Glossary of Terms

This glossary of terms explains the most important terms which are used throughout the list:

• Therapeutic class;

• WHO Anatomical Therapeutic Chemical (ATC) Classification System;

• Active ingredient;

• Product name;

• Pharmaceutical form;

• Classification as Prescription only Medicine (PoM) or Over the Counter medicine (OTC);

• Authorisation Number in Malta and;

• Authorisation Holder Name and Address.

ATC Code and Therapeutic Class

The Anatomical Therapeutic Chemical (ATC) Classification System is used for the classification of medicines. It is controlled by the World Health Organisation (WHO) Collaborating Centre for Drug Statistics Methodology (WHOCC), and was first published in 1976. The classification system divides medicines into different groups according to the organ or system on which they act and/or their therapeutic and chemical characteristics.

In this system, medicines are classified into groups according to the active substance and its indications.

Further information may be found on the WHO ATC website:

http://www.whocc.no/atc_ddd_index/

Active Ingredient

All medicines contain an active ingredient. Some medicinal products may contain more than one active ingredient. An active ingredient is the substance in a medicinal product that is biologically active i.e. produces the desired effect. It is also referred to as active pharmaceutical ingredient (API) or active substance.

Product Name

The authorised name of a medicinal product.

Pharmaceutical Form

The actual physical form in which the medicinal product is available to patients/consumers. There are several pharmaceutical forms the most common being tablets, capsules, creams, eye/ear drops, injections, inhalers and suppositories.

Classification (PoM/OTC)

This describes whether the medicinal product is a Prescription only Medicines (PoM) and therefore requires a prescription from a doctor so that a patient/consumer can buy it from a pharmacy or an Over The Counter product which may be dispensed by a pharmacist from pharmacies without the need of a prescription from a doctor.

Authorisation Number in Malta

Every medicinal product which is authorised to be placed on the market in Malta is given an authorisation number by the Medicines Authority. Authorisation number should be present on the outer carton of the medicinal product.

Authorisation Holder Name and Address

This is the company responsible for placing the medicinal product on the market in Malta and its office address.