CA-Sept12-Doc.6.2.b- Final

PA&MRFG-Sept12-Doc.12.3 - Final

Representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market

Compliance check of applications submitted for the authorisation of biocidal products

Note for Guidance to Member States

1.Introduction

2. Data protection

3. Technical equivalence

4. Alternative suppliers

5.Evaluation of new data on the active substance

1.Introduction

This document is intended to give guidance to Member States Competent Authorities on issues that may arise at the time of checking the compliance of applications submitted for the authorisation of biocidal products.

2. Data protection

The evaluating Competent Authority shall check that the applicant demonstrated access to the required data on the active substance. This may be achieved in a number of ways:

  • By reference to information previously submitted on the active substance to support inclusion in Annex I, which is not protected in accordance with Article 12 of Directive 98/8/EC.
  • By providing evidence of access to the information submitted to support inclusion in Annex I(A), which is protected in accordance with Article 12 of Directive 98/8/EC (see Guidance document on letters of access).
  • By providing alternative and equivalent studies, including published studies, to those protected. In this case, a complete dossier ('alternative supplier' dossier) satisfying the requirements of Annex IIA and IIIA has to be submitted.
  • By providing a case justifying why certain data are not relevant to the uses which are claimed to be supported.

3. Technical equivalence

In case where the source of the active substance contained in the product under consideration is different from the reference source (i.e. the source on which the risk assessment for the purpose of the Annex I inclusion was based), the applicant has to demonstrate that the new source is equivalent to the reference one.

In consequence, the evaluating Competent Authority shall check and determine the technical equivalence of the new source by comparison with the reference source (see also TNsG on technical equivalence and Evaluation Manual chapter 2 Identity).

The evaluating Competent Authority shall prepare a report on the equivalence of the technical specification of the new source using the agreed template.

Reports on technical equivalence shall be made available on CIRCA in a folder under CA-reports/the active substance/PT in question.

If the active substance is not technically equivalent to the one included into Annex I(A), the requirements laid down in these Annexes will not be fulfilled and the biocidal product shall not be authorised.

4.Alternative suppliers

Certain applicants for product authorisation will, instead of a letter of access to a dossier, submit their own dossier on the active substance. This is most likely to be the case when the source of supply of the active substance differs from the one, which supported the Annex I(A) inclusion of the active substance.

The dossier submitted by the applicant shall meet the requirements of Article 8(2)(b) of the Directive.

Where alternative and equivalent studies are submitted, the onus will be placed on the applicant to demonstrate the equivalence of those studies in terms of their support of the agreed end-points and the data protection status of such studies in accordance with Article 12 of Directive 98/8/EC.

Once the technical equivalence has been established, the evaluating Competent Authority will be expected:

- to check that the requirements of Article 8(2)(b) are met, by checking that data, letter of access to data or references to public data, as the case maybe, have been provided,and that the information submitted isof sufficient quality and adequate; and

- to investigate if the new submitted studies lead to different conclusions compared to those submitted in support of the Annex I(A) inclusion.

Only in those cases where an endpoint differs significantly from the one in the list of endpoints (LoEP) agreed at the time of the Annex I inclusion, and when the information provided for the relevant endpoint is of sufficient quality and adequate, should the information in question be assessed in more detail.

In particular, where endpoints are more critical than the ones in the LoEP, the evaluating Competent authority shall assess the information and determines whether the Annex I(A) inclusion needs to be reviewed.

If not, these new data on the active substance will be integrated into the LoEP at the time of the renewal of the Annex I(A) renewal.

Conclusions on compliance checks of 'alternative supplier' dossier shall be made available on CIRCA in a folder under CA-reports/the active substance/PT in question.

5.Evaluation of new data on the active substance

When new data on the active substance are submittedpursuant to requirements of the assessment report and/or the inclusion Directive, these should be evaluated by the ReferenceMemberState(s) (as opposed to the RapporteurMemberState).

However, before starting the evaluation, the Reference Member State should check if these data have been submitted to other Reference Member States and, if that is the case to see whether the evaluation can be organised in such a way as to avoid that these same data are assessed in parallel by different Reference Member States.

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