Article 16(4) of Regulation (EC) No 726/2004 was re-numbered as Article 16(3a) by virtue of the Corrigendum (OJ L 348, 31.12.2010, p1) to Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicines for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medical Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products.