28Mar

Health Canada Has New Electronic Submission Requirements

Health Canada has announced that as of June 1, 2013, it will not be accepting paper copies of administrative regulatory activities. Electronic documents on CD/DVD will be the only acceptable format. Administrative drug submissions include changes to the manufacturer’s and/or product’s name within the DIN submission (division 1) and drug submission (division 8) framework of the Food and Drug Regulations.

Electronic content should be organized in folders. Files should be named according to the ICH Electronic Common Technical Document Specification. Files should not be zipped or password protected.