The Human Medicines Regulations 2012 No. 1916

SCHEDULES

SCHEDULE 8 Material to accompany an application for a UK marketing authorisation

PART 1 General requirements

22.  A copy of any designation of the medicinal product as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products(1) together with a copy of the relevant Agency opinion.

(1)

OJ No L 18, 22.1.2000, p.1, as amended by Regulation (EC) No 596/2009 (OJ No L 188, 18.7.2009, p.14.