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[Audio] Document number: ZFDA/ MCD/GDL/017 Rev.No.00 THE REVOLUTIONARY GOVERMENT OF ZANZIBAR MINISTRY OF HEALTH ZANZIBAR FOOD AND DRUGS AGENCY GUIDELINES FOR REGISTRATION OF PREMISES AND LICENSING OF PHARMACEUTICAL BUSINESS March, 2019 P. O. Box 3595, Mombasa Area, Changu Road, Zanzibar, Tel No: +255-24-2233959 Fax No: +255-24-2233959 Website: www.zfda.go.tz, Email: info@zfda.go.tz.

[Audio] Table of Contents ABBREVIATIONS ............................................................................................................ iii ACKNOWLEDGEMENTS .................................................................................................. iv FOREWORD ..................................................................................................................... v INTRODUCTION .............................................................................................................. 1 DEFINITIONS OF TERMS ............................................................................................... 2 PROCEDURES FOR APPLICATION FOR REGISTRATION OF PREMISES AND PERMITS PRIOR TO OPERATE THE BUSINESS OF PHARMACEUTICALS ................... 4 2. LOCATION ................................................................................................................. 6 4. PREMISES LAYOUT .................................................................................................. 8 4.1. RETAIL PREMISES ................................................................................................ 8 4.2. WHOLESALEPREMISES ........................................................................................ 8 4.4. WAREHOUSEPREMISES ....................................................................................... 9 5. PERSONNEL ............................................................................................................. 9 6. STORAGEFACILITIES ............................................................................................. 11 7. SANITATION AND HYGIENE .................................................................................. 11 8. STOCK CONTROL AND HANDLING ....................................................................... 12 9. RECORDS ANDDOCUMENTATION ........................................................................... 12 10. RECALLS AND WITHDRAWAL ............................................................................ 13 11. CESSATION OFBUSINESS .................................................................................. 13 12. VALIDITY OF PREMISES REGISTRATION ANDPHARMACEUTICAL BUSINESSPERMIT ........................................................................................................ 14 13. PAYMENT OFFEES .............................................................................................. 15 14. LANGUAGE ........................................................................................................... 15 15. NOTIFICATION FOR CHANGE OF REGISTEREDPREMISES ............................. 15 16. REFUSAL OR REVOCATION OF REGISTRATION CERTIFICATE AND PERMIT 15 17. APPEALS .............................................................................................................. 15 18. REFERENCEMATERIALS .................................................................................... 16 i.

[Audio] Annex I: Application forms  Application for PremisesRegistration  Application for BusinessPermit  Application for Medical Representative's Permit Annex II: Registration certificate ofpremises AnnexIII: BusinessPermit AnnexV: InspectionChecklists  New pharmaceutical premises inspectionchecklist  Registered Premises inspection checklist AnnexVI: Particulars/Contents for RecordBooks ii.

[Audio] ABBREVIATIONS 1. DI - DrugInspector 2. ZFDA - Zanzibar Food and Drugs Agency 3. ZFDC - Zanzibar Food, Drugs and Cosmetics,Act 4. ZMC - Zanzibar MedicalCouncil iii.

[Audio] ACKNOWLEDGEMENTS I would like to thank ZFDA staff who contributed for a successful development of these guidelines. Acknowledgement is particularly extended to: 1. Bora MposanjeLichanda - Director of Medicine and Cosmetics 2. AmneNassorIssa - Head of Drug Information Unit 3. Salma Hafidh Ali - Head of Medical Devices Unit 4. SharifaYussuf Ali - Drug Registration Officer 5. Ali Rajab Maulid - Medical Devices Officer 6. Moh'd Hassan Moh'd - Drug Inspector 7. MwadiniAhmadaMwadini - Chief Drug Inspector 8. Omar Haji Ussi - Drug Inspector( Airport) 9. Sabrina IdrissaAhmada - Head of Medicine Registration Unit 10. Khadija Ali Khamis - Head of Port Inspection (Malindi) 11. Abrahman Hamad Mussa - Quality Manager 12. Abdul-Matin Yassin - Planning Officer 13. Nassir S. Buheti - Pharmacovigilance Officer 14. Khadija Ali Abass - Legal Officer Last but not least, ZFDA Management is acknowledged for supporting the deliberation and approval of the guidelines. Bora M. Lichanda Director of Medicines and Cosmetics Zanzibar Food and Drugs Agency iv.

