Time extension – Adaptation of the patient leaflet of medicines authorized by national procedure to the format drafted by the Working Group on Quality Review of Documents (15/05/2015)
Information for the Pharmaceutical companies
15/05/2015
Considering the difficulties expressed by several MA Holder in the performance of readibility testing and consequentely in the submission of the relevant type IB variation – C.I.z (Submission of results of assessments carried out on target patient groups in order to comply with Article 59(3) of Directive 2001/83/EC and any resulting change to the Package Leaflet) within the deadline established in the communication dated 23.07.2013, please be informed that for the medicinal products under letter a) of this communication, the deadline for the submission of the above mentioned variation has been postponed to 01.12.2015.
