EMA Provide Advice on Regulatory Expectations and Flexibility during the COVID-19 Pandemic

In the wake of the on-going COVID-19 pandemic, the EMA has published a Question and Answers document which provides guidance to stakeholders on the implemented adaptations to regulatory framework that have been put in place to address some of the unprecedented challenges of the outbreak and to ensure continuity of supplies of medicines.

The measures introduced cover many different areas of the regulation of medicines, from marketing authorisation applications to manufacturing and importation of medicinal products. These measures have been endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.

Whilst the document particularly focuses on the facilitation of the authorisation and supply of medicines able to treat COVID-19 patients, there is important information for stakeholders of authorised medicines that may not be able to perform their statutory obligations in the current climate.

The guidance will be continuously updated. Here at JensonR+, we will be monitoring the situation throughout the crisis, so follow us on LinkedIn to receive any updates. If you would like to discuss the potential impact of this change to your business, then please do not hesitate to contact us at consultancy@jensongroup.com.

Ben Smith