PLR TRADUZIONI wrote:
QRD v 9.1 is still valid
Did I missed something ?
The latest update was yesterday - 10/06/2015 -
Quote EMA Latest update: June 2015 (version 9.1) (
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp&mid=WC0b01ac0580022c59) 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.
Any further changes affecting some or all of the linguistic versions of the templates will be published on this page.
[Edited at 2015-06-11 14:30 GMT]
[Edited at 2015-06-11 14:30 GMT]