PART 5Marketing authorisations

Offences relating to the Paediatric Regulation

Failure to place on the market taking account of paediatric indication90

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.