Product certificates (CPP)

From 20.03.2023, Swissmedic will issue product certificates (Certificate of a Pharmaceutical Product (CPP)) in the new WHO format

From 20.03.2023, Swissmedic will issue product certificates (Certificate of a Pharmaceutical Product (CPP)) 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 (13.03.2023 to 19.03.2023) to the new format.
• Orders for CPPs in the old format can be submitted via the portal until 12.03.2023.
• From 20.03.2023, 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 (www.swissmedic.ch) from 13.03.2023.

20.03.202

Technical Update CPP Order Form and new Version of the Guidance Request CPP

A new version of the CPP order form (BW302_00_004e_FO Order form for a CPP (Certificate of a Pharmaceutical Product)) and the guidance Request CPP (BW302_00_001e_WL_Request_CPP) is effective immediately.

A technical error has crept into the version (V 6.0) dated 13.03.2023 of the order form (BW302_00_004e_FO Order form for a CPP). Therefore, this form cannot be used for ordering CPPs.

Please use the new version (V 7.0) of this form, which is valid from 17.03.2023, to order CPPs. The version only contains technical adjustments, the content is unchanged.

The 20.03.2023 version of the guidance lists how API manufacturers should be recorded in the W302_00_004e_FO Order form for a CPP (Certificate of a Pharmaceutical Product)) (see items 25-32).