VO-Form / Notification
No marketing / Interruption to distribution
Placing on the market / Resumption of distribution
.
Company stamp (for electronic submission, company name; street, No.; Postal code/town)
……
……
……
Product
Product name:
Active substance(s):
Dosage form:
……
……
……
Authorisation no.:
Dispensing category:
eCTD sequence:
……
……
……
Type of notification: No marketing or interruption to distribution
☐
No marketing for >1 year following first authorisation
(Notification in accordance with Art. 8a, para. 1, VAM)1:
Date of first authorisation:
……
Expected market launch on:
……
Confirmation that the following conditions for authorisation remain fulfilled:
☐ Publication of the product information (Art. 16a VAM1 / Human medicines)
☐ For products with known API for which the product information is identical to that of the reference
product (in according with the criteria of the Administrative Ordinance / Instructions Authorisation of
human medicines with known active pharmaceutical ingredients) co-marketing medicines:
modifications to the reference product-/ base product continue to be applied
☐
Interruption to distribution of >1 year
(Notification in accordance with Art. 8a, para. 2, VAM)1.
Date of last delivery to wholesalers:
……
Expected resumption of distribution on:
……
Confirmation that the following conditions for authorisation remain fulfilled:
☐ Publication of the product information (Art. 16a VAM1./ Human medicines)
☐ For products with known API for which the product information is identical to that of the reference
product (in according with the criteria of the Administrative Ordinance / Instructions Authorisation of
human medicines with known active pharmaceutical ingredients) co-marketing medicines:
modifications to the reference product-/ base product continue to be applied
The Agency revokes the authorisation of a medicinal product if it is not effectively placed on the
market within three years of the authorisation being granted, or if it is no longer distributed for three
consecutive years after being placed on the market. This does not, however, apply to export
authorisations. If existing patent protection prevents the product being placed on the market at the
moment the authorisation is granted, the time limit begins only when the patent protection expires.
The Agency published notifications received on the Swissmedic website, in the section:
1
The Ordinance on Medicinal Products (VAM, SR 812.21.21)
QM-Ident: ZL203_00_001e_FO / V08 / er, cas / er / 28.01.2016
1/2
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Form / Notification
No marketing / Interruption to distribution
Placing on the market / Resumption of distribution
Medicinal product information -> List of Notifications of no marketing / interruption to distribution Veterinary
medicines that are not available on the market will also be marked as „derzeit nicht erhältlich (Ausverkauft /
Nicht lieferbar)!“ in the electronic compendium of veterinary medicines Placing on the market or resumption of
distribution (following interruption)
Placing on the market or resumption of distribution (following interruption)
☐
☐
Placing on the market following first authorisation
(Notification in accordance with Art. 8a, para. 3, VAM) 1:
Date of first authorisation:
Date of notification of non marketing for >1 year following first authorisation:
……
……
Date of placing on the market (first delivery to wholesalers):
……
Resumption of distribution following interruption
(Notification in accordance with Art. 8a, para. 3, VAM) 1:
Date last delivery to wholesalers:
Date of notification of interruption to marketing for >1 year:
……
……
Date of resumption of distribution (first delivery to wholesalers):
……
The Agency deletes the product from the medicinal product information list -> List of notifications of
non-marketing / interruption to distribution on the Swissmedic website. For veterinary medicines, the
comment „derzeit nicht erhältlich (Ausverkauft / Nicht lieferbar)!“ will be deleted from the electronic
compendium of veterinary medicines once it is again available.
The undersigned confirms that the details provided are complete and correct:
Company stamp of applicant / authorisation holder (distribution firm)
……
……
……
Compulsory
Optional (additional signature)
Place, date ……
Place, date ……
Signature
1
……………………………………………….
Signature
…………………………………………….
Responsible person
Name
……
First name ……
Function
……
Tel.
……
E-mail
……
Additional person
Name
……
First name ……
Function
……
This notification must be sent to
Swissmedic, Swiss Agency for Therapeutic Products
P.O. Box, Hallerstrasse 7, 3000 Bern 9
For queries
Tel.
+41 58 462 02 11
Fax
+41 58 462 02 12
The Ordinance on Medicinal Products (VAM, SR 812.21.21)
QM-Ident: ZL203_00_001e_FO / V08 / er, cas / er / 28.01.2016
2/2
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12
VO-Form / Notification
No marketing / Interruption to distribution
Placing on the market / Resumption of distribution
Change history
Version
Valid and
binding as
of:
08
28.01.16
Modified
without
version
change
20.11.14
07
19.05.14
Description, comments (by author)
Author’s
initials
Swissmedic does not send confirmations of receptions by post.
er
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
QM-Ident: ZL203_00_001e_FO
Swissmedic • Hallerstrasse 7 • CH-3000 Berne 9 • www.swissmedic.ch • Tel. +41 58 462 02 11 • Fax +41 58 462 02 12