Temporary Market Authorizations (TMA) Applications

Temporary Market Authorizations (TMA) Applications, although having existed for a while, have only recently been actively used to allow normally non-compliant food products access to market while the Food Directorate gathers further information in support of regulatory amendment to the Food and Drug Regulations (FDR). We have successfully prepared and navigated the Temporary Market Authorizations application process for many eligible food products.

Our services for Temporary Market Authorization (TMA) Applications include:

• Establish initial product classification (to verify product qualifies as a food)
• Determine eligibility of Temporary Market Authorization (to mitigate later requests for reformulation to meet Food Directorate benchmarks or refusal due to novel ingredients)
• Prepare the Temporary Market Authorization application
• Arrange Pre-submission meetings with the Food Directorate
• Correspond with the Food Directorate regarding product approval
• Respond to government clarification requests (CRs) and information request notices (IRNs)
• Respond to government Deficiency Notices or Reformulation Notices
• Assess Health Claim Substantiation and Product Development
• Review of Draft Temporary Market Authorization Letter package, including agreement to be signed with Health Canada by manufacturer or distributor
• Obtain Final Temporary Market Authorization Letter package
• Assist and provide guidance in preparation of Market Research Data required of Temporary Market Authorizations
• Assist in preparation of Incident Reporting required of Temporary Market Authorizations