The Human Medicines Regulations 2012

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

This section has no associated Explanatory Memorandum

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 [F3authorised 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.