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Post-Notice of Compliance (NOC) Changes – Quality Guidance From Health Canada Appendix 2: Quality post-NOC changes of veterinary drugs of this guidance has been updated and superseded by the Post-Notice of Compliance (NOC) Changes: Guidance for quality of veterinary drugs as of…

Guidance document: Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only) Date Adopted: 2009/09/02 Date Posted: 2020/03/23 Effective Date: 2020/04/01 PDF Version Document change log Date: September…

Guidance Document Post-Drug Identification Number (DIN) Changes (PDF Version - 234 KB) Date Adopted: 2009/12/19 Revised Date: 2022/08/02 Effective Date: 2022/08/02 Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to…

Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs Download the alternative format (PDF format, 381 KB, 36 pages) Organization: Health Canada Published: 2020-03-23 Date adopted: 2017/01/19 Date posted: 2020/03/23 Effective…

Guidance Document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs Date Adopted: 2017/01/19 Effective Date: 2017/04/27 Revised Date: 2018/09/28 Foreword Guidance documents are meant to provide assistance to industry and health care…

Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications Pharmacometric approaches play an increasing role in developing drug submissions and clinical trial applications (CTAs). Find out what sponsors should consider when preparing drug…

Draft guidance on the plain language labelling regulations for prescription drugs: Overview Overview General plain language requirement Brand name assessment requirement Contact information requirement Mock-up requirement Glossary Appendix A, abbreviated package inserts Download…

Notice - Revision to Guidance Document: Submission of Pharmacogenomic Information (PDF Version - 445 K) Contact: BGTD Regulatory Affairs Division August 13, 2008 Our file number: 08-108225-127 Table of Contents 1.0 Introduction 1.1 Objectives 1.2 Scope and Application 1.3 Policy…

Patented Medicines Guidance Document - Patented Medicines (Notice of Compliance) Regulations [2018-05-11] Page details 2018-05-11

Oral Contraceptives Guidance for Industry: Clinical Development of Steroidal Contraceptives Used by Women [2002-10-29] Guidelines for the Toxicological Evaluation of Contraceptive Steroids [2000-04-19] Page details 2017-05-04