Menu +

Tag: variations

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 […]