The IPI shall extend the term of protection (Art. 140e ) of certificates issued by six months if the authorisation (Art. 9 TPA1) of a medicinal product containing the product:
contains confirmation that the information on the medicinal product reflects the results of all studies performed in accordance with the paediatric test concept (Art. 11 para. 2 let. a no 6 TPA) considered in the authorisation process; and
was applied for no later than six months after the application for initial authorisation in the European Economic Area of a medicinal product containing the product in which the corresponding medicinal product information reflects the results of all studies performed in accordance with the paediatric test concept considered for the authorisation.
A certificate’s term of protection may only be extended once.