Introductory Text
CHAPTER 1 SUBJECT MATTER AND SCOPE
Article 1.Subject matter
Article 2.Scope
CHAPTER 2 NOTIFICATION AND ADVICE PRIOR TO THE SUBMISSION OF THE APPLICATION FOR RENEWAL
Article 3.Notification of intended studies and advice on intended studies
Article 4.General pre-submission advice
CHAPTER 3 SUBMISSION AND ADMISSIBILITY OF THE APPLICATION FOR RENEWAL
Article 5.Submission of the application for renewal
Article 6.Content of the application for renewal
Article 7.Format and software for the submission of the application for renewal
Article 8.Admissibility of the application for renewal
Article 9.Adoption of a non-renewal Regulation
Article 10.Public access to the information in the application for renewal and consultation of third parties
CHAPTER 4 ASSESSMENT AND RENEWAL REPORT AND REGULATION
Article 11.Assessment by the rapporteur Member State and the co-rapporteur Member State
Article 12.Comments on the draft renewal assessment report
Article 13.Conclusion by the Authority
Article 14.Renewal report and renewal Regulation
CHAPTER 5 REPLACEMENT OF THE APPLICANT, FEES AND CHARGES
Article 15.Replacement of the applicant
Article 16.Fees and charges
CHAPTER 6 FINAL PROVISIONS
Article 17.Repeal
Article 18.Entry into force and application
Signature