Glossary

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This glossary gives definitions for the main regulatory terms used on this website and in European Medicines Agency (EMA) documents.

Click on a letter below to see terms beginning with that letter.

Disclaimer: EMA has developed the definitions in this glossary to help this website's users understand regulatory terminology. Definitions may differ from those given in European Union legislation.

Glossary

Heads of Medicines Agencies

The network of the heads of the regulatory authorities responsible for the regulation of human and veterinary medicines in the European Economic Area. Abbreviated as HMA.

For more information, see Heads of Medicines Agencies.

health technology assessment body

A public organisation that provides recommendations on the medicines and other healthcare interventions that can be paid for or reimbursed. These organisations look at the relative effectiveness and cost effectiveness of medicines that have been authorised.

For more information, see health technology assessment bodies.

herbal medicinal product

Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.

For more information, see herbal medicinal products.

herbal preparations

Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.

For more information, see herbal medicinal products.

herbal substances

All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author).

For more information, see herbal medicinal products.

HMPC

Committee on Herbal Medicinal Products: the committee that is responsible for establishing Community herbal monographs and preparing the Agency’s opinions on questions relating to herbal medicines.

For more information, see Committee on Herbal Medicinal Products (HMPC).

hybrid medicine

A medicine that is similar to an authorised medicine containing the same active substance, but where there are certain differences between the two medicines such as in their strength, indication or pharmaceutical form.

For more information, see generic medicines.