Article 16Changes to the therapeutic indication(s)#
1.Where during the centralised procedure, there is a change of the therapeutic indication(s) initially submitted to the European Medicines Agency, the assessor, with the assistance of the co-assessor, shall assess whether that change affects the assessment scope and inform the JCA Subgroup.
2.The JCA Subgroup shall decide whether the joint clinical assessment shall continue, or whether the assessor, with the assistance of the co-assessor, shall prepare a new assessment scope proposal. The HTA secretariat shall inform the health technology developer of the JCA Subgroup’s decision.
4.The HTA secretariat shall inform the health technology developer of the new assessment scope finalised by the JCA Subgroup and shall request the health technology developer to submit an updated dossier. The deadlines referred to in Article 12(5) shall apply to that request. Articles 14 and 15(1) of this Regulation shall apply with the necessary modifications.