Europe – Labelling flexibilities for COVID-19 therapeutics

The Q&A on labelling flexibilities for COVID-19 vaccines provides various exemptions to vaccine developers in order to facilitate their rapid deployment at large scale during the pandemic. These flexibilities are exceptional and may not be appropriate or necessary for all other products with a COVID19 claim. To avoid any misuse, the full application of these flexibilities will not be automatic.

On the other hand, it is necessary to adopt a pragmatic and balanced approach for future requests from therapeutics’ developers with similar arguments (as for COVID-19 vaccines), i.e. the need for immediate availability; to this end it is also important to consider and manage in the most efficient way the administrative and logistical impact of such requests to National Competent Authorities (NCAs) and EMA, but also to Health Care Professionals (HCPs) and patients…