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    Reaction Reporting

 

Adverse Reaction & Quality Defect Reporting

Report a suspected side effect

The Irish Medicines Board (IMB) monitors the safety and quality of all authorised medicines available on the Irish market on an on-going basis and part of this monitoring is carried out through the review and evaluation of suspected adverse drug reactions (ADRs) and quality defects. The IMB's website includes a facility for reporting these online.

Healthcare professionals

All healthcare professionals are encouraged to use the national system to report suspected ADRs. Suspected ADRs may be reported using the on-line form. A downloadable version of the form is also available, which can be filled in manually and sent freepost to the IMB.

The IMB is always keen to help, encourage and establish good safety and monitoring reporting practices. Any centres or practices wishing to develop their reporting systems should contact the relevant sections of the IMB for further information.

In this regard, for suspected ADR reporting, the IMB Pharmacovigilance Section may be contacted at imbpharmacovigilance@imb.ie, by telephone on +353 (0)1-676 4971, or by fax on +353 (0)1-676 2517.

With respect to quality defect reporting, the IMB Market Compliance Section may be contacted at recallsandqualitydefects@imb.ie, by telephone on +353 (0)1-676 4971 and by fax on +353 (0)1-676 4061.

Members of the public

If you are concerned that you have had a side effect to a medicine, contact your doctor or pharmacist who will advise on any treatment you may need. They may also report the suspected side effect to the IMB. Should you wish, you can also report side effects directly to the IMB.

While having a side effect while taking a medicine does not necessarily mean that it is has been caused by the medicine you took or received, the IMB encourages people to report all suspected side effects so that if there is an issue it can be addressed.

You may report a suspected side effect or adverse reaction in a number of ways:

  1. through your doctor, pharmacist or nurse who can then notify the IMB
  2. directly, via www.imb.ie
  3. by calling the IMB on +353 (0)1-676 4971

Registering with the IMB for safety alerts and updates

Users of the IMB website have the option of registering their contact information with the IMB to enable them to receive direct and immediate notification of alerts/updates by email or text message. To facilitate prompt access to these updates, users are encouraged to avail of this option by registering on www.imb.ie.


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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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