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

¹ If the man­u­fac­ture of a medi­cin­al product re­quires spe­cial meas­ures to be taken, in par­tic­u­lar to guar­an­tee safety, then a re­lease au­thor­isa­tion must be ob­tained from the Agency for each batch be­fore dis­tri­bu­tion; the fore­go­ing is without pre­ju­dice to in­ter­na­tion­al agree­ments on batch re­lease re­cog­ni­tion.

² The Agency shall de­term­ine the cat­egor­ies of medi­cin­al products for which of­fi­cial batch re­lease is re­quired, as well as pro­ced­ure and the re­quire­ments to be ful­filled.

³ It shall pub­lish a list of medi­cin­al products which re­quire a batch re­lease for their dis­tri­bu­tion.