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.
Procedure for modifying other authorisations according to the European harmonized procedure
Modifications to authorisations according to the European harmonized procedure are treated in a procedure governed by the Ordinance on the Implementation of Biocidal Products FDHA (OBP-Implement; SR 813.121). This procedure takes into account the Implementing Regulation (EU) No 354/2013 .
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 pursuant to Article 24 paragraph 2 OBP, the criteria being taken into account in accordance with the Annex of the Implementing Regulation (EU) No 354/2013. 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. 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 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. Details of the procedure are to be found in Articles 12-15 of the OBP-Implement or (after entry into force of the updated MRA) in accordance with the workflow in the R4BP 3.
The scale of fees 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.
Last modification 24.01.2017