Good Manufacturing Practices (GMP) - and Good Distribution Practices (GDP)-certificates
As of 1 January 2019 GMP/GDP certificates to be ordered exclusively via eGov GMP-GDP service
Swissmedic issues GMP and GDP certificates to Swiss-domiciled companies, provided they have a valid and appropriate operating licence. Such orders have hitherto been submitted by e-mail, fax or mail using a corresponding order form.
As of the start of 2019 it is possible to submit this form exclusively via the new eGov GMP-GDP service. This provides secure electronic communication between the ordering party and Swissmedic. Access to the eGov Portal is a prerequisite for using this service. Swissmedic recommends that companies apply for the new eGov service even now via the Swissmedic website
Brief details about the eGov GMP/GDP service can be found in this Information sheet.
This access can be requested only by the corresponding authorisation holders. After the new service has been activated by Swissmedic, the authorisation holder has the option of assigning access rights to the ordering parties. Once the new eGov GMP-GDP service has been launched, orders will no longer be accepted via e-mail, fax or mail.
The GMP/GDP certificates are issued and then sent, as before, by post.
As of 1 January 2019, only the current Swissmedic order form is accepted.
Instructions for uploading the order form can be found here:
In line with the practice adopted by similar authorities abroad, the certificates will in future only be available in English. It will henceforth be possible for a licence holder to use the same order form for more than one operating site. It will be the company's responsibility to obtain any legalisations required. In other words, it will no longer be possible to forward the certificates directly to the Federal Chancellery or to a consular service. Swissmedic will as of January 2019 only forward the certificates to the return address on the application form (this must be a Swiss address).
In 2019 new establishment licences will be introduced. For active pharmaceutical ingredients (API) manufacturers, these will contain a list of all API produced. The same list will automatically be published on the GMP certificates.