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IMB Encourages Online Reporting

Date: 09 July 2008

The IMB monitors the safety and quality of all licensed medicines available on the Irish market on an ongoing basis, and part of this monitoring is carried out through review and evaluation of suspected adverse reactions and suspected quality defects. The IMB website, www.imb.ie, now includes a facility for online reporting of suspected adverse reactions and quality defects associated with the use of medicinal products, and it is hoped that this facility will further enhance the existing reporting system through the provision of a convenient electronic mechanism for reporting.

To avail of the new online facility, reporters can log on to www.imb.ie and follow the link to ‘Online Reporting’, under the Safety and Quality Section of the website, where further instructions on how to complete the individual case report forms are available. Certain mandatory fields are required to successfully submit a report online and these include reporter details and a contact email address. The latter will facilitate return of a unique report identifier number as confirmation of a successfully submitted report. In addition, for adverse reaction reports, in line with the legislative requirements, the minimum criteria for a valid adverse reaction report must be provided for a report to be accepted.

The IMB ‘freepost’ systems for reporting quality defects and adverse reactions to medicinal products remain in place and reporters can continue to use the various downloadable or hard copy forms for reporting purposes.

The IMB is always keen to help, encourage and establish safety and monitoring reporting practices. Any centres or practices wishing to develop their reporting systems should contact the respective IMB sections for further information. In this regard, for suspected adverse reaction reporting, the IMB Pharmacovigilance Section may be contacted on telephone no. 01 6764971, or by fax on 01 6762517. With respect to quality defect reporting, the IMB Market Compliance Section maybe contacted via telephone no. 01 6764971 and by fax on 01 6764061.

   

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