[Audio] FOREWORD The Zanzibar Food and Drugs Agency (ZFDA) was established under the Zanzibar Food, Drugs and Cosmetics Amendment Act NO.3/2017, with the mission of protecting and promoting public health by ensuring quality, safety and effectiveness of food, drugs, cosmetics and medical devices. The Act empowers ZFDA to register premises and issue permits for storing and selling of medicinal products. The registration of premises is done to ensure that they meet prescribed requirements for storage and distribution of pharmaceuticals. Furthermore, the Act provides for regulation of promotion activities related to drugs such that those who are dealing in drug promotion activities are required to be registered by ZFDA. In order to enhance enforcement of the Act, ZFDA has developed these guidelines entitled 'Guidelines for Registration of Premises and Licensing of Pharmaceutical Business'. The guidelines provide guidance to dealers in pharmaceuticals, new applicants and the public on the procedure for submitting applications, requirements for registration of premises and licensing of pharmaceutical business as well as registration of medical representatives involved with medicinespromotion. It is therefore anticipated that pharmaceutical dealers and other stakeholders will strive to meet the requirements stipulated in the guidelines so as to ultimately ensure that medicinal products are stored, distributed and sold from wellconstructed and maintained premises to ensure their quality and safety in order to promote and improve public health. It is anticipated that the guidelines will be revised regularly in response to experiences gathered from their utilization. We therefore encourage all users and the public to give comments and views on the guidelines at any time. Dr. Burhani Othman Simai Executive Director Zanzibar Food and Drugs Agency v.

[Audio] INTRODUCTION Registration of premises for dealing in pharmaceutical businesses is a prerequisite requirement prior to commencing of such businesses. This requirement is stipulated under section 16 of the Zanzibar Food, Drugs and Cosmetics Act No.2/2006. The legislation prohibits the use of any premises for the manufacture, sale, sell, supply or storage of pharmaceuticals unless the premises have been registered by the Zanzibar Food and Drugs Agency (ZFDA) for that purpose. Furthermore to this, section 16 of the same Act requires all dealers in such business to apply to the Authority for licenses and obtain such license before starting operation. Registration of premises and licensing of pharmaceutical businesses shall not be considered as the sole means of controlling operations of these premises. However, there are other valuable means of aid in enforcing relevant legislation, such as adherence to good hygienic and pharmacy practices that ensure day-to- day operations of these premises are in line with the laws and regulations. Basing on these grounds, the Agency is empowered to suspend or revoke the registration certificate and license of any premises found to operate contrary to the law. The guidelines consist of two main parts: the main guidelines and six annexes. The main guidelines give a procedure for application for registration of premises and pharmaceutical business permit. It gives also a guidance on location, premises design and layout, required personnel, storage facilities, sanitation and hygiene, stock control and handling, records and documentation, recalls, reject and withdrawal, cessation of business, validity of premises registration and pharmaceutical business permit, payment of fees, language, notification for change of any or alteration of registered premises, refusal or revocation of registration certificate and permit, appeals and required referencematerials. The annexes include format for application forms, registration certificate of premises, business permit, medical representative permit, inspection checklists and particulars/contents for records books. Dealers should note that, the requirements stipulated in these guidelines are deemed to be minimum. In view to that all dealers are encouraged to adhere to these requirements. 1.

