Drucken
Artikel, Notizen und Markierungen werden geladen... Bitte um etwas Geduld.

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

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 14 November 2018 (Status as of 28 January 2022)

Art. 4 Responsibility and Good Manufacturing Practice

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.