Table 1.
Definitions discussed in this paper
| Term | Definition |
|---|---|
| Medicinal product | (a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or |
| (b) any substance or combination of substances that may be used by or administered to human beings with a view to | |
| (i) restoring, correcting, or modifying a physiological function by exerting a pharmacological, immunological, or metabolic action, or | |
| (ii) making a medical diagnosis | |
| Marketing authorization | Permission granted to a Marketing Authorization Holder legally to sell, supply, or export, procure the sale, supply or exportation, or procure the manufacture or assembly for sale, supply or exportation of a specified medicinal product |
| Authorized medicinal product (‘licensed product’) | A medicinal product, marketed by a specified company, for which there is in force |
| (a) a marketing authorization; | |
| (b) a certificate of registration as a homeopathic medicinal product; | |
| (c) a traditional herbal registration; or | |
| (d) an Article 126a authorization (see below) | |
| Summary of Product Characteristics (SmPC) | That part of the Marketing Authorization that contains essential information for the use of a medicine, including pharmacological properties, authorized indications, qualitative and quantitative information on benefits and harms, information for individualized care, and pharmaceutical information |
| Article 126a authorization | An EU authorization that can be issued to license a product whose use is justified for public health reasons and that has been imported from another Member State in the European Union |
| Authorized modes of use | The ways of using the medicinal product as specified in the Summary of Product Characteristics (see Appendix 2) |
| Unauthorized product (‘unlicensed product’) | A medicinal product for human use in respect of which no marketing authorization has been granted by a relevant licensing authority |
| Label | A notice describing or otherwise relating to the contents of a medicinal product; the agreed terms of the Marketing Authorization granted in respect of a medicinal product and set out in the Summary of Product Characteristics |
| Off‐label prescribing | Prescribing of an authorized product for use in a way that is not described in the Summary of Product Characteristics |