Application for recognition in parallel of an authorisation of an EU Member State

The procedure for recognition in parallel opens the possibility for an applicant to simultaneously undertake an authorisation procedure for a biocidal product in an EU country1 along with a recognition process for the same product in Switzerland. For this, Switzerland follows the provision pursuant to Article 34 of the Regulation (EU) no. 528/2012 (BPR). During the authorisation procedure in an EU State for products that had previously been placed on the market in Switzerland with a transitional authorisation AN or AC, this recognition procedure can ensure a seamless continuation of marketing. In this regard it is also allowed that the applicant for recognition does not correspond to the previous Swiss owner of the transitional authorisation (AN or AC). In this case the period of validity of the transitional authorisation is extended by 3 years, if the application for chronologically parallel recognition clearly states the identity of the product with the Swiss transitional authorisation and the application is received before the deadline (see below).

Authorisations for biocidal products that are, or comprise, genetically modified microorganisms are not recognised in Switzerland.

Procedure

Applications for recognition in parallel are to be submitted exclusively through the Register for Biocidal Products R4BP 3 at the Notification Authority for Chemicals (see internet links). If the application is intended to be submitted for parallel recognition in Switzerland by another person (for example by the owner of the previous Swiss transitional authorisation) as the request for first authorisation in the EU, then the Swiss applicant should initially clarify all legal, technical and IT requirements with the applicant in the EU.

It is recommended, before submitting an application for recognition in parallel, to consult the appropriate chapter in the "Biocides Submission Manual - National Authorisations" of the European Chemicals Agency ECHA (see internet links).

An application for recognition in parallel can be made either simultaneously with the application for the national first authorisation or at a later date with the help of the NA-MRP Wizard (a specific assistance function in the R4BP 3 System). However, it should be noted here that the owner of a transitional authorisation AN or AB may only profit from the extension of the validity period of 3 years if the application for chronologically parallel recognition is submitted via R4BP 3 with the Notification Authority Chemicals before the deadline, i.e. at the latest up to the date of the inclusion of the active substance in the lists of Annexes 1 and 2 of the OBP.

The application for recognition must include the following:

  • the name of the reference Member State (this is the state, whose competent authority assesses the application for authorisation of the biocidal product);
  • the names of the Member States concerned, in which an application for mutual recognition has likewise been made;
  • a summary of the characteristics of the biocidal product (= SPC according to Art. 20 para. 1 let. a number ii BPR in English or in an official language of Switzerland),
  • Safety data sheet
  • Draft label design (in an official language).

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)

If the applicant for the parallel acceptance is not the same as the applicant for the first authorisation, then the former must additionally submit a letter of access for the biocidal product and for each biocidal active substance contained in the product.

The SPC-Editor of ECHA should be used to compile the SPC (see internet links). 

Under certain circumstances, which are regulated in Article 12 para. 2 OBP, the acceptance of an authorisation in regard to the conditions or requirements laid down can differ from the EU-authorisation.

Generally, an application for recognition in parallel will be disposed of by the Notification Authority within 120 days after the competent authority of the rapporteur Member State (= reference Member State in the context of Art. 34 OBP) has sent us the drafts of the assessment report and the SPC. In the case where the Swiss authorities object to the proposed authorisation conditions or propose an adaptation of them, the authorisation can be delayed due to the then required efforts to reach an agreement.

Fees

Pursuant to the Chemicals Fees Ordinance (SR 813.153.1, ChemFO) the fee for a recognition is between CHF 5000 and 10 000. The criteria that determine the fees are defined as follows:

Initial Fee

The initial fee for the recognition of a biocidal product is CHF 5000.- (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.

In case of withdrawal of the application during the procedure, following fees will be charged:

  • Before validation (art. 16 para. 2 OPB): no fees
  • After validation: 25% of the charged fees
  • After the evaluation (art. 17 para. 2 OPB) has started: 50-75% of the charged fees

Surcharges

Each request in regard to missing or incomplete documentation increases the fee by 5 %.

Rebates

The following rebates are granted:

- up to 50%, if:

  • the biocidal product is comparable with the biocidal product that was representative in the active substance approval in the Assessment Report (CAR)
  • the biocidal product is comparable with a biocidal product for which the company has already received a recognition or initial authorisation AL in Switzerland.

Note: the applicant has to apply for a rebate and provide reasons to support this claim.

Advance payment of fees:

The payment of a deposit is a precondition for the treatment of the application by the Swiss authorities. The invoice for the fees will be sent to the authorisation owner through the R4BP 3 System.

Remark

The processes and procedures for the authorisation of biocidal products can be modified as a result of technical and administrative guidelines of the EU Commission and/or the European Chemical Agency ECHA. 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.

 

1 The MRA is also valid in the States of the European Economic Area (EEA).

Last modification 05.06.2018

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