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

¹ Hold­ers of a li­cence un­der Art­icle 3 are re­spons­ible for the pro­cessing and work­ing pro­ced­ures they carry out.

² Medi­cin­al product man­u­fac­ture must be car­ried out in ac­cord­ance with the rules of Good Man­u­fac­tur­ing Prac­tice de­scribed in An­nex 1 or 2.

³ In the man­u­fac­ture of com­ple­ment­ary medi­cin­al products, the GMP rules must be fol­lowed by ana­logy and the spe­cif­ic reg­u­la­tions for the ther­apies con­cerned which are laid down in the phar­ma­co­poei­as re­cog­nised by Swiss­med­ic must be ad­hered to.