English — original text

4th December, 1998 375 GOVERNMENT NOTICE NO. 88 PHARMACY, MEDICINES AND POISONS ACT (CAP. 35:01) PHARMACY, MEDICINES AND POISONS REGULATIONS, 1998 ARRANGEMENT OF REGULATIONS REGULATION PART I—PRELIMINARY 1. Citation 2. Interpretation PART II—FORMS 3. Particulars, etc., on forms 4. Illegible or incomplete forms PART III—LICENSING OF PREMISES AND PERSONS 5. Minimum requirements for premises, etc. 6. Dispensing licences 7. Duration of licences 8. Display of licences 9. Production and return of licences 10. Application for renewal of licences PART IV—CLASSIFICATION, REGISTRATION AND RETENTION OF REGISTRATION OF MEDICINAL PRODUCTS 11. Categories for registration 12. Application for registration and retention of registration of medicinal products 13. Labelling and marking of medicinal products 14. Package inserts 15. Categories for distribution 16. Medicinal products register 17. Certificate of registration for medicinal products 18. Production and return of registration certificates for medicinal products PART V—GENERAL CONDITIONS FOR SALE OF MEDICINAL PRODUCTS 19. Importation of medicinal products with less than one half of shelf-life 20. Delivery and sale of medicinal products with less than one-half of shelf-life 21. Sale of expired medicinal products 22. Medicinal products to be sold from licensed premises 23. Conditions of sale of medicinal products 24. Disclosure of composition of medicinal products

376 4th December, 1998 25. Safe keeping of certain medicinal products 26. Return of medicinal products three months before expiry 27. Return of expired medicinal products 28. Dispensing of medicinal products 29. Labels for dispensed prescription only medicinal products 30. Limit of validity prescription 31. Copy of prescription 32. Records of prescription 33. Preservation of records of prescription 34. Restriction on advertising medicinal products PART VI—SPECIAL CONDITIONS OF SALE FOR PRESCRIPTION ONLY MEDICINES, PHARMACIST INITIATED MEDICINES, PHARMACY MEDICINES, GENERAL SALES LIST MEDICINES AND VETERINARY MEDICINES Division 1—Prescription Only Medicines (POM) 35. Possession of prescription only medicines 36. Supply of prescription only medicines 37. Dispensing of prescription only medicines 38. Storage and safe custody of prescription only medicines Division 2—Pharmacist Initiated Medicines (PIM) and Pharmacy Medicines (P) 39. Supply of pharmacist initiated medicines and pharmacy medicines Division 3—General Sales List Medicines (GSL) 40. Sale of General Sales List Medicines Division 4—Veterinary Medicines 41. Sale of veterinary medicines 42. Conditions of sale of veterinary medicines 43. Use of veterinary medicines on human beings PART VII—SPECIAL PROVISIONS FOR INSTITUTIONS 44. Supply of medicinal products from institutions to out-patients 44. Supply of medicinal products for use within institutions 46. Storage and handling of medicinal products in institutions PART VIII—MISCELLANEOUS PROVISIONS 47. Withdrawal of medicinal products 48. Report of loss or theft of medicinal products 49. Disposal of existing stocks of prohibited medicinal products 50. Availability of Act and regulations FIRST SCHEDULE SECOND SCHEDULE THIRD SCHEDULE FOURTH SCHEDULE

4th December, 1998 377 FIFTH SCHEDULE SIXTH SCHEDULE SEVENTH SCHEDULE EIGTH SCHEDULE NINTH SCHEDULE TENTH SCHEDULE IN EXERCISE of the powers conferred by section 66 of the Pharmacy, Medicines and Poisons Act, I, HARRY THOMSON, Minister of Health and Population, on the advice of the Pharmacy, Medicines and Poisons Board, make the following Regulations— PART I—PRELIMINARY Citation 1. These Regulations may be cited as the Pharmacy, Medicines and Poisons Regulations, 1998. Interpretation 2. In these Regulations, unless the context otherwise requires— “batch number” means the number or other cipher allocated to medicinal product by a manufacturer, by which the origin of raw materials and the complete process of manufacture of the medicinal product can be determined; “business address” in relation to a business, means the full address of the premises where that business is carried on or any abbreviated address approved by the Board; “country of origin” in relation to a medicinal product, means the country where the manufacture of that medicinal product was undertaken; “dangerous drug” or “Controlled Drugs” or “(CD)” means a drug— (a) controlled in terms of the Dangerous Drugs Act; (b) listed in the Tenth Schedule; or (c) registered as such by the Board; “expiry date”, in relation to any batch of a medicinal product, means the date on which the shelf-life of such medicinal product will expire; “general sales list medicine” or “GSL” means a medicinal product to which Division 3 of Part VI applies or a medicinal product registered as such by the Board; “logo” means the mark, device, design, letter, word, name or numeral or any combination thereof which is used in, or proposed to be used, in relation to, any medicinal product for the purpose of indicating a connexion with the principal manufacturer of the medicinal product and the medicinal product itself; “institution” means a hospital, dispensary, clinic, nursing home or other institution at which human ailments are treated; “label”, in relation to a package of a medicinal product, means any written, pictorial or other matter marked on or affixed to the package;

378 4th December, 1998 “package insert” means a pamphlet on which is printed the particulars prescribed in regulation 15; “patent” means a patent registered in terms of the Patents Act and which is of full force and effect; “pharmacist initiated medicine” or “PIM” means a medicinal product listed in the Sixth Schedule or registered as such by the Board; “pharmacy medicine” or “(P)” means a medicinal product listed in the Seventh Schedule or registered as such by the Board; “prescriber” means a medical practitioner, a dentist, or a veterinary surgeon or any other person who is lawfully authorized to prescribe any medicinal product; “prescription” means an order, in writing or orally by a prescriber for the supply of a medicinal product or combination of medicinal products, for the treatment of a person or animal specified therein; “prescription only medicines” or “POM” means a medicinal product listed in the Fifth Schedule, or registered as such by the Board; “shelf-life”, in relation to any batch or a medicinal product, means the period up to which a medicinal product in that batch will retain the potency and properties stated on the label as fixed by the manufacturer. PART II—FORMS Particulars, etc., on forms 3.—(1) Every person who is required to make an application under the Act shall complete the prescribed form and pay the prescribed fees, and shall furnish to the Registrar with such further information or particulars as may be prescribed. (2) All forms shall be completed in English. Illegible or incomplete forms 4. The Registrar may reject any form if any part of the form is illegible or not properly completed. PART III—LICENSING OF PREMISES AND PERSONS Minimum requirements for premises, etc. 5. Any person who applies for registration under the Act shall ensure that the premises comply with— (a) in the case of manufacturing pharmacy business, the minimum requirements set out in Part I of the First Schedule; (b) in the case of wholesale pharmacy business, the minimum requirements set out in Part II of the First Schedule; (c) in the case of retail pharmacy business, the minimum requirements set out in Part III of the First Schedule; (d) in the case of an institution, the minimum requirements set out in Part III of the First Schedule; (e) in the case of a registered dispensing practitioner, the minimum requirements set out in Part IV of the First Schedule; and (f) in the case of a medicine store, the minimum requirements set out the Part V of the First Schedule.

4th December, 1998 379 Dispensing licences 6. An application for a dispensing licence to dispense medicinal products from any premises in accordance with section 35 (4) of the Act shall not be granted where such premises are situated within five kilometres of a pharmacy: Provided that the Board may waive this requirement where the Board considers it in the public interest so to do. Duration of licences 7. Every licence which is issued in respect of premises or to any person pursuant to the Act shall be valid for a period of one year from the date of issue, and may be renewed annually thereafter. Display of licences 8.—(1) Subject to subregulation (2), every licensee shall ensure that his licence is prominently displayed at all times upon the licensed premises to which it relates. (2) Subregulation (1) shall not apply in respect of any period during which the licence is necessarily removed from the licensed premises for the purposes of doing anything in terms of the Act or for any other lawful purpose the proof thereof, in any proceedings against any person for contravention of subsection (1), shall lie upon that person. Production and return of licences 9.—(1) Whenever the Board— (a) cancels any licence; (b) varies or amends the conditions of any licence; or (c) imposes any new condition in respect of or on the renewal of any licence, the Registrar shall request the holder of the licence to produce such licence within such period as the Registrar may specify, and the holder thereof shall produce such licence within the specified period. (2) Any person who fails to comply with a request made in accordance with subregulation (1) shall be guilty of an offence. (3) Whenever the Board varies, amends or imposes any new condition in respect of a licence, the Board shall return such licence duly endorsed to the holder thereof within a reasonable time. Application for renewal of licences 10.—(1) Every application for the renewal of a licence shall be— (a) in the prescribed form; (b) lodged with the Registrar at least two months before the expiry of the licence; and (c) accompanied by the appropriate fee in respect of the licence. (2) If an application for the renewal of a licence is lodged with the Registrar after the time limit as specified in subregulation (1) there shall be paid in addition to the renewal fee an appropriate penalty fee in respect of the licence as determined by the Board. PART IV—CLASSIFICATION, REGISTRATION AND RETENTION OF REGISTRATION OF MEDICINAL PRODUCTS Categories for registration 11. For the purpose of registration, the Board shall divide medicinal products into the categories specified in the Second Schedule.

