Temporary Market Authorizations, 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). Temporary Market Authorizations were the regulatory tool by which most food-like NHPs were transitioned from the NHP to food regulatory sphere in 2012. dicentra was actively involved in this food-like NHP transition, and hence, we have developed expertise in the Temporary Market Authorizations application process and associated regulatory advocacy. We have successfully prepared and navigated the Temporary Market Authorizations application process for a number of transitioned food-like NHP products, as well as new Temporary Market Authorizations eligible food products.
Our services in Temporary Market Authorization applications include:
- Initial Product Classification (to verify product qualifies as a food)
- Initial determination of eligibility of Temporary Market Authorization (to mitigate later requests for reformulation to meet Food Directorate benchmarks or refusal due to novel ingredients)
- Preparation of Temporary Market Authorization application
- Pre-submission meetings with the Food Directorate
- Correspondence and advocacy with Food Directorate regarding product approval
- Responding to government clarification requests (CRs) and information request notices (IRNs)
- Responding to government Deficiency Notices or Reformulation Notices
- Health Claim Substantiation Assessment and Product Development (link to service Page)
- Review of Draft Temporary Market Authorization Letter package, including agreement to be signed with Health Canada by manufacturer or distributor
- Obtaining Final Temporary Market Authorization Letter package
- Assistance and guidance in preparation of Market Research Data required of Temporary Market Authorizations
- Assistance in preparation of Incident Reporting required of Temporary Market Authorizations
With this changing regulatory landscape in the food industry, dicentra’s highly qualified team is well equipped to aid you in successfully gaining temporary market access for your eligible Temporary Market Authorizations food.