OpenLegislation

Regulation 42 Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)I1

United Kingdom

(1)

Regulation 45M M1 is amended as follows.

F1(2)

For paragraph (2)(a) substitute—

“(a)

if—

(i)

in the case of a product for sale or supply in Great Britain, the product has a UK marketing authorisation, certificate of registration or traditional herbal registration, or

(ii)

in the case of a product for sale or supply in Northern Ireland, the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration, and”;

(3)

In paragraph (3), omit “from a state other than an EEA State”.

Annotations

Textual amendments

F1

Reg. 42(2) 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. 31

Marginal citations

M1

Regulation 45M was inserted by S.I. 2013/1855.

Commencement

I1

Reg. 42 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1