380 4th December, 1998 Application for registration and retention of registration of medicinal products 12.—(1) An application for the registration of a medicinal product may be made by— (a) the person who owns the medicinal product; or (b) any other person registered by the Board. (2) Every application for the registration of a medicinal product shall be submitted to the Registrar in the prescribed form and shall be accompanied by— (a) a sample of the medicinal product in the smallest of each of the package forms available for distribution to the public, including the identification marks on such product where appropriate, or if the package forms are not yet available, a sample in a package in which the applicant intends to make the medicinal product available for distribution to the public; (b) detailed information of all advertising material and package inserts which the applicant intends to use; (c) such samples of the medicinal product or the raw materials thereof as the Board may request for analysis; (d) a copy of any literature in support of the application: Provided that the Board may require additional copies of such literature; (e) twenty additional package inserts and twenty labels or copies of the package; (f) at least three copies of all records and batch data relating to a particular batch, which shall include raw material analytical reports, master sheets relating to manufacture and packaging in process control records, final product analytical records and authorized for release, and any other relevant records; and (g) the prescribed fee, together with such additional fees as the Board may require for the purpose of analysing the medicinal product. (3) Every applicant shall, without delay, inform the Board either before or after the registration of a medicinal product— (a) of any alteration of the information or particulars furnished by him in applying for registration in terms of subsection (2); and (b) whether the medicinal product is to be imported as a finished product into, or relabelled or repackaged or dealt with in any other manner, in Malawi. (4) For the purposes of paragraph (b) of subsection (3), “finished product”, in relation to a medicinal product, means a medicinal product which is wholly manufactured outside Malawi and is imported into Malawi ready for sale without having to be relabelled or repackaged. (5) An application for the retention of the registration of a registered medicinal product shall be submitted to the Registrar, in prescribed form at least two months before the expiry of the licence and shall be accompanied by the prescribed fee.

4th December, 1998 381 Labelling and marking of medicinal products 13.—(1) Subject to regulation 29, every medicinal product shall, unless otherwise directed by the Board, bear or incorporate a label on the package in which the medicinal product is sold, on which is printed in clear and indelible letters in the English language and any other language as may be directed or approved by the Board the following particulars which relate to that medicinal product— (a) the name and address of the person who owns the medicinal product; (b) the name and address of the manufacturer; (c) the approved name of the medicinal product and the proprietary name or trade mark, if any, of the medicinal product; (d) the logo, if any, of the person who owns the medicinal product or manufacturer of the medicinal product; (e) the name and percentage of any bacteriostatic or bactericidal agent which is added to the medicinal product as a preservative; (f) the date of manufacture and the expiry date of the medicinal product; (g) the batch number of the medicinal product; (h) the quantity of the medicinal product, in the package; (i) the strength of the medicinal product; (j) the required storage conditions or other necessary precautions for the preservation of the medicinal product; (k) the category of distribution of the medicinal product which may be represented by words or symbols as set out in the Third Schedule; (l) the dosage of the medicinal product and the directions for use; (m) any warning notices which shall be in a colour or print other than the colour or print of the particulars referred to in subparagraph (a) to (l); and (n) any other particulars as may be directed by the Board: Provided that in the case of a small package containing a medicinal product, it shall be adequate to record the information required by paragraphs (c), (f), (g), (h), and on the outer label. (2) Every medicinal product shall where possible be marked with the logo of the owner of the medicinal product or manufacturer of the medicinal product, as the case may be, and such other distinguishing mark for the purpose of identifying such medicinal product. Package inserts 14. Every package of a medicinal product shall, unless otherwise directed by the Board, contain a package insert on which is printed in clear and indelible letters in the English language and any other language as may be directed or approved by the Board the following particulars which relate to medicinal product— (a) the name and address of the owner of the medicinal product; (b) the name and address of the manufacturer of the medicinal product;

382 4th December, 1998 (c) the approved name of the active ingredient of the medicinal product and the proprietary name or trade mark, if any, of the medicinal product; (d) the logo, if any, of the owner of the medicinal product or manufacturer of the medicinal product; (e) the name and percentage of any bacteriostatic or bactericidal agent which is added to the medicinal product as a preservative; (f) the strength of the medicinal product, where applicable; (g) the required storage conditions or other necessary precautions for the preservation of the medicinal product; (h) the category of distribution of the medicinal product which may be represented by words or symbols as set out in Third Schedule; (i) the pharmacological classification of the medicinal product determined in accordance with regulation 11; (j) the dosage of the medicinal product and the directions for use; (k) the description of the pharmacological action of the medicinal product; (l) indications of the medicinal product; (m) contra-indications of the medicinal product; (n) warnings relating to the use of the medicinal product; (o) the side-effects and special precautions of the medicinal product; (p) known symptoms of over-dosage and particulars of its treatment; (q) the identification of the medicinal product; (r) the form in which the medicinal product is presented, whether tablet, capsule or liquid and the colour thereof, (s) the date of publication of the package insert; (t) any necessary warning concerning the administration or use of the medicinal product by children, old people, pregnant women or patients suffering from certain diseases, or the use of the medicinal product in conjunction with the consumption of alcohol or any particular food or any other medicinal product; (u) a summary of relevant information concerning the purpose and the beneficial, detrimental, injurious or other effects of the medicinal product, and the possible dangers that may arise from the prolonged use of the medicinal product; (v) relevant information, including particulars in regard to a specific medicinal product as an antidote (if known), concerning the treatment of a patient in cases where an overdose of the medicinal product has been administered or where a patient reacts adversely to the medicinal product; and (w) any other particulars or warning notices as may be directed by the Board.

4th December, 1998 383 Categories for distribution 15.—(1) Where the Board approves the registration of a medicinal product it shall fix, as a condition of registration, the appropriate category for distribution of that medicinal product, prescribed in the Third Schedule. (2) The same categories for distribution of a medicinal product shall apply to veterinary medicines and shall be identified by the suffix “(VET)”. Medicinal products register 16. The Registrar shall enter in the register in respect of each medicinal product registered by the board— (a) the date of the application for registration of the medicinal product; (b) the number allocated to the application for registration; (c) the proprietary name or trade mark of the medicinal product, if any; (d) the logo of the owner of the medicinal product or manufacturer of the medicinal product, if any; (e) the particulars of the patent of the medicinal product, if any; (f) the approved name of the medicinal product; (g) the form in which the medicinal product is presented, whether tablet, capsule or liquid and the colour thereof; (h) the strength of the medicinal product; (i) the qualitative and quantitative details of every ingredient in each dosage unit of the medicinal product; (j) the name and business address of the owner of the medicinal product; (k) the name and business address of the manufacturer of the medicinal product; (l) the country of origin of the medicinal product; (m) the name and address of the applicant; (n) the number allocated to the inspection report of the place of manufacture, if applicable; (o) the date of registration of the medicinal product; (p) the registration number of the medicinal product; (q) the shelf-life of the medicinal product; (r) the category for distribution of the medicinal product fixed in accordance with regulation 15 and any other conditions of registration; (s) the pharmacological classification of the medicinal product determined in accordance with regulation 11; (t) the date and particulars of any variation in the conditions of registration of the medicinal product; (u) the payment of any fee for the retention or registration of the medicinal product; and

384 4th December, 1998 (v) where applicable, the date of the cancellation of the registration of the medicinal product. Certificate of registration for medicinal products 17. After registering a medicinal product, the Registrar shall issue a certificate of registration in prescribed form. Production and return of registration certificate for medicinal products 18.—(1) Whenever the Board— (a) cancels the registration of any medicinal product; (b) varies or amends the conditions of registration of any medicinal product; or (c) imposes any new conditions on the registration of any medicinal product, the Registrar shall request the holder of the registration certificate concerned to produce such certificate within a reasonable period as the Registrar may specify and the holder thereof shall produce such certificate within the specified period. (2) Any person who fails to comply with a request made in accordance with subsection (1) shall be guilty of an offence. (3) Whenever the Board varies, amends or imposes any new condition on any registration certificate, the Board shall return such certificate, duly endorsed, to the holder thereof within a reasonable period. PART V—GENERAL CONDITIONS FOR SALE OF MEDICINAL PRODUCTS Importation of medicinal products with less than one-half of shelf-life 19. No person shall, without the prior written approval of the Board, import into Malawi any medicinal product which has less than one-half of its shelf-life remaining upon arrival in Malawi. Delivery and sale of medicinal products with less than one-half of shelf-life 20. No person shall, without the prior written approval of the Board, deliver, receive, accept or sell any medicinal product whose shelf-life is less than one-half. Sale of expired medicinal products 21. No person shall sell any medicinal product on a date later than the expiry date which appears on the package of such medicinal product. Medicinal products to be sold from licensed premises 22. No person shall sell any medicinal product unless the sale is effect on premises— (a) licensed under the Act; or (b) authorized in terms of these Regulations: Provided that this regulation shall not apply to the sale of general sales list medicines. Conditions of sale of medicinal products 23. No person shall sell any medicinal product unless— (a) he is authorized to do so; or (b) the sale is effected by or under the continuous personal supervision of an authorized person.

