDULE 1

(regs. 35, 36, 37, 38, 40, 41 and 43)

 

SCHEDULE 1 MEDICINES

NO.

NAME OF THE MEDICINE

CATEGORY

1

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

1A

2

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

1A

3

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

1A

4

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

1A

5

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

1A

6

Acetorphine hydrochloride

1A

7

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

1A

8

Acetyl-methadol see Methadyl acetate

1A

9

Alfentanil

1A

10

Allylprodine; its salt

1A

11

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

1A

12

Alphameprodine; its salts

1A

13

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

1A

14

Alpha-methylphenethylamine see Amphetamine N-(2-(N-methylphenethylamino)propyl)propionanilide see Diampromide Methylphenidate; its salts

1A

15

Amidone see Methadone

1A

16

Amphetamine phosphate

1A

17

Amphetamine sulphat

1A

18

Amphetamine; its salts

1A

19

Anileridine; its salts

1A

20

Benzethidine; its salts

1A

21

Benzylmorphine hydrochloride

1A

22

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

1A

23

Betacetylmethadol; its salts

1A

24

Betameprodine; its salts

1A

25

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

1A

26

Betaminoisopropylbenzene see amphetamine

1A

27

Betaprodine; its salts

1A

28

Bezitramide; its salts

1A

29

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

1A

30

Clonitazene; its salts

1A

31

Codeine hydrochloride see Codeine

1A

32

Codeine phosphate see Codeine

1A

33

Codeine sulphate see Codeine

1A

34

Codoxime see Dihydrocodeinone O-carboxymethyloxime

1A

35

Delta-9-tetrahydrocannabinol see Dronabinol

1A

36

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

1A

37

Desoxyephedrine see Methylamphetamine

1A

38

Desoxynorephedrine see Amphetamine

1A

39

Dexamphetamine phosphate

1A

40

Dexamphetamine sulphate

1A

41

Dexamphetamine; its salts

1A

42

Dextrodiphenopyradine see Dextromoramide

1A

43

Dextromoramide tartrate

1A

44

Dextromoramide; its salts

1A

45

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)

1A

46

Diampromide; its salts

1A

47

Diethylthiambutene hydrochloride

1A

48

Diethylthiambutene; its salts

1A

49

Dihydrocodeine phosphate see dihydrocodeine

1A

50

Dihydrocodeine tartrate see dihydrocodeine

1A

51

Dihydrocodeinone enolacetate see Thebacon

1A

52

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

1A

53

Dihydrocodeinone see hydrocodone

1A

54

Dihydrodeoxymorphine see Desomorphine

1A

55

Dihydrohydroxycodeinone see Oxycodone

1A

56

Dihydrohydroxymorphinone see Oxymorphine

1A

57

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

1A

58

Dihydromorphinone see Hydromorphone

1A

59

Dimenoxadole; its salts

1A

60

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

1A

61

Dimethylthiambutene; its salts

1A

62

Dioxaphetyl butyrate; its salts

1A

63

Diphenoxylate hydrochloride see diphenoxylate

1A

64

Dipipanone hydrochloride

1A

65

Dipipanone; its salts

1A

66

Dronabinol

1A

67

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

1A

68

Ethylmethylthiambutene; its salts

1A

69

Ethylmorphine hydrochloride see Ethyl morphine

1A

70

Etonitazine; its salts

1A

71

Etorphine hydrochloride

1A

72

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

1A

73

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

1A

74

Fenethylline; its salts; its stereoisomers; their salts

1A

75

Furethidine; its salts

1A

76

Glutethimide; its salts; its stereoisomers; their salts

1A

77

Hebaine; its salts

1A

78

Hexobarbitone sodium

1A

79

Hydrocodone bitartrate

1A

80

Hydrocodone; its salts

1A

81

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

1A

82

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

1A

83

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

1A

84

Isomethadone

1A

85

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

1A

86

Levamfetamine

1A

87

Levomethamphetamine

1A

88

Levomethorphane; its salts

1A

89

Levomoramide; its salts

1A

90

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

1A

91

Levorphanol tartrate

1A

92

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

1A

93

Mecloqualone

1A

94

Mephentermine sulphate

1A

95

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

1A

96

Methadone hydrochloride

1A

97

Methadone; its salts

1A

98

Methadyl acetate; its salts

1A

99

Methamphetamine see Methylamphetamine

1A

100

Methylamphetamine hydrochloride

1A

101

Methylamphetamine; its salts

1A

102

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

1A

103

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

1A

104

Methyldihydromorphinone see Metopon

1A

105

Methylphenidate hydrochloride

1A

106

Methylphenidate; its salts

1A

107

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

1A

108

Morpheridine; its salts

1A

109

Morphine acetate see Morphine

1A

110

Morphine hydrochloride see Morphine

1A

111

Morphine methobromide; its esters and ethers

1A

112

Morphine sulphate see Morphine

1A

113

Morphine tartrate see Morphine

1A

114

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

1A

115

Morphine-N-oxide; its esters and ethers

1A

116

Morpholinoethylnorpethidine see Morpheridine

1A

117

Myrophine; its salts

1A

118

Nicomorphine; its salts

1A

119

Noracymethadol; its salts

1A

120

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

1A

121

Normethadone; its salts

1A

122

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

1A

123

Norpipanone; its salts

1A

124

Opium, medicinal

1A

125

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

1A

126

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

1A

127

Papaveretum see Opium, medicinal

1A

128

Pethidine hydrochloride

1A

129

Pethidine; its salts

1A

130

Phenadone see Methadone

1A

131

Phenadoxone; its salts

1A

132

Phenampromide; its salts

1A

133

Phenazocine hydrobromide

1A

134

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

1A

135

Phendimetrazine tartrate

1A

136

Phendimetrazine; its salts

1A

137

Phenmetrazine hydrochloride

1A

138

Phenmetrazine theoclate

1A

139

Phenmetrazine; its salts

1A

140

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

1A

141

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

1A

142

Pholcodine citrate see Pholcodine

1A

143

Pholcodine tartrate see Pholcodine

1A

144

Piritramide; its salts

1A

145

Potassium clorazepate

1A

146

Prazepam

1A

147

Proheptazine; its salts

1A

148

Properidine; its salts

1A

149

Quinalbarbitone

1A

150

Quinalbarbitone sodium

1A

151

Racemethorphan; its salts

1A

152

Racemoramide; its salts

1A

153

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

1A

154

Secobarbitone see Quinalbarbitone

1A

155

Temazepam

1A

156

Thebacon; its salts

1A

157

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

1A

158

Trimeperidine; its salts

1A

159

Amferpramone

1B

160

Amylobarbitone

1B

161

Amylobarbitone sodium

1B

162

Benzphetamine; its salts

1B

163

Bezphetamine hydrochloride

1B

164

Buprenorphine

1B

165

Buprenorphine hydrochloride

1B

166

Butalbital

1B

167

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

1B

168

Chlorphentamine hydrochloride

1B

169

Chlorphentamine; its salts

1B

170

Cyclobarbitone

1B

171

Diethylpropion hydrochloride

1B

172

Lefetamine(SPA)

1B

173

Mazindol

1B

174

Mefenorex; its salts; its stereoisomers; their salts

1B

175

Meperedine see Pethidine

1B

176

Mephentermine; its salts

1B

177

Pemoline

1B

178

Pentazocine hydrochloride

1B

179

Pentazocine lactate

1B

180

Pentobarbitone

1B

181

Pentobarbitone sodium

1B

182

Phentermine

1B

183

Phenylmethylbarbituric acid

1B

184

Pinazepam

1B

185

Pipradrol hydrochloride

1B

186

Pipradrol; its salts

1B

187

Allobarbital

1C

188

Barbitone

1C

189

Barbitone sodium

1C

190

Bromazepam

1C

191

Butobarbitone

1C

192

Butobarbitone sodium

1C

193

Camazepam

1C

194

Chlordiazepoxide

1C

195

Chlordiazepoxide hydrochloride

1C

196

Clobazam

1C

197

Clonazepam

1C

198

Clorazepate

1C

199

Clotiazepam

1C

200

Cloxazolam

1C

201

Delorazepam

1C

202

Diazepam

1C

203

Estozolam

1C

204

Ethchlorvyno

1C

205

Ethinimate

1C

206

Ethyl loflazepate

1C

207

Fencamfamin; its salts; its stereoisomers; their salts

1C

208

Fentanyl; its salts

1C

209

Fludiazepam

1C

210

Flunitrazepam

1C

211

Flurazepam hydrochloride; its salts

1C

212

Flurazepam monohydrochloride

1C

213

Halazepam

1C

214

Haloxazolam

1C

215

Heptabarbitone

1C

216

Hexobarbitone

1C

217

Ketazolam

1C

218

Loprazolam mesylate

1C

219

Lorazepam

1C

220

Lormetazepa

1C

221

Medazepam

1C

222

Meprobamate

1C

223

Methylphenobarbitone

1C

224

Methyprylone

1C

225

Midazolam

1C

226

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

1C

227

Nimetazepam

1C

228

Nitrazepam

1C

229

Nordazepam

1C

230

Oxazepam

1C

231

Oxazolam

1C

232

Phenobarbitone

1C

233

Phenobarbitone sodium

1C

234

Piminodine; its salts

1C

235

Propylhexedrine; its salts; its stereoisomers; their salts

1C

236

Pyrovalerone; its salts; its stereoisomers; their salts

1C

237

Secbutobarbitone

1C

238

Secbutobarbitone sodium

1C

239

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

1C

240

Triazolam

1C

241

Vinylbital

1C

242

Codeine; its salts 1(A)
but if for non-parenteral use and in undivided preparations with ms 1.5% (calculated as base: and not more than 200ml: Schedule 3)

1C

243

Acetyldihydrocodeine; its salts 1(A)
but if for non-parenteral use and:
(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)
(b) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)

1D

244

Codeine; its salts 1(A)
but if for non-parenteral use and:
(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)
(b) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)
(c) 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)

1D

245

Difenoxin (1-(3-cyano-33-diphenyl-propyl)-4-phenylpiperidine4-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

246

Dihydrocodeine; its salts 1A
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 md 10mg (calculated as base: Schedule 3)
(c) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)
(d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 10mg (calculated as base: Schedule 3)

1D

247

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

248

Ethylmorphine; its salts
but if for non-parenteral use and:
(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)
(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2

1D

249

Nicocodine; its salts
but if for non-parenteral use and:
(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)
(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)
Nicodicodine; its salts
but if for non-parenteral use and:
(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)
(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)

1D

1D

1D

1D

250

Norcodeine; its salts
but if for non-parenteral use and:
(a) in undivided preparations with ms 2.5% (calculated as base: Schedule 2)
(b) in single dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)

1D

251

Pholcodine; its salts 1A
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 md 20mg (calculated as base: Schedule 3)
(c) in single-dose preparations with ms per dosage unit 100mg (calculated as base: Schedule 2)
(d) in single-dose preparations with ms per dosage unit 1.5% (calculated as base) and md 20mg (calculated as base: Schedule 3)

1D

252

Propiram; its salts 1A
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

 

(2) SCHEDULE 2 MEDICINES

NO.

