SOP for Pharmacy in Ivory Coast (Free PDF Download)

Pharmacy SOP for Ivory Coast (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy (officine) in Ivory Coast — covering AIRP licensing, ONPCI pharmacist registration, 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 Ivory Coast in line with AIRP regulations and ONPCI professional standards.

2. Scope

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

3. Regulatory Background

• The Autorité Ivoirienne de Régulation Pharmaceutique (AIRP) is the pharmaceutical regulation authority that licenses pharmacies (www.airp.ci).
• The Ordre National des Pharmaciens de Côte d'Ivoire (ONPCI) registers pharmacists; a retail pharmacist must hold a current-year ONPCI attestation and be entered in section 1 of the Order's table.
• Opening an officine requires two licences: the licence de création (creation licence) and the licence d'exploitation (operating licence).
• The gérant pharmacist must hold a Doctor of Pharmacy state diploma (diplôme d'Etat de Docteur en Pharmacie), with certified equivalence for any foreign diploma.
• Transferring an existing pharmacy licence requires a request to the Minister of Health, proof of at least 5 years of professional practice, and a file fee (100,000 FCFA to the AIRP at the time of the official schedule — confirm the current fee before applying).
• Always confirm the current dossier checklist with the AIRP (secretariat@airp.ci) before filing, as requirements are updated.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Pull the current licence checklist from the AIRP (e-Licences portal / secretariat@airp.ci) — do not rely on second-hand lists.
2. Appoint the gérant pharmacist: Doctor of Pharmacy diploma (or certified equivalence), current-year ONPCI attestation, section 1 registration.
3. File for the licence de création, secure compliant premises, then obtain the licence d'exploitation.
4. Display the current licence d'exploitation 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.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (AIRP, supplier or internal finding), the gérant 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 AIRP inspectors on demand.

6. Pro Tips

• Two licences, not one. The création licence lets you set up; only the exploitation licence lets you open — plan the timeline around both, not just the first.
• Keep the ONPCI attestation current. It is an annual document and licensing files require the current year's version — an expired attestation stalls the whole dossier.
• 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.
• Budget the transfer properly. Taking over an existing officine needs 5 years of proven practice plus the AIRP file fee — verify both against the current official schedule before committing.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Ivory Coast? A: The Autorité Ivoirienne de Régulation Pharmaceutique (AIRP) licenses pharmacies; the Ordre National des Pharmaciens de Côte d'Ivoire (ONPCI) registers pharmacists and regulates professional practice.

Q2: What licences does a new pharmacy need? A: Two: the licence de création (creation licence) to set up the officine, and the licence d'exploitation (operating licence) to open and trade.

Q3: What qualifications must the gérant pharmacist hold? A: A Doctor of Pharmacy state diploma (with certified equivalence for foreign diplomas), a current-year ONPCI registration attestation, and entry in section 1 of the Order's table.

Q4: What is required to transfer an existing pharmacy licence? A: A request addressed to the Minister of Health, proof of at least 5 years of professional practice, the existing licences, and the AIRP file fee — confirm the current checklist and fee with the AIRP before applying.

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.