European Commission 14 June 2007, Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council

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European Union · · · Cited by 40 · 14-06-2007

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject-matter and scope
Article 2. Complementarity of procedures
Article 3. Cooperation by the competent authorities of the Member States
Article 4. Burden of proof
CHAPTER II. INFRINGEMENT PROCEDURE
SECTION 1. Inquiry
Subsection 1. Initiation of procedure
Article 5. Initiation of the infringement procedure
Article 6. Request for information
Article 7. Notification
Subsection 2. Measures of inquiry
Article 8. Requests by the Agency
Article 9. Right to be heard
Subsection 3. Report
Article 10. Content and time-limits
SECTION 2. Decision-making stage
Subsection 1. Procedure
Article 11. Statement of objections
Article 12. Right to reply
Article 13. Oral hearing
Article 14. Requests for information
Article 15. New period of inquiry
Subsection 2. Decision and financial penalties
Article 16. Forms of financial penalty and maximum amounts
Article 17. Decision
Article 18. Principles governing the application and quantification of financial penalties
SECTION 3. Non-cooperation
Article 19. Financial penalties
Article 20. Procedure
CHAPTER III. ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS
Article 21. Access to the file
Article 22. Legal representation
Article 23. Confidentiality and professional secrecy
Article 24. Application of time-limits
Article 25. Limitation periods for the imposition of financial penalties
Article 26. Limitation periods for the collection of financial penalties
CHAPTER IV. FINAL PROVISIONS
Article 27. Transitional provision
Article 28. Entry into force

15.6.2007

Official Journal of the European Union

L 155/10

COMMISSION REGULATION (EC) No 658/2007

of 14 June 2007

concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard

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