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

¹ The Re­spons­ible Per­son must have the ne­ces­sary train­ing, tech­nic­al know­ledge and ex­per­i­ence, and be trust­worthy.

² To ob­tain a li­cence in ac­cord­ance with Art­icle 12 para­graphs 1 and 3, the Re­spons­ible Per­son must also ful­fil the fol­low­ing re­quire­ments and tasks:⁴

a.

The Re­spons­ible Per­son must pos­sess a de­gree in phar­ma­co­logy and the ne­ces­sary ex­per­i­ence in the man­u­fac­ture of ready-to-use medi­cin­al products. If the per­son can prove suf­fi­cient know­ledge and ex­per­i­ence in the medi­cin­al products sec­tor, Swiss­med­ic may also re­cog­nise oth­er pro­fes­sion­al qual­i­fic­a­tions for this job.

b.

In grant­ing mar­ket re­lease, the Re­spons­ible Per­son en­sures that each batch is not placed on the Swiss mar­ket un­til all the ap­plic­able con­di­tions of Art­icles 11–13 have been ful­filled and the en­tire sup­ply chain is in con­form­ity with the au­thor­isa­tion and the GDP rules.

³ Swiss­med­ic may spe­cify fur­ther de­tails to Art­icle 17 and this Art­icle, 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.