• Introduction
• Types of Pharmacy Inspections
• Applications
• Conditions of Pharmacy Licence
• Internet Pharmacies
• Pharmacy Roster
• Maltese Legislation pertaining to pharmacy practice
• Further Information

Introduction

Pharmacy practice is regulated in Malta through pharmacy inspections. These inspections are aimed at verifying that the licence conditions and standards as laid down in the Medicines Act 2003 (Chapter 458 of the laws of Malta), Subsidiary Legislation 458.16 and other subsidiary legislation are met. Maintaining the right conditions and standards will ensure that patients are being supplied with medicinal products that are of the right quality, as well as being deemed safe and efficacious. To date there are over 200 licensed retail community pharmacies in the Maltese territory, a number of national hospital pharmacies as well as private in-patients pharmacies and the Non-Governmental Organisation (NGO) Sedqa Pharmacy.

Pharmacy practice activities are monitored by the Scientific and Regulatory Operations Directorate. The pharmacy inspection process has been reengineered in line with the MMA Strategy 2016-2020, optimising regulatory processes into patient-centred actions.

This reengineering process involved two phases:

(i)  The evolvement from adopting a predominantly policing approach with forceful enforcement towards a patient-centred inspection following an innovative educational approach, where concordance between the inspector and the pharmacist is being reached to improve patient safety and care outcomes. Using punitive enforcement as a motivator induced fear and has been identified as a barrier for quality improvement. The implementation of an educational approach in inspections improved communication and cooperation between the regulator and the pharmacist, which led to increased pharmacist motivation to reach concordance on the implementation of patient-centred improvements in pharmacy practice. Inspections incorporating educational discussions are positively influencing the relationship between the regulator and the pharmacist to reach concordance on corrective and preventive actions to be implemented to improve patient safety and care outcomes.

(ii) The innovative pharmacy inspection framework integrates a self-auditing system in the pharmacy inspection process to empower pharmacists and ensure maximal conformity to regulatory requirements which in turn facilitates the auditing of pharmacies through the reduction of on-site inspections. The intended outcome enhances the monitoring of the quality of service and the safety of medicinal products when compared to the traditional on-site inspections. The innovative pharmacy inspection system incorporates the element of risk analysis which will streamline the inspection process of pharmacies by reviewing the inspection frequency based on risk score computation.

Types of Pharmacy Inspections

There are different types of pharmacy inspections that are carried out:

• New applications - these inspections are carried out following the receipt of a new application. These inspections are notified in advance.
• Follow-up inspections - these inspections are notified in advance and are carried out as a follow-up to inspections which needed to carry out works on site and would thus need to be checked to confirm compliance. 
• Renewal inspections - these are carried out according to a risk-based inspection plan. These inspections are not notified in advance.
• Variation inspections - these inspections are carried out following a variation to an existing pharmacy licence such as change in site of the pharmacy. Some variations are administrative in nature and these would not require an inspection such as change in the licence holder.
• Spot check inspections - these inspections are carried out following the receipt of a complaint. These are not notified in advance.
• Self-audit and desk assessment- these self-audits are performed according to a risk-based inspection plan. The self-audit is carried out electronically by the managing pharmacist and submitted to the Medicines Authority together with the necessary evidence. The self-audit report will be subject to a desk assessment review and the inspecting officers communicate with the pharmacist as required.

Applications

Application for a pharmacy licence for medicinal products for human use

Application for a variation to a pharmacy licence

Conditions of Pharmacy Licenses 

Conditions of Community Retail Pharmacies

Conditions of Pharmacies dispensing medical oxygen gas

Conditions of In-Patients Pharmacies

Pharmacies deliveries

The Malta Medicines Authority regulates pharmacy practice activities including deliveries of medicinal products from licensed pharmacies.

Pharmacies providing services through digital sites are covered by the Pharmacy Council Directive.

Internet Pharmacies

Buying medicinal products over the internet and internet pharmacies. For more information click here.

Pharmacy Roster

The official pharmacy roster can be accessed here.

Maltese Legislation pertaining to pharmacy practice 

Pharmacy licences

S.L. 458.16: Pharmacy Licence Regulations

S.L. 458.28: Pharmacies (Opening Hours) Rules

S.L. 458.53: Pharmacy Licences (Fees) Regulations

S.L.458.58: Pharmacy Licence Transfer 

Dangerous drugs rules and regulations

S.L.101.02: Internal Control of Dangerous Drugs Rules

S.L.31.18: Drugs (Control) Regulations

S.L. 458.26: Licensing Fees for Private Medical Premises Regulations

S.L. 101.06: Methadone Rules

Prescription rules as applicable to medicinal products and medicinal gases

S.L. 458.49: Prescription and Dispensing Requirements Rules

S.L. 458.24: Prescription Forms for Free Medicinals Rules

S.L. 458.45: Authorisation of Dispensing of Medicinal Gases from Premises other than a Pharmacy Rules

S.L. 458.52: Dispensing of Medicinal Products (Foundation for Social Welfare Services) Rules

S.L. 458.55: Provision of Medicinal Products through the Genito Urinary Clinic within the Government Health Services

Further Information 

Should you need further information, you may wish to send an email to the pharmacy team on  pharmacies.medicinesauthority@gov.mt