|
000
| 02072nam 2200361zi 4500 |
|---|
| 001 | 9.882674 |
|---|
| 003 | CaOODSP |
|---|
| 005 | 20221107170347 |
|---|
| 006 | m o d f |
|---|
| 007 | cr cn||||||||| |
|---|
| 008 | 191205t20202020onca ob f000 0 eng d |
|---|
| 020 | |a9780660334400 |
|---|
| 040 | |aCaOODSP|beng|erda|cCaOODSP |
|---|
| 043 | |an-cn--- |
|---|
| 086 | 1 |aH164-293/2019E-PDF |
|---|
| 245 | 00|aGuidance document : |bpreparation of regulatory activities in the Electronic Common Technical Document (eCTD) format. |
|---|
| 246 | 10|aPreparation of regulatory activities in the Electronic Common Technical Document (eCTD) format |
|---|
| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2020. |
|---|
| 264 | 4|c©2020 |
|---|
| 300 | |a1 online resource (88 pages) : |billustrations |
|---|
| 336 | |atext|btxt|2rdacontent |
|---|
| 337 | |acomputer|bc|2rdamedia |
|---|
| 338 | |aonline resource|bcr|2rdacarrier |
|---|
| 500 | |aCover title. |
|---|
| 500 | |a"Effective date: March 13, 2020." |
|---|
| 500 | |aIssued also in French under title: Ligne directrice : préparation des activités de réglementation en format Electronic Common Technical Document (eCTD). |
|---|
| 504 | |aIncludes bibliographical references. |
|---|
| 520 | |a"This guidance document defines the electronic Common Technical Document (eCTD) electronic-only format process requirements and provides guidance on the structure and content of information to be included in regulatory activities filed to Health Canada. This guidance document is to be used in the preparation and filing of drug regulatory activities to Health Canada in the eCTD electronic-only format as established by the International Council on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use"--Introduction, page 8. |
|---|
| 650 | 0|aDrugs|xGovernment policy|zCanada. |
|---|
| 650 | 0|aDrugs|xSpecifications|zCanada. |
|---|
| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
|---|
| 775 | 08|tLigne directrice : |w(CaOODSP)9.882675 |
|---|
| 856 | 40|qPDF|s3.98 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-293-2019-eng.pdf |
|---|