179. Omit regulation 219 (amendment of regulation 322 (validity of proceedings)).U.K.
Commencement Information
I1Sch. 2 para. 179 in force at 31.12.2020 immediately before IP completion day, see reg. 1
180. In regulation 221 (amendment of regulation 327 (powers of inspection, sampling and seizure))—U.K.
(a)in paragraph (2), for sub-paragraphs (b) and (c) substitute—
“(b)after paragraph (v), insert—
“(va)an EU marketing authorisation;”.”;
(b)for paragraph (3) substitute—
“(3) In paragraph (2)(g), after paragraph (iv) insert—
“(iva)the requirements of Schedule 12A (further provision as to the performance of pharmacovigilance activities);”.”;
(c)omit paragraphs (4) and (5).
Commencement Information
I2Sch. 2 para. 180 in force at 31.12.2020 immediately before IP completion day, see reg. 1
181. In regulation 222 (amendment of regulation 331 (findings and reports of inspections))—U.K.
(a)for paragraph (2) substitute—
“(2) In paragraph (1)—
(a)for “marketing authorisation” substitute “ UK marketing authorisation, EU marketing authorisation ”;
(b)in sub-paragraph (c), at the beginning, insert “ in the case of a product authorised under a UKMA(NI) or UKMA(UK), ”.”;
(b)for paragraph (3) substitute—
“(3) In paragraph (4)—
(a)for sub-paragraph (b) substitute—
“(b)the guidelines on good distribution practice—
(i)in the case of Great Britain, published under, or that apply by virtue of, regulation C17;
(ii)in the case of Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive;”;
(b)after sub-paragraph (c) insert—
“(d)Schedule 12A; and
(e)the Implementing Regulation (as defined in regulation 177(5)).”.”.
Commencement Information
I3Sch. 2 para. 181 in force at 31.12.2020 immediately before IP completion day, see reg. 1
182. In regulation 223 (insertion of regulation 331A (guidelines on inspections)), in the inserted regulation 331A(3), for “exit day” substitute “ IP completion day ”.U.K.
Commencement Information
I4Sch. 2 para. 182 in force at 31.12.2020 immediately before IP completion day, see reg. 1