[Audio] DEFINITIONS OF TERMS 1. Equipment- Means machines, instrument, apparatus, utensil or appliance, other than a single use item, used or intended to be used in or in connection with pharmaceutical handling and include any equipment used to/intended to be used to clean pharmaceutical premisesfacility. 2. Business- Includes professional practice and any activity carried on by person or a body of persons in relation to products regulated under ZFDC ActNo.2/2006. 3. Premises- Includes land, building structures, basements and vessels and in relation to any building includes a part of a building and any cartilage, forecourt, yard or places of storage used in connection with building or part of that building, and in relation to vessel means ship, boat, aircraft and includes a carriage or receptacle of anykind. 4. Sell- Means sell by wholesale or retail and include import, offer, advertise, keep, expose display, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale or prepare or possess for the purpose of sale and barter or exchange supply or dispose of to any person whether for a consideration or otherwise. 5. Products regulated Under the ZFDC Act No.2/2006- Means Food, Drugs, Cosmetics, Herbal drugs and Medicaldevices. 6. Agency- Means the Zanzibar Food and Drug Regulatory Agency, established under section 3 of the ZFDC Amendments Act No. 3/2017. 7. Executive Director- Means the Chief of the ZFDA appointed under section 6(1) of the ZFDCA amendment No. 3/2017 8. Dispense- Means supply of a drug, drug product or poison on and in accordance with a prescription lawfully given by a medical practitioners, dentists or veterinarysurgeon. 9. Controlled drugs- Means any narcotic drug, psychotropic substance or precursor as listed under section 78 of the ZFDC Act No.2/2006; 10. Drug, medicine or pharmaceutical product- Means any substance or mixture of substances manufactured, sold or presented for usein; (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in man or animal or (ii) restoring, correcting or beneficial modification of organic or mental functions in man or animalor; (iii) disinfection in premises in which drugs are manufactured, prepared or kept, hospitals, equipment and farmhouses; (iv) Articlesintendedforuseasacomponentofanyarticlesspecified 2.

[Audio] in clause (a), (b) or (c); but does not include medical devices or their components, parts or accessories. 11. Inspector- Means an Inspector appointed, authorized or recognized under section 105 of the ZFDC Act No.2/2006. 12. Pharmacy- Includes a registered pharmacy department in a hospital, clinic or health centre or a community pharmacy. 13. Retail Pharmacy business- Means a business, which consists of or includes the retail sale of drug products but does not include professional practice carried on by Medical practitioner, dentist or veterinarysurgeon. 14. Superintendent- Means any person who is a manager and controls the business of apharmacist. 15. Wholesale pharmacy business- Means a business which consists of or includes the wholesaleofdrug products but does not include professional practice carried out on by medical practitioner, dentist or veterinarysurgeon. 3.

[Audio] PROCEDURES FOR APPLICATION FOR REGISTRATION OF PREMISES AND PERMITS PRIOR TO OPERATE THE BUSINESS OF PHARMACEUTICALS *Applicants shall read carefully and understand these guidelinesbefore engaging in construction of the intended premises. 1.1. Applicants are required to get a copy of these Guidelines and read carefully before engaging in construction of the intendedpremises. 1.2. Application for premises registration and permits to operate the business of pharmaceuticals or renewal of permits shall be made in a prescribed application forms to the Executive Director ZFDA through ZFDA offices. The application shall be accompanied with a fee as prescribed under ZFDA Fees and Charges Regulations and paid as per section 13 of these guidelines. The format of the application form is provided as AnnexI. 1.3. The Application forms shall be obtained from the ZFDA head office, sub office Pemba or through the ZFDA Website www.zfdb.go.tz 1.4. Applicant shall be required to fill accurately all the required information in the application form. 1.5. Applicants shall furnish their applications to the respective ZFDA office before any construction/renovations are made into the premises. 1.6. Applicant shall be required to submit a proof of citizen from the relevant authorities and in case of a company; a least one Zanzibari share holder must be present. 1.7. If the applicant is not a superintendent, he/she shall be required to secure the services of a pharmacist as in-charge of the business. In case of a wholesale veterinary medicines business, the in-charge can be either a pharmacist or veterinarysurgeon. 1.8. The applicant shall be made to sign a contract agreement with the superintendent/in-charge of the business and submit the true copy of the original contract to ZFDA for record purposes and attach a copy of registration certificate of the superintendent as issued by the respective councils or professionalboards. 1.9. Applications may be attached with a sketch design of the proposed premises whereby, the Agency through the authorized drug inspector shall go through it to authentify if it suits the purpose of that proposed business. 4.

