Paragraph 4 Extension application

An extension application is an application—

F1(a)

for an extension of a marketing authorisation—

(i)

in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or

(ii)

in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and

(b)

which includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive.

Annotations

F1: Sch. 2 para. 4(a) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(i))