The Q&A developed by European Commission, EMA and the European medicines regulatory network provides guidance to companies on adaptations to the regulatory framework in order to address challenges arising from the COVID-19 pandemic.
Hot regulatory topics include renewals and “sunset clause”.
In case the MAH is not able to respect the submission deadline due to pandemic, the relevant Competent Authority should be contacted before the deadline in order to discuss and agree on the steps to take.
In case the pandemic circumstances change the launch plans of a company, triggering the sunset clause mechanism, MAHs can request an exemption to the relevant Competent Authority making reference to the pandemic situation.
RPN is ready to promptly support the MAHs in liaising with the Authority during COVID-19 emergency to discuss flexibility on regulatory procedures.