Covid-19 : Guidance on more regulatory flexibility for medicines

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The European Commission, EMA and the European medicines regulatory network have
developed a Q&A document to provide guidance to stakeholders on adaptations to the
regulatory framework to address challenges arising from the COVID-19 pandemic,
with a particular focus on crucial medicines for use in COVID-19 patients.
The document explains some regulatory flexibilities that can be applied to help
pharmaceutical companies cope with the consequences of the pandemic, while
ensuring a high level of quality, safety and efficacy for medicinal products made
available to patients in the EU.
The document published today outlines areas where regulatory flexibility is possible
to address some of the constraints marketing authorisation holders may be faced with
in the context of COVID-19. The measures introduced cover different areas of the
regulation of medicines such as marketing authorisations and regulatory procedures,
manufacturing and importation of active pharmaceutical ingredients (APIs) and
finished products, quality variations, and labelling and packaging requirements with
flexibility to facilitate the movement of medicinal products within the EU. Some of the
measures described are reserved for crucial medicines for use in COVID-19 patients.

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