Ordinance
on Licensing in the Medicinal Products Sector
(Medicinal Products Licensing Ordinance, MPLO)

¹ Re­spons­ible Per­sons carry out the dir­ect tech­nic­al su­per­vi­sion of the fa­cil­it­ies and in par­tic­u­lar en­sure com­pli­ance with due di­li­gence with­in the fa­cil­it­ies.

² They are au­thor­ised to is­sue in­struc­tions with­in their sphere of activ­ity.

³ They en­sure their dep­u­tisa­tion by ad­equately qual­i­fied spe­cial­ists.

⁴ If the fa­cil­ity ceases op­er­a­tions, or if op­er­a­tions can be ex­pec­ted to cease im­min­ently, they must re­port this situ­ation to Swiss­med­ic without delay.

⁵ They must have the ne­ces­sary train­ing, ex­pert­ise and ex­per­i­ence, and be trust­worthy.

⁶ They de­cide in­de­pend­ently of the com­pany’s man­age­ment and may not sit on any of the fa­cil­it­ies’ su­per­vis­ory com­mit­tees. Swiss­med­ic may grant a li­cence to small fa­cil­it­ies without such se­greg­a­tion if they can­not im­ple­ment the se­greg­a­tion be­cause of their size.

⁷ If the size and nature of the fa­cil­it­ies per­mit this activ­ity to be per­formed on a part-time basis, re­spons­ib­il­it­ies must be spe­cified in writ­ing and the min­im­um num­ber of hours dur­ing which the Re­spons­ible Per­son must be present in the fa­cil­ity must be de­term­ined.

⁸ Swiss­med­ic may spe­cify fur­ther de­tails, in par­tic­u­lar the min­im­um num­ber of hours dur­ing which the Re­spons­ible Per­son must be present in the fa­cil­ity and the re­quire­ments that they must ful­fil in terms of train­ing and ex­per­i­ence.