Guidance document : preparation of regulatory activities in non-eCTD format.: H164-272/2024E-PDF
"This document defines the filing requirements and provides guidance on the structure, content and transmission of regulatory transactions filed in the non-electronic common technical document (non-eCTD) format. … The objective of this document is to provide operational direction and guidance to sponsors and Health Canada staff on the requirements for the preparation of: regulatory activities for Human drugs and disinfectants pursuant to Part C - Division 1 and Division 5 of the Food and Drug Regulations; regulatory activities for Veterinary drugs pursuant to Part C - Division 1 and Division 8 of the Food and Drug Regulations; Master Files (MFs) …"--Introduction, page 6.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.868510&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance document : preparation of regulatory activities in non-eCTD format. |
| Variant title | Guidance document : preparation of RAs in non-eCTD format |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance document (2016) |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Ligne directrice : préparation des activités de réglementation en format non-eCTD. Title from cover. At head of title: Guidance document. "Effective date: 2024/05/15." "Pub.: 240030"--Page 2. Includes bibliographical references. |
| Publishing information | Ottawa, ON : Health Canada = Santé Canada, May 2024. ©2024 |
| Description | 1 online resource (42 pages) |
| ISBN | 9780660296517 |
| Catalogue number |
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| Departmental catalogue number | 240030 |
| Subject terms | Pharmaceutical policy -- Canada. Disinfection and disinfectants -- Government policy -- Canada. Veterinary drugs -- Government policy -- Canada. |