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.
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.