Health Canada Moving to Electronic Only Format
Posted 20 March 2013 | By
Health Canada has announced that as of 1 June 2013, all "administrative regulatory" submissions must be in electronic format only, submitted either as an electronic common technical document (eCTD) or a Portable Document Format (PDF) file.
Submissions in eCTD format must be used for labeling documents such as product monographs, and are preferred for other regulatory submissions. The electronic submission must include a cover letter, in both electronic and paper format, which explains the reason for the submission, such as cross licensing agreements, product name change, or company name change.
The following media formats are acceptable for electronic submissions:
- Compact Disc-Recordable (CD-R) conforming to the Joliet specification
- Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard
- Digital Versatile Disc-Recordable (DVD+R/-R) recorded in the Universal Disc Format (UDF) standard