The applicant is not identical with the holder of the authorisation for the reference product
Procedure for authorisation AN for identical biocidal products for another company.
Requirements:
- The authorisation AN for the reference product is still valid (Art. 8 para. 1 let. c OBP;
- 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;
- The holder of the reference authorisation is able to issue a Letter of Access (see below);
- You require a user account to enter products in the Product register for chemicals.
Aids:
Procedure:
Basic principles:
- Applications should be submitted online via www.rpc.admin.ch;
- A user account is necessary for online registration User accounts (admin.ch);
- It generally takes up to 60 days to process a complete application;
- Product types, and methods and fields of use that were selected in the data set for the electronic notification but are not displayed on the label or in the instructions, will not be processed and will be rejected;
- Product types, and methods and fields of use that were not selected in the data set for the electronic notification are considered not approved, even if they are listed on the submitted label or instructions;
- Only a product that is not already itself an «identical product» can be considered as a reference product;
- 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.
Entering the data set by the holder of the reference authorisation:
- Duplicate the dataset of the reference product;
- Adjust the relevant elements of the duplicate (e.g., trade name);
- In the «Intended Use» section, you are not allowed to add any elements; otherwise, the product is not identical. However, you may remove elements and apply for the identical product with reduced intended uses;
- Please refrain from making any changes to the «Composition»;
- Under the «Characteristics» section, select the authorisation procedure «Authorisation AN same biocidal product».
- In the «Documents» section, upload a «Letter of Access» as well as the Form «same product» AN/AC ».
Notify the Notification authority:
The holder of the reference authorisation informs the notification authority via email (cheminfo@bag.admin.ch) and instructs it to transfer the duplicate to another registrant. The email includes the following details:
- Subject: CPID | Trade name, application for authorisation as same biocidal product
- Accompanying text:
- I. Application for AN authorisation as same biocidal product
- II. CPID | Trade name
- III. CPID | Authorisation number | Trade name of the reference product
- IV. Contact details
- V. Name of the other registrant
- VI. Contact details of the other registrant (E-Mail, Phone Number)
The Notification authority will transfer the duplicated dataset to the designated authorisation holder and request them to upload the following documentation:
- 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. Technical data sheet or instructions for use;
- c. Swiss Safety Data Sheet or EU Safety Data Sheet with CH cover sheet (if necessary under Art. 19 ChemO) Safety Data Sheet (SDS) (admin.ch);
- d. Completed form «same product» AN/AC;
- e. 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.
Submitting application:
Once you have entered all data and uploaded the necessary documents, please submit the data set to the RPC and subsequently notify us by email.
- email to cheminfo@bag.admin.ch
- Subject: CPID | Trade name, application for authorisation as same biocidal product
- Accompanying text:
- I. Application for AN authorisation as same biocidal product
- II. CPID | Trade name
- III. CPID | Authorisation number | Trade name of the reference product
- IV. Contact details
Fees:
- CHF 250.-
- 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 authorisation of an identical product AN remains valid for as long as the approval of the reference product remains valid. Therefore, excluding any other circumstances, the approval of an identical product ON typically remains valid for an additional 6 months after the last notified active substance of the biocidal product is included in the list according to Annex 1 or 2 OBP for the relevant product types. Thereafter the product may still be placed on the market for up to 360 days and supplied to end consumers for additional 360 days (720 days in total). Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment.
Should the product remain on the market, please take note of the Transitional regulations
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, then the authorisation of biocidal products containing this active substance will be revoked by the Notification Authority. After the decision of the Commission, the product can be placed on the market for up to 360 days and supplied to end consumers for an additional 360 days (720 days in total). Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment.