Swissmedic only issues WHO Certificates in Accordance with the new Format

Recommendation

19/20 March 2025
Barcelona, Spain

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

A CPP (Certificate of a Pharmaceutical Product) certifies the marketability of a medicinal product in the country of origin. The certificates are issued by the authority of the country where the medicinal product is manufactured and authorised (exporting country). These can then serve competent authorities of importing third countries in the following regulatory situations:

In the context of applications for marketing authorisation
In the context of applications for renewal, extension, variation or review of a marketing authorisation.

The WHO (World Health Organisation) recommends the use of a standardised format for this certificate.

From 20 March 2023, Swissmedic will issue CPPs in the new WHO format (according to TRS 1033 - 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations; Annex 9). The changes are detailed in the new version of guidance document BW302_00_001e.

No CPP orders can be accepted during the transition (13 to 19 March 2023) to the new format. Orders for CPPs in the old format can be submitted via the portal until 12 March 2023. From 20 March 2023, new orders can only be submitted using the new input file. The new version of guidance document BW302_00_001e and the new input file will be available on the Swissmedic website from 13 March 2023.

Source: Swissmedic