The European Medicines Agency (EMA) has provided drugmakers with the
specific electronic formats that will be required for information on
all drugs authorized or registered in the EU beginning next year. The
deadline for submission in the new formats is 2 July 2012. EMA issued
both a legal notice including an overview of the main requirements and a
detailed guidance document. In its press release on the subject, EMA
called the release “the first milestone in the implementation of the new
pharmacovigilance legislation.” Drugmakers will be required to submit
original data in the new format and to maintain the information using
the EudraVigilance Medicinal Product Report Message system.
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