Authorisation for parallel trade
A licence for parallel trade can be granted for a biocidal product that is authorised in an EU Member State and is identical to a biocidal product that is already authorised in Switzerland according to the harmonised European procedure.
Prerequisites / Basics
The precondition for submitting an application for parallel trade is that the biocidal product is already authorised in an EU or EFTA Member State ("State of origin") and is identical to a product that is authorised in Switzerland according to the harmonised European procedure ("reference authorisation").
“Identical” to the reference product means:
- 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.
Please refer to the document on the restriction of misleading trade names.
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.
For registration in R4BP3 we recommend the Guide issued by the European Chemicals Agency (ECHA) ECHA Accounts Manual for Industry Users, for drafting and managing the accounts in R4BP3, and the following guidance document: How to use R4BP 3 for the general concepts and functions in the Chemicals portal.
Before submitting the application for parallel trade, we recommend consulting the following guidance documents:
- Practical guide on national authorisation of biocidal products; Chapter “Permit for parallel trade”
- BSM: How to submit an application for National Authorisation; Chapter 16.4 “Parallel trade permit”
Application
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 timely 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.
Period of validity
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.-
Biocidal product families
The provisions for biocidal products also apply accordingly to biocidal product families.
Specifically, the fee calculation – starting from the basic fee for a biocidal product – is based on a special code depending on the size of the biocidal product family.
For more information on biocidal product families, please see here
Change requests
The authorisation for parallel trade cannot be changed. If the reference authorisation is changed, a new application must be submitted for the authorisation for parallel trade.
Extension of the authorisation
In contrast with its reference authorisation - an authorisation for parallel trade cannot be renewed or extended. A new application must be submitted after it expires.