Regulatory Flexibility (28 May 2020)
In the context of COVID-19, the EU institutions and the European Medicines Agency (EMA), play a key role in providing regulatory flexibility that allow for the adaptation of procedures during times of crisis. With the input from stakeholders representing the pharmaceutical supply chain, the EU authorities have developed a Q&A document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. GIRP welcomes the measures introduced, which cover different areas of the regulation of medicines with regards to Good Manufacturing Practices and Good Distribution Practices. Measures include flexibility with regards to the validity of GDP certificates and wholesale distribution authorisations, importation of active pharmaceutical ingredients (APIs) and finished products, labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU, as well as flexibility with regards to the deployment and physical presence of the Responsible Person, and the use of new equipment or newly authorised premises for storage and distribution.
Find the latest version of the Q&A document here.