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 Pharma eReport Blog

Date: 20th February 2012, by: Nicky
Tags: EVMPD, XEVMPD, report

Call for participation: IRISS Forum topic group on Identification of Medicinal Products (including XEVMPD)

The IRISS Forum has issued a Call for Participation in a new IRISS Topic Group, focused on supporting the implementation of the International Standards for Identification of Medicinal Products (IDMP) and, in the shorter-term, support for the implementation of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) in Europe.

The coming ISO standards for Identification of Medicinal Products (IDMP) are currently in development and expected to be implemented by 2015.  In the meantime, the industry faces the challenge of meeting the EMA's requirements for the mandatory provision of information on medicinal products authorised in Europe, under Article 57 of the new EU Pharmacovigilance Legislation.  EVMPD compliance requires detailed information on authorised products to be submitted to the Extended Eudravigilance Medicinal Product Dictionary by 2 July 2012.

The initial targets of the group leading up to the July 2012 deadline and beyond will be:

  • To provide a forum for exchange of information relating to implementation of XEVPRM
  • To share knowledge on issues encountered with EMA acceptance and validation of messages provided
  • To develop best practice documentation for submission and maintenance of product information
  • To ensure that interoperability is achieved between vendor solutions

Nominations should be made to the Lead for the Topic Group Andrew Marr by 29 February 2012.  Full details are available on the IRISS website here.

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