[Audio] 1.10. The proposed business name shall be subject to further review by the Agency before the applicant forwards it to the registrar of business names. 1.11. The Agency may approve or reject the submitted sketch design and the applicant will be informedaccordingly. 1.12. The applicant shall continue with process of construction/renovation of the premises and registration of business names and upon completion shall inform the Agency forinspection. 1.13. The drug inspector shall make sure that the premises applied for registration is inspected to verify if all the requirements have beenmet. 1.14. The inspectors shall when conducting the inspection of that premises use the inspection checklist for new pharmaceutical premises and give their observations and recommendation on the suitability of the premises in the application form. A format of that checklist is provided as AnnexII. 1.15. The inspectors shall make sure that the necessary applicant information are accurately provided as requested in the application form and all information required in the inspection checklist are properlyfilled. 1.16. Inspectors shall also make sure that the full name, registration number and status of the immediate premises superintendent is provided, including his letter of commitment to accept the supervision of the said premises. 1.17. Upon receipt of duly filled in ZFDA application forms, premises inspection report and all other necessary documents from the drug inspectors, the Head of Drug Information Unit shall scrutinize all the documents and if satisfied that all the requirements have been met, shall compile and give its recommendations to Head of Medicine and Cosmetics Department. 1.18. In case if Premises registration or licensing requirements have not been met, the applicant will be informed accordingly to address the shortfalls before considerations. 1.19. The Head of Medicine and Cosmetics may approve, withhold or reject any application by providing reason(s) for its decision of withhold orrejection. 5.

[Audio] 1.20. All applicants, whose applications have been approved, withhold or rejected as the case may be, shall within one week from the day, which the decision was made, send with an official letter informing them on the status of theirapplication. 1.21. Applicants, whose applications have been withheld for any reasons shall be required to carry out corrective measures before they are legible for reconsideration. 1.22. The Agency shall then issue the Premises Registration Certificate and the respective retail, wholesale, retail and wholesale or warehouse permits which allow the applicant to start carrying out the business of a pharmacy. 1.23. Every permit for the business of pharmacy shall expire on the 31stDecember every year. Therefore all dealers of pharmaceutical business shall be required to fill and furnish to ZFDA offices their applications for renewal of permits three (3) months before 31stDecember. 1.24. The renewal shall be done by only filling in the application form for permit and pay the respective annual permit fee prescribed under ZFDA Fees and Charges Regulations. 1.25. Dealers who shall delay to renew their permits beyond 31stJanuary every year shall be required to pay the Agency the prescribed annual permit fee together with 25% penalty. Contrary to that, registration certificate may be revoked and the premises closeddown. 2. LOCATION 2.1. The premises shall be located away from sites or activities that emit obnoxious materials like fumes and contaminants, open sewerage, offensive trade etc. 2.2. Premises located within or near petrol station shall be furnished in such a way that the activities including fuel fumes does not affect in any way the quality of medicines and dispensation process in the pharmacy. The premises shall be required to address among other issues, the fire preventionfacilities. 2.3. Premises located within shopping centres, e.g. shopping malls, supermarkets etc, shall be confined and restricted from other activities conductedthereat. 2.4. The premises shall be designed such that, it shall have no direct link to building with bar, restaurant, medical laboratories, dispensary, clinics or in direct link to residential houses where the business ishoused. 6.

