00000cam 22000008a 4500 9.848996 CaOODSP 20260415074755 cr ||||||||||| 171218s2016 onc o f000 ||eng d CaOODSP eng n-cn--- H13-9/1-2016E-PDF Canada. Health Canada. Guidance document [electronic resource] : preparation of regulatory activities in the "non-eCTD electric-only" format / Health Products and Food Branch. Preparation of regulatory activities in the "non-eCTD electric-only" format [October 2016 edition]. [Ottawa] : Health Canada, c2016. iii, 46 p. : col. ill. "Date adopted: 2016/10/25. Effective date: 2016/10/25. Revised Date: 2016/10/31". Issued also in French under title: Préparation des activités de réglementation en format« électronique autre que le format eCTD ». "Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective. ... This document defines the filing requirements and provides guidance on the structure, content and format of regulatory activities filed in “non-eCTD electronic-only” format. Future refinements and subsequent iterations of this guidance document will continue to be necessary as a result of the transition from paper format to electronic format"--p. i, and p. 1. gccst Regulation gccst Health care products gccst Health protection gccst Drugs Canada. Health Products and Food Branch. Ligne directrice (CaOODSP)9.849035 Guidance document : [May 2024 edition] (CaOODSP)9.868510 PDF 1.07 MB https://publications.gc.ca/collections/collection_2017/sc-hc/H13-9-1-2016-eng.pdf