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

¹ The ap­plic­a­tion for a mar­ket­ing au­thor­isa­tion for a medi­cin­al product which is es­sen­tially the same as a medi­cin­al product whose doc­u­ments are pro­tec­ted in ac­cord­ance with Art­icles 11a or 11b may be based on the res­ults of the phar­ma­co­lo­gic­al, tox­ic­o­lo­gic­al and clin­ic­al tests if:

a.

the hold­er of the mar­ket­ing au­thor­isa­tion for the medi­cin­al product with doc­u­ment pro­tec­tion provides writ­ten per­mis­sion; or

b.

the pro­tec­tion peri­od for the rel­ev­ant doc­u­ments has ex­pired.

² If the holder of the marketing authorisation does not agree, the granting of a marketing authorisation for an essentially identical medicinal product shall be permissible at the earliest on the first day after expiry of the period of protection for the medicinal product with document protection. A corresponding application for marketing authorisation may be submitted at the earliest two years before the end of the term of protection.