Overview

Retail pharmacy businesses (pharmacies) operating in Ireland must register with the PSI. We inspect those pharmacies to assess compliance with pharmacy and medicines legislation and PSI guidance. We also conduct investigations to see if there have been breaches of the code of conduct and legislation.

The Pharmacy Act 2007 gives the PSI significant powers of inspection, investigation and enforcement as part of our regulatory role, in the interest of patient and public health and safety.

Inspections

Authorised Officers (Inspectors) of the PSI carry out inspections to check that pharmacies are providing safe services, meeting legal requirements and operating to standards outlined in PSI guidance. New pharmacies are inspected before opening and all pharmacies are routinely inspected.

Investigations take place where the PSI receives information about the practice of a pharmacist or pharmacy or where a matter needs to be considered in more detail after an inspection. This can involve a series of visits to a pharmacy, taking statements and interviewing relevant pharmacy staff.

We also carry out mystery shopper exercises in pharmacies to check for compliance with legal requirements and guidance in the supply of medicines.

Enforcement

If an inspection or investigation report identifies significant matters, the PSI Council and the Registrar can take action, including taking prosecutions or disciplinary action against a pharmacist or pharmacy.

Pharmacy Assessment System

Pharmacies are expected to carry out a self-audit, called the Pharmacy Assessment System. This will be verified by PSI inspectors during pharmacy inspections.

Inspectors advicePSI guide on the inspection processPSI inspection findings

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