Application for authorisation for parallel trade AN


 An authorisation for a 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 (doc (PDF, 2 MB, 04.04.2017)).

Contrary to a normal application for the authorisation AN, indicate the biocidal active substance, together with its concentration, under the tab ‘composition’ in the RPC. For the GHS classification of the biocidal active substance select “not classified or no data available”. For the chemical manufacturer (of the biocidal active substance) select “placeholder authorisation for parallel trade AN”.

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 supporting document 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 Swiss market with an authorisation for parallel trade

After the digital application in the Chemicals Register (RPC) has been dispatched, the following information must be transmitted by email to the Notification Authority Chemicals (cheminfo@bag.admin.ch) :

  • Tradename and CPID number 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
  • Tradename and authorisation number of the reference product

2. Processing period

Complete applications are generally processed and a decision given 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 CHF1000, unless additional documents have to be requested in order to verify the identity.
If the dossier is incomplete then surcharges will be levied.

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.

A sample of the biocidal product which is to be imported, if this is considered necessary by the Notification Authority.

Last modification 22.08.2019

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