[Audio] 2.5. The premises should have an address of the premises to include plot and house number, street/hamlet, district and region where the business is to be carried out, clearly indicated in the application form for easy communication and reach during supervision andinspection. 2.6. The premises should have a sign board conspicuously displayed and the pharmacy identification logo displayed at the mainentrance. 2.7. In case of Over the Counter outlets, registration ofpremisesshallbeapprovedifthenew OTC is at least 500 meters away from the existing OTC. However, the Agency shall have power to review this requirement from time to time basing on the service need by the community and population increase. 2.8. Veterinary pharmaceutical products may be sold in livestock markets where there are no veterinary pharmaceutical outlets nearby and the following shall be therequirements; 2.8.1 Dealers must be a retail pharmaceutical dealer with registered premises. 2.8.2 Must have a permit for transportation of veterinary pharmaceuticals and selling by using a mobile van. Selling shall be restricted at the car only to maintain the quality ofdrugs. 3. PREMISESDESIGN 3.1. The premises shall be durable, safe and made of permanent building materials so as to protect pharmaceuticals from potential harmful influences. 3.2. The premises shall be roofed with corrugated iron sheets, concrete slabs or tiles and shall have the floor minimally made up of cement, terrazzo, tiles or any other hard washablesurfaces. 3.3. The premises shall be designed and equipped so as to provide protection against rodents, birds, verminetc 3.4. The rooms shall be painted with white or cream washable paint with smooth washable finishing. 3.5. The surrounding should be maintained so as to minimize dust, soil and other contamination to enter thebuilding. 3.6. Sufficient lighting and ventilation shall be provided to enable all operation to be carriedout. 3.7. Premises should be sufficiently secured to prevent theft and unauthorized entry and a "NO SMOKING" sign should be conspicuously displayed at theentrance. 3.8. Thepremisesshallbeprovidedwithsuitableequipmentandfacilitiesfor 7.

[Audio] proper storage, safety keeping and handling of pharmaceuticals. 3.9. Van for carriage or transportation and selling of the pharmaceuticals shall be of light color and easily cleaned. It shall be dust proof, insulated, ventilated, water tight, covered to prevent direct sunlight and provided with special facilities to maintain coldchain. 3.10. In retail outlets where compounding of extemporaneous preparations is taking place there shall be availability of simple dispensing equipment like balances, mortar and pestle, measuring cylinder and a sink in the dispensingarea. 3.11. In Premises providing both human and veterinary drugs, separate displaying shelves and storage cabinets shall be provided for each category. 3.12. Premises dealing in pharmaceutical products shall not stock in the same registered premises chemicals or pesticides used exclusively for plant protections. 3.13. Premises shall have separate secured cabinets with lock and key for keeping controlleddrugs. 3.14. Approval of storeroom located within the pharmacy or warehouse at mezzanine or underground shall be subject to adherence to other premises requirements including provision of sufficient light, air conditioning facilitiesetc. 4. PREMISES LAYOUT 4.1. RETAIL PREMISES 4.1.1 Retail Pharmacy shall have a minimum of two rooms with clear demarcation and linked to each other for displaying and dispensing & store room. The premises must have one main securedentrance. 4.1.2 The minimum total size/ area of the premises shall at least measure 20m2. The rooms should have not less than 2.5m internalheight. 4.1.3 The rooms should be equipped as indicated in the inspection checklist with adequate shelves or pallets as the case may be for proper display and storage of medicinesrespectively. 4.2. WHOLESALEPREMISES 4.2.1 Wholesale pharmacy shall have not less than three rooms with clear demarcation and linked to each other for display, receiving and dispatch, record keeping and storage. The premises must have one main secured entrance. 8.

[Audio] 4.2.2 The premises shall have a minimum total size/ area of at least 40m2. The rooms should have not less than 2.5m internalheight. 4.2.3 The rooms should be equipped as indicated in the inspection checklist with adequate shelves and pallets for proper display and storage of medicinesrespectively. 4.3. RETAIL AND WHOLESALEPREMISES 4.3.1 Premises for both retail and wholesale business shall have at least three rooms namely; display, receiving and dispatch room; sales, record keeping and dispensing room; and the storageroom. 4.3.2 The minimum total size/ area of the premises shall at least measure 40m2. The rooms should have not less than 2.5 m internalheight. 4.3.3 The rooms should be equipped as indicated in the inspection checklist with adequate shelves and pallets for proper display and storage of medicinesrespectively. 4.3.4 A clear demarcation of wholesale receiving/dispatch area from the retail part shall be provided to allow orderly receipt/dispatch of pharmaceuticals inbulk. 4.4. WAREHOUSEPREMISES 4.4.1 Warehouses shall be designed and constructed to ensure good storage conditions, sufficient lighting andventilation. 4.4.2 Warehouses shall have sufficient capacity to allow storage of various categories of pharmaceuticalproducts. 4.4.3 The floor shall be durable to withstand heavy traffic and loads; the premises shall be provided with well-fitted shelves orpallets. 4.4.4 The premises shall be equipped with temperature and humidity control facilities/monitors and fireextinguishers. 4.4.5 A residential home shall not be used as awarehouse. 4.4.6 Warehouse shall only be used for storage purposes and no sells shall be allowed. 5. PERSONNEL 5.1. Permit to sale, supply, stock, dispense and compound any pharmaceutical product on retail or wholesale shall not be issued or renewed unless the person applying for holding such permit is or has a superintendent who is a registered pharmacist in direct control of distribution ofdrugs. 9.

