Commission strips drug safety measures from EU patient info proposal to meet July 2012 deadline
This article was originally published in SRA
The European Commission has backtracked on plans to incorporate some new drug safety measures into the draft legislation on information to patients in an effort to make sure that the measures are approved in time for the implementation of the new pharmacovigilance rules in mid-20121.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.