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

¹ If a medicinal product is submitted with one or more known active substances, the correspondingdocumentationon new indications,modes of ad­min­is­tra­tion, dosage forms or dosages, or on its ap­plic­a­tion to a new tar­get an­im­al spe­cies shall be pro­tec­ted for a peri­od of three years.

² For a new indication, this period of protection shall be set by the Agency, on request, at 10 years if it is expected to bring a significant clinical benefit in comparison with existing therapies and if it is backed up by extensive clinical trials.

³ On re­quest, the Agency shall grant a ten-year doc­u­ment pro­tec­tion for a medi­cin­al product spe­cific­ally and ex­clus­ively for pae­di­at­ric use in ac­cord­ance with the pae­di­at­ric in­vest­ig­a­tion plan, provided that no doc­u­ment pro­tec­tion ex­ists for an­oth­er medi­cin­al product au­thor­ised by the Agency with the same act­ive sub­stance for the same spe­cif­ic pae­di­at­ric use.

⁴ In the case of an important orphan medicinal product, the Agency shall, on request, grant document protection for a period of fifteen years.

⁵ The Fed­er­al Coun­cil shall reg­u­late the de­tails.