This guide includes tables to clarify common questions, ingredient label examples, and tips to verify proper INCI labelling. This document is intended to help clarify the Cosmetic Regulations with respect to ingredient labelling. It is not intended to substitute requirements under the applicable legislation. In case of any discrepancy between this document and the
legislation, the legislation will prevail.
This guideline describes the following points;
The labelling of cosmetics is governed by three Acts and their associated Regulations:
This guideline describes the following points;
The objective of this document is to provide guidance to sponsors to enable them to meet the pre-market and post-market information and regulatory requirements under the Food and Drug Act and its Regulations for the authorization of EUNDs in Canada.
This guidance document is for sponsors seeking to file an Extraordinary Use New Drug Submission (EUNDS) or an Abbreviated Extraordinary Use New Drug Submission (AEUNDS) for drugs considered to be EUNDs.
Investigational medicinal products are produced in accordance with the principles and the detailed guidelines of the Good Manufacturing Practice for Medicinal Products. Other guidelines should be taken into account where relevant and as appropriate to the stage of development of the product. Procedures need to be flexible to provide for changes as knowledge of the process increases, and appropriate to the stage of development of the product.
this guideline describes the following points;
This guideline;
This guideline describes
This guidance document applies to you if you are a party involved in the conduct of clinical trials of drugs in human subjects in Canada.
Interested parties may include:
• sponsor
• qualified investigator (QI)
• contract research organization (CRO)
• site management organization (SMO)
This guidance document covers the following clinical trials of drugs conducted in humans in Canada:
• Phase I to IV
• commercial or academic
• ongoing or completed
• clinical trials involving pharmaceuticals, biologics, gene therapies, cell therapies, blood products, vaccines and radiopharmaceuticals for human use
These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements.
The modified interpretations from the “GMP Guidelines (GUI-0001)” contained in this Annex apply to the
following non-sterile, over-the-counter (OTC) drugs for which a Drug Identification Number (DIN) is issued
based on compliance with a Category IV monograph:
These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements. The guidance provided in this Annex applies to the manufacture and control of bulk intermediates and finished Schedule C drugs. Due to the unique aspects of manufacture and quality control processes associated with their extremely short radioisotope half-life and thus shelf-life of Positron Emitting Radioisotopes and Radiopharmaceuticals (PERs), a separate GMP Annex has been published for this class of Schedule C drugs, and thus PERs are beyond the scope of this Annex.
These guidelines are intended to apply to all persons and companies involved in the storage and transportation of drug products. All persons and companies including fabricators, packagers/labellers, testers distributors, importers, and wholesalers have the responsibility for ensuring that appropriate storage and transportation conditions are maintained from the point of manufacturing up to the delivery of the drug products to the final distribution point. The maintenance of the chain of storage and transportation conditions should be supported by written agreements among the distributor, the importer, the wholesaler, and the transportation provider to preserve drug safety, quality and efficacy. The responsibility of each party is to ensure that the required storage and transportation conditions are met through their respective GMP activities.