Authorisation for parallel trade AN
An authorization AN for parallel trade can be applied for a biocidal product that is placed on the market in the country of origin (EEA) under national regulations and is identical to a biocidal product already authorized in Switzerland with a transitional authorization AN (reference product). The applicant must be able to provide proof of identity.
The establishment of the authorization AN concept for parallel trade aims to prevent a foreign manufacturer of a biocidal product from designating an exclusive representative in Switzerland, allowing them to market the biocidal product at a price set by them without competition.
A prerequisite for the authorisation for parallel trade is that the product is identical to the reference product1 (s. art. 13a para. 1bis OBP).
Identical means:
- a. It has been manufactured by the same company, by an associated undertaking or under licence in accordance with the same manufacturing process;
- b. The products are identical in specification and content in respect of the active substances and the type of formulation;
- c.The products are identical in respect of the non-active substances present;
- d. The products are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on human health, animal health or the environment.
The parallel import of such products is allowed after the Notification Authority Chemicals has granted the authorisation. A corresponding application for this must be submitted to the Notification Authority.
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.
1A reference product is understood to mean that identical product that is already authorised with an AN or AC authorisa-tion in Switzerland.