Health Canada has released a draft Drug Master File (DMF) Guidance Document intended to replace the Product Master File Guidance Document (1994). This guidance document strives to provide assistance to industry and health care professionals in the preparation and filing of DMFs, to ensure that all DMFs contain the necessary information to support a drug submission. The new guidance documents incorporates the International Conference of Harmonization (ICH) guidelines and terminology. It also extends beyond pharmaceuticals, providing directions for biotechnological/biological products, veterinary drug products, and natural health products. Finally, administration requirements and procedures have been updated and clarified, making the content requirements for all types of DMFs more detailed and cross-referenced to ICH and Health Canada guidelines where applicable.
Comments and feedback on this draft document must be submitted to Health Canada by November 4, 2008.
However, the Court did not go so far as saying that ISPs will be relieved of liability under all circumstances. In particular, where an ISP is put on notice that certain content it hosts is defamatory, then the ISP may no longer be exempt from liability.
The draft guidance can be found online at: