Application for Authorisation AN for parallel trade
Procedure for authorisation AN for a biocidal product placed on the market in parallel, identical to a product already authorised by another holder and placed on the market in an EEA country under transitional provisions.
Requirements:
- The Autorisation AN for the reference product is still valid (art. 8 para. 1 let. c OBP);
- The identical product is placed on the market in an EEA state under the transitional provisions;
- The designated authorisation holder is domiciled or has its registered office or branch in Switzerland. PO box addresses without a street name or similar are not valid;
- You require a user account to enter products in the Product register for chemicals.
Hilfsmittel:
Procedure:
Basic principles:
- The Notification authority for chemicals is pre-notified via a form and first conducts a plausibility check;
- The actual application is then submitted online via www.rpc.admin.ch;
- A user account is necessary for online registration User accounts;
- It generally takes up to 60 days to process a complete application;
- Product types, usage methods, and areas are determined by the reference product;
- A reference product can only be a product that is not itself already an “identical product” or an "Autorisation AN for parallel trade”.
- The application is only deemed submitted once the Notification Authority has been additionally notified by email after the data set has been submitted electronically;
- Fees will be charged after the procedure is concluded or expires.
Notifying the Notification Authority:
The applicant first completes the “Application Form for Autorisation AN for Parallel Trade” (also available under Documents) and sends it to the Notification authority for chemicals via email (cheminfo@bag.admin.ch) with the following details:
- Subject: Application for Autorisation AN for Parallel Trade
- Accompanying text:
- Application for Autorisation AN for Parallel Trade
- CPID | Autorisation number | Trade name of the reference product
- Contact details
The Notification authority for chemicals reviews the information and determines whether the requirements are met. Once approved, we will create a dataset for you in the Product register for chemicals (www.rpc.admin.ch) and provide you with a CPID number, which you can use to complete additional details and submit the following documents under the “Documents” section:
- a. Swiss label design, including efficacy claim and instructions for use in at least one of Switzerland’s official languages. The product types applied for must already be listed, or result from the claim or instructions for use;
- b. Original label and usage instructions under which the biocidal product is placed on the market in the country of origin;
- c. Technical data sheet or instructions for use;
- d. Swiss Safety Data Sheet or EU Safety Data Sheet with CH cover sheet (if necessary under Art. 19 ChemO) Safety Data Sheet (SDS) ;
- e. Any additional supporting documents;
- f. Power of attorney1, either with the template or with a personalized letter;
- 1 A power of attorney (PoA) is required if the designated authorisation holder is represented by another person, e.g. a consultant. The power of attorney allows the Notification Authority to contact the representative if they have any questions or queries. If you do not have a representative, no PoA is necessary.
Important Notice
The Notification authority for chemicals may request the following additional documents if needed:
- A translation of the essential parts of the original usage instructions.
- Additional documents proving that the biocidal product is identical to the reference product.
Furthermore, the Notification authority for chemicals may require a sample of the imported biocidal product if deemed necessary.
Submitting application:
Once you have entered all data and uploaded the necessary documents, please submit the dataset and subsequently notify us by email cheminfo@bag.admin.ch.
Fees:
- CHF 350.-
- For each additional query owing to incorrect or missing documents: CHF 50.-
- In individual cases (e.g. investigations involving other authorities or in-depth document or literature searches), fees may be charged according to the actual cost.
Invoicing is usually done after the procedure is completed and is carried out exclusively through the designated authorisation holder.
Validity period:
The Autorisation AN for Parallel Trade remains valid as long as the authorisation of the reference product is valid. Thus, unless other circumstances apply, an issued Autorisation AN for Parallel Trade is generally valid for an additional 6 months after the last notified active substance of the biocidal product has been included in the list according to Annex 1 or 2 OBP for the relevant product types.
After the authorisation expires, the biocidal product may still be placed on the market for up to 360 days. It may continue to be supplied to end users for an additional 360 days (a total of 720 days). Professional or commercial use remains permitted as long as no unacceptable risks to humans, animals, or the environment are expected.