EMA Q&A explains regulatory expectations for drugs during the pandemic
The European Medicines Agency (EMA) and European Commission on Friday released a question and answer document on regulatory expectations for marketing authorization holders (MAHs) and medicines during the COVID-19 pandemic.The Q&A discusses issues related to marketing authorizations, manufacturing and imports, quality variations, product information and labeling.
As far as marketing a medicine in the absence of an authorization, the Q&A says that member states can resort to compassionate use, or authorization of the distribution of an unauthorized medicinal product in accordance with Article 5(2) of Directive 2001/83/EC. To permit prompt assessment of these requests, applicants are asked to send messages to the relevant national competent authority, labeled “CONCERNS COVID-19.”
The Q&A also discusses possible flexibilities for MAHs seeking to renew their marketing authorizations, as well as how if the sunset clause, which can invalidate a marketing authorization, is an issue, MAHs are can request an exemption due to exceptional circumstances and on public health grounds.
On the issue of drug shortages, the guidance further discusses how an exceptional change management process (ECMP) can help MAHs source starting materials, reagents, intermediates or active substances from suppliers not specifically mentioned in the marketing authorization if that is necessary to prevent/mitigate shortages of supplies in the EU.
“The ECMP will permit the swift implementation of changes to suppliers and/or manufacturing/control sites necessary to reduce the risks of shortages under certain conditions intended to ensure the quality of the medicinal product, while deferring the full assessment of the variation,” the Q&A says.
MAHs that wish to rely on the ECMP must notify the relevant national competent authority that granted the marketing authorization or EMA and the Q&A explains what to include in such a notification.
In addition, MAHs facing difficulties with quality controls, due to 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, the Q&A says, noting that the request should be submitted as a variation in accordance with Regulation (EC) No 1234/2008.
And on labeling during the COVID-19 pandemic, the document notes that member states may accept that the product information of products marketed in their territory may not be translated into the relevant official language if there are severe problems of availability of that medicine.
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