NAME OF THE MEDICINE

1

Alfacalcidol (1 alpha hydroxycalceferol)

2

Roxarsone (4-hydroxy-3 nitrophenyl arsonic acid)

3

Abacavir

4

Acebutolol

5

Acepromazine

6

Acepromazine maleate

7

Acetanilide

8

Acetarsol

9

Acetazolamide

10

Acetazolamide sodium

11

Acetohexamide

12

Acetylcarbromal

13

Acetylcholine chloride

14

Acetylcysteine

15

Acetyldigitoxin

16

Acetylstrophanthidin

17

Acetylsulphafurazole

18

Acetylsulphamethoxypyridazine

19

Aconite

20

Acrosoxacin

21

Actinomycin C

22

Actinomycin D

23

Acyclovir (except topical preparation Schedule 3)

24

Adicillin

25

Adiphenine hydrochloride

26

Adrenaline

27

Adrenaline acid tartrate

28

Adrenaline hydrochloride

29

Albumin human (immuno)

30

Alclofenac

31

Alclometasone diproprionate

32

Alcuronium chloride

33

Aldosterone

34

Alendronate

35

Alfacalcidol

36

Alfuzosin

37

Algestone acetonide

38

Algestone acetophenide

39

Alkomide

40

Allyloestrenol

41

Alphadolone acetate

42

Alphaxalone

43

Alprazolam

44

Alprenolol

45

Alprenolol hydrochloride

46

Alprostadil

47

Alseroxylon

48

Altizide

49

Amantadine

50

Ambenonium chloride

51

Ambuside

52

Ambutonium bromide

53

Amcinonide

54

Ametazole hydrochloride

55

Amidopyridone

56

Amikacin sulphate

57

Amiloride

58

Aminocaproic acid

59

Aminodarone hydrochloride

60

Aminoglutethemide

61

Aminophylline

62

Aminopterin sodium

63

Aminosalicylic acid

64

Amiodarone

65

Amiphenazole hydrochloride

66

Amitriptyline

67

Amitriptyline embonate

68

Amitriptyline hydrochloride

69

Amlodipine

70

Ammonium bromide

71

Amodiaquine hydrochloride

72

Amoxapine

73

Amoxycillin

74

Amoxycillin trihydrate

75

Amphomycin

76

Amphotericin

77

Ampicillin

78

Ampicillin sodium

79

Ampicillin trihydrate

80

Amsacrine

81

Amylocaine hydrochloride

82

Anagrelide

83

Anastrozole

84

Ancrod

85

Androsterone

86

Angiotensin amide

87

Anterior pituitary extract

88

Antimony barium tartrate

89

Antimony dimercaptosuccinate

90

Antimony lithium thiomalate

91

Antimony pentasulphide

92

Antimony potassium tartrate

93

Antimony sodium tartrate

94

Antimony sodium thioglycollate

95

Antimony sulphate

96

Antimony trichloride

97

Antimony trioxide

98

Antimony trisulphide

99

Apiol

100

Apomorphine

101

Apomorphine hydrochloride

102

Apramycin

103

Apramycin sulphate

104

Aprotinin

105

Arecoline

106

Arecoline hydrobromide

107

Arecoline-acetarsol

108

Arsanilic acid

109

Arsphenamine

110

Atazanavir

111

Atenolol

112

Atorvastatin

113

Atracurium besylate

114

Azacyclonol

115

Azacyclonol hydrochloride

116

Azaperone

117

Azapropazone

118

Azathioprine

119

Azidocillin potassium

120

Azithromycin

121

Azothioprine

122

Azothioprine sodium

123

Bacampicillin hydrochloride

124

Bacitracin

125

Bacitracin methylene disalicylate

126

Bacitracin zinc

127

Baclofen

128

Barium carbomate

129

Barium chloride

130

Barium sulphide

131

Beclamide

132

Beclomethasone

133

Beclomethasone dipropionate

134

Bemegride

135

Benactyzine hydrochloride

136

Benapryzine hydrochloride

137

Bendrofluazide

138

Benethamine penicillin

139

Benoxaprofen

140

Benperidol

141

Benserazide

142

Benzathine penicillin

143

Benzbromarone

144

Benzhexol hydrochloride

145

Benzilonium bromide

146

Benzoclamine hydrochloride

147

Benzquinamide

148

Benzquinamide hydrochloride

149

Benzthiazide

150

Benztropine mesylate

151

Benzyl penicillin

152

Benzyl penicillin calcium

153

Betahistine hydrochloride

154

Betamethasone

155

Betamethasone adamantoate

156

Betamethasone benzoate

157

Betamethasone dipropiomate

158

Betamethasone sodium phosphate

159

Betamethasone valerate

160

Betaxolol hydrochloride

161

Bethanecol chloride

162

Bethanidine sulphate

163

Bezafibrate

164

Bicalutamide

165

Biperidine hydrochloride

166

Biperidine lactate

167

Bismuth glucollylarsanilate

168

Bisoprolol

169

Bleomycin sulphate

170

Boldenone undecylenate

171

Bretylium tosylate

172

Brimonidine

173

Bromocriptine mesylate

174

Bromperidol

175

Bromvaletone

176

Budesonide

177

Bumetadine

178

Bumetanide

179

Buphenine hydrochloride

180

Bupivacaine

181

Bupivacaine hydrochloride

182

Buspirone hydrochloride

183

Busulphan

184

Butacaine sulphate

185

Butanilicaine phosphate

186

Butriptyline hydrochloride

187

Butylchloral hydrate

188

Cabergoline

189

Calcitonin

190

Calcitriol

191

Calcium aminosalicylate

192

Calcium amphomycin

193

Calcium benzamidosalicylate

194

Calcium bromide

195

Calcium bromidolactobionate

196

Calcium carbimide

197

Calcium folinate

198

Calcium metrizoate

199

Calcium sulphaloxate

200

Candesartan

201

Candicidin

202

Canrenoic acid

203

Cantharidin

204

Capreomycin sulphate

205

Captopril

206

Caramiphen edisylate

207

Caramiphen hydrochloride

208

Carbachol

209

Carbamazepine

210

Carbenicillin sodium

211

Carbenoxolone sodium

212

Carbidopa

213

Carbidopa monohydrate

214

Carbimazole

215

Carbon tetrachloride

216

Carboplatin

217

Carboprostrometamol

218

Carbromal

219

Carbuterol hydrochloride

220

Carindacillin sodium

221

Carisoprodol

222

Carmustine

223

Carvedilol

224

Cefaclor

225

Cefazedone sodium

226

Cefazolin

227

Cefepime

228

Cefixime

229

Cefotaxime

230

Cefoxitin sodium

231

Cefpodoxime

232

Cefprozil

233

Ceftazidime

234

Ceftizoxine sodium

235

Ceftriaxone

236

Cefuroxime sodium

237

Cephalexin

238

Cephalexin sodium

239

Cephaloridine

240

Cephalosporin C

241

Cephalosporin E

242

Cephalosporin N

243

Cephalothin sodium

244

Cephamandole nafate

245

Cephazolin sodium

246

Cephradine

247

Cerium oxalate

248

Chenodeoxycholic acid

249

Chloral antipyrine

250

Chloral betaine

251

Chloral formamide

252

Chloral glycerolate

253

Chloral hydrate

254

Chloralose

255

Chloralurethene

256

Chlorambucil

257

Chloramphenicol

258

Chlorisondamine chloride

259

Chlormadinone acetate

260

Chlormerodrin

261

Chlormethiazole

262

Chlormezanone

263

Chloroquine and its salts (except for prophylaxis of malarial prophylaxis Schedule 3)

264

Chlorothiazide

265

Chlorotrianisene

266

Chloroxazone

267

Chlorphenoxamine hydrochloride

268

Chlorpromazine

269

Chlorpromazine embonate

270

Chlorpromazine hydrochloride

271

Chlorpropamide

272

Chlorprothixene

273

Chlorprothixene hydrochloride

274

Chlortetracycline

275

Chlortetracycline hydrochloride

276

Chlorthalidone

277

Cholestyramine

278

Chorionic gonadotrophin

279

Chormethiazole edisylate

280

Ciclacillin

281

Ciclobendazole

282

Cimetidine & its salts (except for short term relief of heartburn, dyspepsia and hyperacidity 200mg-400mg per single dose- maximum 4800mg Schedule 3)

283

Cinchocaine

284

Cinchocaine hydrochloride

285

Cinchophen

286

Cinoxacin

287

Ciprofloxacin

288

Ciprofloxacin hydrochloride

289

Cisplatin

290

Citalopram

291

Cladribine

292

Clarithromycin

293

Clavulanic acid

294

Clenbuterol hydrochloride

295

Clindamycin and its salts (except for topical preparation Schedule 3)

