It is a medicinal product intended for a rare disease, i.e. it is intended for an indication with a prevalence not exceeding 5 out of 10,000 persons in the EU, a life-threatening, severely debilitating or a serious and chronic condition.

Treatment that is financed by public funds (NHS) and can be drugs that are dispensed either in a pharmacy or in a hospital.

Pharmaceutical form of an active substance or placebo that is investigated or used as a reference in a clinical trial, including products with authorisation when used or combined, in the formulation or packaging, in a manner different from that authorised, or when used to treat an unauthorised indication or to treat a non-authorised indication, or when used to treat a ... Read more

Any substance or combination of substances presented as having properties for treating or preventing disease in human beings or which may be used in human beings or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to ... Read more

The person in charge of the conduct of the clinical trial at a clinical trial site.

Investigator responsible for a team of investigators conducting a clinical trial at a clinical trial site.

The term used to describe the valid reason or rationale for using a diagnostic test, medicine, procedure, etc.

Number of cases.

The medicinal product intended for an individual patient, prepared by or under the direction of a pharmacist expressly to fulfil a detailed medical prescription for the active ingredients it contains, in accordance with the standards of good manufacturing practice and quality control established for this purpose, dispensed in a pharmacy or pharmaceutical service and with the appropriate information provided to the patient, and ... Read more

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects of medicinal products or any other drug-related problems. Monitoring of the side effects and efficacy of medicines, once marketed.