Zimbabwe Pharmaceutical Licensing

MCAZ places manufacturers and pharmacies under a premises licensing system and wholesalers under a wholesale dealer permit system. Personal licences, product market authorisation, import/export and handling dangerous drugs are separate regulatory layers. Company registration or local business formalities cannot replace MCAZ authorisation; conversely, an MCAZ premises licence does not automatically permit the sale of unregistered medicines, importation or handling controlled substances.

This review of Zimbabwe concerns the national MCAZ pathway; pharmaceutical licences are not issued differently by province. The premises must still obtain the relevant local authority approvals for building plans, change of use or use, and an environmental health report at its actual location. For company applications, MCAZ requires evidence of the nationality/ordinary residence of a majority of directors or a ministerial exemption; the materials reviewed are insufficient to extend this into a single rule for foreign ownership, capital, company form or beneficial owners across all business types.

— Retail: Pharmacy premises licence, continuous supervision and retail premises inspection.

— Wholesale: Wholesale Dealer Permit, GSDP and wholesale warehouse inspection.

— Manufacturing: Manufacturing premises licence, cGMP, quality lead and product authorisation are handled separately.

MCAZ states that the activities of its Licensing and Enforcement Division are based on the Medicines and Allied Substances Control Act Chapter 15:03, and include licensing, inspection and enforcement for manufacturers, pharmacies, wholesalers and others. Licensing and inspection matters are considered by the Licensing and Advertising Committee, and the relevant decisions are then approved by the Authority; application review staff do not make final decisions independently.

PCZ is a statutory professional regulatory body established under the Health Professions Act Chapter 27:19. It is responsible for registration, annual practising certificates and CPD for professions including pharmacists and pharmacy technicians. MCAZ licensing guidelines define a “pharmacist” as a person registered under that Act; accordingly, professional status with PCZ and business authorisation from MCAZ must be checked separately.

— MCAZ: Premises, personnel, products, import/export and enforcement regulation.

— PCZ: Personal professional registration and practising certificates for pharmacists, pharmacy technicians and others.

— Local authority/environmental health inspectors: Approvals or reports concerning the planning use and health documentation for proposed premises.

Apply for a retail pharmacy under the MCAZ premises licensing procedure: submit through ZIMDIS, pay the applicable application fee, provide local authority building/use and health documents, company or individual documents, and the retail-pharmacy-specific PCZ confirmation; inspectors will then arrange an on-site inspection. A licence is issued only for premises that pass inspection. If deficiencies are identified, the applicant should explain the corrective action; structural issues may require a reinspection.

The MCAZ 2025 new-pharmacy inspection checklist specifically checks the supervisor and other personnel, visibility of the front shop, cleanliness, natural/artificial lighting, storage protecting medicines from heat, light, moisture and public access, washable floors/walls, security devices, refrigeration equipment, thermometer calibration, water supply, reference materials, registers, prescription-record systems, and dangerous-drug lockable cabinets/registers. The 10-square-metre dispensing workspace in the checklist is a verified inspection item for retail pharmacies, not a general figure for other licence types.

— Prepare the retail pharmacy application based on the actual proposed premises, business scope and supervisor.

— Do not treat payment or a lease as approval to open before the MCAZ inspection is passed and the licence is issued.

— If supplying dangerous drugs, establish separate controlled storage and register controls under the dangerous drugs regulations.

Wholesalers require a MCAZ Wholesale Dealer Permit; this is not simply an extension of an ordinary pharmacy premises licence. MCAZ’s new wholesaler inspection checklist requires physical separation and clear labelling of four areas for receiving, quarantine, storage and dispatch, with corresponding minimum areas of 10, 5, 15 and 10 square metres. It also checks temperature equipment/calibration/logs, security, shelving or pallets, refrigeration equipment and regulatory materials. These figures apply only to the published inspection checklist for “new wholesaler premises”.

Wholesalers should also have a record system capable of capturing batch numbers, manufacturers, expiry dates and customer invoice details, and maintain SOPs signed by an authorised technical person and bearing revision dates, including procedures for receipt checks, storage, cleaning and maintenance, stock security, returns and recalls. A wholesale permit does not authorise supply to unlicensed premises, nor does it waive product market authorisation, import/export or manufacturing requirements.

— Prepare the actual warehouse according to the flows for receiving, quarantine, storage, dispatch and returns.

— Establish traceable batch and expiry records, temperature monitoring, inventory records and recall records.

— If dangerous drugs are held on site, ensure supervision by a licensed pharmacist and use lockable cabinets and registers.

