The Human Medicines Regulations 2012

[F1 PART 10 U.K. Transitional provision in respect of pharmacovigilance

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)

Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day U.K.

58.— (1) Sub-paragraph (2) applies where—

(a) a specified matter in relation to a UKMA(GB) or a THR(GB) has been referred under Article 107i of the 2001 Directive (urgent Union procedure) before IP completion day; but

(b) that procedure has not concluded before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 or 135 (revocation, variation and suspension of UKMA(GB) or THR(GB)) as soon as reasonably practicable.

(3) In making a decision under regulation 68 or 135 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in any procedure provided for by, or referred to in, Section 4 of Chapter 3 of the 2001 Directive;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for by, or referred to in, Section 4 of Chapter 3 of the 2001 Directive; and

(c) any advice it receives from the appropriate committee pursuant to the procedures in Schedule 11 (advice and representations).

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 or 135 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use or the Co-ordination Group for Mutual Recognition and Decentralised Procedures (as the case may be) has given a final opinion in relation to the matter.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11 (advice and representations).

(6) In making a determination under regulation 68 or 135 in accordance with sub-paragraph (2), the licensing authority may adopt or have regard to any decision made, or agreement reached, in relation to the specified matter under Section 4 of Chapter 3 of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.

(7) Sub-paragraph (8) applies where—

(a) a specified matter in relation to a UKMA(GB) or a THR(GB) has been referred under Article 107i of the 2001 Directive before IP completion day; and

(b) that referral has concluded before IP completion day; but

(c) the licensing authority has not, before IP completion day, taken the steps necessary to give effect to that decision or that opinion (as the case may be).

(8) Where this sub-paragraph applies, the licensing authority must take the steps necessary as a result of the decision or opinion to suspend, revoke or vary the UK marketing authorisation or traditional herbal registration—

(a) as soon as reasonably practicable, and, where relevant, within the time period specified in Article 34(3) of the 2001 Directive where a Commission decision requires steps to be taken in relation to a UK marketing authorisation that is not a converted EU marketing authorisation, or traditional herbal registration; or

(b) as soon as reasonably practicable, where a Commission decision or opinion requires steps to be taken in respect of a UK marketing authorisation that is a converted EU marketing authorisation.

(9) In this paragraph—

“concluded before IP completion day”, in relation to an Article 107i referral, means—

(a)

a Commission decision as provided for in Article 107k of the 2001 Directive has been taken before IP completion day; or

(b)

an opinion of the Co-ordination Group for Mutual Recognition and Decentralised Procedures, which constituted the end of the Article 107i referral procedure in accordance with Article 107k(2), has been given before IP completion day;

“specified matter” means a referral made under Article 107i of the 2001 Directive on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities.

Matters on-going at IP completion day in respect of periodic safety update reports U.K.

59.— (1) Sub-paragraph (2) applies where—

(a) a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

(b) that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive;

(c) the procedure described in Article 107e(3) of the 2001 Directive has been completed before IP completion day; but

(d) the licensing authority has not yet taken the steps described in regulation 194 before IP completion day.

(2) Where this sub-paragraph applies, notwithstanding the amendment of regulation 194 (responding to a single assessment of PSUR under Article 107e of the 2001 Directive) by the EU Exit Regulations, the licensing authority must take the steps specified in regulation 194 in respect of the UKMA(GB) or THR(GB) as soon as reasonably practicable.

(3) Sub-paragraph (4) applies where—

(a) a holder of a UKMA(GB) or a THR(GB) has submitted a periodic safety update report under regulation 191 before IP completion day;

(b) that periodic safety report is, immediately before IP completion day, to be assessed in accordance with the single assessment procedure in Article 107e of the 2001 Directive; and

(c) the procedure described in Article 107e(3) of the 2001 Directive has not been completed before IP completion day.

(4) Where this sub-paragraph applies, the licensing authority—

(a) may notify a holder falling within sub-paragraph (3)(a) of the need to provide to it such further information that the licensing authority specifies; and

(b) must, subject to sub-paragraph (5), assess the periodic safety update report in accordance with regulation 195 (obligations on licensing authority to assess PSURs) (as amended by the EU Exit Regulations) as soon as reasonably practicable.

(5) Information required under sub-paragraph (4)(a) must be provided before the end of whatever period the licensing authority may specify.

(6) In making a determination under regulation 195, where sub-paragraph (4) applies, the licensing authority may adopt or have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the periodic safety report and the assessment of that report as a consequence of its involvement in any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

(b) any relevant decision made, or agreement reached, in relation to the periodic safety update report or its assessment before IP completion day, where the United Kingdom participated as a member state in the making of that decision or agreement, under any procedure provided for in Section 2 of Chapter III of the 2001 Directive;

(c) any decision made, or agreement reached, in relation to that marketing authorisation or certificate of registration under Section 2 of Chapter III of the 2001 Directive on or after IP completion day, notwithstanding that the United Kingdom did not participate in the making of that decision or agreement.

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).

Matters on-going at IP completion day in respect of the follow up of final study reports U.K.

61.— (1) Sub-paragraph (2) applies where—

(a) a final study report has been submitted to the Pharmacovigilance Risk Assessment Committee under Article 107p of the 2001 Directive; but

(b) that committee has not, before IP completion day, made recommendations under Article 107q(1) of the 2001 Directive.

(2) Where this sub-paragraph applies—

(a) the licensing authority may, on or after IP completion day, request the holder of a UKMA(GB) or a THR(GB) to submit to it the information specified in regulation 201(2) (submission and evaluation of final study reports for required studies), and such further information relating to the final study report, or the procedure provided for in Chapter 4 of Title IX of the 2001 Directive, as the licensing authority may require; and

(b) that holder of a UKMA(GB) or a THR(GB) must, in any event, undertake the steps specified in regulation 201(5) in respect of that final study report.

(3) Sub-paragraph (4) applies where—

(a) regulation 202(1) (follow-up of final study reports) applied before IP completion day in respect of a final study report; but

(b) the licensing authority has not, before IP completion day, taken the steps specified in regulation 202(2).

(4) Where this paragraph applies, notwithstanding the amendment of regulation 202 by the EU Exit Regulations, the licensing authority must take the steps specified in regulation 202(2) in accordance with the time period specified in that paragraph.

(5) Sub-paragraph (6) applies where—

(a) regulation 202(3) applied before IP completion day; but

(b) the holder of a UKMA(GB) or a THR(GB) has not taken the steps specified in regulation 202(4) before IP completion day.

(6) Where this sub-paragraph applies, notwithstanding the amendment of regulation 202—

(a) the holder of a UKMA(GB) or a THR(GB) must take the steps specified in regulation 202(4); and

(b) the licensing authority must determine that application for a variation in accordance with Part 5 (marketing authorisations) or 7 (traditional herbal registrations).]