4th December, 1998 385 Disclosure of composition of medicinal product 24. No person shall sell any of the medicinal product which is not labelled in accordance with the requirements of regulation 13. Safe keeping of certain medicinal products 25.—(1) No person who sells any medicinal products listed in the Fifth, Sixth or Seventh Schedule shall keep such medicinal products on an open shelf in a part of his premises to which members of the public have access. (2) Any person who has in his possession or under his control or uses any medicinal product shall exercise all reasonable care in the custody, safe keeping and use thereof. Return of medicinal products three months before expiry 26.—(1) Any person who practices or carries on the business of a pharmacy or dispenses any medicinal product may, where a medicinal product is due to expire, return such medicinal product, not less than three months before the expiry date of such medicinal product, to the manufacturer, agent or distributor, as the case may be: Provided that the medicinal product shall be returned in its original unbroken package, as sealed by the manufacturer. (2) On receipt of medicinal products returned pursuant to subparagraph (1), the manufacturer, agent or distributor, as the case may be— (a) shall store such medicinal product in a quarantine area of his premises; and (b) may reimburse the person who returned the medicinal products by— (i) awarding a credit; or (ii) replacing such surrendered the returned medicinal products, to the person concerned. Return of expired medicinal products 27.—(1) Any person who practises or carries on the business of a pharmacist or dispenses any medicinal product shall, where a medicinal product has expired— (a) return such expired medicinal product to the manufacturer, agent or distributor, as the case may be; or (b) destroy such expired medicinal product on site in accordance with standard operating procedures. (2) On receipt of an expired medicinal product the manufacturer, agent or distributor, as the case may be, shall destroy the medicinal product in accordance with standard operating procedures. Dispensing of medicinal products 28.—(1) No person shall dispense any medicinal product in or from an area to which members of the public have access. (2) No person shall own, install or use or cause or permit the installation of, any machine designed or intended to be used to supply any medicinal product.

386 4th December, 1998 Labels for dispensed prescription only medicinal products 29. Every person who dispenses a prescription only medicine shall label such medicinal product with— (a) the registered name, strength and form of the medicinal product; (b) the total quantity of the medicinal product; (c) the directions for use; (d) any warnings; (e) the name of the patient; (f) the name of the prescriber; (g) the prescription reference number allocated to the prescription by the person dispensing the medicinal product; (h) the date on which the prescription only medicine is supplied; and (i) the name and address of the supplier. Limit of validity of prescription 30. No person shall dispense any prescription for the first time later than one month after the date of issue of the prescription. Copy of prescription 31. A copy of a prescription marked “copy—for information—not to be dispensed” may be given to the patient by the person who dispenses the prescription. Records of Prescription 32. The supplier of a prescription shall, on the day of which a prescription is dispensed or, if that is not reasonably practicable, on the business day next following that day, record in a manner acceptable to the Board, a complete copy of the prescription. Preservation of records of prescription 33. Every person who dispenses any medicinal product shall keep or cause to be kept a record of such dispensing for a period of two years and shall preserve such record on the premises in which the dispensing takes place: Provided that where the premises cease to be used or licensed such person shall make arrangements, acceptable to the Board, for the preservation or destruction of such records. Restriction on advertising medicinal products 34.—(1) No person shall advertise any medicinal product without the prior written approval of the Board. (2) No person shall advertise or sell any medicinal product to the public in connexion with any bonus offer or discount. (3) No person shall advertise any medicinal products to members of the public in terms calculated to lead to its use for the treatment of human beings for any of the conditions set out in the Fourth Schedule. PART VI—SPECIAL CONDITIONS OF SALE FOR PRESCRIPTION ONLY MEDICINES, PHARMACIST INITIATED MEDICINES AND PHARMACY MEDICINES, GENERAL SALES LIST MEDICINES AND VETERINARY MEDICINES Division 1—Prescription Only Medicines (POM) Possession of prescription only medicine 35.—(1) No person shall possess a prescription only medicine unless, in accordance with subregulation (2), he is a member of a class of persons authorized to be in possession thereof.

4th December, 1998 387 (2) The classes of persons who are authorized to be in possession of a prescription only medicine shall be— (a) in the case of a dangerous drug, any person who is authorized or licensed in terms of the Dangerous Drugs Act; (b) in the case of a prescription only medicine other than a dangerous drug— (i) prescriber; (ii) any person in the employ and acting under the personal supervision of a prescriber in so far as is necessary in the execution of his duties; and (iii) any person to whom the prescription only medicine has been supplied in accordance with a prescription by a prescriber. Supply of prescription only medicine 36.—(1) Subject to this regulation and regulation 37, no person shall supply any prescription only medicine listed in the Fifth Schedule otherwise than in accordance with the written prescription of a prescriber: Provided that where it is not reasonably practicable for a prescriber to furnish to the supplier such written prescription immediately, the prescription only medicine may be supplied on the oral direction of the prescriber on one occasion only, and the prescriber shall furnish to the supplier a written prescription within three days. (2) For the purpose of this regulation, a prescription shall— (a) bear the name, address and qualifications of the prescriber; (b) specify the name and address of the person for whom it is given or, if the prescription is issued by a veterinary surgeon, of the person for whose animal the prescription is issued; and (c) have written thereon— (i) if issued by a dentist, the words “for dental treatment only” or (ii) if issued by a veterinary surgeon, the words “for animal treatment only”; or (iii) if issued for topical application, the words “for external use only”; (d) if the person for whom the prescription is being issued is under the age of twelve years, state the person’s age; (e) be legibly written, in the handwriting of the prescriber, and contain the following particulars— (i) the date on which the prescription is issued; (ii) the registered name, strength and form of the medicinal product; (iii) the total daily dose of the medicinal product;

388 4th December, 1998 (iv) the total quantity of the medicinal product; and (v) the directions for use; (f) where the medicinal product is packed otherwise than in ampoules, indicate the total amount to be supplied and, except in the case of a medicinal product which is to be used for external treatment only the dose to be taken; (g) where the medicinal product is packed in ampoules, indicate either the total amount to be supplied or the total amount it is intended should be administered or injected and, in either case, the amount it is intended should be administered or injected in each dose; (h) not be for more than thirty days’ supply at the dosage indicated, and not authorize more than five further supplies of thirty days each: Provided that nothing in this paragraph shall apply to the supply of reasonable quantities of medicinal product to persons who intend to depart temporarily from Malawi: and (i) be signed in full by the prescriber issuing it. (3) In an emergency any pharmacist may sell any medicinal product listed in the Fifth Schedule at the request of any person, subject to the following conditions— (a) that the pharmacist by, or under whose supervision the medicinal product is to be sold, has satisfied himself— (i) that there is an immediate need for the medicinal product requested and that it is impracticable in the circumstances to obtain a prescription without undue delay; and (ii) that the medicinal product requested has on a previous occasion been prescribed by a medicinal practitioner, dentist or veterinary surgeon, as the case may be, for the person requesting it; (b) that not more than three days quantity of the medicinal product is sold: Provided that— (i) where a public holiday falls within the three-day period, a sufficient quantity of such medicinal product may be sold; and (ii) where the medical product is in a composite pack which exceeds three days supply a single pack may be sold; (c) that the pharmacist by or under whose supervision the medicinal product is sold, before he delivers such medicinal product makes an entry in his records stating— (i) the date on which the medicinal product is sold; (ii) the registered name, quantity, form and strength of the medicinal product; (iii) the name and address of the person requesting the medicinal product; (iv) the nature of the emergency; and (v) the name of the medicinal practitioner, dentist or veterinary surgeon, as the case may be, if ascertainable; and (d) that the medicinal product is labelled—

4th December, 1998 389 (i) in accordance with regulation 29; and (ii) with the words “Emergency Supply” Dispensing of prescription only medicines 37. Every person who dispenses a prescription only medicine shall ensure that— (a) the prescription is not dispensed more than once, unless the prescriber has directed otherwise and in such event the lawful instructions of the prescriber shall be complied with; and (b) at the time of dispensing, or where a prescription preparation has been supplied in accordance with the proviso to regulation 36 (1), on the subsequent receipt of the prescription, there is noted on the prescription the name and address of the supplier and the date on which the prescription is dispensed. Storage and safe custody of prescription only medicine 38.—(1) Every person who is authorized under regulation 35 (2) (b) to be in possession of a prescription only medicine keep such medicinal product in a place to which members of the public do not have access, and in a cupboard or drawer, or on a shelf reserved solely for the storage of such medicinal products. (2) Any person who is in possession of a prescription only medicine shall keep such medicinal product in a place to which children do not normally have access. Division 2—Pharmacist Initiated Medicines (PIM) and Pharmacy Medicines (PM) Sale of pharmacist initiated and pharmacy medicines 39.—(1) No person other than a pharmacist shall sell a pharmacist initiated medicine listed in the Sixth Schedule at the request of any person, and every such sale shall be subject to the following conditions— (a) that the pharmacist by or under whose supervision the medicinal product is sold, before he delivers such medicinal product, makes an entry in his records stating— (i) the name and address of the person requesting the medicinal product and the person for whom it is intended; (ii) if the person is under the age of twelve years, the age of the person; (iii) the date on which the medicinal product is sold; (iv) the registered name, quantity, form and strength of the medicinal product; (v) the total daily dose of the medicinal product; and (vi) the directions for use; and (b) that the medicinal product is labelled in accordance with regulation 13 as may be appropriate. (2) No person other than a pharmacist, or a person acting under the continous personal supervision of a pharmacist medicines in a medicine store, shall sell a pharmacy medicine listed in the Seventh Schedule.

