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
| Department/Agency | Canada. Health Canada. |
|---|---|
| Collaborating author | Canada. Health Products and Food Branch. |
| Title | Guidance document : preparation of regulatory activities in the "non-eCTD electric-only" format / Health Products and Food Branch. |
| Variant title | Preparation of regulatory activities in the "non-eCTD electric-only" format |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | "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 ». |
| Publishing information | [Ottawa] : Health Canada, c2016. |
| Description | iii, 46 p. : col. ill. |
| Catalogue number |
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| Subject terms | Regulation Health care products Health protection Drugs |