The applications under Article 61(3) are notifications regarding minor changes to the label and the PL, that are not associated with a change to the SmPC, and are not subject to the variation application.

However, submission of the results of user testing is considered outside the scope of the article 61(3) notification procedure. This includes situations where the results of user testing do not lead to a change, or minor changes, to the product information. The recommendation is to submit a Type IB variation procedure under catefory C.I.Z., to comply with Article 59(3) of Directive 2001/83/EC.

Revision of QRD template in all languages in order to reflect the new corporate identity of the European Medicines Agency (new web address and deletion of the acronym EMEA) mainly focused on the package leaflet… Link