Guidance document : preparation of regulatory activities in non-eCTD format.: H164-272/2025E-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 non-eCTD guidance document was first published in 2015 and has been revised several times to reflect the onboarding of additional product lines to the non-eCTD format. This revision prescribes changes that have resulted since the previous version, stemming from various process implementations, such as the mandatory use of the eCTD format and the mandatory use of Regulatory enrolment process (REP). …"--Introduction, page 6.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.957242&sl=0
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| Title | Guidance document : preparation of regulatory activities in non-eCTD format. |
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| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance document : [May 2024 edition] |
| Format | Digital text |
| Electronic document | |
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| Publishing information |
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| Description | 1 online resource (38 pages) |
| ISBN | 9780660796710 |
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| Departmental catalogue number | 250327 |
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