Federal Act
on Medicinal Products and Medical Devices
(Therapeutic Products Act, TPA)

¹ For each medi­cin­al product, a pae­di­at­ric in­vest­ig­a­tion plan shall be drawn up with a view to its mar­ket­ing au­thor­isa­tion which sets out the re­quire­ments for the de­vel­op­ment of the medi­cin­al product in pae­di­at­rics and which must be sub­mit­ted to the Agency.

² The Fed­er­al Coun­cil shall reg­u­late:

a.

the pro­ced­ure;

b.

the re­quire­ments for the pae­di­at­ric in­vest­ig­a­tion plan in ac­cord­ance with the EU pro­vi­sions.

³ It may waive the ob­lig­a­tion to pre­pare a pae­di­at­ric in­vest­ig­a­tion plan, in par­tic­u­lar for medi­cin­al products for the treat­ment of dis­eases that oc­cur only in adults. It may provide for a pae­di­at­ric in­vest­ig­a­tion plan as­sessed by a for­eign au­thor­ity to be taken in­to ac­count.