296

Clindamycin hydrochloride hydrate

297

Clindamycin palmitate hydrochloride

298

Clindamycin phosphate

299

Clindinium bromide

300

Clobetasol

301

Clobetasol 17-propionate

302

Clobetasone butyrate

303

Clofazimine

304

Clofibrate

305

Clomiphene citrate

306

Clomipramine

307

Clomipramine hydrochloride

308

Clomocycline

309

Clomocycline sodium

310

Clonidine

311

Clonidine hydrochloride

312

Clopenthixol decanoate

313

Clopenthixol hydrochloride

314

Clopidogrel

315

Cloprostenol sodium

316

Clorexolone

317

Clorprenaline hydrochloride

318

Clostebol acetate

319

Cloxacillin benzathine

320

Cloxacillin sodium

321

Clozapine

322

Cocculus indicus

323

Co-dergocrine myselate

324

Colchicine (except for acute gout attack maximum 6mg, 0.5-1 mg per single dose Schedule 3)

325

Colestipol hydrochloride

326

Colistin sulphate

327

Colistin sulphomethate

328

Colistin sulphomethate sodium

329

Conium leaf

330

Corticotrophin

331

Cortisone

332

Cortisone acetate

333

Cotarnine chloride

334

Co-tetroxazine

335

Co-trimoxazole

336

Cropropamide

337

Crotethamide

338

Croton oil

339

Croton seed

340

Curare

341

Cycloghosphamide

342

Cyclopenthiazide

343

Cyclopentolate hydrochloride

344

Cyclophosmamide

345

Cyclosporin

346

Cyclothiazide

347

Cyproterone acetate

348

Cytarabine

349

Cytarabine hydrochloride

350

Dacarbazine

351

Dactinomycin

352

Danazol

353

Dantrolene sodium

354

Dapsone

355

Dapsone ethane ortho sulphonate

356

Darunavir

357

Daunorubicin hydrochloride

358

Deanol salts and esters

359

Debrisoquine sulphate

360

Dehydroemetine hydrochloride

361

Delmadinone acetate

362

Demecarium bromide

363

Demeclocycline

364

Demeclocycline calcium

365

Demeclocycline hydrochloride

366

Deoxycortone acetate

367

Deoxycortone pivalate

368

Deptropine citrate

369

Dequalinium chloride

370

Deserpidine

371

Desferroxamine mesylate

372

Desfluorotriamcinolone

373

Desipramine hydrochloride

374

Deslanoside

375

Desmopressin

376

Desonide

377

Desoxymethasone

378

Dexamethasone

379

Dexamethasone 21-isonicotinate

380

Dexamethasone phenylpropionate

381

Dexamethasone pivalate

382

Dexamethasone sodium m-sulphobenzoate

383

Dexamethasone sodium phosphate

384

Dexamethasone trioxaundecanoate

385

Dextromethorphan hydrobromide

386

Dextrothyroxine sodium

387

Diazoxide

388

Dibenzepin hydrochloride

389

Dichloralphenazone

390

Dichlorophernasine hydrochloride

391

Dichlorphenamide

392

Diclofenac and its salts (topical preparation & oral 500mg maximum, 50-100mg per single dose Schedule 3)

393

Dicyclomine hydrochloride (except in antacid preparation Schedule 3)

394

Dienoestrol

395

Diethanolamine fusidate

396

Diethylamine acetarsol

397

Diflucortolone valerate

398

Diflunisal

399

Digitalis leaf

400

Digitoxin

401

Digoxin

402

Dihydrallazine sulphate

403

Dihydroergotamine mesylate

404

Dihydrostreptomycin sulphate

405

Diltiazem hydrochloride

406

Dimercaprol

407

Dimethisoquin hydrochloride

408

Dimethisterone

409

Dimethothiazine mesylate

410

Dimethyl sulphoxide

411

Dimethyltubocurarine bromide

412

Dimethyltubocurarine chloride

413

Dimethyltubocurarine iodide

414

Dinitrodiphenylsulphonylethylenediamine

415

Dinoprost

416

Dinoprostone

417

Diphetarsone

418

Dipivefrin hydrochloride

419

Diprenorphine hydrochloride

420

Dipyridamole

421

Dipyrone

422

Disodium etidronate

423

Disopyramide

424

Disopyramide phosphate

425

Distigmine bromide

426

Disulfiram

427

Disulphamide

428

Dithranol

429

d-Norgestrel

430

Dobutamine hydrochloride

431

Docetaxel

432

Dolutegravir

433

Dompridone

434

Donepezil

435

Dopamine hydrochloride

436

Dothiepin

437

Dothiepin hydrochloride

438

Doxapram hydrochloride

439

Doxazosin

440

Doxepin hydrochloride

441

Doxorubicin

442

Doxycycline

443

Doxycycline calcium chelate

444

Doxycycline hydrochloride

445

Droperidol

446

Drospirenone

447

Drostanolone

448

Drostanolone propionate

449

Duloxetine

450

Dyaxide

451

Dydrogesterone

452

Ecthiopate iodide

453

Edrophonium

454

Efavirenz

455

Emepromium bromide

456

Emetine

457

Emetine bismuth iodide

458

Emetine hydrochloride

459

Emtricitabine

460

Enalapril maleate

461

Epicillin

462

Epirubicin

463

Epithiazide

464

Epoprostenol sodium

465

Ergometrine tartrate

466

Ergotoxine esylate

467

Erythromycin & its salts (except topical preparation Schedule 3)

468

Erythropoietin

469

Escitalopram

470

Esomeprazole & its salts (except for the 14-day treatment for frequent heartburn, at a daily dose of 20 mg and in package sizes of no more than 280 mg of esomeprazole Schedule 3)

471

Estramustine phosphate

472

Etafedrine hydrochloride

473

Ethacrynic acid

474

Ethamsylate

475

Ethchlorvynol

476

Ethebenecid

477

Ethiazide

478

Ethinyloestradiol

479

Ethionamide

480

Ethisterone

481

Ethoheptazine citrate

482

Ethopropazine hydrochloride

483

Ethosuximide

484

Ethotoin

485

Ethulose

486

Ethyl acetanilide

487

Ethyl biscoumacetate

488

Ethyloestrenol

489

Ethynodiol diacetate

490

Etidronate disodium

491

Etomidate

492

Etoposide

493

Factor IX concentrate

494

Factor XII concentrate

495

Factor XIII concentrate

496

Fazadinium bromide

497

Felodipine

498

Fenbufen

499

Fenfluramine hydrochloride

500

Fenoprofen

501

Fenoprofen calcium

502

Fenoterol hydrobromide

503

Fenpipramide hydrochloride

504

Fenpiprane hydrochloride

505

Filgrastin

506

Finasteride

507

Flavoxate hydrochloride

508

Flecainide

509

Fluanisone

510

Fluclorolone acetonide

511

Flucloxacillin sodium

512

Fluconazole

513

Flucytosine

514

Fludarabine

515

Fludrocortisone acetate

516

Flufenamic acid

517

Flugestone

518

Flugestone acetate

519

Flumedroxone acetate

520

Flumethasone

521

Flumethasone pivalate

522

Flunisolide

523

Fluocinolone acetonide

524

Fluocinonide

525

Fluocortolone

526

Fluocortolone hexanoate

527

Fluocortolone pivalate

528

Fluopromazine hydrochloride

529

Fluorometholone

530

Fluorouracil

531

Fluorouracil trometamol

532

Fluoxetine

533

Fluoxymesterone

534

Flupenthixol decanoate

535

Flupenthixol dihydrochloride

536

Fluperolone acetate

537

Fluphenazine deconoate

538

Fluphenazine enanthate

539

Fluphenazine hydrochloride

540

Fluprednidene acetate

541

Fluprednisolone

542

Fluprostenol sodium salt

543

Flurandrenolone

544

Flurbiprofen

545

Fluspirilene

546

Flutamide

547

Fluticasone

548

Fluvastatin

549

Fluvoxamine

550

Follicle stimulating hormone

551

Formosulphathiazole

552

Formoterol

553

Fosfestrol tetrasodium

554

Framycetin sulphate (except topical & ophthalmic preparation Schedule 3)

555

Frusemide

556

Fumagillin

557

Fumagillin bicyclohexylamine

558

Furazolidone

559

Furosemide

560

Fusidic acid

561

Gabapentin

562

Gallamine triethiodide

563

Gelsemine

564

Gelsemium

565

Gemcitabine

566

Gemfibrozil

567

Gentamicin and its salts (except topical and ophthalmic use Schedule 3)

568

Gestodene

569

Gestronol

570

Gestronol hexanoate

571

Glibenclamide

572

Glibornuride

573

Gliclazide

574

Glimepiride

575

Glipizide

576

Glyceryl trinitrate

577

Glycopyrronium bromide

578

Glymide

579

Gonadorelin

580

Gramicidin

581

Granisetron

582

Growth hormone

583

Guanethidine monosulphate

584

Guanoclor sulphate

585

Guanoxan sulphate

586

Hachimycin

587

Halcinonide

588

Haloperidol

589

Heparin and its salts (except for topical use Schedule 3)

590

Heptaminol hydrochloride

591

Hexachlorophene

592

Hexamine phenylcinchoninate

593

Hexoestrol

594

Hexoestrol dipropionate

595

Homatropine

596

Homatropine hydrobromide

597

Homatropine methylbromide

598

Hydralazine hydrochloride

599

Hydrargaphen

600

Hydrobromic acid

601

Hydrochlorothiazide

602

Hydrocortamate hydrochloride

603

Hydrocortisone and its salts & derivatives (except in preparations for external use and ms 1% Schedule 3)

604

Hydroflumethiazide

605

Hydroquinone

606

Hydroxychloroquine sulphate

607

Hydroxymethylgramicidin

608

Hydroxyprogesterone

609

Hydroxyprogesterone enanthate

610

Hydroxyprogesterone hexanoate

611

Hydroxyurea

612

Hydroxyzine embonate

613

Hydroxyzine hydrochloride

614

Hyoscine

615

Hyoscine and its salts (except oral use Schedule 3)

616

Hyoscyamine and its salts (except oral use Schedule 3)

617

Ibuprofen (except in preparation for topical and oral use maximum 9600mg, 400mg per single dose Schedule 3)

618

Idoxuridine

619

Ignatius bean

620

Imipenem

621

Imipramine

622

Imipramine hydrochloride

623

Imipramine ion exchange resin bound salt or complex

624

Immunoglobulins

625

Indapamide hemihydrates

626

Indomethacin (except in preparation for topical, rectal and oral use maximum 750mg, 25mg per single dose Schedule 3)

