Published on 5 June 2025

Application for the authorisation of same products

Biocidal products that are identical to a product or product family (subsequently referred to as "biocidal product") that has already been authorised according to the harmonised European procedure can be authorised as same biocidal products.

This procedure is 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.

Prerequisites / Basics

  • The biocidal product matches the reference product to the greatest possible extent, with the exception of administrative changes. 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. In the Annex, Title 1 of Implementing Regulation (EU) No. 354/2013, you will find the amendments that are considered administrative amendments.
  • Before an application can be submitted, the related reference product must either be already authorised in Switzerland (sequential procedure) or a corresponding application must at least have been submitted (simultaneous processing, parallel procedure).
  • Please refer to the document on the restriction of misleading trade names.

Procedure

  • ·Applications for the authorisation of same products are to be submitted to the Notification Authority for Chemicals exclusively via the Register for Biocidal Products R4BP 3. Dossiers in paper format will not be accepted. For registration in R4BP3 we recommend the Guide issued by the European Chemicals Agency (ECHA) ECHA Accounts Manual for Industry Users , for drafting and managing the accounts in R4BP3, and the following guidance document: How to use R4BP 3 for the general concepts and functions in the Chemicals portal.
  • Applications for the authorisation of same products can be submitted for national authorisations regardless of their original procedure ("authorisation type"). The applications for the authorisation of same products can be submitted both at the same time as (-> in parallel) and after (-> sequentially) the authorisation procedure for the reference product.

The detailed instructions for submitting an application for the authorisation of a same biocidal product can be found in the following submission guides:

Communication between national authorities, ECHA and applicant occurs exclusively through the R4BP. It is therefore important that the status of the submitted application (messages, questions, deadlines for payments/additional documentation etc.) be regularly checked by the applicant in the R4BP.

The submitted dossier will be validated within 30 days, subject to receipt of payment of the deposit. This takes the form of a test for completeness of the submitted documents. As soon as the application is complete it must be disposed of by the Notification Authority within 60 days. In the case where an application for the reference product is also pending, the period for the same product begins from the date of the authorisation of the reference product.

Application

Before submitting an application for the authorisation of a same product, we recommend reading the Guidance document issued by the European Chemicals Agency: Practical guide on same biocidal product authorisations.

The following information has to be submitted with the application:

  • the authorisation number of the reference product or, if this application is still pending, the assigned application number from the R4BP3 product register (case number);
  • the declaration of the proposed administrative deviations between the same biocidal product and the reference product as well as proof that both products are identical in all other respects;
  • a letter of access for the data, on which the authorisation of the reference product is based, when one is not the owner of the data and its term of protection has not yet expired (Art. 27 para. 1 OBP);
  • A draft of the summary of the product characteristics (SPC: Summary of Products Characteristics) of the same biocidal product;
  • Draft of the label;
  • Security data sheet;
  • For Families:

If the biocidal product for which authorisation is being requested using the harmonised European procedure is already on the market in Switzerland under a transitional authorisation:

  • its authorisation number (CHAN or CHAC) and proprietary name (IMPORTANT: additional costs will be charged if queries arise).

Period of validity

The period of validity of an authorisation of a same product is based on the authorisation period of its reference product. The maximum period is usually 10 years. However, the authorisation for a same biocidal product and the authorisation for a reference product can be modified or revoked independently of each other.

Fees

National authorisation of a same biocidal product according to the harmonised European procedure (regardless of whether a reference product AL, recognition or simplified authorisation is involved): CHF 500.- (basic fee).

The fee for biocidal product families is made up of the basic fee for the relevant authorisation (e.g. same product, CHF 500.-). In the case of biocidal product families with one sub-family, the basic fee is increased by 50%. An increase of a further 25% is made for each additional sub-family. 10 biocidal products may be included in each sub-family. For each additional biocidal product in a sub-family, the fee increases by one per cent. No additional charge is made for biocidal products in a biocidal product family or sub-family that do not differ (i.e. whether in their use, method of use etc.) other than by their concentration of pigments, colorants or fragrances.

N.B.: For applications according to the harmonised European procedure, the cost estimate must be settled BEFORE the application is processed. The fee should be paid within 30 days after the invoice date

Biocidal product families

The provisions for biocidal products also apply accordingly to biocidal product families.

Specifically, the fee calculation – starting from the basic fee for a biocidal product – is based on a special code depending on the size of the biocidal product family.

For more information on biocidal product families, please see here.

Change requests

Gesuche für Änderungen müssen über das Register für Biozidprodukte (R4BP3) bei der Anmeldestelle Chemikalien eingereicht werden. Für genauere Informationen konsultieren sie bitte die Seite zu den Änderungen einer Zulassung.

Requests for changes must be submitted to the Notification Authority for Chemicals via the Register for Biocidal Products (R4BP3). If an authorisation that was the subject of an authorisation procedure according to the same product principle, independently departs from the content and conditions of the reference authorisation as a result of changes, it is no longer considered to be identical to the reference authorisation. For further details please consult the page on Changes to an authorisation.

Extension of the authorisation

An application for the renewal of the authorisation must be submitted 550 days, at the latest, before the authorisation expires to the Notification Authority for Chemicals via the Register for Biocidal Products (R4BP3). For further details on the extension of an authorisation according to the harmonised European procedure, please consult the