Draft guidance on the plain language labelling regulations for prescription drugs: Glossary
- Inner label:
- The label on or affixed to an immediate container of a drug.
- Key elements of the label (does not include product monograph or prescribing information):
- These are 8 components identified as being the key pieces of information for the design of safe and clear labels. This does not include all elements required by regulation.
These elements include:
- brand name of health product
- non-proprietary name (proper or common name) of a health product
- strength with or without total amount per total volume
- dosage form
- route of administration (other than oral solids, such as tablets, for products available for self-selection)
- critical warnings, as relevant
- population, as relevant (for example, adult versus pediatric)
- storage instructions, as relevant
- Mock-up:
- A full-colour, actual-size copy of the labels and a colour representation (for example, photograph or PDF) of the packages intended to be used for the sale of the drug. The mock-up includes all presentation and design elements, proposed graphics, fonts, colours, dimensions and text (with a place holder for expiry date, DIN and lot number).
- Outer label:
- The label on or affixed to the outside of a package of a drug.
- Package:
- Includes anything in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed. This does not include cargo or shipping containers.
- Package insert:
- The package insert for prescribed drug products is usually the prescribing information document equivalent to the Part I, health professional information of the product monograph. Sometimes the package insert will consist of Part I of the product monograph and Part III (consumer information) or patient medication information. In certain cases, a wallet card, tear-off pads or handouts may be considered a type of package insert that provides supplementary information to inner or outer labels.
- Patient leaflet:
- A term that is sometimes used to describe printouts of Part III (consumer information) or patient medication information.
- Plain language:
- Plain language is a clear writing style designed to be easy to read and understood by the intended audience. It includes how information is organized and displayed, such as the use of white space, fonts, design elements and colour.
- Product monograph and prescribing information:
- A factual, scientific document on the drug product that is not promotional. It describes the properties, claims, indications and conditions of use for the drug. It also contains other information that may be required for the optimal, safe and effective use of the drug.
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