EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.
The extraordinary regulatory flexibilities covered different areas, including marketing authorisation and related regulatory procedures, manufacturing and importation of active pharmaceutical ingredients and finished products, quality variations, labelling and packaging requirements and compliance. The EC, HMA and EMA also agreed during the pandemic on a series of measures to mitigate the impact of disruptions caused by the public health emergency on inspections of manufacturing facilities or other sites relevant for medicinal products in the EU. The extraordinary flexibilities ensured the continued availability of medicines while making sure that good manufacturing (GMP) and distribution practice (GDP) standards were being adhered to…
