VO-Form
Appl. to extend the authorisation of vet. med. (Not.
procedure in accordance with Art. 39 VAZV / Art. 10-12 VAM)
.
Company stamp (for electronic submission, name of company, street,
No., Postal code/Location)
......
......
......
Explanations regarding the application form





The application to extend the authorisation in accordance with Art. 9, para. 2, VAM must be submitted,
with the documentation required, at the earliest 12 months and at the latest at least 6 months before the
authorisation expires.
Collective applications are not acceptable.
Please complete the form in full. If you are not applying for the authorisation to be extended, it is not
necessary to provide answers to questions 2 and 3.
Your attention is specifically drawn to the fact that no variations can be linked to an application for
extension. These variations must be applied for using a separate application (Form "Application for
authorisation / variation for veterinary medicines (notification procedure in accordance with Art. 39 VAZV /
Art. 10-12 VAM).
Annexes:
For each pack size, one example of the packaging elements used to distribute the product (including any
additional labels).
Authorisation no.:
......
Expiry date of authorisation: ......
Product name:
......
Pharmaceutical form: ......
yes
1.
The applicant does not wish to apply for an extension of the authorisation
2.
The applicant wishes to apply for an extension of the authorisation
3.
The product is available on the Swiss market
If NO: distribution was (temporarily) suspended on
The (re)launch on the Swiss market is planned for
no
.....
.....
Comments
......
QM-Ident: ZL201_00_002e_FO / V05 / lac, cas / ps / 07.03.2016
1/2
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Form
Appl. to extend the authorisation of vet. med. (Not.
procedure in accordance with Art. 39 VAZV / Art. 10-12 VAM)
The applicant hereby confirms, by his / her signature on this form, that with regard to the authorisation
of the product mentioned on page 1 / 2 of this form, only those variations will be carried out that have
previously been submitted to the Agency and approved by it (for further information see Explanations
regarding notification procedure / variations)
The undersigned confirms that the information contained herein is complete and accurate:
Company stamp of applicant / Authorisation holder (distribution company)
......
......
......
Compulsory
Optional (additional signature)
Location, date ...............
Location, date .............
Signature
……………………………..
Signature
……………………………………...
Person responsible
Surname
......
First name ......
Position held ......
Tel.
......
E-mail
......
Additional person
Surname
......
First name ......
Position held ......
Please submit the application to
For enquiries
Swissmedic, Swiss Agency for Therapeutic Products
P.O. Box, Hallerstrasse 7, 3000 Bern 9
Tel.
Fax
QM-Ident: ZL201_00_002e_FO / V05 / lac, cas / ps / 07.03.2016
+41 58 462 02 11
+41 58 462 02 12
2/2
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Form
Appl. to extend the authorisation of vet. med. (Not.
procedure in accordance with Art. 39 VAZV / Art. 10-12 VAM)
Change history
Version
Valid and
binding as
of:
05
04
Modified
without
version
change
Description, comments (by author)
Author’s
initials
07.03.16
There is no need to supply an additional hard copy of entirely
paper-based submissions
lac
20.11.14
Telephone and fax numbers within the document updated, telephone
and fax number in the footer updated, new change history inserted in
the document, document name modified in the header.
cis
Adjustment of regulatory documents relating to authorisation as
a result of the Guidance Document Formal requirements
cas
19.05.14
QM-Ident: ZL201_00_002e_FO
Swissmedic • Hallerstrasse 7 • CH-3000 Bern 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12