Article 57 (xEVMPD) services.
What is Art 57 and xEVMPD?
Our xEVMPD services.
xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) is a database which supports the European Medicinal Agency (EMA) & European National Authorities requirements in accordance with Article 57(2) of Regulation (EC) No. 726/2004 which are mandatory since 2012.
Marketing Authorization Applicants (MAAs), Marketing Authorization Holders (MAHs) and clinical trials sponsors must submit information to the xEVMPD database. It allows the collection, reporting, coding and evaluation of medicinal product data in a standardized and structured way.
xEVMPD’s aim is to create a complete dictionary of medicines authorized for use throughout the EU and EEA, including centrally authorized and nationally authorized products. The information is used for the evaluation of development and authorized adverse drug reactions.
The EMA will in time migrate the database to ISO IDMP standards.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.