Changes to existing authorisations
The administrative procedure that has to be used for each modification of existing authorisations depends on the type of change. There are administrative changes, minor and major changes.
Prerequisites / Basics
- The biocidal product is already on the market with an authorisation in accordance with the EU harmonised procedure.
- Please refer to the document on the restriction of misleading trade names.
Procedure
Applications are to be submitted exclusively through the Register for Biocidal Products R4BP 3 at the Notification Authority for Chemicals, the content being indicated by Article 10 of the OBP-Implement).
All proposed changes are to be arranged into a procedural category. The procedural categories are:
- administrative changes,
- minor changes,
- major changes.
Notification of administrative changes
Insofar as administrative changes are concerned, the authorisation holder is obliged to notify the matters under consideration to the Notification Authority. The technical term for this is Notification.The Notification Authority for Chemicals requires payment of an advance on the fee. After receiving the advance on costs, it will decide on the application within 30 days.
It should be noted that certain changes have to be notified prior to their implementation, whereas other changes must be notified within 12 months after their implementation. Key examples of both types of changes are presented in Title 1 of the Annex of the Implementing Regulation (EU) No 354/2013.
Application for minor or major changes
Applications for minor and major changes shall be addressed to the Notification Authority for Chemicals before their implementation. In both cases the Notification Authority will demand the payment of a deposit for the fee, which has to be paid within 30 days.
After receiving the advance on costs, the Notification Authority for Chemicals validates the application. If the application is complete, it begins the evaluation of the application.
If Switzerland acts as the evaluating authority:
For minor changes, the evaluation of the application takes place within 90 days. For major changes, the evaluation takes place within 180 days. This is followed by the commenting phase with the concerned Member States and the authorisation decision is made within 30 days.
If Switzerland acts as the recognising authority and the application was submitted sequentially:
For minor changes, a decision is issued within 75 days; for major changes within 120 days
Annex Title 2 of Implementing Regulation (EU) No. 354/2013 describes the scope of minor changes. This also defines a demarcation to major changes.
Application
The application for a change must include the following information:
- a list of all the authorisations affected by the proposed changes,
- if applicable, the draft of a revised SPC in an official language of Switzerland; for an authorisation based on mutual recognition, the SPC can also be kept in English only;
- a description of all requested changes;
- a description of the connection between the changes, provided a change is the cause or the result of other changes of the conditions of the same authorisation; the ECHA provides a specific form for each type of variation on its website.
- all relevant documentation to demonstrate that the conclusions of the initial or, where applicable, the previous assessment remain valid.
- For AL authorisations, a PAR adapted to the changes must also be submitted
Before submitting the application for a change, we recommend consulting the following guidance documents:
Practical guide on changes to biocidal products
BSM Application instructions: How to submit an application for National Authorisation
Fees
The scale of fees for recognitions ranges from CHF 320 to 500 for administrative changes, CHF 1000 for minor changes and CHF 2000 for major changes.
The scale of fees for authorisations AL ranges from CHF 320 to 500 for administrative changes, CHF 1000 to 3600 for minor changes and CHF 4000 to 10 000 for major changes.
The fee for biocidal product families is made up of the basic fee for the relevant authorisation (e.g. Authorisation AN, CHF 1000). In the case of biocidal product families with one sub-family, the basic fee is increased by 50%. An increase of a further 25% is made for each additional sub-family. 10 biocidal products may be included in each sub-family. For each additional biocidal product in a sub-family, the fee increases by one per cent. No additional charge is made for biocidal products in a biocidal product family or sub-family that do not differ (i.e. whether in their use, method of use etc.) other than by their concentration of pigments, colorants or fragrances.
In all cases, the Notification Authority will require payment of an advance on costs for the fee, which must be paid within 30 days.