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Glossary for A

Active ingredient
The active ingredient in a medicine that makes it work.


ADR – Adverse drug reaction
An adverse reaction or side effect is an unwanted or unintentional reaction that a person may have after taking a medicine.


Advisory Committees
Committees of experts appointed by the Minister for Health to advise the IMB. There are three advisory committees: ACHM – Advisory Committee for Human Medicines, ACVM – Advisory Committee for Veterinary Medicines, ACMD - Advisory Committee for Medical Devices


AI – Adverse incident
An event which poses a risk to the health and safety of a patient or user of a medical device, or a case of diagnostic equipment not working correctly.


Animal remedy
A substance or a combination of substances for treating or preventing disease in animals. Animal remedies are also known as veterinary medicinal products.


Annual safety report
A report sent to the IMB each year by the sponsor of a clinical trial which gives details of all new safety information on the trial.


Authorisation
An authorisation is an approval. The IMB grants authorisations to companies to sell (or market) their medicines and to manufacture or distribute them. It also gives authorisations for establishments which deal with blood or tissues and cells for human use.





Date Printed: 17 April 2014

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