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

¹ The Re­spons­ible Per­son must have the ne­ces­sary tech­nic­al know­ledge and be trust­worthy. They must also ful­fil the fol­low­ing pro­fes­sion­al re­quire­ments:

a.

for the man­u­fac­ture of ready-to-use medi­cin­al products or in­ter­me­di­ate products, the Re­spons­ible Per­son must be a qual­i­fied phar­macist with pro­fes­sion­al ex­per­i­ence;

b.

for the man­u­fac­ture of labile blood products or im­mun­o­lo­gic­al medi­cin­al products the Re­spons­ible Per­son must have a uni­versity de­gree in medi­cine or a life sci­ence and have the ne­ces­sary pro­fes­sion­al ex­per­i­ence;

c.

for the man­u­fac­ture of act­ive phar­ma­ceut­ic­al in­gredi­ents or med­ic­ated feed­ing­stuffs, the Re­spons­ible Per­son must have a uni­versity de­gree in a life sci­ence and the ne­ces­sary pro­fes­sion­al ex­per­i­ence;

d.

for the man­u­fac­ture of ra­dio­phar­ma­ceut­ic­als, the Re­spons­ible Per­son must have a cer­ti­fic­ate is­sued by the European As­so­ci­ation of Nuc­le­ar Medi­cine for Ra­dio­phar­macy and have the ne­ces­sary ex­per­i­ence.

² If a per­son can prove suf­fi­cient know­ledge and ex­per­i­ence, Swiss­med­ic may also re­cog­nise oth­er pro­fes­sion­al qual­i­fic­a­tions for this job.

³ Swiss­med­ic may spe­cify fur­ther de­tails to Art­icle 5 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.