The Human Medicines Regulations 2012

Obligation on licensing authority to assess PSURs where EU single assessment procedure does not apply U.K.

195.—(1) This regulation applies where PSURs relating to a medicinal product have not been assessed under the EU single assessment procedure because—

[F1 (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 other than the United Kingdom; 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.]

(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.

(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 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