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Tag: medicinal

3. QUALITY VARIATIONS

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC 3.1. Can quality requirements be waived/adapted for medicines intended to be used for the treatment of COVID-19 patients? Without prejudice to the flexibilities afforded by the ECMP, the quality requirements foreseen in the marketing authorisation should be complied with […]

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

The current COVID-19 pandemic has a considerable impact on citizens, patients and businesses. It may force marketing authorisation holders of medicinal products and regulatory authorities to operate under business continuity mode, impacting the standard way of working. Moreover, public health needs may require quick actions or re-prioritisation of operations. The ultimate aim of the EU […]