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

¹ The Agency Coun­cil is the stra­tegic body of the Agency and safe­guards its in­terests. It has the fol­low­ing du­ties:

a.

It draws up the Agency’s stra­tegic ob­ject­ives, sub­mits them to the Fed­er­al Coun­cil for ap­prov­al and re­views them an­nu­ally.

b.

It sub­mits an an­nu­al re­port to the Fed­er­al Coun­cil on the achieve­ment of the stra­tegic ob­ject­ives. It sub­mits to the Fed­er­al Coun­cil the re­port of the Swiss Fed­er­al Audit Of­fice on an audit of the Agency as part of fin­an­cial su­per­vi­sion.

c.

It pro­poses to the Fed­er­al Coun­cil the amount of com­pens­a­tion to be paid by the Con­fed­er­a­tion for ser­vices rendered pur­su­ant to Art­icle 69.

d.

It is­sues the reg­u­la­tions of the or­gan­isa­tion of the Agency.

e.

It is­sues is own rules of pro­ced­ure and shall in par­tic­u­lar lay down the rules on re­cus­al.

f.

It pre­pares and ap­proves a busi­ness re­port for each fin­an­cial year and sub­mits it to the Fed­er­al Coun­cil for ap­prov­al. At the same time, it sub­mits a re­quest to the Fed­er­al Coun­cil for dis­charge and for the ap­pro­pri­ation of any profit. It pub­lishes the busi­ness re­port after ap­prov­al.

g.

It de­cides on the es­tab­lish­ment, amend­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship with the ex­ec­ut­ive dir­ect­or. The es­tab­lish­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship re­quire the ap­prov­al of the Fed­er­al Coun­cil.

h.

It de­cides on the es­tab­lish­ment, amend­ment and ter­min­a­tion of the em­ploy­ment re­la­tion­ship of the oth­er mem­bers of the Man­age­ment Board at the re­quest of the ex­ec­ut­ive dir­ect­or.

i.

It ful­fils oth­er du­ties in the thera­peut­ic products sec­tor which the Fed­er­al Coun­cil as­signs to it.

j.

It su­per­vises the Man­age­ment Board and en­sures that the in­tern­al con­trol sys­tem and risk man­age­ment are ap­pro­pri­ate for the Agency.

k.

It en­acts the pro­vi­sions re­ferred to in Art­icle 82 para­graph 2.

l.

It ap­proves the busi­ness plan and the budget.

m.

It con­cludes the af­fil­i­ation agree­ment with the Fed­er­al Pen­sion Fund (PUB­LICA) and sub­mits it to the Fed­er­al Coun­cil for ap­prov­al.

n.

It reg­u­lates the com­pos­i­tion, elec­tion pro­ced­ure and or­gan­isa­tion of the joint body for the pen­sion fund.

o.

It is­sues reg­u­lat­ory pro­vi­sions which guar­an­tee the in­de­pend­ence of the ex­perts ap­poin­ted by the Agency.

² The mem­bers of the Agency Coun­cil shall ful­fil their du­ties and ob­lig­a­tions with all due care and shall safe­guard the in­terests of the Agency in good faith. The Agency Coun­cil shall take or­gan­isa­tion­al pre­cau­tions to safe­guard the in­terests of the Agency and to pre­vent con­flicts of in­terest.