Medical terms simplifier
EMA’s medical terms simplifier gives plain-language descriptions of medical terms commonly used in information about medicines:
The resource focuses on side effects and other terms used in medicines information and assessments of medicines.
The medical terms simplifier does not cover rarely used terms, most disease states, very specialised areas or the broader field of medical science. EMA will issue updates of the document.
Glossary of regulatory terms
EMA's glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in 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.
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.
More information can be found under Heads of Medicines Agencies.
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.
More information can be found under health technology assessment bodies.
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.
More information can be found under herbal medicinal products.
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.
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).
More information can be found under herbal medicinal products.
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.
More information can be found under Committee on Herbal Medicinal Products (HMPC).
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.
More information can be found under Generic and hybrid medicines.