EU Regualtion No. 1235/2010 amended the marketing authorization holder (MAH) to provide information on medicines. The MAH required to upload the requested data electronically to the European Medicines Agency (EMA) EudraVigilance side bz the 2nd of July 2012. The data are XEVMPD (Extended Eudravigilance Medicinal Product Dictionary) foundation run by the EMA, which is closely linked to the EU pharmacovigilance and adverse reaction reporting systems. The process of registration, information on the necessary documents to the EMA website.
To upload data the MAH should be registered at Eudarvigilance. Information about the process of registration and required documents are avaialable on the website of EMA. Users required to participate trainings and pass the exam will prior to receive a license to upload data. The training courses organized by the Drug Information Association. must pre-register on education. Registration fee is 1550EUR. MedDRA license also required to upload data which is available at MSSO site.
The data with mandatory appendicies should be uploaded for each product strength associated with structured XML format. Most of the information should be encoded EMA, MEDRA databases Properly - eg. Indications of application, active ingredients and excipients, formulations, chemical data, therapy. To keep the database up-to-date is the responsibility of the MAH.
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