An authorisation for parallel trade AN may be sought for a biocidal product that has been placed on the market in the country of origin (EEA) in accordance with the national provisions and is identical to a biocidal product (reference product) that has already been authorised with a transitional authorisation AN in Switzerland. The applicant must be able to establish the proof of identity. Further information concerning the authorisation for parallel trade AN can be found here (PDF, 226 kB, 21.03.2018).
1. Procedure
An application for the authorisation for parallel trade AN must be submitted by electronic means via the Chemical Register (RPC) to the Notification Authority Chemicals. The applicant must be domiciled in Switzerland or have a registered office or branch in Switzerland. Explanations relating to the electronic form can be found in the instructions for the electronic application for authorisations AN (guidance for electronic applications Authorization AN (PDF, 2 MB, 18.11.2020)).
Unlike the procedure for a normal application for authorisation AN, you must first email the Notification Authority for Chemicals (cheminfo@bag.admin.ch) with the following information:
• Trade name of the biocidal product for which you are submitting an application for parallel trade
• Indication that it concerns a first application for the authorisation for parallel trade AN
• Trade name and authorisation number of the reference product
• Information on the biocidal product that has been placed on the market in an EU or EFTA member state in accordance with the national provisions (for example the registration number if available in this country)
The Notification Authority for Chemicals will then give you the CPID number under which you can add the missing information on the authorisation holder and manufacturer in the RPC.
Under the tab “documents” the following documents must be uploaded:
N.B. Access to documents with confidential contents should be made available "owner/Federal authority”. Access can be granted after the document has been uploaded.
a. Signed printout of the last page of the receipt from the RPC (as a PDF).
b. Original label and instructions for use with which the biocidal product is placed on the market in the country of origin
c. The draft label for the biocidal product intended to be placed on the Swiss market with an authorisation for parallel trade, in two official languages
d. Safety data sheet for the biocidal product intended to be placed on the market with an authorisation for parallel trade
e. The completed Application for authorisation of AN parallel trade form (see under Documents below)
After the digital application in the Chemicals Register (RPC) has been dispatched, the following information must be emailed to the Notification Authority for Chemicals (cheminfo@bag.admin.ch) :
Trade name and CPID number of the biocidal product for which you are submitting an application for AN parallel trade.
2. Processing period
Complete applications are generally processed and the terms of authorisation decreed within 60 days.
3. Period of validity
The period of validity of the authorisation for parallel trade of a biocidal product corresponds to the period of validity of the authorisation of the reference product. Following expiry of the period of validity of the authorisation for parallel trade the periods of grace for liquidating stocks are 360 days for placing on the market and an additional 360 days for supplying end consumers. If a decision is taken by the EU Commission to deny the inclusion of the active substance into the Annex 1 BPR or into the Union lists of approved active substances, then the authorisation will be revoked by the Notification Authority. The product may then still be placed on the market for up to 360 days after the decision of the Commission, and still supplied to end consumers for an additional 360 days (insofar as no unacceptable effects on humans, animals and the environment are expected).
4. Fees
The fees amount to CHF 350, unless additional documents have to be requested in order to verify the identity.
Surcharges will be levied if the dossier is incomplete.
IMPORTANT:
The Notification Authority may require the following additional documents:
- a translation of the essential parts of the original instructions for use;
- additional documentation proving that the biocidal product is identical with the reference product.
The Notification Authority may require a sample of the biocidal product which is to be imported if it considers this necessary.
Last modification 20.04.2021
