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

¹ The Re­spons­ible Per­son is re­spons­ible for the dir­ect tech­nic­al su­per­vi­sion of the fa­cil­it­ies and in par­tic­u­lar en­sures that the medi­cin­al products are handled ap­pro­pri­ately.

² They are re­spons­ible for the qual­ity of the man­u­fac­tured medi­cin­al products and en­sure that the leg­al pro­vi­sions ap­plic­able to thera­peut­ic products are ob­served.

³ They are au­thor­ised to is­sue in­struc­tions with­in their sphere of activ­ity.

⁴ They and the com­pany man­age­ment jointly en­sure their dep­u­tisa­tion by ad­equately qual­i­fied spe­cial­ists.

⁵ If the fa­cil­it­ies cease op­er­a­tions, or if op­er­a­tions can be ex­pec­ted to cease im­min­ently, the Re­spons­ible Per­son must re­port this situ­ation to Swiss­med­ic without delay.

⁶ They may not sit on one of the fa­cil­it­ies’ su­per­vis­ory com­mit­tees and must de­cide on the re­lease or re­jec­tion of batches in­de­pend­ently of the com­pany’s man­age­ment. 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 set out in writ­ing and the min­im­um num­ber of hours dur­ing which the per­son must be present in the fa­cil­ity must be de­term­ined.