[Audio] 5.2. The superintendent shall not act in a similar capacity for any other body corporate. 5.3. In case of a wholesale permit to sell veterinary drugs, shall only be issued or renewed if the person applying for holding such permit is or has a registered pharmacist or registered veterinary surgeon in direct control of veterinarydrugs. 5.4. The pharmacist or veterinary surgeon as the case may be, must be respectively registered by ZFDA or professional boardand must reside in the locality where the business is carried out. 5.5. In addition to clause 5.4 the veterinary surgeon, may be required to attend a special training course in handling of pharmaceuticals as approved by the Agency. 5.6. Pharmacy shall be supervised by a superintendent who may be assisted by another pharmacist, pharmaceutical technician or pharmaceutical assistant recognized by the ZFDA or professional board. 5.7. Personnel that shall be allowed to sell veterinary pharmaceutical products in livestock markets must be a veterinary surgeon or a diploma holder in AnimalHealth. 5.8. The owner shall ensure that unqualified personnel who do not possess the prerequisite knowledge do not have access to handling or dispensation ofpharmaceuticals. 5.9. If the owner is not a superintendent, he shall be made to sign a contract agreement with superintendent of which among other things shall address the terms ofterminations. 5.10. Neither superintendent nor owner shall terminate such contract agreement without a prior notice to the Agency and if the Agency is satisfied that the business is not supervised by any superintendent, that business may be closed. 5.11. Every personnel working in the pharmacy shall observe and maintain the following; (i) high standard of personalhygiene; (ii) wear a clean whitecoat; (iii) not to work under the influence of alcohol or illicitdrugs; (iv) conduct himself/ herself under good and orderly behavior; (v) wear identitybadge; 5.12. The superintendent shall be answerable for conducts of personnel working under hisinstructions. 10.

[Audio] MEDICAL REPRESENTATIVES 5.13. No person shall promote pharmaceutical products except in accordance with the Code of Conduct for Promotion as provided in the regulations and as per Part VII of Zanzibar Food, Drugs and Cosmetics Act, 2006. 5.14. Any person who intends to engage in drug promotion must have minimum basic diploma knowledge in pharmaceutical sciences, medical sciences, dental sciences, or veterinary sciences from the recognized institution or any other approved knowledge by ZFDA in consultation with other relevant authorities such as ZMC. 5.15. Any person who intends to engage in drug promotion shall apply in prescribed form to the Executive Director, ZFDA. 5.16. Applications shall be accompanied by relevant fees as prescribed under the Fees and Charges Regulations. 5.17. Applicants shall ensure that all related profession credentials are attached to the application form. 6. STORAGEFACILITIES 6.1. Storage facilities shall protect products from deterioration or infestation by vermin and pests. Specified storage conditions shall be monitored and maintainedaccordingly. 6.2. Controlled storage environment e.g. air conditioning, refrigeration for cold chain products shall be monitored using suitable temperature recording devices and records reviewed andfiled. 6.3. There should be provision for lockable shelves for keeping controlled substances. 6.4. A confined adequate space shall be provided within the premises for storage of returned, recalled, expired, quarantined and substandard or counterfeitpharmaceuticals. 6.5. All pharmaceuticals shall be stored off the floor in well – fitted shelves or pallets. 7. SANITATION AND HYGIENE 7.1. To maintain hygienic working conditions, premises shall have good supply of portable water and proper sink for hand washing. 7.2. The premises shall have a toilet or nearby accessibletoilet. 11.

