Regulation 191 Obligation on holder to submit periodic safety update reports: general requirements

The holder must submit reports known as periodic safety update reports (“PSURs”) in relation to the product to the EMA F1and the licensing authority F2in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2) or, in the case of a holder of a UKMA(GB) F3or a UKMA(UK)(Category 1), to the licensing authority only, in accordance with this regulation, or in a case where paragraph (2) applies, in accordance with regulation 192.

This paragraph applies to—

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.

Each PSUR must contain—

A PSUR in relation to a product authorised under a UKMA(GB) F6or a UKMA(UK)(Category 1) must also include the content, and be submitted in the format, specified in Part 8 of Schedule 12A.

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.

Each PSUR must be submitted electronically.

PSURs must be submitted to the EMA F7and the licensing authority F8in the case of a holder of a UKMA(NI) or a UKMA(UK)(Category 2) or, in the case of a holder of a UKMA(GB) F9or a UKMA(UK)(Category 1), to the licensing authority only, with the frequency and on the dates as set out in paragraphs (8) to (10).

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.

In the case of a conditional marketing authorisation in relation to a product authorised under a UKMA(GB) F11or a UKMA(UK)(Category 1), 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.

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.

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—

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