The following aspects are addressed:
Under point 2, on GMP/GDP for finished products and active ingredients, question 2.1 dealing with the rapid implementation of adaptations in the manufacturing/supply chain to ensure the supply of medicines in the EU has been revised.
In addition, a new question 2.3 has been added, which explains measures to replace on-site inspections of plasma collection centres.
The Q&A document prepared by the European Commission, the EMA and the Heads of Medicines Agencies (HMA) on the more flexible regulatory requirements during the COVID-19 pandemic will be continuously adapted (we reported). As a marketing authorisation holder you should check this page of the EMA regularly for new information.
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