Certain documents must be submitted by the Responsible Person (RP) as proof of the GMP compliance assessment of foreign manufacturers for an application for authorisation (new application) or type IA/IAIN variation that can be notified after the event, a minor type IB variation that must be notified in advance or a type II major variation for an authorised human medicinal product, or for a new application or a variation with or without evaluation of an authorised veterinary medicinal product.
Since the MPLO requires foreign manufacturers to furnish proof that they work in compliance with the GMP requirements valid in Switzerland, the proof should generally have been issued by authorities whose GMP control systems are deemed to be equivalent to that in Switzerland. If no such certificate is available, an audit report may – subject to certain conditions – be submitted as proof of GMP compliance.
Swissmedic has clarified the conditions for the submission of an audit report as proof of the GMP compliance of foreign manufacturers from countries whose GMP control systems are not deemed to be equivalent to that in Switzerland.
Swissmedic adds foreign manufacturers whose GMP compliance is demonstrated by means of an audit report to a list of priority candidates for possible inspections carried out by Swissmedic abroad.
Swissmedic generally reserves the right to inspect, at the expense of the Swiss authorisation holder/applicant, manufacturers from countries whose regulatory authority does not have a GMP control system deemed by Switzerland to be equivalent to the Swiss system (Art. 60 para. 2 MPLO) and, if necessary, to put the application concerned on hold until the inspection has been carried out.
These requirements are set forth in the updated guidance document GMP compliance by foreign manufacturers HMV4 (ZL0000_00_036e) and the form Declaration by the Responsible Person for foreign manufacturers HMV4 (ZL000_00_038e). These documents are valid with effect from 01.05.2023.