[Audio] 7.3. Personnel shall not be allowed to serve the pharmacy if for the time being suffers from any disease in a communicable form, having boils sores, infected wounds where there is reasonable possibility of medicines becomingcontaminated. 8. STOCK CONTROL AND HANDLING 8.1. Any undertaking relating to receiving, keeping, selling, dispensing and compounding of pharmaceutical products shall be subject to control by the Agency. All pharmaceuticals shall be properly labeled and stored in suitable and securedplaces. 8.2. Theft and losses of pharmaceuticals shall be reported to police and ZFDAimmediately. 8.3. Repackaging and re-labeling of pharmaceuticals areprohibited. 8.4. Storage, supply, distribution and recording of controlled drugs and antiretroviral drugs must be in accordance with the respective guidelines. 9. RECORDS ANDDOCUMENTATION 9.1. Any person who owns a pharmaceutical business shall make available the following recording books of which superintendent shall cause to record related information whose particulars in each of recordingbooks. (a) ledger book or an appropriate inventory controlsystem (b) salesbook (c) inspection reports file complaints handlingbook (d) Expired drugsRegister (e) controlled drugs register In addition to above records, a retail pharmacy shall maintain a dispensing book for enabling traceability of any drug dispensed. 9.2. A wholesale pharmacy in addition to the requirements given in clause 9.1 above, shall maintain the followingrecords; (a) Final invoices with corresponding certificate ofimportation (b) Recallbook (c) Copies of deliverynotes. 9.3. The dispensing register and the retained prescription shall be kept and maintained within the premises for not less than two years from the date such prescriptions were last made toit. 12.

[Audio] 10. RECALLS AND WITHDRAWAL 10.1. There shall be a prompt and effective system of recall from the market for products known or suspected to be defective. A progress report on the recall level shall be submitted to ZFDA weekly following the directive from the Agency and the recall shall be completed within sixty (60) days of the directive. 10.2. In case of recall of product initiated by the dealer himself, the Agency shall be notified on the reason ofrecall. 10.3. Recall operations shall be capable of being initiated promptly at least down to the level of hospital, dispensary /clinic andpharmacies. 10.4. The distribution records shall be readily available to the person(s) responsible for recalls and they shall contain sufficient information related to the product, e.g. Name of product in brand and generic, Manufacturer, Dates of Manufacture and Expire, and BatchNumber. 10.5. The disposal of recalled, rejected or withdrawn products from the market shall be effected within one month after completion ofexercise. 10.6. Disposal exercise shall be carried out under supervision of ZFDA inspectors and representatives from other Government Institutions as prescribed in the DisposalGuidelines. 11. CESSATION OFBUSINESS 11.1. The Agency may at any time suspend a permit as it may determine, or revoke, or vary any provisions of such permit. Such suspension and/ or revocation shall lead the Agency to revoke the premises registration certificate. 11.2. Any permit that has been suspended and/ or revoked in accordance with the provision of the Zanzibar Food, Drugs and Cosmetics Act, 2006 may not be renewed except with the consent of the Agency if satisfied with the reasons given by the prior permitholder. 11.3. The Agency among other reasons may issue or declare a business closed down and deleted from the register, if for any reason such premises will be found operating contrary to the prescribed requirements and standards stipulated in theAct. 11.4. Subject to conditions set out in work contract agreement between the proprietor and the superintendent, the operation of the business shall be closed down if the proprietor is not able to secure the supervision of anothersuperintendent. 13.

