French Public Health Code
In forceFor the purposes of this Book, the following definitions shall apply
1° Bioavailability means the rate and intensity of absorption into the body, from a pharmaceutical form, of the active substance or its therapeutic moiety intended to become available at the sites of action;
2° Bioequivalence, the equivalence of bioavailabilities;
3° Primary packaging: the container or other form of packaging with which the medicinal product comes into direct contact;
4° Outer packaging: the packaging in which the immediate packaging is placed;
5° Common name: the international common name recommended by the World Health Organisation, failing which the name of the European or French Pharmacopoeia or, failing that, the usual common name;
6° Strength of the medicinal product: the active substance content, expressed as a quantity per unit of dosage or per unit of volume or weight depending on the presentation;
7° Labelling, the information given on the outer packaging or the immediate packaging;
8° Notable excipient: any excipient whose presence may require precautions for use in certain specific categories of patients;
9° Package leaflet: the information document accompanying the medicinal product and intended for the user;
10° Herbal substance: all plants, parts of plants, algae, fungi, lichens, mainly whole, fragmented or cut, used as they are, dried or fresh, as well as certain exudates which have not undergone specific treatments; herbal substances are precisely defined by the part of the plant used and the botanical name according to the two-word system - genus, species, variety and author;
11° Plant-based preparations: preparations obtained by treating plant substances, such as extraction, distillation, expression, fractionation, purification, concentration or fermentation; they include crushed or pulverised plant substances, tinctures, extracts, essential oils, juices obtained by pressing and treated exudates.
