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

812.212.1 Ordonnance du 14 novembre 2018 sur les autorisations dans le domaine des médicaments (OAMéd)

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 Obligation de déclarer des cantons

Les cantons déclarent à Swissmedic tout changement important au sein de leurs services d’inspection.

 

This document is not an official publication. Only the publication of the Federal Chancellery is legally binding.
Ceci n’est pas une publication officielle. Seule la publication opérée par la Chancellerie fédérale fait foi. Ordonnance sur les publications officielles, OPubl.