627

Indoramin hydrochloride

628

Insulins

629

Iodamide

630

Iodamide meglumine

631

Iodamide sodium

632

Ipratropium

633

Iprindole hydrochloride

634

Iproniazid phosphate

635

Iptratropium bromide

636

Irbesartan

637

Irinotecan

638

Isoaminile

639

Isoaminile citrate

640

Isocarboxazid

641

Isoconazole nitrate (except topical & vaginal preparation Schedule 3)

642

Isoetharine

643

Isoetharine hydrochloride

644

Isoetharine mesylate

645

Isoniazid

646

Isoprenaline hydrochloride

647

Isoprenaline sulphate

648

Isopropamide iodide

649

Isosorbide dinitrate

650

Isosorbide mononitrate

651

Isotretinoin

652

Ispaghula

653

Itraconazole

654

Jaborondi

655

Kanamycin sulphate

656

Ketamine hydrochloride

657

Ketoconazole (except topical & vaginal preparation Schedule 3)

658

Ketoprofen

659

Ketotifen (except cough preparation Schedule 3)

660

Labetolol hydrochloride

661

Lactogernic hormone

662

Lamivudine

663

Lamotrigine

664

Lanatoside C

665

Lanatoside complex A, B and C

666

Lansoprazole (except for the 14-day treatment for frequent heartburn, at a daily dose of 30 mg and in package sizes of no more than 4200 mg of lansoprazole Schedule 3)

667

Latamoxef disodium

668

Latanoprost

669

Lead arsenate

670

Letrozole

671

Levallorphan tartrate

672

Levetiracetam

673

Levocetrizine

674

Levodopa

675

Levofloxacin

676

Levonorgestrel

677

Levothyroxine

678

L-Histidine hydrochloride

679

Lidoflazine

680

Lignocaine and its salts (except topical use 2% Schedule 3 and less than 2% Schedule 4)

681

Lincomycin

682

Lincomycin hydrochloride

683

Liothyronine sodium

684

Lisinopril

685

Lithium carbonate

686

Lithium sulphate

687

Lobeline; its salts

688

Lofepramine

689

Lofepramine hydrochloride

690

Lomustine

691

Lopinavir

692

Losartan

693

Loxapine succinate

694

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

695

L-Tryptophan

696

Luteinising hormone

697

Lymecycline

698

Lynoestrenol

699

Mafenide acetate

700

Mafenide hydrochloride

701

Mafenite propionate

702

Magnesium bromide

703

Magnesium fluoride

704

Magnesium metrizoate

705

Mandragora autumnalis

706

Mannomustine hydrochloride

707

Maprotiline hydrochloride

708

Mebeverine hydrochloride (except in preparation for oral use Schedule 3)

709

Mebhydrolin napadisylate

710

Mecamylamine hydrochloride

711

Meclofenoxate hydrochloride

712

Medrogestrone

713

Medroxyprogesterone acetate

714

Mefenamic acid (except for oral use in dysraenorrhoea Schedule 3)

715

Mefruside

716

Megestrol

717

Megestrol acetate

718

Meglumine iodoxamate

719

Meglumine ioglycamate

720

Meglumine iotraxate

721

Meglumine ioxaglate

722

Melarsonyl potassium

723

Melengestrol

724

Melengestrol acetate

725

Meloxicam

726

Melphalan

727

Melphalan hydrochloride

728

Mepenzolate bromide

729

Mephenesin (except in preparation for oral use Schedule 3)

730

Mepivacaine hydrochloride

731

Meptazinol hydrochloride

732

Mequitazine

733

Mercaptopurine

734

Mercuderamide

735

Meropenem

736

Mersalyl

737

Mersalyl acid

738

Mesna

739

Mesterolone

740

Metabutethamine hydrochloride

741

Metaraminol tartrate

742

Metformin hydrochloride

743

Methacycline

744

Methacycline calcium

745

Methacycline hydrochloride

746

Methallenoestril

747

Methandienone

748

Methandriol

749

Methdilazine hydrochloride

750

Methenolone acetate

751

Methenolone enanthate

752

Methicillin sodium

753

Methimazole

754

Methindizate hydrochloride

755

Methixene

756

Methixene hydrochloride

757

Methohexitone sodium

758

Methoserpidine

759

Methotrexate

760

Methotrexate sodium

761

Methotrimeprazine

762

Methotrimeprazine hydrochloride

763

Methoxamine hydrochloride

764

Methylclothiazide

765

Methyldopa

766

Methyldopate hydrochloride

767

Methylephedrine hydrochloride

768

Methylergotamine maleate

769

Methylpentynol

770

Methylpetynol carbamate

771

Methylprednisolone

772

Methylprednisolone acetate

773

Methylprednisolone sodium succinate

774

Methyltestosterone

775

Methylyhiouracil

776

Methysergide maleate

777

Metoclopramide hydrochloride

778

Metolazone

779

Metomidate hydrochloride

780

Metoprolol tartrate

781

Metronidazole

782

Metronidazole benzoate

783

Mexiletine hydrochloride

784

Mezlocillin sodium

785

Mianserin hydrochloride

786

Minocycline

787

Minocycline hydrochloride

788

Minoxidil (except in topical preparation Schedule 3)

789

Mirtazapine

790

Mithramycin

791

Mitomycin C

792

Mitopodozide

793

Mitozantrone hydrochloride

794

Molindone hydrochloride

795

Mometasone

796

Montelukast

797

Moxifloxacin

798

Moxonidine

799

Mustine hydrochloride

800

Mycophenolate

801

Nadolol

802

Naftidofuryl oxalate

803

Nalbuphine hydrochloride

804

Nalidixic acid

805

Nalorphine hydrobromide

806

Naloxone hydrochloride

807

Nandrolone decanoate

808

Nandrolone laurate

809

Nandrolone phenylpropionate

810

Naproxen

811

Naproxen sodium

812

Natamycin

813

N-Benzoyl sulphanilamide

814

Nebivolol

815

Nedocromil sodium

816

Nefopam hydrochloride

817

Neoarsephenamine

818

Neomycin and its salts (except topical preparation, ophathalmic preparation Schedule 3)

819

Neostigmine bromide

820

Neostigmine methylsulphate

821

Netilmicin sulphate

822

Nevirapine

823

Nialamide

824

Nicotinaldemyde thio-semicarbazone

825

Nicoumalone

826

Nifedipine

827

Nikethamide

828

Niridazole

829

Nitrofurantoin

830

Nitroxoline

831

Nizatidine (except for short term relief of heartburn, dyspepsia and hyperacidity 150mg-300mg per single dose maximum dose 4200mg Schedule 3)

832

N-Methyl acetanilide

833

Nomifensine hydrogen maleate

834

Noradrenaline

835

Noradrenaline acid tartrate

836

Norethandrolone

837

Norethisterone

838

Norethynodrel

839

Norfloxacin

840

Norgestrel

841

Northisterone acetate

842

Northisterone heptanoate

843

Nortriptyline hydrochloride

844

Novobiocin calcium

845

Novobiocin sodium

846

Oestradiol

847

Oestradiol benzanoate

848

Oestradiol cypaionate

849

Oestradiol dipropionate

850

Oestradiol diundecanoate

851

Oestradiol enanthate

852

Oestradiol phenylpropionate

853

Oestradiol undecanoate

854

Oestradiol valerate

855

Oestriol

856

Oestriol di-hemisuccinate

857

Oestrogenic substances, conjugated

858

Oestrone

859

Ofloxacin

860

Olanzapine

861

Oleandomycin phosphate

862

Omeprazole (except for 14-day treatment for frequent heartburn at a daily dose of 20 mg in package sizes of no more than 280 mg of omeprazole Schedule 3)

863

Ondansetron

864

Opipramol hydrochloride

865

Orciprenaline sulphate and its salts (except for use in cough preparation Schedule 3)

866

Orthocaine

867

Ouabain

868

Ovarin gland, dried

869

Oxaliplatin

870

Oxamniquine

871

Oxandrolone

872

Oxantel pamoate

873

Oxatomide

874

Oxbuprocaine hydrochloride

875

Oxcarbazepine

876

Oxedrine tartrate

877

Oxolinic acid

878

Oxophernasine hydrochloride

879

Oxophernasine tartrate

880

Oxpentifyline

881

Oxprenolol hydrochloride

882

Oxybutynin

883

Oxymeterone

884

Oxymetholone

885

Oxypertine

886

Oxypertine hydrochloride

887

Oxyphenbutazone

888

Oxyphencyclamine hydrochloride

889

Oxyphenonium bromide

890

Oxytetracycline and its salts (except for topical and ophthalmic preparation Schedule 3)

891

Oxytocins, natural and synthetic

892

Paclitaxel

893

Pancuronium bromide

894

Pantoprazole (except for the 14-day treatment for frequent heartburn, at a daily dose of 20 mg and in package sizes of no more than 280 mg of pantoprazole Schedule 3)

895

Papaverine

896

Papaverine hydrochloride

897

Papaveroline

898

Papaveroline 2-sulphonic acid

899

Paraldehyde

900

Paramethadione

901

Paramethasone acetate

902

Parathyroid gland

903

Pargyline hydrochloride

904

Paromycin sulphate

905

Paroxetine

906

Pecilocin

907

Pempidine tartrate

908

Penbutolol sulphate

909

Penethamate

910

Penicillamine

911

Penicillamine hydrochloride

912

Penicillin V

913

Pentamidine

914

Pentolinium tartrate

915

Pentoxifylline

916

Perhexiline hydrogen maleate

917

Pericyazine

918

Perindopril

919

Perphenazine

920

Phebutrazate hydrochloride

921

Phenacaine

922

Phenacemide

923

Phenbenicillin potassium

924

Phenelzine sulphate

925

Phenethicillin potassium

926

Pheneturide

927

Phenformine hydrochloride

928

Phenglutarimide hydrochloride

929

Phenindone

930

Phenoxybenzamine hydrochloride

931

Phenoxymethylpenicillin

932

Phenoxymethylpenicillin calcium

933

Phenoxymethylpenicillin potassium

934

Phensuximide

935

Phentolamine hydrochloride

936

Phentolamine mesylate

937

Phenyl aminosalicylate

938

Phenylbutazone

939

Phenylbutazone sodium

940

Phenylephrine hydrochloride (except for nasal, flu & ophthalmic preparation Schedule 3)

