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 assume responsibility for marketed medicines and to ensure appropriate action may be taken when necessary.

The IMB has adopted all relevant pharmacovigilance guidance, as referenced on this website, which should be viewed together with Volume 9A of The Rules Governing Medicinal Products in the European Union.

Contact Details:
All queries relating to the requirements for companies in respect of pharmacovigilance should be addressed to:

Pharmacovigilance Section
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Phone: +353 1 676 4971
E-mail: imbpharmacovigilance@imb.ie