Commission Regulation (EC) No 658/2007 of 14 June 2007 concerning financial penal... (32007R0658)
INHALT
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
- 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
- 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
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