SOP for Pharmacy in Senegal (Free PDF Download)

Pharmacy SOP for Senegal (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy (officine) in Senegal — covering professional licensing, premises setup, procurement, dispensing, storage, 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 Senegal in line with national pharmacy regulations and professional standards.

2. Scope

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

3. Regulatory Background

• The Ordre National des Pharmaciens du Sénégal registers pharmacists and regulates professional practice; confirm current registration steps with the Ordre.
• A retail pharmacy (officine) must be owned and personally managed by a licensed pharmacist (pharmacien titulaire).
• The operating authorization is issued through the Ministry of Health; confirm the current application dossier and inspection steps with the ministry's pharmacy directorate before signing a lease.
• Pharmaceutical regulation in Senegal sits within the UEMOA (WAEMU) regional harmonisation framework — verify any regional requirements that apply to your products.
• Prescription-only medicines may only be dispensed against a valid prescription; controlled substances require dedicated registers — confirm the current register formats with the Ordre.
• Keep all professional records for the retention period required by regulation — confirm the current period with the Ordre, and never destroy records under inspection hold.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Confirm the current licensing dossier with the Ministry of Health's pharmacy directorate and the Ordre National des Pharmaciens du Sénégal.
2. Appoint the pharmacien titulaire (licensed, registered with the Ordre) who will personally manage the officine.
3. Secure premises that meet the structural requirements for a pharmacy, then pass the pre-opening inspection.
4. Display the current operating authorization prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from licensed wholesalers and authorized suppliers.
2. Verify marketing authorizations 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, verified by a pharmacist.
2. Counsel every patient on dosage, duration and storage.
3. Record each dispensing in the prescription register; maintain dedicated registers for controlled substances.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (supplier, 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 to the national pharmacovigilance system.
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 full retention period required by regulation.
2. Make all records available to health inspectors on demand.

6. Pro Tips

• Sort the titulaire paperwork first. The officine must be personally managed by a licensed pharmacist — confirm the registration and authorization chain before signing a lease, not after.
• Verify the dossier, don't inherit it. Licensing checklists circulate informally and go stale — confirm the current dossier directly with the ministry's pharmacy directorate and the Ordre.
• 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.
• Separate the quarantine area physically. Expired, recalled and suspect stock must be unmistakably segregated from saleable stock — a marked shelf is not enough.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Senegal? A: The operating authorization is issued through the Ministry of Health, while the Ordre National des Pharmaciens du Sénégal registers pharmacists and regulates professional practice. Confirm current steps with both before applying.

Q2: Who can own and manage a pharmacy in Senegal? A: A retail pharmacy (officine) must be owned and personally managed by a licensed pharmacist (pharmacien titulaire) registered with the Ordre.

Q3: Can prescription medicines be sold without a prescription? A: No. Prescription-only medicines may only be dispensed against a valid prescription verified by a pharmacist.

Q4: What records must a Senegal pharmacy keep? A: Prescription registers, purchase invoices, temperature logs, recall documentation and ADR reports, kept for the full retention period required by regulation — confirm the current period with the Ordre.

Q5: How are adverse drug reactions reported? A: Suspected adverse drug reactions are reported to the national pharmacovigilance system, with a copy kept in the pharmacy's records.

Q6: Is a recall SOP mandatory? A: A written product tracking and recall procedure is expected as part of professional practice — maintain batch-level traceability from supplier to patient so any recall can be executed immediately.