EMA Updated Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines

On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.

The European Medicines Agency (EMA) together with the Member States, in the context of the Quality Review of Documents (QRD) group, have developed this Questions and Answers (Q&A) document with the aim to provide operational guidance on labelling flexibilities for COVID-19 vaccines. The topics addressed in the present document are primarily based on the European Commission’s Memorandum of Understanding (MoU) with Member States on regulatory flexibility for COVID-19 vaccines; in addition, a number of these topics are stemming from numerous questions received from COVID-19 vaccine developers in the course of the last few months.

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