Pharmacovigilance Risk Assessment Committee: the committee that is responsible for assessing all aspects of the risk management of medicines for human use.For more information, see Pharmacovigilance R [..]

The time that must elapse between the last administration of a veterinary medicine and the slaughter or production of food from that animal, to ensure that the food does not contain levels of the medi [..]

Rapid assessment of medicines in the centralised procedure that are of major interest for public health, especially ones that are therapeutic innovations. Accelerated assessment usually takes 150 eval [..]

Activities relating to public access to European Medicines Agency documents.For more information, see access to documents.

The substance responsible for the activity of a medicine.

Documentation providing detailed information on the manufacturing of the active substance of a medicine.For more information, see Electronic Active Substance Master Files (eASMF).

An ingredient in a medicine that increases or modifies the activity of the other ingredients. Adjuvants are often included in vaccines to enhance the body’s immune response.

A medicine for human use that is based on genes, cells or tissue engineering.For more information, see advanced therapies.

A noxious and unintended response to a medicine.

An untoward medical occurrence in a patient taking part in a clinical trial.