Authorisation for parallel trade

A licence for parallel trade can be granted for a biocidal product that is authorised in an EU Member State1 and is identical to a biocidal product that is already authorised in Switzerland.

Preliminary remarks

Based on the Mutual Recognition Agreement (MRA) of 14 April 2015 the procedure for the authorisation of parallel trade is governed by the provisions of Article 53 of the Regulation (EU) 528/2012 (BPR) 2. An equivalent legal basis can be found in Article 13a of the Swiss Ordinance on Biocidal Products (OBP, SR 813.12).

Procedure

Applications for the authorisation for parallel trade are to be submitted exclusively through the Register for Biocidal Products R4BP 3 at the Notification Authority for Chemicals (see internet links). Dossiers in paper format will not be accepted.

An application for the authorisation for parallel trade can be filed when the biocidal product that is authorised in the EU or EFTA Member State is identical to the Reference product3, i.e.:

a) It is manufactured by the same company, by an affiliated company or manufactured under licence using the same manufacturing process;
b) The specification and the content of active substances as well as the type of formulation are identical;
c) It is identical in regard to the inactive substances present;
d) It is identical or equivalent in size, material and type of packaging in regard to potential adverse effects on human or animal health or on the environment.

The application for the authorisation for parallel trade must include the following information:

a) Name and authorisation number of the biocidal product in the EU or EFTA Member State;
b) Name and address of the competent authority of the EU or EFTA Member State;
c) Name and address of the authorisation holder in the EU or EFTA Member State;
d) Original label and directions for use, with which the biocidal product is distributed in the EU or EFTA Member State, if the Notification Authority deems that they are required for the examination;
e) Name and address of the applicant;
f) Name to be given to the biocidal product intended to be distributed;
g) Draft label for the biocidal product intended to be distributed, in two official languages;
h) A sample of the biocidal product to be imported, when the Notification Authority deems this to be required;
i) Name and authorisation number of the Reference product;
j) Translation of the essential parts of the original directions for use, when the Notification Authority requests it.

On receipt of the application for authorisation of a biocidal product for parallel trade the Notification Authority sends an invoice for the total expected fee to the applicant by means of R4BP 3. The timely4 payment of the cost estimate is required for the Notification Authority to process the application. The processing period is 60 days max. The Notification Authority can obtain additional information from the competent authority of the EU or EFTA Member State, when deemed necessary for the identification of the product.

If the authorisation for the parallel trade is granted by the Notification Authority in agreement with the assessment authorities, then the authorisation for placing on the market and the professional and commercial use of the biocidal product is subject to the same conditions and requirements as for the Reference product.

The authorisation for the parallel trade of a biocidal product remains valid for the remaining validity period of the authorisation of the Reference product. This is also the case when the authorisation of the reference product, upon application by the authorisation holder, is revoked, insofar as the requirements for the authorisation of the reference product are still met.

The Notification Authority revokes the authorisation for parallel trade if the authorisation for the biocidal product in the EU or EFTA Member State is revoked on the grounds of safety or effectiveness.

Fees

Fees for processing an application for the authorisation for parallel trade are CHF 2500.-.

Remark

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 A parallel MRA applies to the EFTA States Iceland, Liechtenstein and Norway based on the EFTA-Agreement (Annex I).

2 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.

3 Herein, the reference product is understood to mean that identical product, which is already authorised in Switzerland.

4 Within 30 days after receipt of the invoice.

Last modification 21.11.2016

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