The Human Medicines Regulations 2012

[F1Matters on-going at IP completion day in respect of the follow up of final study reportsU.K.

This section has no associated Explanatory Memorandum

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).]

Textual Amendments