Application for the authorisation of same products AN/AC

Biocidal products that are identical to an already authorised product (AN) or to a product family or to a single member of a product family (in connection with an authorisation AN) can be authorised as a same biocidal product AN/AC (Art. 15 para. 1 OBP).

The related reference product must either be already authorised in Switzerland or an application AN must at least have been submitted. This procedure is also described in the industry as a back-to-back authorisation. It concerns identical products that are intended to be placed on the market under another trade name or by another authorisation holder.

Identical means that the biocidal product matches the reference product to the greatest possible extent, with the exception of administrative changes (Art. 4 of the Implementing Ordinance-Biocidal Products FDHA). Therefore, a same biocidal product differs from the reference product solely in administrative aspects (e.g. different name, other authorisation holder) or by limited conditions of use.

Procedure

Processing period of the application

The submitted dossier will generally be validated and evaluated within 60 days.

Period of Validity

For the same biocidal products, whose reference product is based on an AN or AC authorisation, and whose active substances have all been included in the lists according to Annex 1 and/or 2 OBP, an application for the authorisation of a same product or a corresponding application according to Art. 22 para. 2 OBP must be submitted in due time (at the latest up to the acceptance date of the last active substance – see Art. 22 OBP). For details of this procedure, account should also be taken of the section on parallel acceptances.

Fees

Authorisation of a same product to a reference product AN/AC with a letter of access (i.e. with different authorisation owners):  CHF 250.-

Authorisation of a same product to a reference product AN/AC without a letter of access (i.e. with the same authorisation owner): CHF 200.-

Remark

The processes and procedures for the authorisation of biocidal products could be modified at short notice. Consequently, we advise interested parties to regularly consult the website of the Notification Authority Chemicals and to subscribe to the Consumer Protection newsletter from the FOPH. 

Last modification 13.04.2017

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