The Human Medicines Regulations 2012

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.