812.212.1 Ordinance of 14 November 2018 on Licensing in the Medicinal Products Sector (Medicinal Products Licensing Ordinance, MPLO)

812.212.1 Verordnung vom 14. November 2018 über die Bewilligungen im Arzneimittelbereich (Arzneimittel-Bewilligungsverordnung; AMBV)

Art. 60 Ordering and conduct of inspections

1 The competent authority may at any time order inspections in Switzerland or carry them out themselves whenever they consider this necessary.

2 Swissmedic may inspect manufacturers of medicinal product abroad and facilities abroad that engage in wholesale trading in medicinal products, at the importing company’s expense. It informs this company in advance.

3 In those States with which Switzerland has signed an agreement for the mutual recognition of GMP systems, Swissmedic only carries out inspections in justified exceptional cases and after consultation with the competent healthcare authorities in that State.

Art. 59 Meldepflicht der Kantone

Die Kantone melden der Swissmedic Änderungen innerhalb ihrer Inspektorate.

 

This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.
Dies ist keine amtliche Veröffentlichung. Massgebend ist allein die Veröffentlichung durch die Bundeskanzlei.