Guidance document : preparation of regulatory activities in the "non-eCTD electric-only" format / Health Products and Food Branch.: H13-9/1-2016E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.848996&sl=0
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| Title | Guidance document : preparation of regulatory activities in the "non-eCTD electric-only" format / Health Products and Food Branch. |
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| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Later edition | Guidance document : (2024) |
| Format | Digital text |
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| Description | iii, 46 p. : col. ill. |
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