Published on 5 June 2025

Extension/Renewal of existing authorisations

For a biocidal product that has obtained an authorisation according to the harmonised European procedure, the period of validity can be extended by means of a corresponding application.

Prerequisites / Basics

National authorisations according to the harmonised European procedure are normally valid for a maximum period of 10 years.

To ensure that a national authorisation according to the harmonised European procedure that was the subject of mutual recognition can be extended together with the reference authorisation, the same terms and conditions of authorisation must apply to both the reference authorisation and the recognition (in accordance with Art. 1 (2) or (3) EU 492/2014).
In other words, deviations of the recognition from the reference authorisation (AL) are limited to:

  • changes of an administrative nature (in accordance with (EU) no. 354/2013) or
  • restrictions ordered by the authorities based on Art. 37 BPR

If the terms and conditions of authorisation for the recognition versus those of the national authorisation (AL) differ from the above, a separate application for extension must be submitted for the recognition. In this case, grouped submission of the extension of the recognition with the national authorisation (AL) is not possible.

Procedure

  • Applications for recognition in parallel are to be submitted exclusively through the Register for Biocidal Products R4BP 3 at the Notification Authority for Chemicals (see internet links).
  • The application for the extension of a recognition should be submitted to the Notification Authority at the same time as the application for extension of the authorisation in the reference state.
  • The application for extension must be submitted via R4BP at least 550 days prior to the expiration of the authorisation.
  • The processing time by the authorities for a non-comprehensive evaluation is 270 days and for a full evaluation 455 days. This is followed by the commenting phase with the concerned Member States and the authorisation decision is made within 30 days.
  • National authorisations according to the harmonised European procedure are normally prolonged for a maximum period of 10 years.

Application

An application for extension of a national authorisation (AL) – also known as a first authorisation, or a reference authorisation – or Union authorisation should be submitted to the national authority that assessed the first application (reference member state). If the national authorisation (AL) was the subject of mutual recognition, the application for extension must also be submitted concurrently to all member states in which the national authorisation (AL) was recognised (in R4BP as a grouped submission). The application for extension must be submitted via R4BP at least 550 days prior to the expiration of the authorisation.

The application must contain the following information:

  • the name of the EU or EFTA Member State that granted the authorisation and that assesses the application for extension, or the name of the EU or EFTA Member State selected by the applicant, together with the confirmation that this State has already agreed to assess the application (Reference State);
  • a list of the EU and the other EFTA Member States in which the authorisation or recognition is to be extended, together with the issued authorisation numbers;
  • confirmation by the applicant that these authorisations fulfil the requirements specified in Article 15b of the OBP-Implement; i.e. that these differ only in administrative changes (in accordance with Annex Title 1 of Regulation (EU) No. 354/2013) or restrictions imposed by the authorities on the basis of Art. 37 BPR.
  • the draft of the SPC: in an official language of Switzerland or in English. After the reference Member State has completed the assessment, the applicant must submit an SPC in the language of the decision; i.e. in an official national language.

In addition, for authorisations AL and Union authorisations that have been assessed by Switzerland (in individual cases, subsequent documents may also be requested from the Notification Authority for Chemicals for recognition):

  • All data required according to Annex 5 OBP that has been generated by the applicant since the authorisation or, if applicable, since the last renewal,
  • the applicant's assessment as to whether the conclusions of the first or, where applicable, the previous evaluation are still valid, together with the relevant information.

Before the application for extension is submitted, we recommend consulting the following guidelines:

Practical guide on renewal of national authorisation and authorisations subject to mutual recognition

Biocides Submission Manual How to submit an application for National Authorisation, chapter 7.

Fees

The fees are CHF 500 – 10,000 (without comprehensive assessment) or CHF 11,000 – 45,000 (comprehensive assessment) for assessment of an extension of a first authorisation AL, or CHF 500 – 1,300 for renewal/extension of a national authorisation based on the recognition procedure.