00000000cam 2200000zi 4500
0019.957242
003CaOODSP
00520260415081038
006m     o  d f      
007cr cn|||||||||
008251110e202511##onc     ob   f000 0 eng d
020 |a9780660796710
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-272/2025E-PDF
24500|aGuidance document : |bpreparation of regulatory activities in non-eCTD format.
24617|aGuidance document : |bpreparation of RA in non-eCTD format
250 |a[November 2025 edition].
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cNovember 2025.
264 4|c©2025
300 |a1 online resource (38 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Ligne directrice : préparation des activités réglementaires en format non-eCTD.
500 |aTitle from cover.
500 |a"Effective date: 2025/11/27."
500 |a"Pub.: 250327"--Page 2.
504 |aIncludes bibliographical references.
520 |a"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.
650 0|aPharmaceutical policy|zCanada.
650 0|aDisinfection and disinfectants|xGovernment policy|zCanada.
650 0|aVeterinary drugs|xGovernment policy|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.957241
795 |tGuidance document : |b[May 2024 edition]|w(CaOODSP)9.868510
85640|qPDF|s1.10 MB|uhttps://publications.gc.ca/collections/collection_2026/sc-hc/H164-272-2025-eng.pdf
986 |a250327