Medicines Authority Logo
Medicines Authority

Awtorità dwar il-Mediċini

 



 

 

             Why are some medicinal products classified as

             Over the Counter (OTC) and others as Prescription only Medicines (POM)

 

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

European Directive 2001/83 EC specifies that medicinal products shall be subject to medical prescription where they:

- are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision, or

- 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

- contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or

- are normally prescribed by a doctor to be administered by injection.

Information on whether a specific product is Prescription only Medicine (POM) or Over the Counter medicine (OTC) is available on the Malta Medicines List.   Prescriptions are valid for six months, except for antibiotics where a prescription cannot be dispensed after 10 days of its issue date.

Prescription for psychotropic substances and narcotic drugs (green prescriptions) can not be repeated, thus are to be dispensed only once.  Green prescriptions are to be accompanied by a control card which is issued by the Drugs 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.