Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 ... (32006R1901)
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Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
- REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 12 December 2006
- on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
- (Text with EEA relevance)
- TITLE I
- INTRODUCTORY PROVISIONS
- CHAPTER 1
- Subject matter and definitions
- Article 1
- Article 2
- CHAPTER 2
- Paediatric committee
- Article 3
- Article 4
- Article 5
- Article 6
- TITLE II
- MARKETING AUTHORISATION REQUIREMENTS
- CHAPTER 1
- General authorisation requirements
- Article 7
- Article 8
- Article 9
- Article 10
- CHAPTER 2
- Waivers
- Article 11
- Article 12
- Article 13
- Article 14
- CHAPTER 3
- Paediatric investigation plan
- Section 1
- Requests for agreement
- Article 15
- Article 16
- Article 17
- Article 18
- Article 19
- Section 2
- Deferrals
- Article 20
- Article 21
- Section 3
- Modification of a paediatric investigation plan
- Article 22
- Section 4
- Compliance with the paediatric investigation plan
- Article 23
- Article 24
- CHAPTER 4
- Procedure
- Article 25
- CHAPTER 5
- Miscellaneous provisions
- Article 26
- TITLE III
- MARKETING AUTHORISATION PROCEDURES
- Article 27
- CHAPTER 1
- Marketing authorisation procedures for applications falling within the scope of Articles 7 and 8
- Article 28
- Article 29
- CHAPTER 2
- Paediatric use marketing authorisation
- Article 30
- Article 31
- CHAPTER 3
- Identification
- Article 32
- TITLE IV
- POST-AUTHORISATION REQUIREMENTS
- Article 33
- Article 34
- Article 35
- TITLE V
- REWARDS AND INCENTIVES
- Article 36
- Article 37
- Article 38
- Article 39
- Article 40
- TITLE VI
- COMMUNICATION AND COORDINATION
- Article 41
- Article 42
- Article 43
- Article 44
- Article 45
- Article 46
- TITLE VII
- GENERAL AND FINAL PROVISIONS
- CHAPTER 1
- General provisions
- Section 1
- Fees, community funding, penalties and reports
- Article 47
- Article 48
- Article 49
- Article 50
- Section 2
- Standing committee
- Article 51
- CHAPTER 2
- Amendments
- Article 52
- ‘Article 15a
- Revocation of an extension of the duration
- ‘Article 17
- Appeals
- Article 53
- Article 54
- Article 55
- ‘Article 73a
- CHAPTER 3
- Final provisions
- Article 56
- Article 57
- COMMISSION STATEMENT
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