The administrative procedure that has to be used for each modification of existing authorisations AN and AC corresponds to a summary procedure.
1 Summary procedure for authorisations AN and AC
Changes to existing authorisations AN and AC (including authorisations of identical/similar products as well as frame-formulations/product families which refer to an AN or an AC authorisation) must be notified beforehand to the Notification Authority and may only be implemented after the ruling (provision) has been issued. There are changes, which have to be notified via a notification mail to the Notification Authority while others have to be notified via the product register for chemicals (RPC) and an additional mail to the Notification Authority.
Documents which are affected by the change (e.g. label, safety data sheet) or which are necessary for the proof (efficacy) have to be uploaded to the register.
Documents with confidential content should have an access level “author & federal authorities”. The access level can only be assigned after the document has been uploaded.
1.1 Changes, which have to be notified via notification mail to the Notification Authority
- Changes concerning the authorisation holder (name, address etc)
- Request to transfer the authorisation to another holder1)
The mail has to be sent to firstname.lastname@example.org and contain the following information: name of the biocidal product, CPID number and a description of the change.
1.2 Changes, which have to be notified via the product register for chemicals (RPC) and an additional mail to the Notification Authority
- Trade name of the biocide
- Changes concerning the formulator of the biocide
- Product type
- Type of preparation (e.g. solid)
- Field of application, methods of application, aim of application
- Category of users
- Changes concerning the formulator of the active substance
- Change in the formulation (Important: The composition must be 100% and must include all components. Applications with incomplete compositions cannot be processed.)
- Change affecting the classification or/and the labelling
- Conditions of use
- Changes concerning the efficacy of the biocidal product
- Change of the active substance supplier according to art 62d (see guidance provision of evidence required under art 62d (PDF, 561 kB, 19.10.2016))
- Advertisement (label)
These changes have to be done directly in the product register for chemicals. Afterwards the Notification Authority has to be informed about the change by sending a mail to email@example.com containing the following information: name of the biocide, CPID number and a short description of the change done in the product register for chemicals.
The Notification Authority will generally issue an amended compliance order. The fee for such changes depends on the required time and effort and will be between CHF 150 and 600 per modified product.
1) The request to transfer the authorisation must be submitted to the following address: Federal Office of Public Health, Notification Authority Chemicals (Anmeldestelle Chemikalien), CH – 3003 Bern.
Last modification 22.08.2019