390 4th December, 1998 Division 3—General Sales List Medicines (GSL) Sale of general sales list medicines 40. Any person may, subject to any other written law relating to the sale of goods, sell any general sales list medicine: Provided that such medicinal product is labelled in accordance with regulation 13 and is sold in original unbroken packs. Division 4—Veterinary Medicines Sale of veterinary medicines 41. The provisions of Division 1, 2 and 3 shall apply, mutatis mutandis, to the sale of veterinary medicines. Conditions of sale of veterinary medicines 42. The sale of veterinary medicines by an authorized dealer shall be in original unbroken packs, sealed by the manufacturer. Use of veterinary medicines 43. No person shall use any veterinary medicine for the treatment of human beings. PART VII—SPECIAL PROVISIONS FOR INSTITUTIONS Supply of medicinal products from institutions to outpatients 44. The provisions of Division 1 of Part VI shall apply to any medicinal product dispensed from an institution to an out-patient. Supply of medicinal products for use within institutions 45.—(1) In any institution in which medicinal products are dispensed in a dispensary or pharmaceutical department, no medicinal product shall be supplied from that dispensary or pharmaceutical department, except in cases of emergency, for use in wards, operating theatres or other sections of the institution, unless such medicinal product is supplied on the directions of a prescriber. (2) Every package of a medicinal product supplied under subsection (1) shall be labelled with— (a) the registered name, form, strength and quantity of the medicinal product; (b) the directions for use; (c) the name of the patient; (d) the date on which such medicinal product is supplied; and (e) the name of the prescriber. Storage and handling of medicinal products in institutions 46.—(1) Every medicinal product in an institution shall be stored in place to which no unauthorized person has access. (2) Every person who handles or distributes medicinal products in an institution shall ensure that no unauthorized persons have access to such medicinal products during the handling or distribution of such medicinal products. PART VIII—MISCELLANEOUS PROVISIONS Withdrawal of medicinal products 47.—(1) Where the Board is of the opinion that the withdrawal of any medicinal product is necessary for the protection of the public, the Board may require any person to withdraw such medicinal product in accordance with such procedures as the Board may determine.

4th December, 1998 391 (2) Every person who is in possession of a medicinal product required to be withdrawn under subregulation (1) shall comply with the procedure for the withdrawal of such medicinal product as determined by the Board. Report of loss or theft of medicinal products 48. Any person, other than a person to whom a prescription preparation is lawfully dispensed, who is in possession of any medicinal product and who misplaces or loses such medicinal product or from whom such medicinal product is stolen, shall report such loss or theft, as the case may be, to a police officer and to the Registrar as soon as is reasonably practicable, and in any case within twenty-four hours of the occurrence of the loss or theft. Disposal of existing stocks of prohibited medicinal products 49. If at any time any medicinal product becomes prohibited any person other than a person to whom a medicinal product is lawfully dispensed who is in possession of such medicinal product at the time shall inform the Board of his possession, and shall dispose of such medicinal product in such manner as the Board may direct. Availability of Act and regulations 50. A copy of the Act and these Regulations shall be available at all premises licensed under the Act. FIRST SCHEDULE PART I—MINIMUM REQUIREMENTS FOR PREMISES USED FOR MANUFACTURING PHARMACY BUSINESS 1. Premises 1.1 Premises should be sited to avoid contamination from the external environment or from other nearby activities and in existing premises, effective measures should be taken to avoid such contamination. 1.2 Animal houses should be well isolated from manufacturing areas. 1.3 Premises should be constructed and maintained so as to be protected against weather, ground seepage and the entrance and harbouring of vermin, birds and pests. 1.4 Premises should be designed and laid-out in such a way that the risk of mix-up or contamination of one product or material by another is minimized. This especially applies to premises for the handling of highly toxic or sensitizing materials such as hormones, cytotoxic agents and antibiotics. 1.5 Protection from the weather should be provided for receiving and despatch areas and for materials and products in transit. 1.6 Premises should be maintained in a good state of repair. The condition of buildings should be reviewed regularly and repairs effected where necessary. Special care should be exercised to ensure that buildings and repair or maintenance operations do not hazard products. 1.7 Premises should have sufficient space to suit the operations to be carried out, allow an efficient flow of work, and permit effective communication and supervision. 1.8 The processing of materials for non-medicinal use should be separated from the processing of medicinal products.

392 4th December, 1998 1.9 Cloakrooms should be separate form, or partitioned from processing areas. Toilets should be well ventilated and should not open directly to manufacturing areas. 1.10 Premises in which medicinal products are manufactured or stored should be made secure, with access restricted to authorized personnel. 1.11 Floors in processing areas should be made of impervious materials, laid on an even surface, free from cracks and open joints, and should allow prompt and efficient removal of any spillages. Walls should be sound and finished with a smooth, impervious and washable surface. Ceilings should be so constructed and finished that they can be maintained in a clean condition. 1.12 Pipework, light fittings, ventilation points and other services in manufacturing areas should be sited to avoid the creation of uncleanable recesses; and should be sealed into any walls and partitions through, which they pass service should preferably be run outside the processing areas. 1.13 Drains should be of adequate size, and should have trapped gullies and proper ventilation. Open channels should be avoided where possible, but if they are necessary, they should be shallow to facilitate cleaning and disinfection. 1.14 Buildings should be effectively lit and properly ventilated, with air control facilities including temperature, humidity and filtration facilities appropriate both to the operations undertaken within them and to the external environment. 1.15 Air intakes and exhausts, and associate pipework and trucking should be sited to avoid product contamination hazards. 1.16 Manufacturing areas should not be used as a general right of way for personnel or except of materials used in the manufacturing process, for storage of materials. 1.17 All premises, including processing areas, laboratories, stores, passage ways, external surroundings should be maintained in a clean and tidy condition. 1.18 Waste material should not be allowed to accumulate but should be collected in suitable receptacles for removal to collection points outside the building, and disposed of at regular and frequent intervals. Special care is necessary over the disposal of waste containing dangerous, highly toxic or sensitizing materials such as hormones, cytotoxic agents, sensitizing antibiotics. Disposal of raw materials, printed packing materials and rejected products should be carefully controlled and documented. 1.19 There should be made available written cleaning procedures and schedules for manufacturing and storage areas. 1.20 Adequate space, preferably separated from processing areas, should be provided for cleaning and storing equipment, and the storage of cleaning materials. 2. Storage areas 2.1 Storage areas should be designed, laid-out and be of sufficient capacity to permit effective and orderly segregation of the various categories of material stored and allow rotation of stock. 2.2 Segregated storage should be provided for rejected, recalled, expired or returned goods. Where the maintenance quarantine status depends upon storage in separate areas, such areas should be provided with restricted access.

4th December, 1998 393 2.3 Labels and other printed packaging materials, including labels for starting materials and for bulk and intermediate products, should be stored in a secure manner that will permit issue only to authorized person in accordance with formal documented procedures. Storage arrangements should permit separation of different labels and other printed materials and avoidance of mix-up. 2.4 Goods should be stored off the floor. Provision should be made for shelving, racking and pelleting and in a manner that will permit easy cleaning and the use of pest control agents by trained personnel without risk of contamination. 2.5 All goods should be stored under cover. 2.6 All materials containers should be clean before they are admitted to stores and checked again for cleanliness before issued to manufacturing areas. 2.7 Where special storage conditions such as temperature, humidity and security are required, these should be provided, checked and monitored. 3. Equipment 3.1 Equipment should be designed and located to suit the process and products for which it is to be used. Equipment should be maintained so as to be fit to perform contemplated functions and present no hazard to the product and personnel. 3.2 Manufacturing equipment should be easily and conveniently cleanable, both inside and outside. There should be available written instructions for cleaning of equipment and suitable cleaning facilities should be provided. 3.3 Equipment should not be a hazard to products through leaking joints, lubricant drips, or through inappropriate modifications or adaptations. 3.4 Equipment used for weighing, measuring, testing and recording should be subject to regular recorded checks for accuracy and working order, in accordance with a written planned maintenance schedule. 4. Qualifications of personnel 4.1 The key personnel are the person responsible for production and the person responsible for quality control, who should be different persons, neither of whom should be responsible to the other, but who should both have a responsibility for achieving the requisite quality. 4.2 Manufacturing operations shall be carried out under the supervision of a registered pharmacist with adequate relevant post graduate training with the support of suitably qualified personnel such as a pharmacy technologist or pharmacy assistant. 4.3 All quality control operations shall be carried out under the supervision of an appropriately trained pharmacist or chemist with relevant post graduate training with the support of suitably qualified personnel such as pharmacy technologist, laboratory technologist or chemist. 4.4 All manufacturing and quality control processes should be done in accordance with Good Manufacturing Practices (GMP) as approved by Board.

394 4th December, 1998 PART II—MINIMUM REQUIREMENTS FOR PREMISES FOR WHOLESALE PHARMACY BUSINESS (reg. 5) 1. Premises and equipment 1.1 Premises should be sited to avoid contamination from the external environment or from the nearby activities and in existing premises, effective measures should be taken to avoid such contamination. 1.2 Premises should be constructed and maintained so as to be protected against weather, ground seepage and the entrance and harbouring of vermin, birds, pests and pets. 1.3 Protection from the weather should be provided for receiving and despatching areas and for materials and products in transit. 1.4 Premises should be maintained in good state of repair. The condition of buildings should be reviewed regularly, and repairs effected where necessary. Special care should be exercised to ensure that buildings, repair and maintenance operations do not hazard products. 1.5 Premises should provide sufficient space to suit the operations to be carried out, allow an efficient flow of work, and permit effective communication and supervision. 1.6 Cloakrooms should be separate from or partitioned from processing areas. Toilets should be well ventilated and should not open directly to storage areas. 1.7 Premises in which medicinal products are stored should be secure, with access restricted to authorized personnel. 1.8 Floors in processing areas should be made of impervious materials, laid on an even surface, free from cracks and open joints and should allow prompt and efficient removal of any spillages. Walls should be sound and finished with a smooth, impervious and washable surface. Ceilings should be so constructed and finished that they can be maintained in a clean condition. 1.9 Buildings should be effectively lit and properly ventilated, with air control facilities including temperature and humidity appropriate both to operations undertaken within them and to the external environment. 1.10 All premises, including processing areas, stores, passage ways and external surroundings, should be maintained in a clean and tidy condition. 1.11 Waste material should not be allowed to accumulate, but it should be collected in suitable receptacles for removal to collection points outside the building and disposed of at regular and frequent intervals. Special care is necessary over the disposal of waste containing dangerous, highly toxic or sensitizing materials such as hormones, cytotoxic agents, sensitizing antibiotics. 1.12 Segregated storage should be provided for rejected, expired or returned goods. 1.13 Goods should be stored off the floor. Provision should be made for shelving, racking and pelleting, and in a manner that will permit easy cleaning and the use of pest control agents by trained personnel without risk of contamination.

