000	02060nam  22003138a 4500
001	9.848996
003	CaOODSP
005	20240521101208
007	cr |||||||||||
008	171218s2016    onc     o    f000 ||eng d
040	|aCaOODSP|beng
043	|an-cn---
086	1 |aH13-9/1-2016E-PDF
110	1 |aCanada. |bHealth Canada.
245	10|aGuidance document |h[electronic resource] : |bpreparation of regulatory activities in the "non-eCTD electric-only" format / |cHealth Products and Food Branch.
246	10|aPreparation of regulatory activities in the "non-eCTD electric-only" format
260	|a[Ottawa] : |bHealth Canada, |cc2016.
300	|aiii, 46 p. : |bcol. ill.
500	|a"Date adopted: 2016/10/25. Effective date: 2016/10/25. Revised Date: 2016/10/31".
500	|aIssued also in French under title: Préparation des activités de réglementation en format« électronique autre que le format eCTD ».
520	|a"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.
692	07|2gccst|aRegulation
692	07|2gccst|aHealth care products
692	07|2gccst|aHealth protection
692	07|2gccst|aDrugs
710	1 |aCanada. |bHealth Products and Food Branch.
775	08|tLigne directrice |w(CaOODSP)9.849035
794	|tGuidance document : |b(2024)|w(CaOODSP)9.868510
856	40|qPDF|s1.07 MB|uhttps://publications.gc.ca/collections/collection_2017/sc-hc/H13-9-1-2016-eng.pdf