The Human Medicines Regulations 2012

Offences relating to the Paediatric Regulation U.K.

Offences in connection with withdrawal of product from the market U.K.

89.—(1) This regulation applies to a person (“H”) if—

(a) H is the holder of a UK marketing authorisation;

(b) H has benefited from one or more rewards or incentives under [F1 Article 37 or 38] of the Paediatric Regulation in relation to the product to which the authorisation relates, and

(c) all of the periods of protection provided pursuant to those Articles have expired in relation to H.

(2) H is guilty of an offence if H ceases to supply the product without previously in accordance with Article 35 of the Paediatric Regulation —

(a) transferring the UK marketing authorisation to another person who has declared an intention to continue to supply the product; or

(b) allowing such a person to use the pharmaceutical, pre-clinical and clinical documentation contained in the file on that product as provided for in regulation 56.

(3) H is guilty of an offence if H—

(a) ceases to supply the product; and

(b) does not in accordance with Article 35 of the Paediatric Regulation inform the EMA of H's intention to do so before the beginning of the period of six months ending immediately before the day on which H does so.

Textual Amendments

F1 Words in reg. 89(1)(b) substituted (31.12.2020) by S.I. 2019/775, reg. 90A (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)

Failure to place on the market taking account of paediatric indication U.K.

90.—(1) A person (“P”) is guilty of an offence if—

(a) P is the holder of a UK marketing authorisation;

(b) P obtains a paediatric indication in respect of the product to which the authorisation relates following completion of an agreed paediatric investigation plan;

(c) the product was placed on the market for other indications before P obtained that paediatric indication; and

(d) P fails to place the product on the market taking account of the paediatric indication in accordance with Article 33 of the Paediatric Regulation before the end of the period of two years beginning immediately after the day on which the paediatric indication is authorised.

(2) In this regulation “paediatric indication” means a term of the marketing authorisation enabling the product to which it relates to be used by or administered to persons under the age of 18 years.

Failure to notify results of third country clinical trials U.K.

F2 91.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Reg. 91 omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 90B (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 67)

Failure of sponsor of UK paediatric clinical trial to notify results of trial U.K.

92.—(1) This regulation applies to the sponsor (“S”) of a paediatric clinical trial in the United Kingdom in respect of a medicinal product if—

(a) the product has a UK marketing authorisation but S is not the holder of the authorisation; or

(b) the product does not have a marketing authorisation.

(2) S is guilty of an offence if S does not submit the results of the clinical trial to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of twelve months beginning with the day on which the trial ended.

Failure to notify results of paediatric study U.K.

93.—(1) This regulation applies to a person (“H”) if—

(a) H is the holder of a UK marketing authorisation; and

(b) H sponsors a paediatric study in respect of the product to which the authorisation relates.

(2) H is guilty of an offence if H does not submit the results of the study to the licensing authority in accordance with Article 46(1) of the Paediatric Regulation within the period of six months beginning with the day on which the study ended.

(3) H is guilty of an offence if H does not submit the results of any clinical trial that forms part of that study to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of six months beginning with the day on which the trial ended.

Failure to submit report to EMA U.K.

94.  The holder of a marketing authorisation is guilty of an offence if the holder fails to submit an annual report to the EMA as required by Article 34(4) of the Paediatric Regulation.