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Home / Activities / Pharmaceutical Activities and Inspections / Pharmacies

Pharmacies


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 Strategy and Operations Unit within the Regulatory Operations, Medicines Intellegence and Access Directorate.


Types of Pharmacy Inspections

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

  • New applications - Inspections carried out following the receipt of a new application. These inspections are notified in advance.
  • Follow-up inspections - 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 - Inspections carried out according to a risk-based inspection plan. These inspections are not notified in advance.
  • Variation inspections - Inspections carried out following a variation to an existing pharmacy licence such as change in site of the pharmacy. Variations where only the name of the pharmacy, Managing Pharmacist or Licence Holder is being changed are considered as administrative variations and do not require an inspection. 
  • For Cause inspections - Inspections are carried out following the receipt of a complaint. These are not notified in advance.
  • Self-audit and desk assessment- 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 

In the case of  fast-track applications for a variation to a pharmacy licence, please include the request when submitting documentation through E-mail


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

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


Pharmacy Roster

The official pharmacy roster can be accessed here.


Maltese Legislation pertaining to pharmacy practice 


Pharmacy licences

Renewal Fees for pharmacy licences are calculated in accordance with S.L 458.46 and S.L.458.53.

S.L. 458.16: Pharmacy Licence Regulations

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

S.L. 458.46: Medicines Authority (Fees) Regulations

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