|
25.05.2011
Health Canada further increases scope of submissions beeing accepted in eCTD-only format
|
 |
|
Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. A corresponding Notice has been released yesterday on Health Canada's website.
The new submission types accepted in eCTD only filing format are: - Notifiable Changes (NC); (Note: NCs were accepted since August 2010 in eCTD format if they were related to a previously filed submission in eCTD format)
- Responses to clarifaxes (If related to a submission filed in eCTD format)
These two submission types complement the existing list of submission types that are in scope of eCTD-only submissions as announced by Health Canada in August last year (see our related News article). Health Canada further informs that cover letters and electronic media must be sent directly to the Submission and Information Policy Division (SIPD) in order to ensure timely processing of these submissions. The Letter of Attestation is not required for submissions or sequences in the eCTD electronic-only filing format.
The Notice contains additional instructions regarding the - Clarifax process
- Information required in the Cover Letter, and
- Packaging of submissions
It is available on Health Canada`s website as downloadable PDF (see link at the bottom of this article).
[Source: Health Canada website]
- Related News:
 Health Canada increases scope of submissions being accepted in eCTD electronic-only filing format - 04.10.2011 14:19- CA: Update from Health Canada regarding scope of submissions being accepted in eCTD format and acceptance of electronic-only submissions - 24.08.2010 12:01
<- Back to: News
|
|
