The Human Medicines Regulations 2012

[F1 Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies) U.K.

60.— (1) Where the Pharmacovigilance Risk Assessment Committee has, before IP completion day—

(a) issued a letter endorsing a draft study protocol under Article 107n(2)(a) of the 2001 Directive;

(b) informed a holder of a UKMA(GB) or a THR(GB) that the study is a clinical trial under Article 107n(2)(c) of the 2001 Directive; or

(c) informed a holder of its endorsement of a substantial amendment to that protocol under Article 107o of the 2001 Directive,

the licensing authority is deemed to have accepted the draft study protocol, or the amended draft study protocol, or made that decision (as the case may be) under regulation 199(5) (submission of draft study protocols for required studies) or 200(5)(b) (amendment to study protocols for required studies).

(2) Where sub-paragraph (1) applies, the licensing authority may request the holder of a UKMA(GB) or a THR(GB) to provide to it any information in relation to the procedures under Article 107n or 107o of the 2001 Directive within a specified time period, and that holder must provide that information within that time period.

(3) Sub-paragraph (4) applies where, before IP completion day—

(a) a holder of a UKMA(GB) or a THR(GB) is proposing to, or, pursuant to Article 21a or 22a of the 2001 Directive, is under a duty to, undertake a non-interventional post-authorisation safety study; and

(b) the procedure specified in Article 107n or 107o of the 2001 Directive has not concluded before IP completion day.

(4) Where this sub-paragraph applies, on and after IP completion day, the holder must—

(a) submit any further information that has been required of it by the Pharmacovigilance Risk Assessment Committee to the licensing authority; and

(b) submit to the licensing authority such further information that it may request in relation to the procedures under Article 107n or 107o of the 2001 Directive within a time period specified by the licensing authority, whether or not that information has already been submitted to, or received from, that Committee before IP completion day,

and the licensing authority must assess that information in accordance with regulation 199 or 200 (as the case may be).

(5) In this paragraph, “not concluded before IP completion day” means that—

(a) a holder of a UKMA(GB) or a THR(GB) is proposing to, or, pursuant to Article 21a or 22a of the 2001 Directive, is under a duty to, undertake a non-interventional post-authorisation safety study;

(b) the Pharmacovigilance Risk Assessment Committee has not taken any of the steps specified in sub-paragraph (1)(a) to (c).]

Textual Amendments

F1 Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)