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Notice: Guidance on the Clinical Assessment of Abuse Liability for Drugs with Central Nervous System Activity July 4, 2019 Our reference number: 19-111910-93 Health Canada continues to support regulatory alignment with other respected regulatory authorities, where possible. By…

Notice of Compliance with conditions (NOC/c) An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC)), with the condition that the sponsor undertake additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued…

Notice: Revisions to the Guidance Document: Management of Drug Submissions and Applications July 25 2019 Our file number: 19-112562-576 Health Canada revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSG) . This document provides…

Notice - Revision to the Post-Notice of Compliance (NOC) Changes - Notices of Change: Level III Form July 31, 2019 Our file number: 19-112939-775 1. Introduction Revisions to change #2 (Appendix 1) have been made to the Guidance Document: Post-Notice of Compliance (NOC) Changes:…

Notice: Release of the revised Post-Notice of Compliance (NOC) Changes - Quality Guidance Document July 31, 2019 Our file number: 19-112899-963 Health Canada is pleased to announce the release of the revised Post-Notice of Compliance (NOC) Changes - Quality guidance document. The…

Notice: Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs August 8, 2019 Our reference number: 19-111918-266 Health Canada revised the Guidance Document: Questions and Answers: Plain Language Labelling Regulations…

Notice of Consultation on the Prescription Drug List (PDL): Epinephrine chloride (topical solution) From Health Canada Current status: Open Opened on August 12, 2019 and will close to new input on October 26, 2019. This Consultation provides an opportunity to comment on the…

Notice: Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Safety and Efficacy August 12, 2019 Our file number: 19-110903-997 Health Canada is pleased to announce the release of the revised Guidance Document: Post-Notice of Compliance (NOC)…

Templates on applications and submissions for drug products Some documents are only available by request and are labeled as "available upon request". When you select one of those links, an email message will open with the required information already filled in. Simply 'Send' the…

Health Canada approves updates to Mifegymiso prescribing information: Ultrasound no longer mandatory Contact: BMORS Enquiries Health Canada is informing Canadians that the prescribing and patient information for Mifegymiso has been updated to reflect that an ultrasound is no…