4th December, 1998 395 1.14 Where special storage conditions such as temperature, humidity and security are required; these should be provided, and checked and monitored regularly. In particular, controlled temperature environments should be equipped with temperature recorders. 1.15 Van selling should be restricted to items on the general sales list. 2. Qualifications of personnel 2.1 Wholesale operations shall be carried out under the direct full time supervision of a registered pharmacist, with the support of a suitably qualified personnel such as a pharmacy assistant or pharmacy technologist, who shall be responsible for the funding, procurement, clearing, receipting, storage, distribution and documentation relating to medicinal products. 2.2 The services of a locum may be used. 3. Records 3.1 Adequate records shall be maintained for— (a) receipts source, quantity, expiry dates and batch number of medicinal products; (b) sales (source, quantity, expiry dates and batch number of medicinal products) despatches shall be countersigned by a pharmacist. Orders shall be signed by authorized persons known to the wholesaling unit; (c) stock (balances) of each batch and consignment; (d) disposal of rejected or/expired products and records shall be kept for a minimum period of 2 years. All expired products must be notified to the Board when destroyed plus method of destruction used. PART III—MINIMUM REQUIRMENTS FOR PREMISES USED FOR RETAIL PHARMACY BUSINESS (reg. 5) 1. Premises 1.1 Premises shall be constructed and maintained so as to be protected against weather, ground seepage and the entrance and harbouring of vermin, pest and pets. 1.2 Premises should be maintained in a good state of repair. The condition of buildings should be reviewed regularly, and repairs effected where necessary. Special care should be exercised to ensure that buildings, and repair or maintenance operations do not hazard products. 1.3 Premises should provide sufficient space to suit the operations to be carried out, allow an efficient flow of work, and permit effective communication and supervision. 1.4 Toilets should be well ventilated and should not open directly to storage areas. 1.5 Floors should be made of impervious materials, laid to an even surface, and should be free from cracks and open joints. If not carpeted floors should have tiles to facilitate easy cleaning. Walls should be sound and finished with a smooth, impervious and washable surface. Ceilings should be so constructed and finished that they can be maintained in a clean condition.

396 4th December, 1998 1.6 Buildings should be effectively lit and properly ventilated with air control facilities. 1.7 All premises, including stores, passage ways and external surroundings, should be maintained in a clean and tidy condition. 1.8 Premises in which midicinal products are stored should be made secure, with access restricted to authorized personnel. 1.9 Waste material should not be allowed to accumulate, but it should be collected in suitable receptacles for removal to collection points outside the building and disposed of at regular and frequent intervals. 1.10 The dispensary should be separate and independent from other operations, and should be locked when the pharmacist is not present. The dispensary should have running water (cold and warm) and adequate working and cleaning benches with formica tops and adequate shelving. 1.11 The dispensary and consulting room should be elevated overlooking pharmacy and medicine counter. 2. Equipment and reference books 2.1 A Pharmacy shall, where relevant, have measuring cylinders, a stirring rod, counting trays, balance, fridge, a fixed lockable DDA cupboard, current edition of Martingale and other books such as British National Formulary (BNF),United States Pharmacopoela (USP) and Malawi National Formulary (MNF). 3. Records 3.1 Patient profile cards should be kept where possible. 3.2 Prescriptions should be kept for a minimum period of two years and should be numbered and filed chronologically. 3.3 Record of receipts with expiry dates and Lot. No. should be kept for a minimum of two years. 4. Labelling 4.1 Labelling of dispensed medicine products should include— (a) name of patient; (b) name of medicine, its strength and quantity dispensed; (c) directions for use; (d) date of dispensing; and (e) name of pharmacy or dispensing unit. The Pharmacist shall communicate to the patient any other pertinent information. 5. Prescription 5.1 A presciption should have— (a) name of patient; (b) name of medicine, its strength and quantity dispensed; (c) directions for use; and (d) signature, date and address of the prescriber.

4th December, 1998 397 5.2 A prescription should be checked and endorsed after dispensing. 6. Personnel 6.1 A retail pharmacy should be under the direct supervision of a full-time registered pharmacist assisted by appropriately trained personnel approved by the Board. PART IV—MINIMUM REQUIREMENTS FOR REGISTERED DESIPENSING PRACTITIONER (reg. 5) 1. Dispensary layout 1.1 Dispensary shall be separated from the clinical areas. 1.2 Dispensary should be maintained in good state of repair. The general condition of the building should be reviewed regularly and repairs effected where necessary. 1.3 Dispensary should be clean and tidy at all times. 1.4 Floors and walls should be free from cracks and made of impervious material for easy cleaning. 1.5 Dispensary should be effectively lit and properly ventilated. 1.6 Dispensary should be made adequately secure with no access to unauthorized persons. 1.7 Dispensary should have running water (cold and warm), adequate shelving for medicines and other supplies, adequate patient waiting area with seats. 1.8 A toilet for staff with running water, must be provided but should not open directly to the dispensing area. 2. Storage room (if separated from dispensary) 2.1 The main storeroom for medicines should have adequate lighting and ventilation. 2.2 Medicines and other supplies should be arranged on shelves in an orderly manner. 2.3 Medicines should be protected from direct sunlight and excess heat and kept well out reach of patients. 2.4 Storeroom should be provided with adequate security measures including adequate locking system, burglar bars and there shall be restricted entry into storeroom. 3. Dispensing requirements 3.1 Labelling of dispensed medicinal products must be legible and should include— Name of patient; Name of medicine, its strength and quantity dispensed; Directions for use of medicine; Date of dispensing; Name of surgery or clinic or dispensing unit.

398 4th December, 1998 4. Equipment and reference books 4.1 Measuring cylinders for dispensing reconstituted powders must be made available. 4.2 Refrigerator in good working condition must be provided. 4.3 Medicine counting trays for tablets and capsules must be provided. 4.4 Dispensing packs or containers must be available. 4.5 A fixed lockable cupboard for controlled medicines, including narcotics must be provided. 4.6 Current editions of the following publications must be made available— Current edition martindale; Pharmacy, Medicines and Poisons Board Act and Regulations; Pharmacy, Medicines and Poisons Board schedules of registered medicines; Malawi National Formulary; Malawi Standard Treatment Guidelines. 5. Records 5.1 Patient profile cards should be maintained. 5.2 Dispensed prescriptions should be kept or a minimum of 2 years and should be filed orderly. 5.3 Records of sources of medicinal products, receipt of goods, stock movement should be available and kept for a minimum of 2 years. 6. Human Resources 6.1 A dispensary should be managed and supervised by a full time registered health professional in the medical, nursing or pharmacy field. 6.2 Other suitably qualified staff may also be employed to assist the supervisor. PART V—MINIMUM REQUIREMENT FOR OPERATION OF A MEDICINE STORE 1. Premises 1.1 Premises should be constructed and maintained so as to be protected against weather, ground seepage and the entrance and harbouring of vermin and pests. 1.2 Premises should be maintained in a good state of repair. The condition of the buildings should be reviewed regularly, and repairs effected where necessary. Special care should be exercised to ensure that building, repair or maintenance operations do not hazard the products. 1.3 Premises should provide sufficient space to suit the operations to be carried out, allow an efficient flow of work and permit effective communication and supervision. 1.4 Toilets should be well ventilated and should not open directly to the medicine store. 1.5 Floors should be made of impervious material and should be free from cracks and open joints. Walls should be sound and finished with a smooth, impervious and washable surface. Ceilings should be so constructed and finished that they can be maintained in a clean condition. 1.6 The building should be effectively lit and properly ventilated.

4th December, 1998 399 1.7 All premises, including stores, passage ways and external surroundings, should be maintained in a clean and tidy condition. 1.8 Premises in which medicinal products are stored should be made secure, with access restricted to authorized personnel. 1.9 Waste material should not be allowed to accumulate, but should be collected in suitable receptacles for removal to collection points outside the building and disposed of at regular and frequent intervals. 1.10 Adequate shelving should be provided. SECOND SCHEDULE (reg. 11) PHARMACOLOGICAL CLASSIFICATION CATEGORIES OF MEDICINAL PRODUCTS PART I—HUMAN CLASSIFICATION 1. Anaesthetics 1.1 General anaesthetics and medical gases 1.2 Local anaesthetics 1.2.1 Injectable 1.2.2 Topical 1.3 Cholinesterase inhibitors and muscle relaxants used in anaesthesia 2. Analgesics and antipyretics 2.1 Single ingredient products 2.2 Compound products 3. Drugs used in rheumatism and gout 3.1 Nonsteroidal anti-inflammatory drugs 3.2 Drugs for gout 3.3 Special antirheumatic drugs 4. Narcotic analgesics/Narcotic Antagonists 4.1 Narcotic analgesics 4.2 Narcotics antagonists 5. Antihistamines 6. Antidotes 6.1 General 6.2 Specific 6.3 Drugs used in the treatment of addictions— 6.3.1 Alcohol 6.3.2 Nicotine 6.3.3 Narcotis 6.3.4 Phychotropics 6.3.5 Others

