EMA updates requirements for pharmacovigilance legislation
The European Medicines Agency requires marketing-authorization holders to update the information on authorized medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.
This includes completing previously submitted information with additional data elements included in the new data-submission format, bringing medicine information up–to-date, and checking that the quality of the information is in line with the updated reporting requirements. Companies need to complete this process by the end of 2014.
The additional elements that are now required include:
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