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Notice of Consultation on the Prescription Drug List: Tramadol April 24, 2019 Our file number: 19- 109012-92 The Prescription Drug List (PDL) is a list of medicinal ingredients that when found in a drug, require a prescription. It does not include medicinal ingredients that are…
Notice: Release of Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs) May 3, 2019 Our file number: 19-106654-60 The above referenced guidance document was released by Health Canada and is posted on the website. This guidance document provides…
Scientific/Expert Advisory Committee: Health Products for Women – Summary of Affiliations and Interests Contact: Policy Bureau Enquiries Related Information: Scientific Advisory Committee on Health Products for Women (SAC-HPW): Membership List and Biographies Purpose of Summary…
Structured Format for Product Monographs From Health Canada Current status: Closed This consultation ran from May 15, 2019 to June 29, 2019. Health Canada is seeking feedback on a new structured format for product monographs. The new Structured Product Monograph is based on…
Performance Standards for the Fees in Respect of Drugs and Medical Devices Order Access the archived versions of this list: 2020-01-30 to 2023-02-21 2023-02-22 to 2024-01-02 2024-01-03 to 2024-06-18 Download the alternative format (PDF format, 577 KB, 14 pages) This document…
Final Report: Fees for Drugs and Medical Devices Download the alternative format (PDF format, 1.9 MB, 37 pages) Organization: Health Canada Published: 2019-05-15 Cat.: H164-261/2018E-PDF ISBN: 978-0-660-29017-1 Pub.: 180675 Table of Contents Executive Summary Section I:…
Notice of Consultation on the Prescription Drug List: Vitamin D May 22, 2019 Our file number: 19-11025-630 This Notice of Consultation provides an opportunity to comment on the proposal to amend the Prescription Drug List (PDL) qualifier for Vitamin D to allow non-prescription…
Notice: Regulatory Enrolment Process (REP) implementation and expansion of the scope for the Common Electronic Submissions Gateway (CESG) June 21, 2019 Our file number: 19-112683 - 23 The Regulatory Enrolment Process (REP) Pharmaceutical and Biologic drugs pilot, which included…
Draft guidance document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format From Health Canada Current status: Closed Opened on June 26, 2019 and will close to new input on August 26, 2019. This is a technical document…
Drug and medical device highlights 2018: Helping you maintain and improve your health Download the alternative format (PDF format, 8 MB 86 pages) Organization: Health Canada Published: 2019-06-27 Learn about the new drugs and medical devices that Health Canada approved for sale…
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