Medicines and Allied Substances Act 2013 - ZAMRA

1 THE Medicines AND Allied SUBSTANCESACT, 2013 ARRANGEMENT OF SECTIONSPA RT IPRELIMINARYS ection1. Short title2. InterpretationPA RT I ITHE ZAMBIA Medicines REGULATORY AUTHORITY3. Continuation and re-naming of Pharmaceutical RegulatoryAuthority4. Seal of Authority5. Functions of Authority6. Powers of Authority7. Constitution of Board of Authority8. Functions of Board9. Expert Advisory Committee10. Committees11. Delegation of functions of Board12. Director-General13. ImmunityPART IIIREGISTRATION AND REGULATION OF PHARMACIES, HEALTH SHOPS ANDAGRO-VETERINARY SHOPS14. Prohibition of operation of unregistered pharmacy, healthshop or agro-veterinary shop15. Application for certificate of registration16. Issue of certificate of registration17. Rejection of application18. Display of certificate of registration19. Annual return20. Surrender of certificate of registration21.

2 Transfer of certificate of registration22. Amendment of certificate of registration23. Suspension or cancellation of certificate of registration24. Closure of pharmacy Medicines and Allied Substances [No. 3 of 20134725. Loss of certificate of registration26. Management of hospital pharmacies27. Standard of pharmacy practice28. Dispensing certificate29. Agro-veterinary shop permit30. Health shop permit31. Register of Pharmacies, Agro-veterinary Shops andHealth Shops32. Publication of registered pharmacies, agro-veterinaryshops and health shopPA RT I VLICENCIES, IMPORT AND EXPORT PERMIT33. Prohibition of manufacture, distribution, etc. medicine orallied substance without pharmaceutical licence34. Pharmaceutical licence35. Import permit36. Export permit37. Additional requirements for import or export for narcoticdrugs, psychotropic Substances and precursors38.]

3 Register of Licences and PermitsPA RT VREGISTRATION OF Medicines AND Allied SUBSTANCES39. Marketing authorisation40. Categories of medicine41. Medicines list42. Prohibition of sale of prescription only Medicines withoutprescription43. Labelling of medicine44. Sale of medicine , Advertising of medicines46. Recall of medicine , etc. from circulation47. Monitoring medicine and Allied substance48. Register of Marketing AuthorisationsPA RT V IREGULATION OF CLINICAL TRIALS49. Prohibition of conducting clinical trial without certificate50. Application for clinical trial certificate48No. 3 of 2013] Medicines and Allied SubstancesSingle copies of this Act may be obtained from the Government Printer, Box 30136, 10101 Lusaka, Price K Grant of certificate52. Inspection of clinical trial sites53. Register of Clinical Trial CertificatePART VIITHE NATIONAL DRUG QUALITY CONTROL LABORATORY54.

4 National Drug Quality Control LaboratoryPART VIIIINSPECTIONS55. InspectorsPA RT I XGENERAL PROVISIONS56. Appeals57. Authority to manufacture patented medicine58. General offences59. Prohibition of manufacture, import, export, etc of sub-standard, counterfeit or adulterated medicine or alliedsubstances60. Prohibition of supply of expired medicine61. Prohibition of deceptive act62. Prohibition of sale, etc of harmful cosmetics63. Sale and preparation of cosmetics under insanitaryconditions64. Standards of cosmetics65. Prohibition of sale of harmful devices66. General penalty67. Offence by body corporate or unincorporate body68. Guidelines69. Regulations70. Repeal of Act No. 14 of 2004 FIRST SCHEDULESECOND SCHEDULE Medicines and Allied Substances [No. 3 of 201349 GOVERNMENT OF ZAMBIAACTNo. 3 of 2013 Date of Assent:21st March, 2013An Act to continue the existence of the PharmaceuticalRegulatory Authority and re-name it as the ZambiaMedicines Regulatory Authority; provide for the functionsand powers of the Authority; provide for the registrationand regulation of pharmacies, health shops and agro-veterinary shops; provide for the registration andregulation of Medicines and Allied Substances ; providefor the regulation of the manufacture, importation,exportation, possession, storage, distribution, supply,promotion, advertising, sale and use of Medicines andallied Substances ; provide for the regulation and controlof clinical trials; repeal and replace the PharmaceuticalAct, 2004.]

5 And provide for matters connected with, orincidental to, the by the Parliament of RT Act may be cited as the Medicines and AlliedSubstances Act, this Act, unless the context otherwise requires administer means to give a substance to a human being oranimal orally, by injection or by introduction into the bodyin any other way or by external application, whether bydirect contact with the body or not; adulterated medicine means any medicine (a) consisting in whole or in part of any filthy, putrid,decomposed, deleterious or foreign substance ;(b) that is prepared or stored under unsanitary conditions;(c) whose container is composed of any poisons ordeleterious substance ;(d) that contains a colouring agent that is not prescribed;or(e) that contains any harmful or toxic substance ; agro-veterinary shop means a place or premises permittedto sell prescribed veterinary medicinal products and alliedsubstances under the control of a relevant veterinaryprofessional as determined by the Authority; Medicines and Allied Substances [No.]

