Latest EMA GVP (XVI) Module UpdateEurope-map-colour

The final Addendum I to Module XVI on educational materials is published, taking into account comments from the public consultation.
Further, revision 1 of Module XV on safety communication, with revision 1 of the template for Direct Healthcare Professional Letters (DHPCs) and a new template for DHPC-Communication Plans in GVP Annex II, and the second Product- or Population-Specific Considerations, namely on biological medicinal products, are released for public consultation over two months.

Also, a revision of the GVP structure is presented on page 6 of this Introductory Note.

For timelines when the remaining new Considerations will be published for public consultation, please see the EMA GVP Webpage
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