The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

[F1 New regulation 135ZA (amendment of regulation 167 (supply to fulfil special patient needs)) U.K.

135ZA.   In regulation 167 (supply to fulfil special patient needs)—

(a) in paragraph (6), for “or imported into the United Kingdom from a country other than an EEA State” substitute “, imported into Northern Ireland from a country other than an EEA State or Great Britain, or imported into Great Britain from a country other than an approved country for import or Northern Ireland”;

(b) in paragraph (7)—

(i) for “imported from an EEA State” substitute “imported into Northern Ireland from an EEA State or imported into Great Britain from a country other than an approved country for import”;

(ii) for sub-paragraph (a) substitute—

“(a) it is manufactured or assembled in that State or country (as appropriate) by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i) in the case of a product for sale or supply in Northern Ireland, the provisions of the 2001 Directive as implemented in that State, and

(ii) in the case of a product for sale or supply in Great Britain, in accordance with the provisions applicable in that country; or”;

(iii) for sub-paragraph (b) substitute—

“(b) it is manufactured or assembled as an investigational medicinal product in that State or country (as appropriate) by the holder of an authorisation in relation to its manufacture or assembly in accordance with—

(i) in the case of a product for sale or supply in Northern Ireland, Article 13 of the Clinical Trials Directive as implemented in that State, and

(ii) in the case of a product for sale or supply in Great Britain, regulations 13 and 43 of the Clinical Trials Regulations,”.]

Textual Amendments

F1 Reg. 135ZA inserted (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. 102

Commencement Information

I1 Reg. 135ZA in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1