SOP for Pharmacy in Cameroon (Free PDF Download)

Pharmacy SOP for Cameroon (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy (officine) in Cameroon — covering Ministry of Public Health authorisation, Ordre National des Pharmaciens du Cameroun (ONPC) registration, staffing, procurement, dispensing, recall handling and recordkeeping. 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 pharmacy in Cameroon in line with the law governing the practice and organisation of the pharmacy profession and Ministry of Public Health requirements.

2. Scope

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

3. Regulatory Background

• The practice and organisation of the pharmacy profession in Cameroon is governed by Law No. 90/035 of 10 August 1990.
• Opening a retail pharmacy requires authorisation from the Ministry of Public Health (Santé publique); the application is made to the Ministry with the required business, premises and professional documentation.
• The pharmacist must be registered with the Ordre National des Pharmaciens du Cameroun (ONPC), the professional order regulating pharmacists.
• The pharmacy must be under the effective control of a registered pharmacist, with adequate premises meeting safety and storage standards verified by inspection.
• All official documents, contracts and filings must be in French — prepare the full dossier in French from the start.
• Confirm current authorisation fees, premises standards and required documents with the Ministry of Public Health and the ONPC before opening, as requirements are updated periodically.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the business entity and secure compliant premises (suitable layout, secure and temperature-appropriate storage, handwashing facilities, adequate workspace).
2. Appoint the titulaire pharmacist — a pharmacy graduate registered with the ONPC.
3. Compile the authorisation dossier in French: business registration, lease or title documents, premises layout, equipment list and the titulaire's professional credentials.
4. Submit the application to the Ministry of Public Health and pay the prescribed fees.
5. Undergo the premises inspection — correct any defects the inspectors identify.
6. Display the current authorisation and the titulaire's ONPC registration prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from licensed suppliers and verify product registration.
2. 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 only against valid prescriptions for prescription-only medicines, 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 (Ministry, manufacturer or internal finding), the titulaire 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 national pharmacovigilance channels.
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 for the period the authorities require — confirm the current retention period with the Ministry of Public Health.
2. Make all records available to inspectors on demand.

6. Pro Tips

• Draft the dossier in French from day one. Every official document, contract and filing must be in French — translating at the end slows the application.
• Sort ONPC registration early. The titulaire must be registered with the Order before the authorisation can proceed — don't leave it to the final week.
• Design for inspection. Adequate storage, security, sanitation and equipment are checked against premises standards — build to the standard, not to a guess.
• 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.

7. Frequently Asked Questions

Q1: Who authorises a pharmacy to open in Cameroon? A: The Ministry of Public Health (Santé publique) grants the authorisation to open a retail pharmacy, after review of the dossier and inspection of the premises.

Q2: What law governs pharmacy practice in Cameroon? A: Law No. 90/035 of 10 August 1990 on the practice and organisation of the pharmacy profession.

Q3: Must the pharmacist be registered with the professional order? A: Yes. The pharmacist in charge must be registered with the Ordre National des Pharmaciens du Cameroun (ONPC).

Q4: Can a non-pharmacist own a pharmacy? A: The authorisation and the premises must be under the effective control of a registered pharmacist — confirm the current ownership rules with the Ministry of Public Health and the ONPC before structuring the business.

Q5: In what language must the application be made? A: French. All official documents, contracts and filings in Cameroon must be in French.

Q6: Is a recall SOP required? A: Batch-level traceability and rapid recall execution are expected of every pharmacy — a written product-tracking and recall procedure is essential for inspections and for patient safety.