The Human Medicines Regulations 2012

Offences relating to the Paediatric Regulation

Offences in connection with withdrawal of product from the market

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 any of Articles 36, 37 and 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.

Failure to place on the market taking account of paediatric indication

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

91.—(1) This regulation applies to a person (“P”) if—

(a) a decision by the EMA in respect of a paediatric investigation plan is addressed to P;

(b) the plan refers to clinical trials carried out in third countries (“third country clinical trials”); and

(c) P is established in the United Kingdom.

(2) P is guilty of an offence if P does not enter into the database referred to in Article 11 of the Clinical Trials Directive the details set out in that Article in relation to the third country clinical trials in accordance with Article 41(1) of the Paediatric Regulation within whichever is the later of—

(a) the period of one month beginning after the day on which the decision was received; or

(b) the period of one month beginning after the day on which the necessary permission to conduct the clinical trial was received from the competent authorities in the country where the clinical trial is to take place.

(3) P is guilty of an offence if P does not submit the results of those clinical trials to the EMA in accordance with Article 41(2) of the Paediatric Regulation within the period of—

(a) six months, if P is the holder of a marketing authorisation for the medicinal product concerned; or otherwise

(b) twelve months,

beginning with the day on which the last of those trials ended.

(4) Paragraph (3) does not apply, and regulation 93(3) shall apply, in the case of a clinical trial that forms part of a paediatric study to which regulation 93 applies.

Failure of sponsor of UK paediatric clinical trial to notify results of trial

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

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

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.