400 4th December, 1998 7. Anti-infective drugs 7.1 Penicillins 7.1.1 Non beta-lactamase resistant 7.1.2 Beta-lactamase resistant 7.2 Other antibacterials 7.2.1 Aminoglycosides 7.2.2 Cephalosporins 7.2.3 Sulphonamides (including combinations with trimethoprim) 7.2.4 Tetracyclines 7.2.5 Others 7.3 Antituberculars 7.4 Antileprotics 7.5 Antimalarials 7.6 Antiprotozoals (other than antimalarials) 7.7 Anthelmintics 7.8 Antischistosomals 7.9 Antitrypanosomals 7.10 Leishmanicides 7.11 Antifilarials 7.12 Antifungals (systemic) 7.13 Antivirals 7.14 Urinary antiseptics 8. Antimigraine drugs 9. Antineoplastic and immunosuppressive drugs 9.1 Alkylating agents— 9.1.1 Nitrogen mustard 9.1.2 Alkyl sulphonates 9.1.3 Nitrosureas 9.1.4 Triazines 9.2 Antimetabolites— 9.2.1 Folic acid analogues 9.2.2 Pyrimidine analogues 9.2.3 Purine analogues 9.3 Natural products and their derivatives— 9.3.1 Vinca alkaloids 9.3.2 Antibiotics 9.3.3 Enzymes

4th December, 1998 401 9.4 Miscellaneous cytotoxic agents 9.5 Hormones and hormone inhibitors— 9.5.1 Hormones 9.5.2 Hormones inhibitors 9.6 Immunosupressive agents 10. Drugs affecting the blood 10.1 Anti-anaemia preparations— 10.1.1 Iron 10.1.2 Folates 10.1.3 Vitamin B12 10.1.4 Combinations 10.2 Anticoagulants 10.3 Anticoagulant antagonists 10.4 Haemostatics 10.5 Drugs modifying platelet function 10.6 Drugs altering blood viscosity 11. Blood production/blood substitutes 11.1 Plasma substitutes and expanders 11.2 Plasma fractions for specific uses 12. Cardiovascular drugs 12.1 Antianginal drugs 12.2 Antiarrhythmic drugs 12.3 Antihypertensive drugs— 12.3.1 Vasodilators 12.3.2 Beta blockers 12.3.3 Centrally acting antihypertensives 12.3.4 Ganglion blockers 12.3.5 Others 12.4 Cardiac glycosides

402 4th December, 1998 12.5 Diuretics and antidiuretics— 12.6 Calcium antagonists 12.7 Sympathomimetic cardiac stimulants 12.8 Drugs modifying scrum lipids 12.9 Other cardiovascular drugs 13. Central nervous system drugs 13.1 Anticonvulsants 13.2 Psychotherapeutic drugs— 13.2.1 Antidepressants 13.2.2 Anxiolytics 13.2.3 Antipsychotics 13.3 Hypnotics 13.4 Antiparkinsonian drugs 13.5 Drugs for myaesthenia gravis 13.6 Muscle relaxants, centrally acting 13.7 CNS stimulants 13.8 Drugs improving cerebral blood flow or metabolism 13.9 Respiratory stimulants, centrally acting 14. Dermatological and topical preparations 14.1 Topical anti-infectives 14.1.1 Antibiotics 14.1.2 Sulphonamides 14.1.3 Antifungals 14.1.4 Antiseptics and disinfectants 14.1.5 Scabicides and pediculocides 14.2 Topical corticosteroids— 14.2.1 Plain 14.2.2 Combinations 14.3 Topical antihistamines 14.4 Topical local anaesthetics 14.5 Acne preparations— 14.5.1 Topical 14.5.2 Systemic

4th December, 1998 403 14.6 Preparations for psoriasis— 14.6.1 Topical 14.6.2 Systemic 14.7 Anti-dandruff preparations 14.8 Keratolytic 14.9 Topical cytotoxic 14.10 Sunscreen agents 14.11 Melanin stimulants 14.12 Melanin inhibitors 14.13 Astringents 14.14 Emollients 14.15 Rubefacients 14.16 Medicated dressings 14.17 Vaginal preparations 14.18 Heavy metal preparations 14.19 Others 15. Diagnostic agents 15.1 Miscellaneous— 15.1.1 Serological 15.1.2 Skin tests 15.1.3 Blood grouping 15.1.4 Others 15.2 Radiocontrast media 15.3 Reagent strips and tablets 16. Gastrointestinal drugs 16.1 Antacids 16.2 Antiemetics 16.3 Antihaemorrhoidals 16.4 Antispasmodics 16.5 Laxatives— 16.5.1 Lubicants and softeners 16.5.2 Stimulants

404 4th December, 1998 16.5.3 Bulking agents 16.5.4 Osmotic agents 16.5.5 Combinations 16.5.6 Others 16.6 Antidiarrhoeals 16.7 Gastric/peptic ulcer drugs 16.8 Gastrointestinal enzymes 16.8.1 Pancreatic enzymes 16.8.2 Other GIenzymes 16.9 Appetite depressants— 16.9.1 Centrally acting 16.9.2 Locally acting 17. Endocrine system drugs 17.1 Corticosteroids 17.2 Androgens 17.3 Oestrogens 17.4 Progestogens 17.5 Sex hormones combinations (excluding contraceptive preparations) 17.6 Insulins 17.7 Oral antidiabetic drugs 17.8 Thyroid hormones/inhibitors— 17.8.1 Thyroid hormones 17.8.2 Thyroid inhibitors 17.9 Parathyroid hormones/inhibitors— 17.9.1 Parathyroid hormones 17.9.2 Parathyroid inhibitors 17.10 Pituitary hormones/inhibitors— 17.10.1 Pituitary hormones 17.10.2 Pituitary inhibitors 17.11 Tropic hormones 17.12 Hormone inhibitors (other than the above) 17.13 Fertility stimulants 17.14 Others

4th December, 1998 405 18. Immunologicals 18.1 Sera/immunoglobulins— 18.1.1 Antitoxins 18.1.2 Antivenons 18.1.3 Immune globulins 18.1.4 Others 18.2 Vaccines 19. Ophthalmic drugs 19.1 Anti-infective 19.1.1 Antibiotics 19.1.2 Suphonamides 19.1.3 Antivirals 19.1.4 Antiseptic 19.1.5 Others 19.2 Corticosteroids— 19.2.1 Without antibiotics 19.2.2 With antibiotics 19.3 Local anaesthetics 19.4 Miotics 19.5 Mydriatics 19.6 Diagnostics 19.7 Systemic 19.8 Contact lens preparations 19.9 Topical decongestants and anti-allergics 19.10 Others 20. Ear, nose, throat and mouth preparations 20.1 Ear— 20.1.1 Anti-infective 20.1.2 Anti-inflammatory 20.1.3 Analgesic 20.1.4 Wax removers 20.1.5 Others

406 4th December, 1998 20.2 Nose— 20.2.1 Anti-infective 20.2.2 Corticosteroid (plain and combination) 20.2.3 Antihistamines (plain and combination) 20.2.4 Other decongestants and anti-allergics 20.2.5 Cauterising preparations 20.2.6 Others 20.3 Throat and mouth— 20.3.1 Special dental preparations 20.3.2 Mouth ulcer preparations 20.3.3 Local analgesics/anaesthetics (including tooth ache and teething preparations) 20.3.4 Antiseptic mouthwashes, gargles, sprays, paints, etc. 20.3.5 Antiseptic lozenges 20.3.6 Others 21. Drugs used in labour, delivery and contraception 21.1 Labour and delivery— 21.1.1 Pre-partum uterine contraction stimulants 21.1.2 Post-partum uterine contraction stimulants 21.1.3 Uterine contraction inhibitors 21.2 Hormonal contraceptives— 21.2.1 Combined oral contraceptives 21.2.2 Progesterone—only oral contraceptives 21.2.3 Injectables 21.2.4 Others 21.3 Spermicides 21.4 Intrauterine devices 21.5 Barrier devices 22. Drugs acting on the respiratory tract 22.1 Anti-asthmatic drugs— 22.1.1 Systemic bronchodilators 22.1.2 Inhalation bronchodilators 22.1.3 Inhalation corticosteroids

4th December, 1998 407 22.1.4 Other inhalation products 22.1.5 Other systemic products 22.2 Cough and cold preparations— 22.2.1 Antitussives 22.2.2 Expectorants 22.2.3 Decongestants 22.2.4 Mucolytics 22.2.5 Combination products 22.3 Inhalations and vapour rubs 23. Agents correcting or modifying body fluid composition 23.1 Oral— 23.1.1 Oral rehydration products 23.1.2 Oral electrolyte replacement 23.2 Parenteral— 23.2.1 Large volume infusions 23.2.2 Injections 23.3 Dialysis products— 23.3.1 Peritoneal dialysis solutions 23.3.2 Haemodialysis solutions 23.4 Ion exchange resins 23.5 Agents modifying urinary pH 23.6 Haemoperfusion products 24. Vitamins, minerals and tonics 24.1 Vitamins (excluding combinations)— 24.1.1 Vitamin A and analogues 24.1.2 Vitamin B group (single compounds, except B12, see 10.1.3) 24.1.3 Vitamin C 24.1.4 Vitamin D and analogues 24.1.5 Vitamin E and analogues 24.1.6 Vitamin K and analogues 24.1.7 Other preparations of single vitamins (except folate, see 10.1.2) 24.2 Vitamin B compound preparations 24.3 Multivitamins (excluding vitamins plus minerals) 24.4 Minerals (except iron, see 10.1.1, and electrolytes, see 13.1.2)— 24.4.1 Single minerals 24.4.2 Compound preparations

