Europe – Questions and answers on labelling flexibilities for COVID19 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.

The flexibilities discussed in this document take into account the preparedness work of COVID-19 vaccine developers and the associated logistics of early printing packaging activities. The ultimate goal is to facilitate the large scale and rapid deployment of COVID 19 vaccines for EU citizens within the existing legal framework…