[Audio] 11.5. Where the superintendent has given the proprietor a notice, the superintendent shall continue to supervise the premises and the proprietor shall during those days continue to pay the superintendent monthly salaries until the end of the notice or any changes within the notice, such notice given either by the proprietor or the superintendent must be furnished to the Agency. 11.6. If the proprietor wishes to close down his business because of any reason(s), he shall officially inform the Agency in advance, so that the disposal of pharmaceutical products is done under the immediate supervision of thesuperintendent. 11.7. A business that has been issued with a closure order shall surrender the premises registration certificate and valid permit to ZFDA head office of sub office Pemba depending on the location of the premises. 11.8. ZFDA inspectors shall have the responsibility of making follow up to ensure that no registration certificate or permit remain in unauthorizedhands. 11.9. Businesses that have been issued with closure order shall be deleted from register immediately and in case they would wish to re- open their premises, they shall be required to apply as newapplicants. 11.10. If it happens the superintendent dies, the y shall give the proprietor a 90 days closure notice to look for another registered superintendent or else dispose of his stock to lawfully registered dealers. During that time the business may be under the immediate supervision of a diploma holder in the relatedprofession. 11.11. Any person or representative of any deceased person who immediately before his death was lawfully in possession of any permit to deal with pharmaceuticals, or any appointed liquidator, receiver or other person dealing with the property of any person who has ceased to be entitled to possess any permit to deal with pharmaceuticals, may with written permission be allowed by the Agency to sell those pharmaceuticals to a licensed wholesale dealer or to any authorized seller ofdrugs. 12. VALIDITY OF PREMISES REGISTRATION ANDPHARMACEUTICAL BUSINESSPERMIT 12.1. Every premises registration certificate shall be issued once and it shall not be renewed. Premises registration certificate shall remain valid provided that the following conditions aremet; (a) premises start to operate within six (6) months following the approval orregistration (b) business permit isrenewed (c) The premises have been maintained and remained in conditions which led to its initialregistration (d) There is no change of ownership, business name orlocation. 14.

[Audio] 12.2. The permit shall be annually renewed unless suspended, cancelled or revoked by theAgency. 12.3. Every permit issued by the Agency shall expire on the 31stDay of December every year. 13. PAYMENT OFFEES 13.1. Payment of fees shall be done either through the followingways:- (a) People's Bank of Zanzibar account number 021103000579 for local currency and 02210000015 for foreigncurrency 13.2. All bank charges shall be borne byapplicants. 14. LANGUAGE All the prescribed information shall be submitted in English or Kiswahili and all communications regarding the application shall be made in any of these two languages. 15. NOTIFICATION FOR CHANGE OF REGISTEREDPREMISES 15.1. Any change of location (shift of premises), trade name of the premises, ownership or any other change of registered premises, shall be made to the Executive Director. 15.2. An intention to change location of registered premises shall be made in writings to the Agency before the change is made and the Agency shall notify the applicant on the procedure to befollowed. 15.3. The Agency shall have final say on the location and name of the proposedpremises. 16. REFUSAL OR REVOCATION OF REGISTRATION CERTIFICATE AND PERMIT 16.1 The Agency may by giving reasons refuse to register any premises, and may at any time suspend, cancel, revoke or amend premises registration certificate and permit. 17. APPEALS 17.1. Any person aggrieved by a decision of the Agency in relation to any application for registration of premises or permit may make representations to the Agency, whereby he shall submit information and arguments to convince the Agency to reconsider itsdecision. 15.

[Audio] 17.2. After reconsideration of the application, if the Agency still rejects the application, the applicant may appeal to Minister responsible for Health matters. 18. REFERENCEMATERIALS 18.1. The following reference materials shall be made available in the pharmacy:- (a) The ZFDC Act No. 2 of 2006 and itsregulations. (b) Zanzibar Treatment Guideline (c) British National Formulary (d) Good Dispensing Manual(English/Swahili) (e) Guidelines for Registration and licensing of pharmaceutical premises (f) List of registered drugs with currentedition (g) Veterinary formulary: Hand book of Medicines used in veterinary Practice 18.2. If possible the following and other relevant reference materials shall be made available; (a) Extra Pharmacopoeia (Martindale) current edition (b) Merck Veterinary Manual Latest Edition 18.3. The Agency may recommend other reference from time to time..

[Audio] All rights reserved: This is a controlled document. It must not be copied without authorization from the Quality Manager or Director of Department or Executive Director. Only originals or authorized copies shall be used as working documents.