Monthly Archives: June 2015

New Centralised Template (Version 9.1., 06/2015) published

EMA has published updated templates of the centralised template on their website.

At a quick glance, it seems to me that the quality of the Finnish template has not been improved, but here is the general description of the update from the EMA website:

Latest update: June 2015 (version 9.1)

  • Addition of guidance on the acceptance of combined summaries of product characteristics (SmPCs) for different strengths of the same pharmaceutical form.
  • Revision of guidance on the dates to be recorded in section 9 of the SmPC (i.e. date of first authorisation and date of latest renewal).
  • Revision of guidance and new standard statements in Annex II.
  • New guidance for the inclusion of quick response (QR) codes on the labelling and package leaflet.
  • Revision of guidance on the list of local representatives in the package leaflet as a result of the revised European Commission (EC) Guideline on the packaging information of medicinal products for human use (i.e. no need to have the whole list of local representatives in the actual printed package leaflet).
  • Improvements in most language versions.