¹ 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 TPA²⁷⁷) of a medicinal product containing the product:

a.

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

b.

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.

² A paediatric certificate shall only be issued if no supplementary protection certificate in accordance with Article 140a exists.

³ Article 140b paragraph 1 applies mutatis mutandis.

⁴ The term of protection of a paediatric certificate may not be extended.