Switzerland: New Declaration of the Responsible Person for foreign Manufacturers

Swissmedic has clarified the conditions for the submission of an audit report as evidence of GMP compliance by foreign manufacturers from countries whose GMP control system is not considered equivalent by Switzerland.

Background: Since according to the Medicinal Products Licensing Ordinance (MPLO) it has to be proven that the foreign manufacturers work in compliance with the GMP requirements applicable in Switzerland, the supporting documents should normally be issued by authorities whose GMP control system is considered equivalent. If no such certificate is available, an audit report can also be submitted as evidence of GMP compliance under certain conditions.

For this purpose, Swissmedic has published a so-called "Guidance document GMP compliance by foreign manufacturers" and a form "Declaration by the Responsible Person for foreign manufacturers".

The aim of this guidance is to clarify which documents can be submitted for the following notifications:

• authorisation application (new application),
• minor variation of type IA/IAIN to be notified after the event,
• minor variation of type IB to be notified in advance,
• major variation of Type II of an authorised medicinal product for human use
• new application or variation with or without assessment of a veterinary medicinal product,

to verify the GMP (Good Manufacturing Practice) compliance of foreign manufacturers of active pharmaceutical ingredients and/ or ready-to-use medicinal products by the Responsible Person (RP).

Since the RP is responsible for ensuring that the ready-to-use medicinal products released for the market are manufactured in accordance with GMP, it must also ensure that the active substances contained therein are also manufactured in accordance with GMP. The verification of GMP compliance of foreign manufacturers must be carried out regularly under the responsibility of the RP. The documents such as GMP certificates, audit reports, inspection reports, site master file taken into account for this verification can be requested from Swissmedic at any time and/or verified on the occasion of inspections.

Source: Communication from Swissmedic