6 3 of 201351 EnactmentShort titleInterpretation[22nd March, 2013 Allied Substances include acaricides, cosmetics,disinfectants, food supplements, feed additives andsupplements, medical and surgical sundries, medical devicesand condoms; animal has the meaning assigned to it in the Animal HealthAct, 2010; animal health facility has the meaning assigned to it in theVeterinary and Veterinary Para-Professions Act, 2010; assemble in relation to a medicine , means enclosing themedicine or Allied substance of the same description in acontainer before the medicine or Allied substance is sold orsupplied; Authority means the Zambia Medicines RegulatoryAuthority provided for under section three; biological product includes vaccine, immune sera, anti-toxin, anti-venom, toxoid, blood and blood components,allergy products used in the prevention, treatment or cureof disease or condition in human beings and animalssynthesised from living organisms or other product; Board means the Board of the Authority constituted undersection seven; certificate of registration means the certificate ofregistration of a pharmacy; Chairperson means the person appointed as Chairpersonof the Board under section seven; clinical trial means the systematic study involving humanparticipants or animal subjects that serves to answer theefficacy of a medicine , biological products or method ofprevention or treatment; committee means a committee of the Board establishedunder section ten.]

7 Cosmetic means any substance manufactured or sold foruse in cleansing, beautifying or altering the hair, eyes, teethor nails, or complexion of the skin, and includes deodorantsand perfumes; counterfeit medicine or Allied substance means a medicineor Allied substance which is deliberately or fraudulentlymislabeled or misrepresented with respect to identity orsource, or a medicine or Allied substance which (a) has wrong ingredients;(b) contains active ingredients or not;(c) has insufficient or excess active ingredients; or(d) has fake packaging;52No. 3 of 2013] Medicines and Allied SubstancesAct No. 27 of2010 Act No. 45 of2010 deal means to sell or offer for sale or trade by wholesale; dental surgeon means a person registered as such underthe Health Professions Act, 2009; Director-General means the person appointed as Director-General under section twelve; dispense means to count, measure or decant a medicinefrom a bulk supply or to prepare, mix, dissolve or supply amedicine for the treatment of a person or animal, but doesnot include the administration of medicine ; distribute means the division and movement ofpharmaceutical products from the premises of themanufacturer of the products or from another central pointor to an intermediate point or to the end user by means ofany method of transport; Expert Advisory Committee means the Expert AdvisoryCommittee established under section nine.

8 Former Authority means the Pharmaceutical RegulatoryAuthority established under the repealed Act; health facility has the meaning assigned to it in the HealthProfessions Act, 2009; health shop means a place or premises permitted to sell aprescribed list of medicine by the Authority, under thecontrol of an authorised person as determined by theAuthority; hospital has the meaning assigned to it in the HealthProfessions Act, 2009; hospital pharmacy means a pharmacy which is part of ahealth facility; ingredient in relation to the manufacture or preparation ofa substance , includes anything which is the sole active orinactive ingredient of that substance ; inspector means a person appointed as an inspector undersection fifty-five; label means to affix to, or otherwise display on, a containeror package, a notice describing the ingredients and contentsthereof; Laboratory means the National Drug Quality ControlLaboratory established under section fifty-four; manufacture in relation to a medicine or Allied substance ,includes any process carried out in the course of makingthat medicine or Allied substance , but does not include theprocess of Medicines and Allied Substances [No.]

9 3 of 201353 Act No. 24 of2009 Act No. 14 of2004 Act No. 24 of2009 Act No. 24 of2009(a)dissolving or dispensing a product in, or diluting ormixing it with, some other substance for purposesof administering it; or(b)the incorporation of a medicine in any animal feed; marketing authorisation means the authorisation granted,under section thirty-nine, for the placement of a medicineor Allied substance on the market; medical device includes an instrument, apparatus,component, part or accessory manufactured or sold foruse in the diagnosis, treatment, mitigation or prevention ofa disease, disorder or abnormal physical state or thesymptoms of the disease, or abnormal physical state inhuman beings or animals; medical doctor means a person registered as a medicaldoctor under the Health Professions Act, 2009; medicine means human medicine , veterinary medicine ,medicinal product, herbal medicine or any substance ormixture of Substances for human or veterinary use intendedto be used or manufactured for use for its therapeuticefficacy or for its pharmacological purpose in the diagnosis,treatment, alleviation, modification or prevention of diseaseor abnormal physical or mental state or the symptoms ofdisease in a person or animal; medicinal product means any substance or combinationof Substances which may be administered to human beingsor animals in order to make a medical diagnosis or torestore, correct or modify the physiological functions inhuman beings or animals; member means a person appointed as a member of theBoard under section seven; midwife means a person registered as a midwife underthe Nurses and Midwives Act, 1997.

10 Nurse means a person registered as a nurse under theNurses and Midwives Act, 1997; package means anything in or by which any medicine ,herbal medicine , therapeutic substance or Allied substanceis enclosed, covered or contained, and includes primaryand secondary packaging; pharmaceutical licence means the licence issued, undersection thirty-four, to a person to manufacture, distributeor deal in a medicine or Allied substance ; pharmacist means a person registered as a pharmacist54No. 3 of 2013] Medicines and Allied SubstancesAct No. 24of 2009 Act No. 31of 1997 Act No. 31 of1997under the Health Professions Act, 2009; pharmacy means a drugstore, druggist, chemist or anybusiness or premises registered as such under sectionsixteen; prescription means a written direction given by anauthorised prescriber directing that a stated amount of amedicine specified in the direction be dispensed for theperson or animal named in the direction; prescription only medicine means a medicine dispensedonly on prescription; Register means, in relation to (a) pharmacies, health shops and agro-veterinary shops,the Register provided for under section thirty-one;(b)licences and permits, the Register of Licences andPermits provided for under section thirty-eight;(c) marketing authorisation, the Register of MarketingAuthorisations provided for under section forty-eight.