7/8 September 2022
The Swiss authority Swissmedic has published a new auxiliary document. This document is intended to clarify which documents should be submitted as part of an authorisation application with type IA/IAIN variations, type IB variations, type II variations in order to demonstrate compliance with GMP regulations of foreign manufacturers of APIs and/or medicinal products. This verification is the responsibility of the Responsible Person (RP).
The document is intended for marketing authorisation holders or applicants for marketing authorisation of ready-to-use medicinal products manufactured abroad and/or in Switzerland and containing APIs from foreign manufacturers.
The RP is responsible for checking the GMP conformity of the manufacturers on a regular basis. Documents such as GMP certificates, audit reports, inspection reports and Site Master Files, etc. - which are taken into account in such reviews - can be requested from Swissmedic at any time and / or checked during inspections.
For this purpose, there is the so-called "Declaration by the Responsible Person for foreign manufacturers HMV4" (RP Declaration). In this declaration, the RP confirms the GMP conformity of the manufacturer on the basis of an audit carried out by the marketing authorisation holder or by a third party commissioned by the marketing authorisation holder and on the basis of the documents mentioned above.
What has to be submitted additionally is listed in detail in the document "Guidance document GMP compliance by foreign manufacturers HMV4".