941

Phenytoin

942

Phenytoin sodium

943

Pheprocoumon

944

Phernasone sulphoxylate

945

Phthalylsulphacetamide

946

Phthalylsulphathiazole

947

Physostigmine

948

Physostigmine aminoxide salicylate

949

Physostigmine salicylate

950

Physostigmine sulphate

951

Pilocarpine

952

Pilocarpine hydrochloride

953

Pilocarpine nitrate

954

Pimozide

955

Pindolol

956

Pioglitazone

957

Pipenzolate bromide

958

Piperacillin sodium

959

Piperidolate hydrochloride

960

Pipothiazine palmitate

961

Piracetam

962

Pirbuterol acetate

963

Pirbuterol hydrochloride

964

Pirentanide

965

Pirenzepine hydrochloride

966

Piroxicam (except topical preparation and oral for use in acute gout attack maximum 100mg, per single dose 20mg Schedule 3)

967

Pituitary powdered (posterior globe)

968

Pituitatry gland (whole dried)

969

Pivampicillin hydrochloride

970

Pivmecillinam

971

Pivmecillinam hydrochloride

972

Pizotifen and its salts (except cough preparation Schedule 3)

973

Plicamycin

974

Poldine methylsulphate

975

Polidexide

976

Polidexide hydrochloride

977

Polidexide sulphate

978

Polymyxin B sulphate (except topical & ophthalmic preparation Schedule 3)

979

Polyoestradiol phosphate

980

Polythiazide

981

Potassium aminosalicylate

982

Potassium arsenite

983

Potassium bromide

984

Potassium cancrenoate

985

Potassium clavulanate

986

Potassium perchlorate

987

Pralidoxime chloride

988

Pralidoxime iodide

989

Pralidoxime mesylate

990

Pramipexole

991

Pravastatin

992

Prazosin hydrochloride

993

Prednisolone

994

Prednisolone 21-steaglate

995

Prednisolone acetate

996

Prednisolone butylacetate

997

Prednisolone hexanoate

998

Prednisolone m-sulphobenzoate

999

Prednisolone pivalate

1000

Prednisolone sodium m-sulphobenzoate

1001

Prednisolone sodium phosphate

1002

Prednisone

1003

Prednisone acetate

1004

Prenalterol hydrochloride

1005

Prenylamine lactate

1006

Prilocaine hydrochloride

1007

Primaquine phosphate

1008

Primodine

1009

Probenecid

1010

Probucol

1011

Procainamide hydrochloride

1012

Procaine hydrochloride

1013

Procaine penicillin

1014

Procarbazine hydrochloride

1015

Prochlorperazine edisylate

1016

Prochlorperazine maleate

1017

Prochlorperazine mesylate

1018

Procyclidine hydrochloride

1019

Progesterone

1020

Proguanil hydrochloride

1021

Prolintane hydrochloride

1022

Promazine embonate

1023

Promazine hydrochloride

1024

Promethazine and its salts (except topical and oral use Schedule 3)

1025

Propanidid

1026

Propantheline bromide

1027

Propicillin potassium

1028

Propiomazine hydrogen maleate

1029

Propofol

1030

Propranolol hydrochloride

1031

Propylphenazone

1032

Propylthiouracil

1033

Proquamezine fumarate

1034

Proquazone

1035

Prostaglandin F2 alpha tromethamine

1036

Protamine sulphate

1037

Prothionamide

1038

Prothipendyl hydrochloride

1039

Protriptyline hydrochloride

1040

Proxymetacaine hydrochloride

1041

Pseudoephrine hydrochloride

1042

Pseudoephrine sulphate

1043

Pyrazinamide

1044

Pyridostigmine bromide

1045

Pyrimethamine

1046

Quetiapine

1047

Quinapril

1048

Quinestradiol

1049

Quinestrol

1050

Quinethazone

1051

Quingestanol

1052

Quinidine

1053

Quinidine bisulphate

1054

Quinidine phenylethylbarbiturate

1055

Quinidine polygalacturonate

1056

Quinuronium sulphate

1057

Rabeprazole

1058

Racephedrlne hydrochloride

1059

Raltegravir

1060

Ramipril

1061

Ranitidine and its salts (except in concentrations of 150 mg or less per oral dosage unit and indicated for the treatment of heartburn, in package sizes containing more than 4500 mg of ranitidine Schedule 3)

1062

Rauwolfia (serpetina and vomitoria)

1063

Reproterol hydrochloride

1064

Rescinnamide

1065

Reserpine

1066

Rfamide

1067

Rifampicin

1068

Rifamycin

1069

Rimiterol hydrobromide

1070

Risedronic acid

1071

Risperidone

1072

Ritodrine hydrochloride

1073

Ritonavir

1074

Rolitetracycline nitrate

1075

Ropinirole

1076

Rosuvastatin

1077

Rosuvastatin

1078

Roxithromycin

1079

Salazosulphadimidine

1080

Salbutamol

1081

Salbutamol and its salts (except inhaler, autohaler and oral use Schedule 3)

1082

Salbutamol sulphate

1083

Salmetrol

1084

Saquinavir

1085

Saxagliptin

1086

Selegiline hydrochloride

1087

Sera and antisera

1088

Sertraline

1089

Serum gonadotrophin

1090

Sibutramine

1091

Simvastatin

1092

Sissomycin sulphate

1093

Sodium aminosalicylate

1094

Sodium antimonylgluconate

1095

Sodium apolate

1096

Sodium arsanilate

1097

Sodium arsenite

1098

Sodium bromated

1099

Sodium bromide

1100

Sodium cacodylate

1101

Sodium cromoglycate (except for use in ophthalmic & inhalation preparation Schedule 3)

1102

Sodium ethacrynate

1103

Sodium fluoride

1104

Sodium fucidate (except topical preparation Schedule 3)

1105

Sodium methylarsinate

1106

Sodium metrizoate

1107

Sodium monofluorophosphate

1108

Sodium stibogluconate

1109

Sodium valproate

1110

Sotalol hydrochloride

1111

Spectinomycin

1112

Spiramycin

1113

Spiramycin adipate

1114

Spirinolactone

1115

Stannous fluoride

1116

Stanolone

1117

Stanozolol

1118

Stilboestrol

1119

Stilboestrol dipropionate

1120

Streptodornase

1121

Streptokinase

1122

Streptomycin

1123

Streptomycin sulphate

1124

Strychnine

1125

Strychnine arsenate

1126

Strychnine hydrochloride

1127

Succinylsulphathiozole

1128

Sucralfate

1129

Sulbactam sodium

1130

Sulconazole nitrate

1131

Sulfabromethazine

1132

Sulfacytine

1133

Sulfadicramide

1134

Sulfadoxine

1135

Sulfametopyrazine

1136

Sulfamonomethoxine

1137

Sulfapyrazole

1138

Sulphacetamide

1139

Sulphacetamide and its salts (except topical and ophthalmic use Schedule 3)

1140

Sulphacetamide sodium

1141

Sulphachlorpyridazine

1142

Sulphadiazine

1143

Sulphadiazine sodium

1144

Sulphadimethoxine

1145

Sulphadimidine

1146

Sulphadimidine sodium

1147

Sulphafurazole

1148

Sulphafurazole diethanolamine

1149

Sulphaguanidine

1150

Sulphaloxic acid

1151

Sulphamerazine

1152

Sulphamerazine sodium

1153

Sulphamethizole

1154

Sulphamethoxazole

1155

Sulphamethoxydiazine

1156

Sulphamethoxypyridazine

1157

Sulphamethoxypyridazine sodium

1158

Sulphamethylphenazole

1159

Sulphamoxole

1160

Sulphanilamide

1161

Sulphaphenazole

1162

Sulphapyridine

1163

Sulphapyridine sodium

1164

Sulphaquinoxaline

1165

Sulphaquinoxaline sodium

1166

Sulpharsphenamine

1167

Sulphasalazine

1168

Sulphasomidine

1169

Sulphasomidine sodium

1170

Sulphathiourea

1171

Sulphathiozole

1172

Sulphathiozole sodium

1173

Sulphatolamide

1174

Sulphaurea

1175

Sulphinpyrazone

1176

Sulphomyxin

1177

Sulpiride

1178

Sulthiame

1179

Sumatriptan

1180

Suxamethonium bromide

1181

Suxamethonium chloride

1182

Suxethonium bromide

1183

Tacrine hydrochloride

1184

Talampicillin

1185

Talampicillin hydrochloride

1186

Talampicillin napsylate

1187

Tamoxifen

1188

Tamoxifen citrate

1189

Tamsulosin

1190

Teclothiazide potassium

1191

Teicoplanin

1192

Telmisartan

1193

Temozolomide

1194

Tenofovir

1195

Terbutaline

1196

Terbutaline sulphate

1197

Testosterone

1198

Testosterone 17B chloral hemiacetal

1199

Testosterone acetate

1200

Testosterone cyclohexylpropionate

1201

Testosterone cypionate

1202

Testosterone decanoate

1203

Testosterone enanthate

1204

Testosterone isocaproate

1205

Testosterone phenylpropionate

1206

Testosterone propionate

1207

Testosterone undecanoate

1208

Tetrabenazine

1209

Tetracaine

1210

Tetracosatrin

1211

Tetracosatrin acetate

1212

Tetracycline and its salts (except for topical and ophthalmic use Schedule 3)

1213

Thallium acetate

1214

Theophylline

1215

Thiethylperazine

1216

Thiethylperazine di-(hydrogen malate)

1217

Thiocarlide

1218

Thioguinine

1219

Thiopentone sodium

1220

Thiopropazate hydrochloride

1221

Thioproperazine mesylate

1222

Thioridazine

1223

Thioridazine hydrochloride

1224

Thiotepa

1225

Thiothexene

1226

Thiouracil

1227

Thymoxamine hydrochloride

1228

Thyroid

1229

Thyrotrophin

1230

Thyrotrophin releasing hormone

1231

Thyroxine sodium

1232

Tianulin hydrogen fumarate

1233

Tiaprofenic acid

1234

Ticarcillin sodium

1235

Tigloidine hydrobromide

1236

Timolol maleate

1237

Tioconazole (except topical & vaginal use Schedule 3)