408 4th December, 1998 24.5 Vitamins plus minerals 24.6 Tonics— 24.6.1 Tonics with vitamins 24.6.2 Tonics with minerals 24.6.3 Tonics with vitamins and minerals 24.6.4 Others 25. Nutritional agents 25.1 Intravenous nutrition preparations 25.2 Milk substitutes 25.3 Special oral foods 26. Enzymes (excluding gi tract) 27. Enzyme inhibitors 28. Homeopathic, Herbal and dutch remedies 23.1 Homeopathic remedies 28.2 Herbal remedies 28.3 Dutch remedies 29. Radioactive isotopes, and kits for their preparations 29.1 Diagnostic 29.2 Therapeutic 30. Environmental disinfectants and decontaminants THIRD SCHEDULE (regs. 11,12 and 13) CATEGORIES FOR THE DISTRIBUTION OF MEDICINAL PRODUCTS Prescription Only Medicines (POM) are medicinal products controlled under Division 1 of Part VI. Pharmacist Initiated Medicines or (PIM) are medicinal products controlled under Division 2 of Part VI. Pharmacy Medicines are medicinal products controlled as such under Division 2 of Part VI. General Sales List Medicines (GSL) are medicinal products suitable for self medication and which are controlled under Division 3 of Part VI. Controlled Drugs (““CD””) are medicinal products listed in the Tenth Schedule. FOURTH SCHEDULE (reg. 34 (3)) CONDITIONS FOR WHICH ADVERTISING IS PROHIBITED Alcoholism Appendicitis Arteriosclerosis Cardiovascular disease Cataract Diabetes Hernia Kidney stone Pneumonia

4th December, 1998 409 Prostrate gland disorders Epilepsy Gallstones Gangrene Glaucoma Hypertension Hypotension Tuberculosis HIV/Aids related diseases FIFTH SCHEDULE (regs. 2 and 36) PRESCRIPTION ONLY MEDICINES (POM) Human Medicines Acebutolol Acetanilide Acetazolamide Acetohexamide Acetylcarbromol Acetylcysteine Acetyldigoxin Actinomycin-D Acyclovir (excluding topical preparations) Aescin, other than preparations for external use Alclofenac Alcuronium Alfacalcidol Alfadolonum Alfaxalonum Allopurinol Alseroxylon Amantadine Amidopyrine Amilorideaminocarproic acid Amineptile Amitriptyline Amoxapine Amoxycillin Amphotericin Ampicillin Anaesthetic agents (including local anaesthetics for oral inhalation and injection excluding preparations for local use and procaine for oral use)

410 4th December, 1998 Anti-microbial substances (including those synthesized naturally or in the laboratory for treatment of specific infections except when used topically and for application into eye/ear) Antimony Apronal Atenolol Atracurium Atropine Aurothiomalate Azacyclonal Azapropazone Azathioprine Baclofen Beclomethasone Benactyzine Benzatropine Benzoctamine Benzydamine Betahistine Betamethasone Betanidine Biperiden Bromocriptine Bromvaletone Brucine Bumadizon Bumetanide Bupivacaine Buserelin Busulfan Butriptyline Calcitonin Calcium dobesilate Cantharidates (excluding for topical use) Cantharidin Captodiame Captopril Carbamazepine Carbenicillin Carbidopa

411 4th December, 1998 Carbimazole Carbochol Caribromal Carisoprodol Ceftriaxone Cefuroxine Cephalosporins (all generations) Cetirizine Chlorambucil Chloramphenicol Chlormethiazole Chlorotrianisene Chlorpromazine Chlorpropamide Chlorprothixene Ciclosporin Cilazapril Cimetidine Cinchophen Cisapride Clavulanic acid Clibrate Clindamycin Clioquinol Clobetasol Clofazimine Clomifene Clomipramine Clonidine Clopamide Clorexolone Clothiapine Clotiapine Clotrimazole Cloxacillin Clozapine Colestyramine

412 4th December, 1998 Conjugated oestrogens Corticosteroids (excluding hydrocortisone 1per cent) Cortisone acetate Cotarnine Co-trimoxazole Cromoglycic aid Curate Cyclandelate Cyclarbamate Cyclopentolate Cyclofenil Cyclopenthiazine Cyclophosphamide Cycrimine Cyproterone Cytararabine Dacarbazine Danazol Dapsone (except in combination with pyrimethamine for malaria prophylaxis) Daunorubicin Deanol Debrisoquine Demecarium bromide Desferrioxamine Desipramine Desmopressin acatate Dexamethasone Dibenzepin Dichloralphenazone Diethylcarnamazine Digitalis digoxin and other cardiac glycosides Dihydralazine Dihydroergocristine Diloxanide furoate Diltiazem Dimercaprol Dimetotiazine

413 4th December, 1998 Dinoprost Dinoprostone Dioxyanthanol (dithranol) Diphenidol Diprocetyl Dipyridamole Dipyrucetyl Disopyramide Disulfiram Diuretics Dobutamine Domperidone Dopamine Dosulepin Doxapram Doxazosin Doxepin Doxorubicin Doxycycline Droperidol Dyflos Ectylurea Edrophonium Emetine Emylcamate Enalapril Enzymes (for injection) Erythrityl tetranitrate Erythromycin Ethacrinic acid Ethambutol Ethchlorvynol Ethinamate Ethoheptazine Ethosuximide Etomidate Famciclovir

414 4th December, 1998 Famotidine Fenbufen Fencamfamin Fenfluramine Fenlofenac Fenoprofen Flucloxacillin Fluconazole Flucytosine Fludrocortisone Flufenamic acid Flumazenil Fluocinolone Fluorouracil Fluoxetine Fluphenazine Flurbiprofen Fluticasone Folic acid Folinic acid Framycetin (other than topical) Furazolidine Furosemide Fusidic acid Gallamine Gamolenic acid Gelsenium Gemfibrozil Gentamicin Gilibornuride Glafenine Glibenclamide Griseofulvin Guanethidine Guanidine Halofantrine Halometasone

415 4th December, 1998 Haloperidol Halothane Hapatitis-B vacc Heparin Hexamethonium Hexapropymate Hermones natural or synthetic Human chrorionic gonadotropin Hyaluronidase Hycanthone Hydralazine Hydrochlorthiazide Hydroxyprogesterone Hydroxyzine Hyoscine Imipramine Indapamide Indinavir Indomethacine Indoprofen Insulin Iodozuridine Iron injectabler preparations Isoconazole Isoetarine Isoflurane Isoniazid Isoprenaline Isopyrine Isosorbide Isradipine Ketaconazole (except topical) Ketamine Ketoprofen Ketorolac Ketotifen Labetalol

416 4th December, 1998 Lamivudine Lanatoside Laudezium Levallorphan Levobunolol Levocastine Levodopa Levonorgestrel Lidoflazine Lincomycin Lisinopril Lithium Lobella Loratidine Loxapine Lucanthone Maprotiline Mazindol Medroxyprogesterone Mefloquine Meglumine Melphalan Mephenesin Mephenytoin Mephonoxalone Mercaptopurine Mersalyl Mesna Mesuximide Metaraminol Methamine Methacarbamol Methoxamine Metformin Methapyrilene Methohexitone Methofrexate Metipranolol

417 4th December, 1998 Metoprol Metrifonate Metronidazole Metyldopa Metylsergide Mexiletine Mianserin Milrinone Minoxidil Mitoxantrone Moclobemide Molindone Monoamine oxidase inhibitors Moxisylate Mupirocin Nadolol Nalidixic acid Naloxone Natamycin Neostigmine Nicotine Nifedipine Niflumic acid Niridazole Nitrofurantoin Nizatidine Nomifensine Norfloxacin Nux vomica Nystatin (for intra-oral use only) Oestradiol Ofloxacin Olanzapine Omeprazole Orphenadrine Oxamniquine Oxolinic acid

418 4th December, 1998 Oxprenolol Oxyphenisatin Oxytetracyline Oxytocin Pancuronium Paraldehyde Pargyline Pefloxacin Penbutolol Penciclovir Penicillins Penterythritol tetranitrate Perhexiline Phenacaine Phenacemide Phenacetin Phenaglycodol Phenbutrazate Phenindione Phenothiazines (except promethazine, anthelmintics) Phensuximide Phentolamine Phenytoin Physostigmine Phytomenadione Picrotoxin Pimozide Pindolol Piracetam Piroxicam Pituitary gland extracts intended for topical use and inhalants Pizotifen Poldine Plasma expanders Potassium chloride (only injection) Practolol Pravastatin

419 4th December, 1998 Praziquantel Praxosin Prednisolone Prednisone Prenylamine Primidone Probenecid Procaine hydrochloride Procainamide Procarbazine Procaterol Prochlorperazine Procycline Prolintane Propanidid Propofol Propranolol Propylthiouracil Protamine Prothipendyl Protryptiline Pyrazinamide Pyridostigmine Pyritinol Quinapril Quinethazone Quinidine Quinine Ranitidine Rauwolfia Reserpine Rifampicin Ritodrine Rosoxacin Roxithromycin Sabadilla Seriraline

420 4th December, 1998 Sodium calcium edetate Sodium pentosan polysulphate Sotalol Spectinomycin Spironolactone Streptodornase and other similar enzymes Streptokinase Strophathus Styramate Sulfinpyrazone Sulfiram Sulindac Sulphinpyrazone Sulphonal Sulphonamides (including combinations with other active ingredients) except in combination with pyrimethamine for treatment of malaria and for topical use and ophthalmic use Sulpiride Sulthiamine Sumatriptan Suxamethonium Syrosingopine Talozamide Talozoline Tamoxifen Tenoxicam Terfenadine Tetrabenazine Tetracycline Thiacetazone Thiamphenicol Thioguanine Thionamide Thiopentone Thioridazole Thiotepa Thiothixine Thymoxamine

