SOP for Pharmacy in Egypt (Free PDF Download)

Pharmacy SOP for Egypt (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Egypt — covering Egyptian Drug Authority (EDA) licensing, the responsible-pharmacist rules, procurement, dispensing, the national track-and-trace system, 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, traceability, recall and recordkeeping procedures required to operate a retail pharmacy in Egypt in line with EDA regulations.

2. Scope

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

3. Regulatory Background

• The Egyptian Drug Authority (EDA) licenses pharmaceutical institutions through its Central Administration of Pharmaceutical Institutions Licensing.
• The responsible pharmacist must hold a valid pharmacy practice license and a current pharmacists syndicate membership card, and must be registered with the EDA as the pharmacy's manager before the licence issues.
• A pharmacist may not own or be a shareholder in more than one pharmacy — confirm any ownership structure against this rule before applying.
• The licensing file requires an affidavit that the pharmacist has practised in a pharmacy for at least one year (counted from the practice license date).
• Pharmacies are the lawful dispensing point in Egypt's Unified National Electronic Pharmaceutical Track-and-Trace System — every dispensed package must be documented in the national traceability system using the approved EPCIS protocol.
• Always confirm the current licensing dossier with the EDA before filing, as guidelines are versioned and updated.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Pull the current licensing guideline from the EDA — do not rely on second-hand checklists.
2. Appoint the responsible pharmacist: valid practice license, current syndicate membership card, at least one year of pharmacy practice.
3. File the licensing dossier with the EDA branch in the pharmacy's governorate and pass the premises inspection.
4. Display the current EDA licence prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from EDA-registered products and licensed suppliers.
2. Verify registration status 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 and traceability

1. Dispense prescription-only medicines only against valid prescriptions, verified by a pharmacist.
2. Counsel every patient on dosage, duration and storage.
3. Record every dispensed package in the Unified National Electronic Pharmaceutical Track-and-Trace System per the EDA's EPCIS protocol.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (EDA, manufacturer or internal finding), the responsible 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, traceability records, recall files and ADR reports for the full retention period required by regulation.
2. Make all records available to EDA inspectors on demand.

6. Pro Tips

• One pharmacist, one pharmacy. The single-pharmacy ownership rule kills multi-branch plans before they start — structure ownership to comply from day one.
• Get the responsible pharmacist registered early. EDA registration as manager is a precondition of the licence, not a post-opening formality.
• Treat traceability as dispensing, not admin. Every package must be documented in the national system — build the EPCIS step into the dispensing workflow, not as an end-of-day chore.
• 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 licenses a pharmacy in Egypt? A: The Egyptian Drug Authority (EDA), through its Central Administration of Pharmaceutical Institutions Licensing, licenses pharmaceutical institutions including retail pharmacies.

Q2: What must the responsible pharmacist hold? A: A valid pharmacy practice license, a current pharmacists syndicate membership card, EDA registration as the pharmacy's manager, and at least one year of pharmacy practice documented by affidavit.

Q3: Can one pharmacist own multiple pharmacies in Egypt? A: No. A pharmacist may not own or be a shareholder in more than one pharmacy.

Q4: What is the track-and-trace requirement? A: Pharmacies are the lawful dispensing point in Egypt's Unified National Electronic Pharmaceutical Track-and-Trace System — every dispensed package must be documented in the national system using the approved EPCIS protocol.

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.