The Human Medicines Regulations 2012

Obligation on licensing authority to assess PSURs F1 ... U.K.

195.— [F2 (A1) This regulation applies in the circumstances specified in paragraphs (1) and (1A).]

(1) This regulation applies where PSURs relating to a medicinal product [F3 authorised for sale or supply authorised under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation] have not been assessed under the EU single assessment procedure because—

[F4 (a) the medicinal product to which the PSUR relates—

(i) has not been authorised to be placed on the market in accordance with the 2001 Directive in an EEA State F5 ...; and

(ii) a harmonised EU reference date and frequency of submission of PSURs have not been established for that product under Article 107c of the 2001 Directive; or

(b) the medicinal product is one that is imported into the UK under a parallel import licence.]

[F6 (1A) This regulation applies where PSURs relating to a medicinal product authorised for sale or supply under a UKMA(GB) or THR(GB) have been submitted to the licensing authority under regulations 191 to 192.]

(2) The licensing authority must assess the PSURs to determine whether there are any relevant changes.

(3) Where the licensing authority has assessed a PSUR under paragraph (2) it must—

(a) consider whether any action concerning the authorisation or registration of the product to which the PSUR relates is necessary; and

(b) vary, suspend, or revoke the authorisation or registration as appropriate.

[F7 (3A) If the licensing authority considers under paragraph (3)(b) that an authorisation or registration needs to be varied, it may require the holder to submit to the licensing authority, within a time period that the licensing authority specifies, an application for a variation, including—

(a) an updated summary of the product characteristics; and

(b) an updated package leaflet.]

(4) In this regulation—

“EU reference date” has the meaning given in regulation 193(6);

“EU single assessment procedure” has the meaning given in regulation 194(5); and

“relevant changes” in relation to a medicinal product means—

(a)

new risks,

(b)

risks that have changed, or

(c)

changes to the risk-benefit balance.

Textual Amendments

F1 Words in reg. 195 heading omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 155(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 195(A1) inserted (31.12.2020) by S.I. 2019/775, reg. 155(2A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(a))

F3 Words in reg. 195(1) inserted (31.12.2020) by S.I. 2019/775, reg. 155(2B)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(a))

F4 Reg. 195(1)(a)(b) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 21 and reg. 195(1)(a)(b) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 21

F5 Words in reg. 195(1)(a)(i) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 155(2B)(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(a))

F6 Reg. 195(1A) inserted (31.12.2020) by S.I. 2019/775, reg. 155(3) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 122(b)); 2020 c. 1, Sch. 5 para. 1(1)

F7 Reg. 195(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 155(4); 2020 c. 1, Sch. 5 para. 1(1)