Paragraph 2A Waiver or refund: converted EU marketing authorisationsF1
Where the licensing authority revokes a converted EU marketing authorisation in accordance with paragraph 6(3) of Schedule 33A to the Human Medicines Regulations, the periodic fee payable under regulation 38(1) in relation to that authorisation shall be refunded, or if it has not yet been paid, shall be waived.
In this paragraph, “converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the 2012 Regulations.
Annotations
Textual amendments
- F1
Sch. 8 para. 2A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 10(3) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)
Notes on Schedule 8
Textual amendments
- F1
Word in Sch. 8 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 10(2) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)