Regulatory Flexibility (11 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 industry and full-service healthcare distributors, 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. The measures introduced cover different areas of the regulation of medicines such as marketing authorisations and regulatory procedures (including the automatic extension of the validity of GDP certificates and Wholesale Distribution Authorisations until the end of 2021), manufacturing and importation of active pharmaceutical ingredients (APIs) and finished products, quality variations, and labelling and packaging requirements with flexibility to facilitate the movement of medicinal products within the EU.
While the first Q&A publication focused mainly on Good Manufacturing Practice (GMP) procedures, GIRP has been working closely with regulators to push them to allow for further flexibility on the level of Good Distribution Practice (GDP). This will include flexibility for example with regards to the deployment and physical presence of the Responsible Person, adapted Change Management procedures and transit times for medicines for human use. The revised Q&A document which should reflect regulatory flexibility for GDP is expected to be published in May 2020.