Paragraph 22
F1 In the case of a medicinal product for sale or supply in Northern Ireland, 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 M1 together with a copy of the relevant Agency opinion.
Annotations
Textual amendments
- F1
Words in Sch. 8 para. 22 substituted (31.12.2020) by S.I. 2019/775, reg. 50(7) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 38(f))
Marginal citations
- M1
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.