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

812.212.1 Ordinanza del 14 novembre 2018 sulle autorizzazioni nel settore dei medicamenti (Ordinanza sull'autorizzazione dei medicamenti, OAMed)

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 Obbligo di notifica dei Cantoni

I Cantoni notificano a Swissmedic i cambiamenti avvenuti in seno ai propri ispettorati.

 

This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.
Il presente documento non è una pubblicazione ufficiale. Fa unicamente fede la pubblicazione della Cancelleria federale. Ordinanza sulle pubblicazioni ufficiali, OPubl.