Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements

The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not required, sponsors are invited to provide a brand name assessment should one be available.

Data and Resources

Additional Info

Field Value
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward