Draft guidance on co-packaged drug products: Glossary

Some of the definitions indicate if they are from the Medical Devices Regulations (MDR) or Food and Drug Regulations (FDR).

Co-packaged drug products:

Products made up of 2 or more components sold together as a unit in a single package, at least 1 of which is a prescription or non-prescription pharmaceutical or biologic drug for human use subject to the FDR.

Convenience packs:

Convenience packs bring together authorized therapeutic products (drug and other components), with their individually authorized packaging and labelling, to be sold as a single unit for the user’s convenience. The co-packaging of authorized products in a convenience pack must not:

• recommend the use of the constituent products in combination
• suggest a new indication or intended use that has not been previously authorized for the individual components
• impact the intended use, safety, efficacy or quality of the individual components

Cosmetic:

Includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth. Includes deodorants and perfumes.

Drug-device combination product (DDCP):

A therapeutic product that combines at least 1 drug component and at least 1 device component such that the distinctive nature of the drug and device components are integrated into a single product. Examples include a:

• device that carries or delivers a drug over time (for example, implant)
• device impregnated with a drug (for example, to maintain stent patency)
• drug delivery system (for example, autoinjector)

Drug kits are co-packaged drug products made up of 2 or more components, at least 1 of which is a prescription or non-prescription pharmaceutical or biologic drug subject to the FDR, where the:

• components are used in combination to achieve a new or overarching indication and
• drug kit or components include labelling that provides specific instructions for the use of the components together
  • for example, as part of a treatment regimen

Drug component inner label:

The label on or affixed to an immediate container of the drug product. In the case of a drug kit, this is the label on or affixed to the drug component’s immediate containers. A drug kit may contain many different component inner labels, depending on the number of drug components in the kit.

Drug component outer label:

Any label on or affixed to the outside of the package (for example, a carton) of the drug. In the case of a drug kit, this is the outer label affixed to the packaging of 1 of the drug components, if applicable. A drug kit may include several component outer labels, depending on the number of drug components in the kit and their approved labelling.

Drug kit outer label:

Any label on or affixed to the outside of a drug kit’s package (the outermost surface of the drug kit packaging) that contains all components within this package and is presented as a single unit.

Fixed dose combination drug (FDC):

Two or more drugs combined into a single dosage form without co-packaging.

Key elements of the label:

These are 8 components (aside from the product monograph and prescribing information) identified as being the key pieces of information for the design of safe clear labels. This does not include all elements required by regulation.

These elements include:

1. brand name of health product
2. non-proprietary name (proper or common name)
3. strength with or without total amount per total volume
4. dosage form
5. route of administration (other than oral solids, such as tablets, for products available for self-selection)
6. relevant critical warnings
7. relevant population (such as adult or pediatric)
8. relevant storage instructions

Mock-up:

A full-colour, actual-size copy of the labels and package insert, and a colour representation (for example, photograph or PDF) of the packages that will be used for the sale of the drug. Includes all presentation and design elements, proposed graphics, fonts, colours, dimensions and text (with a place holder for expiry date, DIN and lot number).

Package:

Includes anything in which any food, drug, cosmetic or device is entirely or partly contained, placed or packed. Does not include shipping cartons or containers.

Package insert:

For prescribed drugs, this is usually the prescribing information document equivalent to Part I health professional information of the product monograph. Sometimes the package insert will consist of Part I of the product monograph or 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. Some non-prescription drugs (Division 8 drugs) will have a package insert for consumers that consists of patient medication information or Part III consumer information of the product monograph.