SOP for Pharmacy in Malawi (Free PDF Download)

Pharmacy SOP for Malawi (Free PDF Download)

A complete standard operating procedure template for opening and running a retail pharmacy in Malawi — covering Pharmacy and Medicines Regulatory Authority (PMRA) premises licensing, medicine classification schedules, 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 Malawi in line with the PMRA Act No. 9 of 2019 and PMRA practice standards.

2. Scope

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

3. Regulatory Background

• The Pharmacy and Medicines Regulatory Authority (PMRA), established under the PMRA Act No. 9 of 2019, regulates medicines, pharmacy practice and pharmaceutical businesses in Malawi.
• A retail pharmacy must hold a current PMRA premises registration; the application requires the premises layout sketch, the supervising pharmacist's PMRA registration and valid practising certificate, a signed contract from the full-time personnel, business registration, the MRA taxpayer identification number and proof of fee payment.
• Medicines are classified into schedules: POM (prescription-only), PIM (pharmacist-initiated), P (pharmacy-only), GSL (general sales list) and CD (controlled drugs).
• Controlled drugs are subject to the Dangerous Drugs Act Cap 35:02, with strict rules on prescribing, dispensing, storage and records.
• Dispensing of all POMs must be from registered pharmacy premises under the direct supervision of a registered pharmacist.
• Confirm current licensing fees, schedule lists and premises standards with the PMRA before opening, as requirements are updated periodically.

4. Responsibilities

5. Procedure

5.1 Licensing and premises setup

1. Register the business and secure premises; prepare the premises layout and sketch.
2. Appoint a full-time registered pharmacist as superintendent, holding a valid PMRA practising certificate.
3. Submit the PMRA premises-registration application: application form, layout sketch, pharmacist registration certificate, valid practising certificate, signed personnel contract, business registration, MRA TIN and proof of fee payment.
4. Display the current PMRA premises registration prominently in the pharmacy.

5.2 Procurement

1. Source medicines only from PMRA-licensed suppliers; import permits where applicable are issued by the PMRA.
2. Verify registration status of every incoming product against the PMRA register.
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. Keep controlled drugs in a locked, access-restricted area with a dedicated register.
3. Separate quarantined, expired and recalled stock in a clearly marked area.

5.4 Dispensing

1. Dispense POMs only against valid prescriptions from registered prescribers, verified by a pharmacist.
2. Dispense PIMs only under direct pharmacist supervision, recording the supply and counselling the patient.
3. Counsel every patient on dosage, duration and storage.
4. Record each dispensing in the prescription register; maintain the controlled-drug register per the Dangerous Drugs Act.

5.5 Product tracking and recall

1. Maintain batch-level traceability from supplier to patient for every product.
2. On a recall notice (PMRA, 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 to the PMRA pharmacovigilance system promptly.
2. File a copy of each report with the pharmacy's records.

5.7 Recordkeeping

1. Keep prescription registers, controlled-drug registers, purchase invoices, temperature logs, recall files and ADR reports for the period the PMRA requires — confirm the current retention period with the PMRA.
2. Make all records available to PMRA inspectors on demand.

6. Pro Tips

• Start with the checklist, not the lease. The PMRA's minimum-requirements list (layout sketch, pharmacist papers, TIN, fee receipt) is the real application — assemble it before signing premises.
• Nail the medicine schedules. Staff who can't distinguish POM from PIM from GSL will misdispense — train and test the whole team on the five schedules.
• Treat the CD register as sacred. Controlled-drug entries must balance to the tablet; discrepancies trigger the harshest penalties.
• Temperature logs are legal evidence. Twice-daily fridge logs, signed — inspectors ask for them first after a cold-chain complaint.
• Re-verify fees annually. Premises registration and practising certificates renew on a cycle — diary the renewals so the licence never lapses.

7. Frequently Asked Questions

Q1: Who licenses a pharmacy in Malawi? A: The Pharmacy and Medicines Regulatory Authority (PMRA), established under the PMRA Act No. 9 of 2019, registers premises and regulates the pharmacy profession and medicines.

Q2: What documents are needed to register a retail pharmacy? A: The completed application form, premises layout sketch, the pharmacist's PMRA registration certificate and valid practising certificate, a signed full-time personnel contract, business registration, the MRA taxpayer identification number and proof of fee payment.

Q3: How are medicines classified in Malawi? A: Into five schedules: POM (prescription-only), PIM (pharmacist-initiated), P (pharmacy-only), GSL (general sales list) and CD (controlled drugs).

Q4: What rules apply to controlled drugs? A: Controlled drugs fall under the Dangerous Drugs Act Cap 35:02, with strict requirements for prescribing, dispensing, locked storage and dedicated registers — confirm the current rules with the PMRA.

Q5: Can POMs be dispensed without a pharmacist present? A: No. Dispensing of all prescription-only medicines must be from registered pharmacy premises under the direct supervision of a registered pharmacist.

Q6: How should suspected adverse drug reactions be handled? A: Report every suspected adverse drug reaction to the PMRA pharmacovigilance system promptly, and file a copy of each report with the pharmacy's records.