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Commission Implementing Regulation (EU) No 844/2012Show full title

Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER 1 ADMISSIBILITY

    1. SECTION 1 Application for renewal

      1. Article 1.Submission of the application

      2. Article 2.Format and contents of the application

      3. Article 3.Checking of the application

      4. Article 4.Contacts prior to submission of supplementary dossiers

      5. Article 5.Access to the application

    2. SECTION 2 Supplementary dossiers

      1. Article 6.Submission of supplementary dossiers

      2. Article 7.Contents of supplementary dossiers

      3. Article 8.Admissibility of the application

      4. Article 9.Replacement of the applicant

      5. Article 10.Refusal of renewal where applications are inadmissible

  3. CHAPTER 2 ASSESSMENT

    1. Article 11.Assessment by the assessing competent authority

    2. Article 11a.For the purposes of assessment of the approval criteria set...

    3. Article 11b.The Agency shall endeavour to adopt the opinion on a...

    4. Article 12.Comments on the draft renewal assessment report

    5. Article 13.Conclusion by the assessing competent authority

    6. Article 13a.Fees and charges

    7. Article 14.Renewal decision

  4. CHAPTER 3 TRANSITIONAL AND FINAL PROVISIONS

    1. Article 15.Transitional provisions

    2. Article 16.Entry into force and application

  5. Signature

    1. ANNEX

      Format for applications, as provided for in Article 2(1)

      1. The application shall be in writing, signed by the applicant,...

      2. A copy of the application shall be sent to the...

      3. MODEL

        1. 1. Information concerning the applicant

          1. 1.1. Name and address of the applicant including the name of...

        2. 2. Information to facilitate identification

          1. 2.1. Common name (proposed or ISO-accepted) specifying, where relevant, any variants...

          2. 2.2. Chemical name (IUPAC and CAS nomenclature).

          3. 2.3. CAS, CIPAC and EC numbers (if available).

          4. 2.4. Empirical and structural formula, molecular mass.

          5. 2.5. Specification of purity of the active substance in g/kg which...

          6. 2.6. Classification and labelling of the active substance in accordance with...

        3. 3. New information

          1. 3.1. List of new information intended to be submitted together with...

          2. 3.2. List of new studies intended to be submitted on vertebrate...

          3. 3.3. Timetable of any new and ongoing studies.

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