MCAZ GL-14 applies to proposed local pharmaceutical manufacturers and existing manufacturers expanding their manufacturing scope, and states that all licensed manufacturing sites should comply with current WHO GMP as adopted in MCAZ GMP guidelines. It recommends applying to the GMP inspection department for a design review during the design phase. Design documentation includes scaled floor plans, process/material/personnel flow diagrams and HVAC zoning/pressure-differential diagrams; the review focuses on contamination and cross-contamination control and rational workflow.

After construction and qualification of facilities/utilities and equipment, the manufacturing site should apply to MCAZ for a licence. The GMP inspection checks the approved design, DQ/IQ/OQ/PQ, quality systems, competence of key personnel, and documentation for process validation, technology transfer, cleaning validation, intermediate hold times and analytical method validation. The initial licence conditions require satisfactory completion of process validation or technology transfer before release for sale; therefore, the premises licence itself does not mean that a new product is ready for commercialisation.

— Conduct MCAZ GMP design review and gap assessment before leasing land, construction or procurement.

— Apply based on the actual dosage forms/activities and approved scope of manufacturing; do not treat a factory licence as authorisation for all dosage forms.

— Prepare product registration, validation, stability and market authorisation documentation in parallel.

Personal professional authorisation is separate from business premises authorisation. PCZ provides registration, annual practising certificates and CPD services for pharmacists, pharmacy technicians and other professionals. For MCAZ personal licence applications, applicants must pass its forensic pharmacy examination or demonstrate familiarity with medicines custody/dispensing regulations, and submit a valid practising certificate from the relevant professional body, identity or residency information, and a declaration of good character/police clearance. MCAZ may grant exemptions based on other examinations passed or practical experience.

For storage and distribution, MCAZ GSDP requires the pharmacist or pharmacy technician responsible for proper handling, storage and distribution to have sufficient education, training or experience to perform the role. During business hours, operations must be continuously supervised in person by a licensed pharmacist or licensed pharmacy technician. Premises for dangerous drugs must be supervised by a licensed pharmacist. Manufacturing has separate, specialised authorisation and responsibilities for an Authorized/Qualified Person.

— First verify the individual's professional registration with PCZ and valid practising certificate.

— Then apply to MCAZ for the applicable personal licence and supervision arrangements for the actual personnel.

— For manufacturing premises, separately submit evidence of the Authorized/Qualified Person's qualifications, experience and ongoing training.

Each proposed licensed premises must be applied for by specific address, with approved building plans from the local authority, a 1:100 floor plan, a local trading licence for premises use or change of use, and an environmental health report. MCAZ GSDP further requires premises to be appropriately sited, designed, constructed and maintained to prevent contamination, pests and unauthorised access. Medicines must be stored off the floor, and premises must have segregated areas, logical workflow, adequate lighting, and cleaning and maintenance.

Refrigerated, frozen and other storage areas with specified conditions must be monitored, reviewed and supported by retained temperature records; temperature monitoring devices must be calibrated regularly, with calibration records retained. Goods receipt and dispatch areas should also be protected from dust, rain and contamination. Temperature or humidity excursions should trigger an assessment of product suitability; having a refrigerator installed is not a substitute for meeting label conditions, monitoring or deviation management.

— Retail: prepare the premises for dispensing, storage, refrigeration, security and record-keeping in accordance with LEF-56.

— Wholesale: prepare the premises for zoning, segregation, temperature control, SOPs and traceability in accordance with LEF-55.

— Manufacturing: construct and maintain the premises in accordance with reviewed designs, qualification requirements and cGMP documentation.

Premises applications are submitted through the MCAZ ZIMDIS online platform, with the applicable fee schedule paid. General attachments listed by MCAZ include approved building plans, a 1:100 floor plan, local trading licence, health report, company constitutive documents/CR14 or personal details, and a declaration or police clearance showing that the applicant or directors have not been convicted in the preceding three years of an offence relating to medicines or dishonesty. Retail pharmacies must also submit PCZ compliance confirmation. Once the application is complete, inspectors contact the applicant to arrange an inspection.

MCAZ guidance states that, “where possible,” premises inspections for complete applications in Harare take place within two days of receipt, and within five days outside Harare; inspection reports are sent to applicants at the specified point, and licences are processed within two working days after the premises pass inspection. Outstanding application matters must be completed within 60 days of submission, otherwise the application is closed and a new application should be made. These are conditional process targets in current guidance and must not be represented as a guaranteed total approval period for an individual case.

— Determine the premises category, proposed site, company/individual applicant and actual supervisors.

— Upload the relevant local, company, good-character, professional and technical documents, and pay the fee.

— Undergo inspection, respond to each deficiency and, where required, undergo re-inspection.

