VO-Form

Submission of Changes to a Clinical Trial
and Answer to Conditions

Swissmedic
Please leave this section blank for Swissmedic:
Received by Swissmedic on / Reviewed by:
(Clinical Study Reviewer)
Signature:
For internal use only / Completed on:
by:
Signature:
For internal use only
For further instructions on the use of this form please read the information given on our web page trials in the “Guidelines for submission of changes”.
This part must be completed by the applicant:
Purpose of submission: Please tick a box.
☐Submission of a document concerning more than one trial
Caution: A separate form must be used for each Swiss representative!
☐Submission of one or several documents concerning a single trial
☐Answer to condition(s) in Swissmedic letter dated:
  1. Please enter the Swissmedic reference number of the clinical trial (e.g. 20XXDRXXXX see Swissmedic authorization) and the sponsor trial code.
    If several trials are concerned, provide the reference numbers of all trials on separate lines.

Swissmedic reference number / Sponsor trial code
  1. Information regarding the submission: Please enter text
RE:
Rationale/information:
  1. Please enter the title, version and date of the submitted document(s) next to the reference to the corresponding section of the CTA dossier. Write “NA” for empty sections.
Each document has to be entered on a separate line
Section of the CTA-Dossier / Document title and version
(e.g. Investigational Medicinal Product dossier for IMP X) / Document date / K* / A*
S3: Ethics Committee (REC)
S4: Foreign Regulatory Authorities (RA)
S5: Clinical trial protocol
S6: Investigator’s Brochure** or SmPC
S7: Pharmaceutical quality documentation
S8: Proof of compliance of GMP
S9: IMP labels
S10: Other documents / information, letter(s) to 3rd parties (e.g.DIL), etc.
*A = Approved / K = Acknowledged
The cross indicates if the changes to the clinical trials mentioned in the documents are approved, or if they are only acknowledged. Acknowledgement of receipt will be sent by e-mail only.
**Complete also section 4 of this form
  1. Mandatory additional information regarding the submission of an Investigator’s Brochure
    Only to be filled if an Investigator’s Brochure is submitted

Risk/Benefit-Statement:
  1. Applicant’s Confirmation
    Completion of this section is mandatory.
/ I hereby confirm that all the information provided in this form is correct and that the application documents submitted in paper and in electronic format (CD) are the same.
Swiss sponsor or Sponsor representative in Switzerland
(contact for correspondence and invoices)
Company / institution:
Contact person:
Address (in CH):
Phone:
E-mail:
Applicant
(if different from above mentioned representative in Switzerland):
Company / institution:
Contact person:
Address:
Phone:
E-mail:
Date: Signature:

Fees:Evaluation of amendments and other submissions will be invoiced with CHF 200/hour if amount of work is more than ½ hour, and will be charged once the submission has been processed (Art. 3 4, Ordinance on fees levied by the Swiss Agency for Therapeutic Products).

QM-Ident: BW101_10_004e_FO / V02 / gav / jaf / 05.05.20171 / 2

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