News Category: Regulatory news
In preparation for the launch of the new EudraVigilance System and the move to the simplified reporting of adverse reaction reports on 22nd November 2017, the HPRA has published details of the national arrangements that will be in place during this changeover period. Details can be found in Issue 57 of the HPRA Medicinal Products Newsletter and in the Regulatory Information section of the website.
Marketing Authorisation Holders should familiarise themselves with these national arrangements, and plan accordingly. Reference should also be made to the EudraVigilance Go-Live Plan published on the EMA Website, as well as to Revision 2 of Module VI of the Good Pharmacovigilance Practice guide, effective from 22nd November 2017.
Any queries should be sent to medsafety@hpra.ie