1238

Tiotropium bromide

1239

Tobramycin

1240

Tobramycin sulphate

1241

Tocainide hydrochloride

1242

Tofenacin hydrochloride

1243

Tolazamide

1244

Tolazoline hydrochloride

1245

Tolbutamide

1246

Tolbutamide sodium

1247

Tolmetin sodium dehydrate

1248

Tolperisone

1249

Topiramate

1250

Torasemide

1251

Totaquine

1252

Tranexamic acid

1253

Tranylcypromine sulphate

1254

Trazadone

1255

Treosulfan

1256

Treotinon

1257

Tretamine

1258

Tretinoin

1259

Triacetyloleandomycin

1260

Triamcinolone

1261

Triamcinolone acetonide

1262

Triamcinolone diacetate

1263

Triamcinolone hexacetonide

1264

Triamterene

1265

Tribromoethyl alcohol

1266

Triclofos sodium

1267

Tricyclamol chloride

1268

Trienbolone acetate

1269

Trientine dihydrochloride

1270

Trifluoperazine

1271

Trifluoperazine hydrochloride

1272

Trifluoperidol

1273

Trifluoperidol hydrochloride

1274

Trilostane

1275

Trimepramine mesylate

1276

Trimeprazine

1277

Trimeprazine tartrate

1278

Trimetaphan camsylate

1279

Trimetazidine

1280

Trimetazidine hydrochloride

1281

Trimethoprim

1282

Trimipramine maleate

1283

Trimustine hydrochloride

1284

Tripolidine

1285

Tropicamide

1286

Tubocurarine chloride

1287

Tybamate

1288

Tylosin

1289

Tylosin phosphate

1290

Tylosin tartrate

1291

Tyrothricin

1292

Uramustine

1293

Urea stibamine

1294

Uridine-5-triphosphoric acid

1295

Urifollitrophin

1296

Urokinase

1297

Ursodeoxycholic acid

1298

Vaccines

1299

Valaciclovir

1300

Valproic acid

1301

Valsartan

1302

Vancomycin hydrochloride

1303

Vasopressin tannate

1304

Vecuronium bromide

1305

Venlafaxine

1306

Verapamil hydrochloride

1307

Vidagliptin

1308

Viloxazine hydrochloride

1309

Vinblastine sulphate

1310

Vincristine sulphate

1311

Vindesin sulphate

1312

Vinorelbine

1313

Viomycin pantothenate

1314

Viomycin sulphate

1315

Vitamin A

1316

Vitamin A acetate

1317

Vitamin A palmitate

1318

Vitamin D

1319

Vitamins

1320

Warfarin

1321

Warfarin sodium

1322

Xylazine hydrochloride

1323

Yohimbine hydrochloride

1324

Zidovudine

1325

Zimeldine hydrochloride

1326

Zoledronic acid

1327

Zomepirec sodium

1328

Zopiclone

1329

Zuclopenthixol hydrochloride

 

(3) SCHEDULE 3 MEDICINES

NO.

NAME OF THE MEDICINE

1

Acetylsalicylic acid label (1)

2

Acetylsalicylic acid label (1)

3

Aconite in preparations and mixtures of ms 0.02%

4

Acyclovir

5

Adrenaline, if-

6

Adrenaline, if- (a) in inhalers

7

Adrenaline, if- (b) in preparations for external use

8

Aescin and its salts

9

Aesculin

10

Albendazole

11

Allopurinol

12

Amethocaine

13

Amethocaine and its salts in preparations for non-parenteral use (except those intended for local ophthalmic use: Schedule 2).

14

Amethocaine gentisate

15

Amethocaine hydrochloride

16

Astemizole

17

Atropine & its salts in preparations for external use and anti-diarrhoeal preparations, (except those intended for local ophthalmic & parenteral use: Schedule 2)

18

Atropine sulphate

19

Azatadine maleate label (5)

20

Belladonna alkaloid

21

Benzocaine

22

Benzocaine in preparations for external use and ms 4% (except preparations for local ophthalmic use: Schedule 2))

23

Benzoyl peroxide

24

Benzoyl peroxide in preparations for external use with ms 10%

25

Bromhexine hydrochloride

26

Brompheniramine maleate

27

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

28

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

29

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

30

Butalbital

31

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

32

Butylscopolamine

33

Cantharidin in preparations for external use and ms 0.01%

34

Caramiphen edisylate in:

35

Caramiphen edisylate in:(a) tablet preparations and ms 7.5mg (calculated as base)

36

Caramiphen edisylate in:(b) liquid preparations and ms 0.1% (calculated as base)

37

Carbenoxolone sodium in preparations for external use ms 2%

38

Carbocisteine

39

Cetirizine

40

Cetirizine and its salts

41

Chloramphenicol

42

Chloramphenicol cinnamate

43

Chloramphenicol palmitate

44

Chloramphenicol sodium succinate

45

Chlorhexidine

46

Chloroquine phosphate

47

Chloroquine sulphate

48

Chlorpherinamine maleate, label (5) (But in preparations for parenteral use: Schedule 2)

49

Cimetidine

50

Cimetidine hydrochloride

51

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

52

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

53

Cinnarizine

54

Clemastine, label (5)

55

Clioquinol

56

Clioquinol in preparations for external use

57

Clotrimazole

58

Colchicine

59

Cromoglycate Sodium

60

Cromolyn Sodium

61

Cyanocobalamin (except parenteral use Schedule 2)

62

Cyclizine hydrochloride in preparations for non-parenteral use

63

Cyproheptadine

64

Dequalinium chloride in:

65

Dequalinium chloride in:(a) throat lozenges or throat pastilles and ms 0.25mg

66

Dequalinium chloride in:(b) external paint preparations and ms 1%

67

Desloratadine

68

Dextromethorphan hydrobromide

69

Dextromethorphan hydrobromide in preparations for internal use with md 15mg (calculated as base)

70

Diclofenac and its salts

71

Dicyclomine hydrochloride

72

Diethylamine Salicylate

73

Di-Iodohydroxyquinoline

74

Dimenhydrinate in preparations for non-parenteral use label (5)

75

Dimethindine maleate, label (5)

76

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

77

Diphenhydramine hydrochloride in preparations for non-parenteral use, label (5)

78

Diphenylpyraline hydrochloride, label (5)

79

Econazole

80

Econazole and its salts

81

Econazole nitrate

82

Emetine hydrochloride in preparations for internal or external use and ms 1 % (calculated as base)

83

Emetine in preparations for internal or external use and ms 1 %

84

Ephedrine & its salts 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)

85

Ephedrine & its salts: (b) nasal sprays or nasal drops and ms 2% (calculated as base), label (4)

86

Ergotamine tartrate

87

Etofylline

88

Ferrous & its salts (except Iron in preparations for internal use and mdd 100mg (calculated as iron) Schedule 4 and Iron preparation for parenteral use Schedule 2)

89

Ferrous arsenate

90

Fexofenadine Hydrochloride

91

Folic acid

92

Folic acid (Schedule 2) in preparations for internal use and mdd 500 micrograms

93

Glucagon

94

Gramicidin in preparations for external use and ms 0.02%

95

Griseofulvin

96

Heparin

97

Heparin calcium

98

Hexachlorophene in preparations for external use and:

99

Hexachlorophene in preparations for external use and:(a) in soaps with ms more than 0.1% but not more than 2% label (6)

100

Hexachlorophene in preparations for external use and:(b) in medicines other than soaps or aerosols with ms more than 0.1% but not more than 0.75% label (6)

101

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

102

Hydrocortisone

103

Hydrocortisone 17-butyrate

104

Hydrocortisone acetate

105

Hydrocortisone caprylate

106

Hydrocortisone hydrogen succinate

107

Hydrocortisone sodium phosphate

108

Hydrocortisone sodium succinate

109

Hydroxychloroquine sulphate for the prophylaxis of malaria Labelling for malaria prophylaxis

110

Hydroxymethylgramicidin in throat lozenges or throat pastilles

111

Hyoscine

112

Hyoscine butylbromide

113

Hyoscine hydrobromide

114

Hyoscine methobromide

115

Hyoscine methonitrate

116

Ibuprofen

117

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

118

Indomethacin

119

Ipecacuanha see emetine

120

Iron; its salts

121

Isoconazole nitrate

122

Ketoconazole

123

Ketotifen

124

L-Histidine hydrochloride used as an ingredient in dietary or nutritional medicines as an amino acid

125

Lignocaine

126

Lignocaine hydrochloride

127

Loperamide hydrochloride

128

Loratadine

129

Mebendazole

130

Mebeverine hydrochloride

131

Mefenamic acid

132

Mefloquine Hydrochloride

133

Mephenesin

134

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

135

Mepyramine maleate

136

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

137

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

138

Miconazole

139

Miconazole and its salts

140

Miconazole nitrate

141

Mupirocin

142

N-acetylcysteine

143

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

144

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

145

Naphazoline and its salts: (b) in eye drops and ms 0.015%

146

Naphazoline hydrochloride

147

Naphazoline nitrate

148

Neomycin

149

Neomycin palmitate

150

Neomycin sulphate

151

Neomycin undecanoate

152

Niclosamide

153

Nitrofurazone

154

Nitrofurazone in preparations for external use

155

Nystatin

156

Orphenadrine and its salts

157

Orphenadrine citrate

158

Orphenadrine hydrochloride

159

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

160

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

161

Oxymetazoline

162

Oxytetracycline

163

Oxytetracycline calcium

164

Oxytetracycline dihydrate

165

Oxytetracycline hydrochloride

166

Paracetamol label (3)

