11.07.2011
To the attention of Marketing Authorisation Holders
Given implementation of the new pharmacovigilance legislation, pharmaceutical companies need to add to the “EudraVigilance Medicinal Product Dictionary”, in electronic format, information about medicinal products authorised for marketing in the European Union (Romania included), starting with September 2011, via the EudraVigilance Gateway (in .XSD compliant format) or from January 2012, via a programme to be provided by the European Medicines Agency starting with that date.
The process needs to be closed on 2 July 2012.
For further information, please access (and keep updated with) the following links:
http://eudravigilance.ema.europa.eu/
http://www.ema.europa.eu/