Labelling Flexibilities for COVID-19 Therapeutics

On 12 March 2021 the EMA announced the availability of guidance on labelling flexibilities for COVID-19 treatments.

The guidance is available on flexibilities to help developers of COVID-19 treatments prepare and roll out packaging and labelling for their treatments quickly.

It describes EMA’s criteria for deciding if a COVID-19 treatment can benefit from the same temporary labelling exemptions as COVID-19 vaccines.

Read the pdf 
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