SOP for Pharmacy in Tanzania (Free PDF Download)

Pharmacy SOP for Tanzania (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Tanzania — covering TMDA premises licensing, Pharmacy Council of Tanzania practice requirements, the Type 1 pharmacy vs ADDO distinction, procurement, dispensing, storage, recall handling, recordkeeping and pharmacovigilance. Adapt the bracketed fields to your premises and adopt it as your operations manual.

1. Purpose

To define the licensing, staffing, procurement, dispensing, storage, recall and recordkeeping procedures required to operate a retail (Type 1) pharmacy in Tanzania in line with TMDA regulations and Pharmacy Council of Tanzania practice standards.

2. Scope

Applies to the superintendent pharmacist, all pharmacists, pharmaceutical technicians and support staff at [Pharmacy Name], [Address].

3. Regulatory Background

• The Tanzania Medicines and Medical Devices Authority (TMDA) licenses pharmaceutical premises and regulates medicines, including product registration and post-market surveillance.
• The Pharmacy Council of Tanzania (PCT) registers pharmacists and regulates pharmacy practice.
• A retail (Type 1) pharmacy must operate under the direct supervision of a PCT-registered pharmacist and may sell prescription-only, pharmacy-only and general-sale-list medicines. Conditions inspected include air-conditioning, refrigeration and a dispensing window.
• An ADDO (Accredited Drug Dispensing Outlet) is a lower tier: it is supervised by a person who completed the 5-week ADDO training course — no registered pharmacist is required — and it may sell only general-sale-list medicines plus specified antibiotics on prescription.
• The superintendent must be a registered pharmacist in direct control of the pharmacy, registered by the PCT, resident in the locality where the business operates, and not employed by any other organisation; they may not act in a similar capacity for another business. Physical supervision of at least 15 hours per 7-day week is expected (full-time preferred), and the superintendent may be assisted by a pharmacist, pharmaceutical technician or pharmaceutical assistant recognised by the PCT.
• Premises registration requires: the BRELA company certificate, a premises drawing showing the layout, a contract with the superintendent pharmacist plus their letter of acceptance to supervise. The TMDA inspects the premises before issuing the premises registration certificate and business licence.
• Confirm current fees, forms and premises standards with the TMDA and the Pharmacy Council of Tanzania before you apply — regulations and fee schedules change.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the company with BRELA and secure premises with at least a display room, dispensing room and store room.
2. Appoint a superintendent pharmacist (PCT-registered, resident in the locality, not employed elsewhere, minimum 15 hours' physical supervision per week).
3. Compile the application dossier — BRELA certificate, premises layout drawing, superintendent contract and acceptance letter.
4. Submit to the TMDA and pass the premises inspection; display the registration certificate and business licence prominently once issued.

5.2 Procurement

1. Source medicines only from licensed suppliers and TMDA-registered products.
2. Verify TMDA registration numbers on every incoming consignment.
3. Check expiry dates, batch numbers and physical condition on receipt; quarantine anything suspect.

5.3 Storage

1. Store per label conditions; maintain the cold chain for thermolabile products with twice-daily temperature logs.
2. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Dispense prescription-only medicines only against valid prescriptions from an authorised prescriber, verified by a pharmacist.
2. Counsel every patient on dosage, duration and storage.
3. Record each dispensing in the prescription register.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (TMDA, manufacturer or internal finding), the superintendent pharmacist initiates the recall immediately.
3. Identify and quarantine all affected batches, notify patients where required, and return stock per the recall notice.
4. Document the entire recall: batches, quantities, notifications, returns.

5.6 Pharmacovigilance

1. Report every suspected adverse drug reaction through the TMDA's pharmacovigilance system — confirm the current reporting channel with the TMDA.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, purchase invoices, temperature logs, recall files and ADR reports organised and retrievable.
2. Confirm the minimum record-retention period with the TMDA and the Pharmacy Council of Tanzania, and make all records available to inspectors on demand.

6. Pro Tips

• Choose your tier deliberately. A Type 1 pharmacy needs a full-time registered pharmacist; an ADDO needs only 5-week-trained supervision but sells a far narrower range. Pick the model your staffing can sustain.
• One superintendent, one pharmacy. A pharmacist may not superintend two businesses and must not be employed elsewhere — verify exclusivity before you appoint.
• Drill the recall. Run a mock recall once a year; the first time you trace a batch should not be during a real one.
• Temperature logs are legal evidence. Twice-daily fridge logs, signed — inspectors ask for them first after a cold-chain complaint.
• Pass inspection the first time. Air-conditioning, refrigeration, a dispensing window and the three-room layout are checked on site — fix the premises before the TMDA visit, not after.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Tanzania? A: The TMDA licenses the premises and regulates the medicines; the Pharmacy Council of Tanzania (PCT) registers the pharmacists and regulates practice.

Q2: What is the difference between a Type 1 pharmacy and an ADDO? A: A Type 1 pharmacy operates under a registered pharmacist and can sell prescription-only, pharmacy-only and general-sale-list medicines. An ADDO is supervised by someone with 5 weeks' ADDO training (no pharmacist required) and may sell only general-sale-list medicines plus specified antibiotics on prescription.

Q3: What are the superintendent pharmacist's requirements? A: A PCT-registered pharmacist in direct control of the pharmacy, resident in the locality, not employed by any other organisation, not acting in a similar capacity for another business, and physically supervising at least 15 hours per 7-day week.

Q4: Can one pharmacist supervise two pharmacies? A: No — the superintendent may not act in a similar capacity for any other body corporate.

Q5: What documents are needed for premises registration? A: The BRELA company certificate, a premises drawing showing the layout, and a contract with the superintendent pharmacist plus their letter of acceptance to supervise — followed by a TMDA inspection.

Q6: How are adverse drug reactions reported? A: Through the TMDA's pharmacovigilance system, with a copy filed in the pharmacy's records. Confirm the current reporting channel with the TMDA.