Application for the authorisation of same products

Biocidal products that are identical to an already authorised product or product family can be authorised as a same biocidal product (Art. 15 para. 1 OBP).

The related reference product must either be already authorised in Switzerland or an application must at least have been submitted. 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.

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

An application for the authorisation of a same product shall always be submitted through the R4BP register for biocidal products.

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 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

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)

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.

Period of Validity

The authorisation for a same biocidal product and the authorisation for a reference product can be modified or revoked independently of each other.

Fees

Authorisation of a same product to a reference product AL, recognition or simplified authorisation: CHF 500.- (basic fee).
The fee for biocidal product families is made up of the basic fee for the relevant authorisation (e.g. Authorisation AN, CHF 1000). 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.

Remark

The processes and procedures for the authorisation of biocidal products can 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 05.06.2018

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