167

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

168

Phenazone

169

Phenazone and derivatives

170

Phenazone salicylate

171

Phenindamine tartrate

172

Pheniramine maleate

173

Phenylephrine hydrochloride

174

Piperazine & its salts

175

Piroxicam

176

Pizotifen

177

Pizotifen hydrogen maleate

178

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

179

Polymyxin B sulphate

180

Polyvinyl alcohol

181

Potassium chloride

182

Potassium chloride (except injectable Schedule 2)

183

Potassium citrate

184

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

185

Proguanil hydrochloride for prophylaxis of malaria Labelling for malaria prophylaxis

186

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

187

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

188

Pseudoephedrine and its salts (except in preparations for internal use with md 60mg and mdd 180mg Schedule 3)

189

Pseudoephrine hydrochloride

190

Pseudoephrine sulphate

191

Pyrantel and its salts

192

Pyrantel embonate

193

Pyrantel tartrate

194

Quinine and its salts (except in preparations for internal use md 100mg (calculated as base) and mdd 300mg (calculated as base) Schedule 3)

195

Ranitidine hydrochloride

196

Salbutamol

197

Salbutamol sulphate

198

Sildenafil

199

Siver sulphadiazine

200

Sodium apolate in preparations for external use

201

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

202

Sodium cromoglycate

203

Sodium fluoride:

204

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

205

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

206

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

207

Streptodornase in preparations for external use

208

Streptokinase in preparations for external use

209

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

210

Sulphacetamide

211

Sulphacetamide sodium

212

Terbinafine

213

Terfenadine

214

Tetracycline

215

Tetracycline hydrochloride

216

Tetracycline phosphate complex

217

Tetrahydrozoline

218

Tetryzoline Hydrochloride

219

Theophylline

220

Thiabendazole

221

Tildenafil

222

Tinidazole

223

Tioconazole

224

Tyrothricin in throat lozenges or throat pastilles

225

Vardenafil

226

Zinc Bacitracin

 

(4) SCHEDULE 4 MEDICINES

NO.

NAME OF THE MEDICINE

1

8-Hydroxyquinoline

2

Aluminium and its salts

3

Alverine Citrate

4

Amino Acids

5

Ammonium Chloride

6

Amyl-M-Cresol

7

Aniseed Oil

8

Arachis Oil

9

Ascorbic acid in preparations for non-parenteral use

10

Benzoic Acid

11

Benzydamine Hydrochloride

12

Benzyl Benzoate

13

Bisacodyl

14

Boric acid

15

Caffeine

16

Calcium and its salts

17

Camphor

18

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

19

Carboxymethylcellulose Sodium

20

Castor Oil

21

Cetalkonium Chloride

22

Cetrimide

23

Cetylpyridinium Chloride

24

Chlorbutol

25

Chlorhexidine:

26

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

27

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

28

Cinnamon Oil

29

Coal Tar

30

Crotamiton

31

Dimethicone

32

Docusate Sodium

33

Eucalyptus Oil

34

Folic acid in preparations for internal use and mdd 200 micrograms

35

Gentian Violet

36

Glycerol

37

Guaifenesin

38

Hexachlorophene: in preparations for external use and:

39

Hexachlorophene: in preparations for external use and:(a) in soaps with ms 0.1% label (6)

40

Hexachlorophene: in preparations for external use and:(b) in aerosols with ms 0.1% label (6)

41

Hexachlorophene: in preparations for external use and:(c) in medicines other than soaps or aerosols with ms 0.1% label (6)

42

Hydroxyquinoline sulfate

43

Ichthammol

44

Kaolin

45

Lactulose

46

Liquid Paraffin

47

Magaldrate

48

Magnesium and its salts

49

Magnesium trisilicate

50

Menthol

51

Methyl Salicylate

52

Monosulfiram

53

Oral Rehydration Salts

54

Paracetamol in tablet preparations with ms 500mg and not more than 30 tablets label (3)

55

Pectin

56

Phenol

57

Phenolphthalein

58

Podophyllum Indian

59

Podophyllum resin

60

Potassium hydroxyquinoline sulfate

61

Povidone-Iodine

62

Pyridoxine

63

Salicylic Acid

64

Selenium Sulphide

65

Sennosides A – B

66

Simethicone

67

Sodium Bicarbonate

68

Sodium Chloride

69

Sodium fluoride in dentifrices and ms 0.33%

70

Sodium monofluorophosphate in dentifrices and ms 1.14%

71

Stannous fluoride in dentifrices and ms 0.62%

72

Tartaric Acid

73

Trace Elements (except for parenteral use Schedule 2)

74

Turpentine Oil

75

Undecenoic Acid

76

Urea

77

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

78

Vitamin A in: (b) preparations for external use

79

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

80

Vitamin A acetate in: (b) preparations for external use

81

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

82

Vitamin A palmitate in: (b) preparations for external use

83

Vitamin D in:(a) preparations for internal use with mdd 10 mcg

84

Vitamin D in:(b) preparations for external use

85

Vitamins, mixed in non-parenteral preparations

86

Zinc Chloride

87

Zinc Oxide

88

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

 

NOTES

Explanation of abbreviations and other phrases used in lists of medicines

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.

SCHEDULE 2
PRECURSOR CHEMICALS

(reg. 47)

 

Precursor chemicals in Tables I and II of the 1988 Convention

Table I

Acetic anhydride

N-Acetylanthranilic acid

Ephedrine

Ergometrine

Ergotamine

Isosafrole

Lysergic acid

3,4-Methylenedioxyphenyl-2-propanone

Norephedrine

Phenylacetic acid

alpha-Phenylacetoacetonitrile

1-Phenyl-2-propanone

Piperonal

Potassium permanganate

Pseudoephedrine

Safrole

Note: The salts of the substances are listed in the table whenever the existence of such salts is possible.

Table II

Acetone

Anthranilic acid

Ethyl ether

Hydrochloric acid

Methyl ethyl ketone

Piperidine

Sulphuric acid

Toluene

Note: The salts of the substances listed in the table whenever the existence of such salts is possible.

SCHEDULE 3
BANNED MEDICINES

(reg. 69)

 

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-(methyIenedioxy) 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.

SCHEDULE 4
FORMS

(regs. 3, 5, 9, 11, 16, 17, 18, 19, 20, 21, 22, 24, 26, 27, 28, 32, 50, 54, 55, 60, 61, 64 and 66)

<OB:FO:”_14BF8A77E481A36″,5.45972,7.06667; SD:255,255,255><OB:FO:”_FF109A77E481A36″,5.45972,7.72014; SD:255,255,255><OB:FO:”_204AE2A77E481A37″,5.45972,7.72014; SD:255,255,255><OB:FO:”_305895A77E481A37″,5.45972,7.10972; SD:255,255,255><OB:FO:”_3F82D0A77E481A37″,5.45972,7.92361; SD:255,255,255><OB:FO:”_4F9B85A77E481A38″,5.45972,1.85972; SD:255,255,255><OB:FO:”_54C790A77E481A38″,5.45972,7.76319; SD:255,255,255><OB:FO:”_659B4BA77E481A38″,5.46389,7.94583; SD:255,255,255><OB:FO:”_772096A77E481A39″,5.45972,7.94306; SD:255,255,255><OB:FO:”_884AEAA77E481A39″,5.45972,7.94306; SD:255,255,255><OB:FO:”_99AFD4A77E481A39″,5.45972,7.94306; SD:255,255,255><OB:FO:”_AB0832A77E481A3A”,5.45972,7.94306; SD:255,255,255><OB:FO:”_BCF678A77E481A3A”,5.45972,7.94306; SD:255,255,255><OB:FO:”_CDFB4CA77E481A3A”,5.45972,7.94306; SD:255,255,255><OB:FO:”_DE9174A77E481A3B”,5.25347,4.69306; SD:255,255,255><OB:FO:”_E812F9A77E481A3B”,5.25347,5.70694; SD:255,255,255><OB:FO:”_F384FEA77E481A3B”,5.25347,7.84653; SD:255,255,255><OB:FO:”_102FA4AA77E481B0″,5.25347,6.99306; SD:255,255,255><OB:FO:”_1105056A77E481B0″,5.34028,2.64653; SD:255,255,255><OB:FO:”_115CD8BA77E481B0″,5.34028,5.65972; SD:255,255,255><OB:FO:”_121D9E0A77E481B0″,5.34028,7.97986; SD:255,255,255><OB:FO:”_1311EC6A77E481B1″,5.34028,1.39028; SD:255,255,255><OB:FO:”_13421A6A77E481B1″,5.34028,7.38681; SD:255,255,255><OB:FO:”_14347C2A77E481B1″,5.34028,7.80972; SD:255,255,255><OB:FO:”_152A440A77E481B1″,5.34028,5.92639; SD:255,255,255><OB:FO:”_15EBAFBA77E481B1″,5.34028,7.87986; SD:255,255,255><OB:FO:”_16E77F1A77E481B2″,5.34028,7.39306; SD:255,255,255><OB:FO:”_17D1ED5A77E481B2″,5.34028,4.61319; SD:255,255,255><OB:FO:”_186AB6CA77E481B2″,5.34028,7.69028; SD:255,255,255><OB:FO:”_1962738A77E481B3″,5.34028,6.37986; SD:255,255,255><OB:FO:”_1A2F161A77E481B3″,5.45972,7.88333; SD:255,255,255><OB:FO:”_1B27BC9A77E481B3″,5.45972,3.17361; SD:255,255,255><OB:FO:”_1B9B504A77E481B3″,5.45972,7.92986; SD:255,255,255><OB:FO:”_1C9E262A77E481B4″,5.45972,8.15972; SD:255,255,255><OB:FO:”_1DA6E1EA77E481B4″,5.45972,7.74028; SD:255,255,255><OB:FO:”_1EA1C66A77E481B4″,5.45972,8.25; SD:255,255,255><OB:FO:”_1FB4210A77E481B5″,5.45972,7.94028; SD:255,255,255><OB:FO:”_20B23ACA77E481B5″,5.45972,6.4; SD:255,255,255><OB:FO:”_21853F6A77E481B5″,5.45972,7.83681; SD:255,255,255><OB:FO:”_227F7F0A77E481B5″,5.45972,6.70972; SD:255,255,255><OB:FO:”_235AEEEA77E481B6″,5.45972,5.45347; SD:255,255,255><OB:FO:”_24094A3A77E481B6″,5.45972,3.35; SD:255,255,255><OB:FO:”_24819F0A77E481B6″,5.45972,7.62986; SD:255,255,255><OB:FO:”_257045AA77E481B6″,5.45972,1.28681; SD:255,255,255><OB:FO:”_25A6872A77E481B6″,5.45972,7.75972; SD:255,255,255><OB:FO:”_269E3B4A77E481B7″,5.45972,2.20694; SD:255,255,255><OB:FO:”_26EC2F8A77E481B7″,5.45972,4.88333; SD:255,255,255><OB:FO:”_2799EDFA77E481B7″,5.45972,7.37639; SD:255,255,255><OB:FO:”_288437BA77E481B7″,5.45972,1.57361; SD:255,255,255><OB:FO:”_28C68B1A77E481B7″,5.45972,4.93681; SD:255,255,255><OB:FO:”_296B864A77E481B8″,5.45972,7.48681; SD:255,255,255><OB:FO:”_2A695E4A77E481B8″,5.45972,7.98333; SD:255,255,255><OB:FO:”_2B706FAA77E481B8″,5.45972,6.12361; SD:255,255,255><OB:FO:”_2C4D463A77E481B8″,5.45972,8.12361; SD:255,255,255><OB:FO:”_2D5EC77A77E481B9″,5.45972,8.12361; SD:255,255,255><OB:FO:”_2E75AA9A77E481B9″,5.45972,7.67014; SD:255,255,255><OB:FO:”_2F81BEBA77E481B9″,5.45972,7.92986; SD:255,255,255><OB:FO:”_30945E1A77E481BA”,5.45972,7.56667; SD:255,255,255><OB:FO:”_31867E7A77E481BA”,5.46389,3.3; SD:255,255,255><OB:FO:”_3200D96A77E481BA”,5.45972,7.73681; SD:255,255,255><OB:FO:”_32FEE3AA77E481BB”,5.45972,6.83333; SD:255,255,255><OB:FO:”_33E1E40A77E481BB”,5.45972,8.05; SD:255,255,255><OB:FO:”_34EFBC0A77E481BB”,5.45972,7.59028; SD:255,255,255><OB:FO:”_35E04E6A77E481BB”,5.31667,4.19306; SD:255,255,255><OB:FO:”_366DDCDA77E481BC”,5.31667,6.19028; SD:255,255,255><OB:FO:”_3730EBAA77E481BC”,5.31667,4.37639; SD:255,255,255><OB:FO:”_37C7499A77E481BD”,5.31667,7.74028; SD:255,255,255><OB:FO:”_38C8DB9A77E481BE”,5.31667,7.87986; SD:255,255,255><OB:FO:”_39C5EA9A77E481BF”,5.31667,4.37361; SD:255,255,255><OB:FO:”_3A54BD4A77E481B10″,5.31667,7.62639; SD:255,255,255><OB:FO:”_3B3F652A77E481B10″,5.31667,7.62639; SD:255,255,255><OB:FO:”_3C2F522A77E481B11″,5.31667,7.62639; SD:255,255,255><OB:FO:”_3D1F534A77E481B11″,5.31667,6.12361; SD:255,255,255><OB:FO:”_3DE2C63A77E481B12″,5.31667,6.12361; SD:255,255,255><OB:FO:”_3EA4FE2A77E481B12″,5.31667,6.87639; SD:255,255,255><OB:FO:”_3F7A156A77E481B12″,5.31667,3.87639; SD:255,255,255

