PART 11U.K.Pharmacovigilance

Periodic Safety Update ReportsU.K.

Obligation on holder to submit periodic safety update reports: general requirementsU.K.

191.—(1) The holder must submit reports known as periodic safety update reports (“PSURs”) in relation to the product to the EMA [F1and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,] in accordance with this regulation, or in a case where paragraph (2) applies, in accordance with regulation 192.

(2) This paragraph applies to—

(a)a [F2UK] marketing authorisation granted pursuant to regulations 51 (applications for UK marketing authorisations relating to generic medicinal products) or 54 (application relating to products in well-established medicinal use); or

(b)a traditional herbal registration.

(3) In the following paragraphs of this regulation—

“authorisation” means a UK marketing authorisation or an Article 126a authorisation;

“the holder” means the holder of a UK marketing authorisation or an Article 126a authorisation; and

“product” means a product to which a UK marketing authorisation or Article 126a authorisation relates.

(4) Each PSUR must contain—

(a)summaries of data relevant to the benefits and risks of the product, including results of all studies, with a consideration of their potential impact on the authorisation for the product;

(b)a scientific evaluation of the risk-benefit balance of the product; and

(c)all data relating to the volume of sales of the product and any data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the product.

[F3(4A) A PSUR in relation to a product authorised under a UKMA(GB) must also include the content, and be submitted in the format, specified in Part 8 of Schedule 12A.]

(5) For the purposes of paragraph (4)(b), the scientific evaluation must be based on all available data, including data from clinical trials conducted outside the terms of the authorisation for the product.

(6) Each PSUR must be submitted electronically.

(7) PSURs must be submitted to the EMA [F4and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,] with the frequency and on the dates as set out in paragraphs (8) to (10).

(8) In the case of an authorisation granted on or after 21st July 2012, the holder must submit PSURs with the frequency as specified in the authorisation for the product, with the dates of submission being calculated from the date of authorisation.

[F5(8A) In the case of a conditional marketing authorisation in relation to a product authorised under a UKMA(GB), the holder must submit PSURs immediately upon the request of the licensing authority and at least every six months beginning with the date on which the authorisation for the medicinal product is granted or renewed by the licensing authority.]

(9) In the case of an authorisation granted before 21st July 2012 which specifies the frequency and dates of submission of PSURs, the holder must submit PSURs with the frequency and on the dates as specified in the authorisation for the product.

(10) In the case of an authorisation granted before 21st July 2012 which does not specify the frequency and dates of submission of PSURs, the holder must submit a PSUR—

(a)immediately upon the request of the licensing authority;

[F6(b)where—

(i)in relation to a product authorised under a UKMA(NI) or UKMA(UK), the product has not yet been placed on the market within the EEA or Northern Ireland, at least every six months following authorisation until the placing on the market within the EEA or Northern Ireland, or

(ii)in relation to a product authorised under a UKMA(GB), the product has not yet been placed on the market in Great Britain, at least every six months following authorisation until the placing on the market within Great Britain; and]

[F7(c)where—

(i)in relation to a product authorised under a UKMA(NI) or UKMA(UK), the product has been placed on the market within the EEA or Northern Ireland—

(aa)at least every six months during the first two years following the initial placing on the market,

(bb)once a year for the following two years, and

(cc)every three years after that;

(ii)in relation to a product authorised under a UKMA(GB), the product has been placed on the market in Great Britain—

(aa)at least every six months during the first two years following the initial placing on the market,

(bb)once a year for the following two years, and

(cc)every three years after that.]

F8(11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments