# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 19C: Fees for assessment of post-authorisation safety studies


(1) This regulation applies to post-authorisation safety studies initiated, managed or financed by the holder of a marketing authorisation in compliance with obligations imposed under regulation 59 or 61 of the Human Medicines Regulations.
(2) The fee payable by the holder of a marketing authorisation upon submission of the draft protocol for a post-authorisation safety study in accordance with regulation 199(2) of the Human Medicines Regulations—
(a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding draft protocol has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £1,308;
(b) where sub-paragraph (a) does not apply and—
(i) the study is to be conducted in the United Kingdom only; or
(ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,
is £9,949; and
(c) in any other case, is £1,308.
( 3) The fee payable by the holder of a marketing authorisation upon submission of the final study report for a post-authorisation safety study in accordance with regulation 201(2) of the Human Medicines Regulations—
(a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding final study report has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £1,308;
(b) where sub-paragraph (a) does not apply and—
(i) the study is to be conducted in the United Kingdom only; or
(ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,
is £9,949; and
(c) in any other case, is £1,308.

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Source: https://www.legislation.gov.uk/uksi/2016/190/regulation/19C (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19C
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.