Guidance for Marketing Authorisation Holders - National Reporting of Adverse Drug Reactions
In accordance with European and national legislation, marketing authorisation holders (MAHs) are required to ensure that an appropriate system for pharmacovigilance is in place in order to assume responsibility for marketed medicines and to ensure appropriate action may be taken when necessary in accordance with relevant EU guidance included in GVP Module I.
MAHs should ensure that the pharmacovigilance systems in place are in line with their regulatory obligations and are regularly monitored to ensure compliance. Pharmacovigilance inspections will be conducted by the HPRA on a routine/triggered basis, as appropriate.
Expedited Reporting Requirements
Expedited reporting requirements for marketing authorisation holders (MAH) are in accordance with relevant EU guidance included in GVP Module VI.
Companies should note that the requirements for expedited reporting will change on 22nd November 2017. Please see the section below and Issue 57 of the HPRA Medicinal Products Newsletter for more detail.
In accordance with national and international legislation and the GVP Module VI, the current reporting requirements (up to 22nd November 2017) are as follows:
- All suspected, serious adverse reactions (reported either by a healthcare professional or consumer/patient) occurring in Ireland should be submitted to the HPRA within 15 days of first notification of any personnel within the company.
- Companies are not required to report non-serious adverse reactions. In addition, companies are not required to report serious or non-serious adverse reactions occurring outside Ireland, as the HPRA will access such reports through the EudraVigilance database.
Please note that the HPRA will forward all Irish serious cases received directly to EudraVigilance. During the transitional period, MAHs should not report these Irish serious cases to EudraVigilance as this will lead to duplicate reporting.
Reports to EudraVigilance and other NCAs should be submitted in accordance with the European Medicines Agency document on Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim arrangements.
In accordance with EU and national legislation, marketing authorisation holders, clinical trial sponsors and holders of certificates of traditional use are required to submit relevant adverse reaction reports electronically.
Guidance on electronic reporting requirements can be found in the HPRA Guide to Electronic Transmission of ICSRs and SUSARs associated with the use of Human Medicines
From 22nd November 2017 onwards:
All reporting shall be in line with the final reporting arrangements as described in Directive 2001/83/EC as amended. Therefore all serious and non-serious ICSRs that occur in Ireland will be reportable directly to EudraVigilance by the MAH and not to the HPRA. These final reporting arrangements are further described in Revision 2 of GVP Module VI (Management and reporting of adverse reactions to medicinal products), which comes into effect on 22 November 2017.
To allow for the transition to this new reporting system, the HPRA will close its gateway at 00:00 on 04 November 2017 and MAHs should cease submitting ICSRs to HPRA from this time. Any Irish ICSRs due for submission between 04 and 21 November should be submitted directly to EudraVigilance after the new system go-live on 22 November 2017.
Please refer to Issue 57 of the HPRA Medicinal Products Newsletter for more detail of the national arrangements, and to the EMA website for the European go-live plan.
MAHs should note that in accordance with GVP module VI, the HPRA will continue to liaise with MAHs in follow-up of ICSRs occurring in Ireland, where considered necessary.
Clinical Trial SUSAR Reporting Requirements
Irish SUSAR reports are reportable to the HPRA in parallel with reporting to the EudraVigilance clinical trials module. Please refer to the HPRA Guide to Clinical Trial Applications for more information.
During the cutover period from 04 November 2017 to 22 November 2017 the HPRA gateway will be not be available – therefore any SUSARs due for submission during this period should be sent to the HPRA after go-live of the new EudraVigilance system on 22 November 2017. Please also refer to the Go Live Plan published on the EMA website.
Contact Details for pharmacovigilance queries:
Health Products Regulatory Authority
Kevin O'Malley House
Fax: +353 1 676 2517