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.