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

¹ Hos­pit­al phar­macists and per­sons in pos­ses­sion of a can­ton­al li­cence in ac­cord­ance with Art­icle 30 TPA who pre­pare medi­cin­al products in ac­cord­ance with Art­icle 9 para­graph 2 let­ters a–c^bis or para­graph 2^bis TPA must carry out a risk as­sess­ment in ac­cord­ance with An­nex 3. This pro­vi­sion does not ap­ply to the cases set out in para­graph 6 be­low.

² The con­duct of these risk as­sess­ments should be doc­u­mented. This doc­u­ment­a­tion should be presen­ted to the can­ton­al su­per­vis­ory au­thor­ity on re­quest.

³ If the risk as­sess­ment pro­duces a value be­low the threshold spe­cified in An­nex 3, a can­ton­al man­u­fac­tur­ing li­cence is re­quired in­stead of a li­cence is­sued by Swiss­med­ic.

⁴ The li­cence is gran­ted if it can be en­sured that the rules of Good Man­u­fac­tur­ing Prac­tice for small quant­it­ies of medi­cin­al products in ac­cord­ance with An­nex 2 are ob­served.

⁵ The can­tons reg­u­late the oth­er con­di­tions for the grant­ing of the li­cence in ac­cord­ance with para­graph 3 and peri­od­ic­ally carry out fa­cil­ity checks.

⁶ Any per­son who man­u­fac­tures ra­dio­phar­ma­ceut­ic­als re­quires a li­cence gran­ted by Swiss­med­ic.