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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 for medicinal products marketed in the EU, including medicinal products that are administered to COVID-19 patients.

MAHs facing difficulties to perform the quality controls foreseen in the marketing authorisation, due to e.g. a significant increase of manufacturing capacity to meet the demands of patients in the EU or other circumstances related to the COVID-19 pandemic, are invited to contact the competent authorities and to present an adapted control scheme based on a risk-based approach. This request should be submitted as a variation in accordance with Commission Regulation (EC) No 1234/2008.

Other changes to the quality requirements foreseen in the marketing authorisations should also be processed in accordance with the Commission Regulation (EC) No 1234/2008.

To permit prompt assessment of these variation applications, applicants are requested to identify any such communication with the subject “CONCERNS COVID-19” next to the procedure number in the email heading.