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Good Laboratory Practice (GLP) covers the organizational process and the conditions under which non-clinical health and environmental safety studies are …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document non-clinical laboratory study data supporting drug product applications and submissions good laboratory practice non-clinical health and environmental safety studies quality and validity of test data international acceptance of data principles

A non-prescription drug Category IV Monograph outlines the permissible conditions of use and labelling requirements, such as dose, intended use, …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Non-prescription drugs category IV monographs permissible conditions of use labelling requirements dose intended use directions for use warnings active ingredients drugs safety and efficacy profile

The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document labelling requirements labelling of pharmaceutical drugs drugs for human use Food and Drugs Act

The safe use of non-prescription drugs depends on consumers being able to identify the desired product and also being able …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Labelling requirements non-prescription drugs safe use of non-prescription drugs guidance document label and package a health product and a consumer a health product and healthcare professional plain language labelling

A nonprescription drug labelling standard outlines the permissible conditions of use and labelling requirements, such as dose, intended use, directions …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Non-prescription Drugs labelling standards drug product permissible conditions of use labelling requirements dose intended use directions for use warnings active ingredients combinations

Hepatotoxicity caused by exposure to a drug or non-infectious agent is injury or damage to the liver that may be …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document pre-market evaluation hepatotoxicity exposure to a drug or non-infectious agent damage to the liver impaired liver function detection assessment mitigation reporting requirements of hepatotoxicity human health products health products

Health Canada initiated a Hormone Replacement Therapy (HRT) class labelling project in light of new safety information derived from the …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance for industry product monographs non-contraceptive estrogen progestin-containing products hormone replacement therapy safety information women's health initiative trial women's health initiative memory study

This proposed guidance will assist manufacturers, packagers, and distributors of non-prescription drugs in developing plain language labelling content for a …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document drug facts table non-prescription drugs plain language labelling important product information

An antiseptic product is considered to be one that inactivates, reduces, prevents or arrests growth of microorganisms with the inherent …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document antiseptic drugs human-use human-use antiseptic drugs inactivates reduces prevents or arrests growth of microorganisms mitigate or prevent disease

This monograph applies to products in the form of liquid concentrate that are intended to be used for acute and …

Record Modified: Jul 7, 2021
Record Released: Jul 7, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Haemodialysis Solutions monograph liquid concentrate acute and chronic haemodialysis medicinal ingredients concentrations and combinations deviations in ingredients concentrations and indications product labelling