MCAZ requires applicable fee-schedule fees to be paid for applications and renewals, but this guide does not quote unverified line-item rates as a single price for retail, wholesale or manufacturing. Manufacturing GL-14 separately lists a design review fee of USD658 or the equivalent in local currency at the prevailing bank exchange rate; construction progress verification may be charged at USD1,000 or the equivalent in local currency. The manufacturing GMP inspection fee should be confirmed with the Licensing Unit. These items are not equivalent to the total cost of setting up a plant, premises licensing, product registration or import fees.

MCAZ GL-01 provides that premises/personnel licences or permits are generally valid for 12 months. Pharmacies and wholesalers renew on the anniversary of the initial licence/permit; expiry dates for personnel categories are specified separately by category. Renewals must be submitted and paid for through the online platform before expiry. If the application was submitted on time and no approval or refusal notice has been received before expiry, the licence or permit remains valid until MCAZ notifies the applicant of its decision. The current process target for a complete renewal application is ten working days.

— Confirm fees with MCAZ based on the application category, actual premises and current fee schedule.

— Pharmacies/wholesalers should start renewal before their respective anniversary date, not wait until the expiry date.

— For manufacturing projects, separately verify fees for design review, GMP inspection, premises licensing and product documentation.

Swipe horizontally to view all items

GSDP requires storage and distribution entities to establish and implement a documented quality system covering GSP/GDP, quality risk management, management review, responsibilities, outsourced activities, self-inspection/quality audits, returns, complaints, recalls, deviations and CAPA. Personnel must receive and document initial and ongoing training. Inventory must be updated after every receipt, dispatch, loss or adjustment, generally retained for five years, and counted regularly. Apply first-expiry, first-out; remove expired products from saleable stock and segregate them.

MCAZ may conduct supervisory, investigative and routine inspections. Its website states that pharmacies are generally subject to a full routine inspection at least once every two years, but this may be annually based on risk; manufacturers and wholesalers are also inspected. If premises are not continuously supervised in person by a licensed supervisor, inspectors may order closure. Reopening may be authorised only after supervision is confirmed and the re-inspection fee is paid.

— Maintain current premises/permit, personal supervision and applicable product status.

— Use written procedures to manage receipt, storage, transport, complaints, returns, recalls, deviations and CAPA.

— Implement temperature control, inventory management, FEFO, training, audits and traceable records.

MCAZ requires licence or permit holders to obtain authorisation before any administrative or structural change after licensing. Administrative changes include a trading name, director composition, supervisor or qualified person; structural changes may include floor plans, personnel/material flows, HVAC and water systems. Changes of directors require an updated CR14 and, where applicable, a PCZ compliance letter. Replacement of a supervisor requires new premises and personnel applications, confirmation of supervision and a resignation letter. A change of address must be notified in writing, and the new premises must go through the licensing process again.

Premises licences and permits are non-transferable. MCAZ GL-02 requires written notice and submission of a pre-sale regulatory clearance using LEF-113 before any sale, transfer, assignment or change of ownership. The new owner must submit a new application with the sale agreement, clearance letter, proof of payment, company/director information, and local and health documents. A transaction without clearance may constitute a major non-compliance and may result in the buyer not being licensed; a share, asset or control transaction does not automatically transfer the old licence to the new entity.

— Apply for pre-sale regulatory clearance and address outstanding compliance matters before signing or completing a transaction.

— Before changes to a supervisor, director, trading name or structure, determine whether they are administrative, structural or manufacturing changes.

— Before implementation, complete a written application, technical documentation and any required inspections for a change of address, new dosage form or additional manufacturing activity.

Product marketing authorisation is separate from premises operations. For conventional human and veterinary medicines, MCAZ processes registration using MC-8, a complete dossier, screening checklist, samples, sample submission form and payment verification; complementary medicines use CM-1 and the corresponding dossier. MCAZ GSDP expressly prohibits the sale of unregistered medicines unless written authorisation has been obtained, for example under section 75 of MASCA. Unregistered medicines authorised in this way must also be stored separately, labelled and recorded.

Imports and exports are also handled separately. The MCAZ Import and Export Unit processes applications for medicine imports and exports and verifies consignments at ports of entry; imports of registered medicines must still comply with the requirements for authorised importers and authorised premises. The section 75 authorisation for unregistered medicines applies to routes for individuals, hospitals, clinics or non-governmental organisations, for example, where there is a clinical need. Separate permits must be obtained for each import or export of narcotic drugs, psychotropic substances and precursor substances, and MCAZ must be notified in writing at the time of import or export.

— Check each product's MCAZ registration/approval, holder, labelling and market status.

— For cross-border consignments, separately prepare for import/export applications, product status and port-of-entry verification.

— Obtain separate controlled permits, and meet storage and record-keeping requirements, for narcotic drugs, psychotropic substances, precursors and dangerous drugs.