Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 4)

Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 4)

Abuse of a medicinal product: 

Persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects [DIR 2001/83/EC Art 1(16)].

Active substance:

Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis [DIR 2001/83/EC Art 1(3a)].

Advanced therapy medicinal product (ATMP):

A medicinal product for human use that is either a gene therapy medicinal product, a somatic cell therapy product or a tissue engineered products as defined in Regulation (EC) No 1394/2007 [Reg (EC) No 1394/2007 Art 1(1)].

Adverse event (AE):

Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment [Dir 2001/20/EC Art 2(m)].

An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (see GVP Annex IV, ICH-E2D Guideline).

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EMA GVP Annex I:

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