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 proof of identity.
1. Procedure
The applicant must be domiciled in Switzerland or have a registered office or branch in Switzerland.
Please complete the "Application for Authorization for Parallel Trade AN" form (see "Documents" below). Send it to us via email at cheminfo@bag.admin.ch.
The Notification Authority for Chemicals will review the information and determine if the requirements are met. Subsequently, we will create a record for you in the Product register for chemicals at www.rpc.admin.ch and provide you with the CPID number, which you can use to complete further details. In the communicated record in the Chemical Product Register, please submit the following documents under the "Documents" section:
a. Original label and instructions for use of the biocidal product that is placed on the market in the country of origin.
b. Draft label for the biocidal product to be marketed in Switzerland with authorization for parallel trade (in two official languages).
c. Safety data sheet for the biocidal product to be marketed with authorization for parallel trade.
d. Any other supporting documents, if applicable.
For explanations on the electronic form, please refer to the instructions for the electronic application for authorisations AN (see "Documents" below).
After the electronic application has been submitted in the Product register for chemicals (RPC), the following information must be transmitted 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 grace periods 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 in Annex 1 BPR or in the Union lists of approved active substances, 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 20.07.2023
