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Apply Good Distribution Practices (GDP) Certificates Switzerland : swissmedic.ch

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Organisation : Swissmedic
Facility Name : Apply Good Distribution Practices (GDP) Certificates
Country : Switzerland
Website : https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/bewilligungen_zertifikate/authorisations/certificates.html

How To Apply Good Distribution Practices (GDP) Certificates?

Step 1: Go to the link https://www.swissmedic.ch/swissmedic/en/home/services/egov-services/portal/egov-portal-registration.html
Step 2: Click on New Registration
Step 3: Enter Product (eGov Service)
Step 4: Enter eSubmissions platform
Step 5: Give your personal details
Step 6: Click on Send button

Good Manufacturing Practices (GMP) & 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

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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.
**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.

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