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Drugs and Health Products

Listing of Monographs

Pre-Cleared Information

Pre-cleared information (PCI) is any form of information supporting the safety, efficacy or quality of a medicinal ingredient or natural health product that NHPD has reviewed and determined to be acceptable. PCI can be used to speed up the evaluation of the NHP, and serves as a reliable source of product information for consumers.

Single Ingredient Monographs

A monograph is a written description of particular elements on an identified topic. Single ingredient monographs apply to formulations containing only one medicinal ingredient.

Monographs in the lists below which are followed by an asterisk (*) have been uploaded directly onto the NHP Ingredients Database and are available to generate in the ePLA by pre-populating the required fields. Those monographs without an asterisk are currently referenced by the NHP Ingredients Database but do not yet have a generated monograph, which means that less information is pre-populated in the ePLA. When attesting to a monograph with an asterisk, which means attesting to a generated monograph, the 'Compendial from Generated Monographs' application type must be selected from the Compendial from Generated Monograph Electronic Product Licence Application Form. When attesting to a monograph without an asterisk, which means attesting to a monograph that is not generated, the 'Compendial' application type must be selected from the Electronic Product Licence Application Form.

Compendial from Generated Monograph Electronic Product Licence Application Form
Electronic Product Licence Application Form

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Product Monographs

A monograph is a written description of particular elements on an identified topic. Product monographs apply when there is more than one medicinal ingredient or to outline the conditions of use based on a product category (e.g. medicated skin care products, antiseptic skin cleansers, etc). The monographs below are currently referenced by the NHP Ingredients Database but do not yet have a generated monograph, which means that less information is pre-populated in the ePLA. When selecting the application type in an ePLA, the 'Compendial' application type must be selected when attesting to a product monograph.

Electronic Product Licence Application Form

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Abbreviated Labelling Standards

Abbreviated Labelling Standards (AbLS) contain pre-cleared information for a product or ingredient and can be used as supporting evidence for safety and/or efficacy in a Non-traditional application.

Compendial from Generated Monograph Electronic Product Licence Application Form
Electronic Product Licence Application Form

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