Pre-submission meeting for national- and Union authorisation applications
- Applicant to approach the competent authority (CA) via the Ctgb Account Manager not later than 18 months before the expected date of submission of the application and, in addition, the approval date of the active substance(s) must be published via an Implementing Regulation.
- The applicant presents (to the Ctgb Account manager) the biocidal product family (BPF) including relevant information:
- i.e. active substance(s) (AS(s)), product types (PT(s)), intended use(s), user category/ies, the number of meta-SPCs foreseen and the number of products in the BPF
- e.g. list of foreseen concerned Member States (cMSs) in case of mutual recognition (MR) procedures, number of (existing) products covered by the BPF, etc
- The Ctgb Account Manager checks whether the application can be accepted according to the workplan as approved by the Ctgb management.
- Once the applicant has the eCA agreement of the CA to conduct the evaluation, the applicant will not contact other CA’s for this purpose and should inform other CAs of the agreement reached with the eCA.
- After an eCA agreement has been signed, the pre-submission(s) meeting can be organized.
Setting and responsibilities:
a. The applicant contacts the Ctgb Service Desk. The Servicedesk informs the applicant about the PSM procedure and administrative requirements and coordinates the administrative handling, including invoicing, of the PSM.
b. The applicant shall propose a draft agenda (based on the proposal below) and will submit background documents for the preparation of the meeting, including specific questions for the different parts of the evaluation. The applicant will have to provide the overview of the BPF according to the overview Excel template agreed upon at CG-21. After receiving the necessary documents, the Service Desk will discuss the date of the meeting with the applicant and the Ctgb Planning Bureau.
c. The length of the meeting will be established by the eCA according to the draft agenda proposed by the applicant.
d. At the meeting, the applicant briefly presents the intended use(s) of the products covered by the BPF and the eCA gives recommendations and advices on the issues identified by the applicant. The eCA gives an indication on whether the BPF structure and the worst case(s) identified by the applicant might be acceptable or not. In case the eCA disagrees based on the presented data during the pre-submission meeting, the applicant shall address these concerns before the submission of the application.
e. The meeting should identify specific scope or PT allocation issues, as well as technical matters for which there is no agreed harmonized approach in Guidances or TAB’s. In these cases the eCA might need to consult the other member states (e-consultations of one of the WGs, HelpEx, or e-consultation of the CG, depending on the issue) in order to obtain a proposed way forward.
f. The applicant should prepare minutes ofthe meeting which are afterwards checked (and updated if necessary) by the eCA. It is the responsibility of the applicant that these minutes reflect all the items discussed and action points agreed during the meeting and the relevant deadlines.
2. Agenda / Content
The following issues are to be discussed during the pre-submission meeting in relation to BPF applications:
a. 1st level: Overall information on the BPF. What is the argumentation for similar uses, similar composition and similar levels of risk and efficacy within the whole BPF?
b. 2nd level: Meta SPCs. How many meta-SPCs are planned, how are they divided and what is the argumentation for this division?
c. Are there any specific information requirements for the BPF?
d. Testing strategy to secure that the whole range of meta-SPCs is covered by the assessment, i.e. for:
- Physical/chemical: including definition of representative products at BPF/Meta SPCs level (for each end point) that cover all lower and higher limits of each (co-)formulant at meta SPC level (or BPF level)
- Efficacy: including definition of representative products at BPF/Meta SPCs level, co-formulant impact on efficacy and the definition of the worst case, (soiling etc.). In case of lacking guidance the testing strategies need to be agreed with the eCA, possibly in a written procedure.
- Human and animal health
e. Definition of worst case risk assessments strategy for environment and human/animal health as well as for efficacy.
f. Where relevant, Article 5(2) assessment and/or comparative assessment. – Where a BPF contains an active substance which is candidate for substitution, the intended uses within each meta-SPC will be subject to comparative assessment. As a result, all or some of those uses could be eventually prohibited or restricted where suitable alternatives meeting the conditions of Article 23(3) of the BPR are available.
g. Practical issues, such as expected CA fee for the suggested BPF (eCA should urge the applicant to contact ECHA regarding their fees) and timelines regarding the application submission.
h. Applicant to present compliance or identified issues with the Ctgb Validation Checklists.
3. Limitations / disclaimer
Before the pre-submission takes place the applicant should be informed about the following limitations of the support that the eCA can provide:
a. The eCA is willing to provide all necessary support to the applicant, but it cannot and will not replace the assistance the applicant can get from his own experts or by hiring a consultancy.
b. Any recommendation provided by the eCA is based on the data provided by the applicant for the meeting and does not anticipate the outcome of the dossier evaluation.
c. The eCAs’ comments are non-binding recommendations and it is still up to the applicants to decide how to implement these recommendations or even find a better solution. The applicant is fully responsible for the quality and pertinence of the data submitted with the application.
d. The eCA in general is not in the position to participate in the development of new test strategies or approaches for exposure and/or risk assessment and risk mitigation measures. For such developments, the applicant is advised to rely on their own expertise or hire external expertise at their own expenses. However, the applicant is invited to present their intended strategy and discuss it with the eCA on a generic level.