OpenLegislation

Regulation 66 Amendment of regulation 60 (conditions of UK marketing authorisation: exceptional circumstances)I1F1

United Kingdom

In regulation 60—

(a)

after “UK marketing authorisation” in each place it occurs (including the heading to the regulation) insert “or parallel import licence”;

(b)

after “the authorisation” in each place it occurs insert “or licence”;

(c)

in paragraph (3), after “an authorisation” insert “or licence”;

(d)

for paragraph (9) substitute—

“(9)

The licensing authority must notify the EMA of any UKMA(NI) or UKMA(UK) that it has granted subject to a condition included in accordance with this regulation.”;

(e)

in paragraph (10), after “a marketing authorisation” insert “or licence”.

Annotations

Textual amendments

F1

Reg. 66 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 49

Commencement

I1

Reg. 66 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1