Roche pharmacovigilance inquiry - ball now in EC's court
This article was originally published in Scrip
The EMA has completed its inquiry into allegations that Roche failed to comply with its pharmacovigilance obligations regarding its 19 centrally authorized medicines, and has sent a report outlining its conclusions to the European Commission.
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Under EU rules, once a medicinal product has been placed on the market in a country of the EEA – the EU plus Iceland, Liechtenstein and Norway
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