|
000
| 02298nam 2200409zi 4500 |
|---|
| 001 | 9.868510 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20240521100943 |
|---|
| 006 | m o d f |
|---|
| 007 | cr mn||||||||| |
|---|
| 008 | 190218e202405 onc ob f000 0 eng d |
|---|
| 020 | |a9780660296517 |
|---|
| 040 | |aCaOODSP|beng|erda|cCaOODSP |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH164-272/2024E-PDF |
|---|
| 245 | 00|aGuidance document : |bpreparation of regulatory activities in non-eCTD format. |
|---|
| 246 | 17|aGuidance document : |bpreparation of RAs in non-eCTD format |
|---|
| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cMay 2024. |
|---|
| 264 | 4|c©2024 |
|---|
| 300 | |a1 online resource (42 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 de réglementation en format non-eCTD. |
|---|
| 500 | |aTitle from cover. |
|---|
| 500 | |aAt head of title: Guidance document. |
|---|
| 500 | |a"Effective date: 2024/05/15." |
|---|
| 500 | |a"Pub.: 240030"--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 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. |
|---|
| 650 | 0|aPharmaceutical policy|zCanada. |
|---|
| 650 | 0|aDisinfection and disinfectants|xGovernment policy|zCanada. |
|---|
| 650 | 0|aVeterinary drugs|xGovernment policy|zCanada. |
|---|
| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
|---|
| 775 | 08|tLigne directrice : |w(CaOODSP)9.868511 |
|---|
| 795 | |tGuidance document |b(2016)|w9.848996 |
|---|
| 856 | 40|qPDF|s1.20 MB|uhttps://publications.gc.ca/collections/collection_2024/sc-hc/H164-272-2024-eng.pdf |
|---|