Application for recognition
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 for an authorisation granted for a biocidal product (Reference product) in an EU or EFTA Member State.
Prerequisites / Basics
- All active substances that have been incorporated into the lists in Annex 1 or Annex 2 OBP.
- Applicants must have a registered office or branch office in Switzerland or in an EU or EFTA Member State.
- Authorisations for biocidal products that are, or comprise, genetically modified microorganisms are not recognised in Switzerland.
- Please refer to the document on the restriction of misleading trade names.
Procedure
- Applications for the authorisation for recognition are to be submitted to the Notification Authority for Chemicals exclusively via the Register for Biocidal Products R4BP 3 (see internet links). 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.
- A procedure for recognition can be applied for both simultaneously (-> parallel recognition procedure) and subsequently (sequential recognition procedure) to the approval procedure for the reference authorization.
- 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.
- It is recommended, before submitting an application for recognition, to consult the appropriate chapter in the “Practical guide on national authorisation of biocidal products” as well as “BSM Application instructions: How to submit an application for National Authorisation” of the European Chemicals Agency ECHA..
Application
The application for recognition must include the following:
- 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 English or in an official language of Switzerland). After the reference Member State has completed the assessment the applicant must submit an SPC in the language of the decision (approval language), i.e. inan 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”.
Additionally, if a biocidal product family is involved:
If a procedure for recognition in parallel is involved and the biocidal product is already on the market in Switzerland under a transitional authorisation AN or AC:
- its authorisation number (CHAN or CHAC) and proprietary name
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 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. 33/34 OBP) has sent us the drafts of the assessment report and the SPC.
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.
Period of validity
The period of validity is based on the period of validity of the reference authorisation in the EU/EFTA State; the maximum period is usually 10 years.
Fees
Pursuant to the Chemicals Fees Ordinance (SR 813.153.1, ChemFO) the fee for a recognition for a biocidal product is CHF 5000.
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
Subsequent claims / requests due to missing or inadequate documents may be invoiced.
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 Biocidal product family
Change requests
Requests for changes must be submitted to the Notification Authority for Chemicals via the Register for Biocidal Products (R4BP3). For further details please consult the page on Changes to existing authorisations
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 please consult the page on Extension of existing authorisations