EMA issue updated guidance on EVMPD requirements

On 1 September 2011, EMA posted a substantial set of documents associated with the mandatory requirement for MAHs to submit EVMPD data for all authorised products in the European Union by 2 July 2012.

The documents include :

  • Slightly updated explanatory notes
  • Detailed guidance, now split into 6 separate documents (with significant changes from the previous version of 1 July 2011)
  • XML schema files for the EVPRM message and the Structured Substance Information message (note : an acknowledge message schema has also been posted but at present is only accessed through a hyperlink in one of the documents)
  • Controlled vocabularies and some naming conventions

These can be accessed on the EMA website by clicking here.