Introductory Text
CHAPTER 1 ADMISSIBILITY
SECTION 1 Application for renewal
Article 1.Submission of the application
Article 2.Format and contents of the application
Article 3.Checking of the application
Article 4.Contacts prior to submission of supplementary dossiers
Article 5.Access to the application
SECTION 2 Supplementary dossiers
Article 6.Submission of supplementary dossiers
Article 7.Contents of supplementary dossiers
Article 8.Admissibility of the application
Article 9.Replacement of the applicant
Article 10.Refusal of renewal where applications are inadmissible
CHAPTER 2 ASSESSMENT
Article 11.Assessment by the assessing competent authority
Article 11a.For the purposes of assessment of the approval criteria set...
Article 11b.The Agency shall endeavour to adopt the opinion on a...
Article 12.Comments on the draft renewal assessment report
Article 13.Conclusion by the assessing competent authority
Article 13a.Fees and charges
Article 14.Renewal decision
CHAPTER 3 TRANSITIONAL AND FINAL PROVISIONS
Article 15.Transitional provisions
Article 16.Entry into force and application
Signature
ANNEX
Format for applications, as provided for in Article 2(1)
The application shall be in writing, signed by the applicant,...
A copy of the application shall be sent to the...
MODEL
1. Information concerning the applicant
1.1. Name and address of the applicant including the name of...
2. Information to facilitate identification
2.1. Common name (proposed or ISO-accepted) specifying, where relevant, any variants...
2.2. Chemical name (IUPAC and CAS nomenclature).
2.3. CAS, CIPAC and EC numbers (if available).
2.4. Empirical and structural formula, molecular mass.
2.5. Specification of purity of the active substance in g/kg which...
2.6. Classification and labelling of the active substance in accordance with...
3. New information
3.1. List of new information intended to be submitted together with...
3.2. List of new studies intended to be submitted on vertebrate...
3.3. Timetable of any new and ongoing studies.