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Notice: Tablet Scoring of Subsequent-entry Pharmaceutical Products March 28, 2017 Our file number: 17-103376-453 Pursuant to Part C, Division 8 of the Food and Drug Regulations (FDR) and of Division 1 of the FDR, this Notice is to inform sponsors of Health Canada's position with…

Guidance on switching from prescription to non-prescription status: Overview Overview Switch process Additional information Principles and factors Consumer use studies Market experience Contact us Glossary Template Document change log Date Change Location Nature of and/or reason…

Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [Health Canada, 2010] (PDF Version - 109 K) Contact: Policy Bureau Enquiries Date Adopted: February, 2003 Revised: 2013/12/19 Effective: 2013/12/19 Health Products and Food Branch Notice December 20, 2013 Our…

Frequently Asked Questions - Guidance Document for Industry - Review of Drug Brand Names General Would the requirements of this revised guidance apply if my submission is already in the queue? Answer: No. Full implementation of this guidance document will commence twelve months…

Guidance Document for Industry - Review of Drug Brand Names Full implementation of this guidance document will commence twelve months after registration of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) in…

Reconsideration of Final Decisions The Reconsideration process is a formal dispute resolution process that applies to dispute arising between Health Canada and sponsors of human drug submissions. It is intended to be initiated when informal mechanisms have failed to resolve the…

Guidance document: Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions Foreword Guidance documents provide assistance to industry and health care professionals on how to comply with policies, governing statutes and regulations. Guidance…

QT/QTc Interval Prolongation E14/S7B Q&As: Questions & Answers - Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential [2022-02-21] E14 Q&As (R3): Questions & Answers - The Clinical Evaluation of QT/QTc Interval Prolongation and…

Product Vigilance The ongoing initiative to modernize the Food and Drugs Act and subsidiary regulations is intended to provide Health Canada the necessary authorities and tools to effectively regulate health products throughout their lifecycles. The vigilance of health products…

Priority Review - Canada.ca Priority Review Priority Review of Drug Submissions - Guidance [2007-12-20] Page details 2017-05-04