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.
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. Guidance on electronic reporting requirements can be found in the HPRA Guide to Electronic Transmission of SUSARs associated with the use of Human Medicines
Contact Details for pharmacovigilance queries:
Health Products Regulatory Authority
Kevin O'Malley House
Fax: +353 1 676 2517