The provisions of the first paragraph shall apply to applications for an extension submitted in accordance with the provisions of Article 36 of Regulation (EC) No 1901/2006 of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001/20/EC and 2011/83/EC and Regulation (EC) No 726/2004.
Article R617-2-1
Updated 7 Nov 2023

