National Reporting of Adverse Drug Reactions

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 the final reporting arrangements as described in Directive 2001/83/EC as amended, and in GVP Module VI (Management and reporting of adverse reactions to medicinal products). Therefore all serious and non-serious ICSRs that occur in Ireland are reportable directly to EudraVigilance by the MAH. There are no additional national reporting requirements.

MAHs should note that in accordance with GVP module VI, the HPRA will liaise with MAHs in follow-up of ICSRs occurring in Ireland, where considered necessary.

Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting Requirements

Please see the Reporting of Suspected Unexpected Serious Adverse Reactions webpage for information.

Contact Details for Pharmacovigilance Queries

Pharmacovigilance Section
Health Products Regulatory Authority
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace 
Dublin 2

Fax: +353 1 676 2517