BW101 10 019E FO Change of Swiss Representative

VO-Form

Change of Swiss Representative

Received by Swissmedic on: (please leave blank)

This application must be sent to Swissmedic as soon as possible prior to the date of change of the representative in Switzerland, in order to ensure that correspondence is sent to the correct address.

Please fill in one form per trial.

1Clinical trial

Clinical trial on / select the product type
(*tissue engineering, cell therapy, ex vivo gene therapy)
Trial code / Swissmedic Ref:

2Contact details

2.1Sponsor

The sponsor is a person, company, or institution headquartered or represented in Switzerland that takes responsibility for organising a clinical trial, and in particular for the initiation, management, and financing of the trial in Switzerland (Art. 2 ClinO / Art. 1.53 ICH-E6). An investigator who takes responsibility for organising a clinical trial in Switzerland is also a sponsor (Art.2 ClinO / Art. 1.54 ICH-E6).
Sponsor
Contact person
Address
Phone / fax / email

2.2New representative in Switzerland

Foreign sponsor:
If the sponsor is headquartered in another country, a natural or legal person must be designated as a representative in Switzerland and assume responsibility for fulfilling all obligations in respect of communication (including invoicing) with the authority in the manner of a domicile for service (Art. 2c ClinO, Art. 11b para. 1 Administrative Procedure Act (APA, CC 172.021)).
Swiss sponsor:
Representative means contact address in Switzerland for all correspondence (official letters, invoices) with the authority.
Company / institution
Contact person
Address
Phone / fax / email
The change of representative is effective as of

2.3(Optional) Information for invoicing

All invoices will always be addressed and sent to the above given contact address in Switzerland.
However, in case the invoice is to be paid by an institution which is abroad, Swissmedic can add the comment “Invoice will be paid by...” in the reference part of the invoice.
“Invoice will be paid by...”

2.4Contact for information and/or scientific questions on the trial

This contact will communicate with authority for information or scientific questions related to the trial. It can be the sponsor, the representative given in point 2.2. or any other contracted representative such as the CRO in Switzerland or abroad.
Contact for information on the trial / Select the answer /
Company / institution
Contact person
Address
Phone / fax / email

3Signature

Sponsor

In my capacity as sponsor I hereby confirm that all the information provided in this form is correct.
Full name: / Position:
Place / Date: / Signature:
Send your application to the following address
-for trials onmedicinal products: / -for trials on transplant products, gene therapy products and genetically modified organisms (GMO):
Swissmedic, Swiss Agency for Therapeutic Products
Clinical Trials Division
P.O. Box
CH – 3000 Berne 9 / Swissmedic, Swiss Agency for Therapeutic Products
Transplant Products Unit
P.O. Box
CH – 3000 Berne 9
Contact for further information :

+41 58 462 03 87 / Contact for further information:

+41 58 462 02 43

QM-Ident: BW101_10_019e_FO / V02 / coa / jaf / 27.11.20151 / 2

Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12