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Allinone approach

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Title: Allinone approach


1
All-in-one approach
Seminar for Biocides Authorities, Sofia, 19 April
2006 Elisabeth Fassold Expert Centre Biocides
2
Overview
  • Application dossier requirements
  • Biocidal substances
  • Biocidal products
  • Guidance
  • Work with the all-in-one approach
  • CA report information transfer

3
Application dossier requirements I
  • Legal provisions, biocidal substances
  • BPD Article 11, Procedure for inclusion of an
    active substance in Annex I, IA or IB
  • 2nd Review Regulation (EC) No 2032/2003, Annex
    IV, Requirements for the complete dossier and
    the summary dossier
  • Legal provisions, biocidal products
  • BPD Article 8, Requirements for authorisation

4
Application dossier requirements IIbiocidal
substances
  • Annex IV, Requirements for the summary dossier
  • (b) The summary dossier must include the
    following
  • in the case of a collective dossier, the name
    of all participants concerned and a person
    designated by them as being responsible for
    the collective dossier and the processing of the
    dossier in accordance with this Regulation
  • for each point of Annex IIA and IIB, or Annex
    IVA and IVB, to Directive 98/8/EC, and where
    specified the relevant parts of Annex IIIA and
    IIIB to the Directive, the summaries and results
    of studies and trials
  • list of references used
  • risk assessment
  • overall summary and assessment
  • a check by the participant or, where
    appropriate, by the person designated as
    responsible for a collective dossier of the
    completeness of the dossier.

5
Application dossier requirements III biocidal
substances
  • Annex IV, Requirements for the summary dossier
  • (c) The formats made available by the Commission
    must be used for submission of the dossiers. In
    addition, the special software package (IUCLID)
    made available by the Commission must be used
    for those parts of the dossiers to which IUCLID
    applies. Formats and further guidance on data
    requirements and dossier preparation are
    available on the ECB homepage at
    http//ecb.jrc.it/biocides.

6
Application dossier requirements IV biocidal
substances
  • Annex IV, Requirements for the summary dossier
  • (d) For existing active substances that have been
    or are being evaluated under the review
    programme for plant protection products in
    accordance with Article 8(2) of Directive
    91/414/EEC , the required format for an
    application for inclusion in Annex I thereto may
    be used for the preparation of the dossier for
    inclusion of the existing active substance in
    Annex I, IA or IB to Directive 98/8/EC, taking
    into account relevant differences in the dossier
    requirements. A summary of the dossier must be
    entered in IUCLID. Additional information
    related to the biocidal use must be submitted in
    accordance with the requirements of this
    Regulation.

7
Guidance
  • European Chemicals Bureau http//ecb.jrc.it/bioci
    des/
  • Technical Notes for Guidance (TNsG) on
    Preparation of Dossiers and Study Evaluation
  • includes all details on the all-in-one approach

8
Application dossier - substances
  • Dossier Structure
  • National application form and other legal
    requirements
  • Active Substance Annex I/IA inclusion plus
    Representative Product
  • Application form (EU)
  • Completeness check forms
  • Study summaries - Doc III
  • Risk assessment - Doc II
  • Summary - Doc I
  • Test and study reports (Doc IV)
  • IUCLID file (supplement to Doc III)

9
Structure of the dossier
TNsG on Preparation of Dossiers, modified to
practical use
10
Work with the all-in-one approachCompleteness
check
Application form - doc I
11
Work with the all-in-one approachCompleteness
check
Serves for
? communication with applicant
? after completeness confirmed it is sent to
applicant ? summary dossier
  • after evaluation, all in one into CA report

12
Work with the all-in-one approachCompleteness
check, quality of data
Completeness check form
13

Work with the all-in-one approachEvaluation
Study summary - doc III
  • after evaluation, all-in-one into CA report

14
Risk assessment - doc II
Doc. II Risk Assessment
Doc. II-C Risk Characterisationfor Use of A.S.
in B.P.(s)
Doc II-AEffects and ExposureAssessmentActive
Substance
  • The risk assessment should be performed by the CA
    based on
  • the risk assessment submitted by the applicant
  • the critically evaluated study summaries
  • other relevant information

LIMITED ALL IN ONE
15
Doc. IEvaluationReport
  • Statement of subject matter and purpose
  • Overall summary and conclusions
  • Proposal for the decision
  • Background for decision
  • Proposed decision on inclusion in I, IA
  • Justification for the restriction(s)
  • Demand for further information
  • Appendix List of end points
  • List of abbreviations
  • Check for completeness

16
CA Report information transfer I
17
CA Report information transfer II
18
Product authorisation/registration- dossier
structure
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