SCHEDULE 5
FEES

<OB:FO:”_48453A77E49A24NEW”,5.31319,7.69028; SD:255,255,255

<OB:FO:”_4100C65A77E481B13″,5.31667,7.78681; SD:255,255,255><OB:FO:”_41F8BB7A77E481B13″,5.31667,7.78681; SD:255,255,255><OB:FO:”_42F3CF3A77E481B13″,5.31667,6.92014; SD:255,255,255><OB:FO:”_43D030DA77E481B13″,5.31667,6.74306; SD:255,255,255><OB:FO:”_44A4677A77E481B14″,5.31667,5.4; SD:255,255,255><OB:FO:”_45536B2A77E481B14″,5.31667,7.89653; SD:255,255,255><OB:FO:”_465246AA77E481B14″,5.31667,8.05; SD:255,255,255><OB:FO:”_475632EA77E481B14″,5.04306,8.05; SD:255,255,255

<OB:FO:”_483FDF4A77E481B15″,5.15625,1.86458; SD:255,255,255

SCHEDULE 6
LIST OF GUIDLINES

(reg. 2)

(As published in the Authority’s Website)

 

Human:

1. Botswana Quality Registration Guidelines (reg. 3, reg. 67)

2. Botswana Bioequivalence/Interchangeability Guidelines (reg. 3)

3. Botswana Variation Guideline (reg. 11 and reg. 12)

4. Botswana Renewal Guideline (reg. 5)

5. SADC Registration Guidelines for Human Medicines (reg. 3)

6. WHO Prequalification Guidelines (reg. 3)

7. WHO Biosimilars Guidelines (reg. 3)

8. WHO Variation Guidelines (reg. 11 and reg. 12)

9. EMA Variation Guidelines (reg. 11, reg. 12)

10. ICH Guidelines (reg. 3, reg. 11 and reg. 12)

11. US FDA Guidelines (reg. 3, reg. 11 and reg. 12)

12. EMA Scientific Guidelines for Human Medicines (reg. 3, reg. 11 and reg. 12)

13. EMA Scientific Guidelines on Biological Human Medicines (reg. 3 and reg. 11)

14. Guidelines for donation of unregistered medicines (reg. 10)

15. SADC Product Information Guidelines

16. Minister’s Guidelines on Dispensing and Prescribing of Medicines

Veterinary:

1. Veterinary Medicines Registration Guidelines

Complementary Medicines

1. Botswana Complementary Medicines Registration Guidelines (reg. 66)

2. Botswana Complementary Medicines Variation Guidelines (reg. 66)

3. Botswana Complementary Medicines Renewal Guidelines (reg. 66)

Cosmetics:

1. Botswana Cosmetics Registration Guidelines (regs. 60, reg. 61, 62, 63, 64 and reg. 65)

Inspections and Licensing Guidelines

1. Guidelines for licensing pharmacy operations (reg. 16, 17, 18, 19, 20, 24, 25, 26, 54 and 55)

2. Guidelines for dispensaries in surgeries and Institutional dispensaries (regs. 21, 22, 23, 24, 54 and 55)

3. Guidelines for licensing medicines wholesale operation (regs. 19, 20, 24, 25, 26, 54 and 55)

4. WHO GMP Guidelines (regs. 17, 18, 24, 25, 26, 54 and 55)

5. WHO GCP Inspections Guideline (reg. 55 and 57)

6. Guideline for licensing Veterinary Medicinal Products Retailing (Veterinary Regulations)

Import and export:

1. Import and Export Guidelines (regs. 26, 27, 28, 29, 50, 51, 52 and 53)

Clinical Trials:

1. Botswana Guidelines for Clinical Trials (regs. 55, 56, 57, 58 and 59)

Pharmacovigilance:

1. Pharmacovigilance Guidelines

Advertising and Promotion:

1. Advertising and Promotion Guidelines

MEDICINES AND RELATED SUBSTANCES (PROHIBITION OF USE OF CERTAIN MEDICINES IN ANIMALS) ORDER

(section 50(3))

(19th April, 2024)

ARRANGEMENT OF PARAGRAPHS

    PARAGRAPH

    1.    Citation

    2.    Prohibition of use of certain medicines in animals

    3.    Revocation of Statutory Instrument No. 76 of 2020

S.I. 50, 2024.

1. Citation

This Order may be cited as the Medicines and Related Substances (Prohibition of Use of Certain Medicines in Animals) Order.

2. Prohibition of use of certain medicines in animals

Any person who uses in animals, any substance in the first column, commits an offence and is liable to the penalty set out under section 50(4) of the Act—

 

Substance

Exception

Amantadine

 

Aristolochia spp. and preparations thereof

 

Baloxavir marboxil

 

Carbapenems

 

Carboxypenicillins

 

Ceftaroline

 

Ceftobiprole

 

Celgosivir

 

Chloramphenicol

Animals not intended to produce food

Chlorfenvinphos

Animals not intended to produce food

Chloroform

 

Chlorpromazine

Animals not intended to produce food

Clenbuterol

Animals not intended to produce food

Colchicine

Animals not intended to produce food

Colistin

 

Combinations of cephalosporins
with beta-lactamase inhibitors

 

Dapsone

 

Diclofenac

 

Dichlorophen

 

Dimetridazole

 

Diminazine

Treatment of biliary fever in canines

Eravacycline

Estradiol 17 ß

Animals not intended to produce food, treatment of pyopmetra, fetal maceration or mummification in cattle

Favipiravir

 

Fidaxomicin

Fipronil

Galidesivir

Gentian violet (in food or feed of all
food-producing animals species)

Glycopeptides

Glycopeptides- all agents, including vancomycin

Animals not intended to produce food

Glycylcyclines

Isoflupredone

Animals not intended to produce food

Lactimidomycin

Laninamivir

Lipopeptides

Methisazone/metisazone Molnupiravir

Monobactams

 

Nitazoxanide

 

Nitrofurans (including furazolidone)

Animals not intended to produce food

Nitroimidazoles – all agents, including Dimetridazole, ipronidazole, metronidazole

Small animal medicine

Omadacycline

Oseltamivir

Oxazolidinones

Penems

Peramivir

Phenylbutazone

Equids not intended for slaughter

Piperazine

Equids not intended for slaughter

Phosphonic acid derivates

 

Plazomicin

 

Resorantel

 

Ribavirin

 

Rimantadine

 

Ronidazole

 

Siderophore cephalosporins

 

Tizoxanide

 

Triazavirin

 

Umifenovir

 

Ureidopencillins

 

Zanamivir

 

 

3. Revocation of Statutory Instrument No. 76 of 2020

Statutory Instrument No. 76 of 2020 is hereby revoked.

ATTORNEY GENERAL’S CHAMBERS

Botswana e-Laws Online

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