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

¹ Any per­son man­u­fac­tur­ing or dis­trib­ut­ing ready-to-use thera­peut­ic products must put in place a sys­tem of no­ti­fic­a­tion. He must no­ti­fy the Agency of any ad­verse event or re­ac­tion which:

a.

is or may be at­trib­ut­able to the thera­peut­ic product it­self, its use or to in­cor­rect la­belling or in­struc­tions;

b.

may en­danger or dam­age the health of the con­sumer, of the pa­tient, of a third party or of the treated an­im­als.

² Any per­son man­u­fac­tur­ing or dis­trib­ut­ing thera­peut­ic products must fur­ther­more no­ti­fy the Agency of any qual­ity de­fects and any fur­ther find­ings and as­sess­ments which could in­flu­ence the basis of eval­u­ation.

³ Any per­son who pro­fes­sion­ally dis­penses thera­peut­ic products or ad­min­is­ters them to hu­mans or an­im­als or who is en­titled to do so as med­ic­al per­son­nel must no­ti­fy the Agency of any ser­i­ous or pre­vi­ously un­known ad­verse ef­fects and in­cid­ents, ob­ser­va­tions of oth­er ser­i­ous or pre­vi­ously un­known facts or qual­ity de­fectsthat are of significance for drug safety.¹⁴²

3^bis Any per­son who man­u­fac­tures or places on the mar­ket thera­peut­ic products must re­port to the Agency any sus­pi­cion of il­leg­al trad­ing in thera­peut­ic products by third parties that come to its know­ledge in con­nec­tion with its activ­it­ies, its products or their com­pon­ents.¹⁴³

⁴ Con­sumers, pa­tients and their or­gan­isa­tions as well as in­ter­ested third parties, may no­ti­fy the Agency for ad­verse events and re­ac­tions with thera­peut­ic products.

⁵ The no­ti­fic­a­tions re­ferred to in para­graphs 1–3 shall be made in ac­cord­ance with the re­cog­nised rules of good vi­gil­ance prac­tice.¹⁴⁴

⁶ The Fed­er­al Coun­cil shall define the re­cog­nised rules of good vi­gil­ance prac­tice. It shall take in­to ac­count in­ter­na­tion­ally re­cog­nised guidelines and stand­ards.¹⁴⁵

⁷ Em­ploy­ees of per­sons and or­gan­isa­tions who man­u­fac­ture, dis­trib­ute, pre­scribe or dis­pense thera­peut­ic products are en­titled to no­ti­fy the com­pet­ent au­thor­it­ies of ob­ser­va­tions that in­dic­ate a vi­ol­a­tion of the pro­vi­sions of this Act.¹⁴⁶