VO-Form

Co-marketing confirmation

This co-marketing confirmation form should be completed in full.

Any remarks you wish to make should be made in an accompanying letter.

By the present confirmation, the undersigned hereby undertake to comply with the following terms and conditions:

  • In order to facilitate the licensing procedure for the co-marketing product, the licence-holder for the basic preparation hereby authorizes the designated licence-holder of the co-marketing product to make comprehensive reference to the scientific documentation of the basic preparation. This authorization shall remain in force even after the licence has been granted for the co-marketing product, in particular with regard to any changes to the basic preparation, which must be directly applied to the co-marketing product.
  • The entity in charge of manufacturing the basic preparation hereby acknowledges that the basic preparation and its co-marketing product are absolutely identical (same manufacturing process, same qualitative and quantitative composition of the finished product in terms of the active ingredients, excipients, and primary packaging).
  • The licence-holder for the basic preparation, the licence-holder of the co-marketing product, and the entity in charge of manufacturing hereby undertake to keep each other up to date on documentation and any events that affect quality, efficacy and safety of use of the two preparations. They undertake in particular to coordinate every application to modify the two preparations. In the interests of public health, Swissmedic reserves the right to transmit any necessary information or data about the basic preparation or the co-marketing product to the licence-holder of the basic preparation or to the licence-holder of the co-marketing product.

Application number: …………………… (issued on initial application reception)

Name (brand) and Swissmedic licence number of the basic preparation:

°°°°°

Name (brand) of the co-marketing product:

°°°°°

Date, stamp, and signature (with name and address) of the licence-holder of the basic preparation:

°°°°°

Date, stamp, and signature (with name and address) of the licence-holder of the co-marketing product:

°°°°°

Date, stamp, and signature (with name and address) of the entity responsible for manufacturing the product:

(Signature of the Responsible Person for galenic manufacturing or the Responsible Person for the firm issuing the batch certificate).

°°°°°

QM-Ident: ZL108_00_001e_FO / V03 / er, cas / dts / 01.03.20141 / 1

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

VO-Form

Co-marketing confirmation

Change history

Version / Valid and binding as of: / Modified without version change / Description, comments (by author) / Author’s initials
20.11.14 / Telephone and fax number in the footer updated, new change history inserted in the document, document name modified in the header / cis
03 / 01.03.14 / Insert the Barcode / cas
26.01.17 / The footnote has been removed: see Swissmedic Journal Pulication 10/2010 / vy

QM-Ident: ZL108_00_001e_FO

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