Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements (English, HTML)

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Publisher-reported update

2021-07-27

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.

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