421 4th December, 1998 Thyroid gland extract Thyroxine Tiaprofenic acid Timolol Tinidazole Tolbutamide Tolfenamic acid Tolmetin Tranexamic acid Tranylcypromine Tretamine Tretion Triamcinolone Triamterene Tribromethyl alcohol Trichlorethyl alcohol Trifluperidol Trihexyphenidyl (benzhexol) Trimethadion Trimethaphan Trimethoprim Trimipramine Trioxsalen Tubocurarine Turpicamide Vaccines, Sera and Antigenes Valacyclovir Valproic acid Vancomycin Vasopressin Verapamil Veratrum Viloxazine Vinblastine Vincristine Vindesine Warfarin

422 4th December, 1998 Xameterol Zidovudine SIXTH SCHEDULE (regs. 2 and 39) PHARMACIST INITIATED MEDICINES (PIM) Human Medicines Acetarsol Acyclovir (topical use only) Alimezamine All topical anti-fungal medicines (excluding whittields. undecylenic acid) All vaginal anti-fungal medicines Astemisole Belladonna Bismuth suppository (in combination with steroids) Caramiphen Cetirizine Chloral all salts and derivatives Chloramphenicol (topical use) Chlorbenoxamine Chlormezanone Chloroquin Chlorphenoxamine Cinnarizine Codeine (less than 10 mg per unit dose) Colchicin Crotamiton Cyanocobalamine (except injection) Cyproheptadine Diclofenac (except injectable form) Diclofenamide Ephedrine (containing less than 30 mg per unit dose) Fenoterol Glyceryl trinitrate Hexachlorophene Ibuprofen (more than 200 mg per unit dose) Kaolin/pectin (oral preparations) Loperamide Mefenamic acid Methenamine (hexamine) Nephenesin

423 4th December, 1998 Orciprenaline Pholcodine Pirbuterol Podophyllin Potassium chloride (for oral use) Povidone-iodide pessary Pyrental pamoate Rimiterol Salbutamol (except injectable forms but including for inhalation) Salmeterol Sodium aescinate (topical use only) Sulphonamides (including those in combinations for intra-vaginal and ophthalmic use) Sucralfate Terbutalin (except injection but including inhalation) Terfenadine Tetracycline (topical only) Theophylline (except injectable forms) Thiabendazole Vitamin E (more than 100 mg per unit dose) Yohimbine SEVENTH SCHEDULE (regs. 2 and 39) PHARMACY MEDICINES Human Medicines The salts, preparations and admixtures of the following— aconite aescin, preparations intended for topical use only albendazole alkali fluorides other than dentifrices containing not more than 0.3 per centum of the alkali salts of hydrofluoric acid Aloxiprin Aminopentamidine Amino-alcohols, esterified with benzole acid, phenylacetic acid; phenylpropionic acid, cinnamic acid, or the derivatives of these acids, their salts, being preparations for oral use only P-Aminobenzic acid Ammonia (see H.S.A) Amyl nitrate Anethole trithione Anthraquinones Antimirobial substances (chemotherapeutic substances) synthesized in nature or a laboratory, for use as eye ointment containing 1 per cent chloramphenical tetracycline or oxytetracycline for use in eye infections other than eye ointments containing 1 per centum tetracycline or oxytetracycline for the use in trachoma

424 4th December, 1998 Anthistamine substances, the following— Antazoline Bromazine Buclizine Carbenoxolone Calamine (topical use) Chlorphenamine Chlorphenoxamine, preparations containing 10 mg or less per unit dose Clemastine Clemizole Cyclizine Dexchlorpheniramine Diphenhydramine Diphenylpyraline Doxylamine Isothipendyl Mebhydrolin Meclozine Phenindamine Pheniramine Promethazine containing 25 mg or less per unit dose Propylenediamine Pyrrhobutamine Thenalidine Topropamine Triprolidine Tetra subsituted N derivatives of ethylenediamine or propylenediamine Apomorphine Atropine for oral treatment and in combination with other active ingredients Arsenic Barium Belladonna and the alkaloids thereof Bemegride Benzyl Benzoate (topical use) Benzoyl peroxide Benzoic acid (topical use) Bephenium Bisacodyl

425 4th December, 1998 Bitolterol mesylate Bismuth subgallate Bromelains Bromhexine Calciferol Camylotin Carbocisteine Carbuterol Cetrimide Cetylpyridinium chloride Chlorbutol, except when intended for use as a preservative Chlormezanone, preparation containing 100 mg or less in combination with an analgesic or anti-asthmatic drug Chloroform, other than preparations containing less than 10 per centum chloroform Chlorhexidine Chlorphenesin Chlorphenoxamine Choline theophyllinate Chrysarobin Clioquinol (Iodochlorhydroxyqunoline) Clobutinol Colocynth Creosote, obtained from wood, other than substances containing less than 50 per centum creosote Dapsone, preparations in combination with pyrimethamine and intended for prophylaxis of malaria Dequalinium Dextromethorphan Detrophan Dibromopropamidine Dicycloverine (Dicyclomine) Diethylamine salicylate Dimethicon Diloxanide Diphenoxylate, preparations containing 2.5 mg or less per unit dose in combination with other active ingredients Domiphene bromide Enzymes, except those intended for injection Etafedrine Ethylchloride

426 4th December, 1998 Fedrilate Ferric and ferrous salts, and combinations Floctafenine Fluoride sodium, excluding dental pastes and gels Folic acid Formaldehyde, other than when used as a preservative Gamma benzene hexachloride Glucuronic acid Halquinol (Chlorhydroxyquinoline) (Di-iodohydroxyquinoline) Hexachlorophene, preparations containing less than 1 per centum hexachlorophene Hexetidine Hexoprenaline Hydrochloric acid, as diluted solution for achlorhydria Hydrotalcite Iodine, iodides Isoaminile Jalap Lead, salts, other than preparations for hair containing less than 0.5 per centum of lead Mebendazole Mefenamic acid Mepyramine maleate Methxyphenamine Myrtecaine Naphazoline Niclosamide Nicotinic acid Nitric acid (see H.S.A.) Noscapine Oxalic acid Oxetacaine Oxyphencyclimine Oxymetazoline Pancreatin Pantothenic acid Pentifyllin Pentoxyverine Phenazone

427 4th December, 1998 Phenindamine Phenolphthalein Phenylephrine, other than preparations containing less than 0.2 per centum phenylephrine intended for topical use Phenylpropanolamine Povidone iodine, other than preparations intended for topical application Potassium hydroxide Promethazine, preparations containing 25 mg or less Proguanil Propamidine Propantheline bromide Pyridoxine Pyrimethamine Selenium Sodium hydroxide Stavesacre (Staphisagria) and alkaloids thereof, other than in soaps, ointments and lotions Sulphuric acid (see H.S.A.) Terpine hydrate Tolazoline (intended for topical use) Tribenoside Trichloracetic acid Vitamin A other than preparations containing 10 thousand units or less of Vitamin A activity per unit dose Xylometazoline Zinc Sulphate Any substance derived from any other substances referred to in any of the items in this Schedule unless expressly excluded therefrom EIGHTH SCHEDULE GENERAL SALES LIST MEDICINES Human Medicines Acetylsalicylic acid (packs of less than 20 including strip or blister pack) Aluminium hydroxide Ascorbic acid (less than 500 mg per unit dose) Caffeine Camphor Chlorinated xylenol Dequalinium Hexetidine Hydroquinone (for external use only containing 2 per centum or less hydroquinone) Ipecacuana

428 4th December, 1998 Liquid paraffin Magnesium hydroxide Magnesium sulphate Magnesium Trisilicate Menthol Methyl salicylate (in liniments only) Paracetamol (packs of less than 20 including strips or lister packs) Piperazine Psyllium Sulphonamide (only in combination with pyramethamine for treatment of malaria) NINTH SCHEDULE (reg. 2) PROHIBITED SUBSTANCES (PS) Bufotenine Glutethimide Lysergamide Lysergide and other N-alkyle derivatives of lysergamide which includes the drug commonly known as L.S.D., but not including methyaergide maleate Mescaline Methaqualone Methyprylon Psilocin N.N-Diethyltryptamine N.N.Dimethyltryptamine 2,5-Demethoxy-4, a, dimethylphenthylamine Any sterioisomerio form, ester, ether or salt of a substance prohibited and any preparation containing any proportion of the above-mentioned drugs TENTH SCHEDULE (reg. 2) CONTROLLED DRUGS (CD) PART I—NARCOTICS Acetyldihydrocodeine Alfentanil Cocaine Codeine Dextropropoxyphene Dihydrocodeine Diphenoxylate Fentanyl Hydrocodon Methadone Morphine Opium

4th December, 1998 429 Pethidine Pholcodine Tilidine PART II—PSYCHOTROPIC SUBSTANCES Alprazolam Bromazepam Buprenorphine Chlordiazepoxide Clobazam Clonazepam Clorazepate Diazepam and other compounds containing the chemical structure of dihydro-1, 4- Benzo-diazepine substituted to any degree Dipotassium Clonazepate Flunitrazepam Flurazepam Ketazolam Lorazepam Lormetazepam Medazepam Meprobamate Methylphenidate Midazolam Nitrazepam Oxazepam Pentazocin Pentobarbitone Phenobarbitone Phentermine Prazepam Temazepam Triazolam Made this 30th day of August, 1998. (FILE NO. C.6/8) HARRY THOMSON Minister of Health and Population Printed and published by THE GOVERNMENT PRINTER, Zomba, Malawi—11769—(Price K37.50)