597 - We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?

  • The PAAB may consider correspondence between the manufacturer and Health Canada when those correspondence clearly indicate Health Canada approval. When this cannot be determined to be the case, PAAB may need to contact Health Canada directly on behalf of the sponsor in order to confirm approval of the referenced DOF. Note that submission as part of the NDS does not in and of itself confirm that the content has been approved by Health Canada.