Upon application the IPI shall issue a paediatric supplementary protection certificate (paediatric certificate) for active ingredients or active ingredient compositions of medicinal products with a protection period of six months from the expiry of the longest term of the patent, provided 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.
2A paediatric certificate shall only be issued if no supplementary protection certificate in accordance with Article 140a exists.
3Article 140b paragraph 1 applies mutatis mutandis.
The term of protection of a paediatric certificate may not be extended.