Application for mutual recognition in sequence of an authorisation of an EU Member State

Preliminary remarks

The procedure for mutual recognition in sequence of an authorisation (hereinafter called "Recognition", cf. Art. 12 of the Ordinance on Biocidal Products OBP) is based on chapter 18 of the Mutual Recognition Agreement, MRA, revised on 14 April 2015) between Switzerland and the EU, and Article 33 of the Regulation (EU) 528/2012 BPR[1]. The agreement opens up the possibility to an applicant with a registered office or branch office in Switzerland or in an EU or EFTA Member State to obtain recognition in Switzerland[2],[3] for an authorisation granted for a biocidal product (Reference product) in an EU or EFTA Member State. 

This recognition procedure harmonises the implementation and coordination of applications for recognition in the EU and EFTA Member States. However, authorisations for reference products that are, or comprise, genetically modified microorganisms are not recognised in Switzerland (Art. 12 para. 4 OBP).

Procedure

Applications for the recognition of an authorisation from a Reference State are to be submitted through the Register for Biocidal Products R4BP 3 with the Notification Authority for Chemicals (see links). 

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

The application for recognition must include the following documents:

  • The letter of access to the biocidal product if the applicant is not identical with the holder of the authorisation of the reference product;
  • The letter of access to the active substances comprised in the biocidal product;
  • A summary of the characteristics of the biocidal product (= SPC according to Art. 20 para. 1 let. a number ii BPR in the language of the decision (an official language of Switzerland).
  • A draft of the label and of the safety data sheet, insofar as the latter has to be created. These drafts should be uploaded with the application in R4BP 3 in the section "Documents".
  • Overview document for the biocidal product family (XLS, 29 kB, 03.09.2019) (only required for biocidal product families)

If the application for recognition in Switzerland is not submitted by the holder of the authorisation of the reference product, rather e.g. by the former holder of the transitional authorisation AN or AC, then all legal, technical and information technical conditions linked with their application have to be clarified beforehand with the holder of the authorisation of the reference product. The Notification Authority for Chemicals cannot undertake this task.

On receipt of the application for recognition the Notification Authority sends an invoice for the total expected fee to the applicant by means of R4BP 3. The timely[4] payment of the cost estimate is required for the Notification Authority to process the application.

As soon as the application is totally "valid", the Notification Authority informs the applicant of the date of application. The application documents will be evaluated by the authority[5] within 120 days of this date.

If the Notification Authority concludes that it only intends to recognise the authorisation of the reference state with conditions and/or requirements, namely because this is needed for the protection of the environment or of human health, then it will inform this to the applicant and to the authorities in the EU or EFTA Member States, following the procedure of Article 33 and 35-37 BPR. The Swiss authorities and those of the Member States concerned will then endeavour to arrive at a common position in regard to the contested points in the context of the recognition. The underlying instruction may then possibly have to be adjusted for this. One possibility for Switzerland not to recognise or adapt the requirements of a national authorisation or Union authorisation is to make a derogation. If no agreement is reached between Switzerland and the EU, then, based on the MRA, the dossier will be sent to the "Joint Committee", where renewed attempts will be made to reach an agreement. In such cases the corresponding administrative provisions will not be granted until the disagreements between the contractual parties have been settled.

Particular rules apply to applications for recognition of the authorisation of a reference product that comprises active substances under Article 5 para. 2 or Article 10 para. 1 BPR.

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.

Remarks

An application for the authorisation of a biocidal product that is identical to a biocidal product that is already authorised in Switzerland or for which a corresponding application is pending, has to be made as an application for an identical biocidal product (Art. 15 OBP).

The 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.

 

[1] Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 on the placing on the market and the use of biocidal products.

[2] If the authorisation for the biocidal product in the EU Member State is still pending, then an application for chronologically parallel recognition has to be made → see separate guidelines under Biocidal products → Authorisations → Authorisation for parallel recognition

[3] The recognition of a Union authorisation is regulated in Art. 14a OBP; see separate guidelines under Biocidal products → Authorisations → Union Authorisation

[4] Within 30 days after receipt of the invoice.

[5] The Notification Authority deals with third parties, the evaluation is made internally by the evaluation authorities.

Last modification 03.09.2019

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