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Home / Patient / Consumer / Know more about Medicines Regulation / Non-prescription and prescription only medicines

Non-prescription and prescription only medicines

 

Introduction

In Malta, all medicinal products are dispensed only from pharmacies. The classification whether a medicinal product should be dispensed with or without a valid prescription is done as part of the Marketing Authorisation process.  Through this process, the Medicines Authority ensures the quality, safety and efficacy of the medicinal product.

Products subject to a medical prescription

The legislation (Subsidiary Legislation 458.34) specifies that medicinal products shall be subject to medical prescription where they:

  1. are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision, or
  2. are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or
  3. contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or
  4. are normally prescribed by a doctor to be administered by injection.

Information on whether a specific product is prescription or non-prescription medicine is available on the Search for Medicines facility.

Validity of Prescriptions

Prescriptions are valid for six months from date in which it is written, except for antibiotics where a prescription cannot be dispensed after 10 days of its issue date.

Dispensing prescriptions issued from EU Member States other than Malta (Article 81(3) of the Medicines Act, Chapter 458 of the laws of Malta): It shall be lawful for a pharmacist to dispense any medicinal product on the prescription of a medical practitioner, dentist or veterinary surgeon from an EU member state provided that the pharmacist can ascertain that such medical practitioner, dentist or veterinary surgeon is licensed to practice his profession in the member state of origin.

Prescription for psychotropic substances and narcotic drugs

Prescription for psychotropic substances and narcotic drugs (green prescriptions) cannot be repeated, thus are to be dispensed only once.  Green prescriptions are to be accompanied by a control card which is issued by the Drug Control Unit.  In urgent cases, when the control card for green prescriptions is not available, an urgent prescription may be prescribed by the medical practitioner, against which a maximum of one week supply of medicine can be dispensed.

Last updated: 18/03/2020