Pre-submission meeting for biocidal products

Do you wish to discuss specific points or bottlenecks in your dossier, do you have questions about procedures or are there any substantive aspects that are unclear? In any of these cases, please do not hesitate to request a pre-submission meeting. This meeting is intended for applicants (authorisations for products or substances under the Biocidal Products Regulation) who have already indicated when they will submit their dossier. These can be applications for national authorisation, but also for Union authorisations.

The Ctgb offers the pre-submission meetings to help applicants improve the quality of their dossiers. During a pre-submission meeting the Ctgb answers procedural and substantive questions, and your points for discussion or bottlenecks are addressed. Following the meeting, you will receive a report with the recommendations that were discussed. During a pre-submission meeting, the Ctgb does not make any statements about the completeness of your dossier, but it can ascertain shortcomings. It is not a formal assessment of the dossier, and in that sense no rights can be derived from the meeting. During the pre-application phase the Ctgb does not conduct any assessments of dossiers or components of dossiers.

Experience with the pre-submission meetings for plant protection products has shown that such a meeting improves the likelihood of a successful application. According to expectations, the costs of the pre-submission meeting are justified later on in the assessment process, because the meeting helps you to submit a higher-quality dossier. For applications submitted under the Biocidal Products Regulation, the Ctgb validates an application preceding the assessment. In this validation, it determines whether the application is administratively correct. The dossier is substantively reviewed only during the assessment phase. During this phase, applicants have only a single possibility to submit supplementary information. For example, if the exact use or the composition of the substance must be clarified during the assessment process – if the risk assessment necessitates this – and no possibilities remain to submit this information, the Ctgb may be compelled to reject the application.

Due to planning requirements, please request a pre-submission well in advance.

For the pre-submission meeting, an advance payment of €10,000 is required. The actual costs of the meeting are calculated on the basis of subsequent costing, in accordance with the Ctgb Tariffs Decree. Four weeks before the meeting, the Ctgb must have received the following:

  • the advance payment of €10,000
  • a list with the questions and bottlenecks
  • the dossier in accordance with the prescribed formatting, including a draft Product Assessment Report (PAR) and corresponding studies. The dossier must therefore include the risk assessment.

Please take account of these requirements. Supplementary information and questions that are not submitted well in advance will not be processed by the Ctgb. If the advance payment is not received within four weeks before the meeting, the Ctgb will cancel the meeting.

If you have questions or special needs, please contact the account manager.

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