Archemin

Advice & reporting for the chemical and pharmaceutical industries

Pharmacovilance: EMA publishes format for data transmission

Sat, 02/07/2011 - 12:35pm -- Tomas Bellemans

The EMA just published detailed instructions for marketing authorisation holders on the electronic submission of safety information on medicinal products for human use.

By 2 July 2012 at the latest, marketing authorisation holders shall electronically submit information on human medicines authorised in the EU using the EudraVigilance Medicinal Product Report Message (EVPRM) as the format. Independent of the authorisation procedure of the medicinal product.

Our team of accredited Pharmacovigilance specialists will gladly help you if you require assistance in these matters.