Council of the European Union and European Parliament 12 December 2006, 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)

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European Union · · · Cited by 2,874 · 27-12-2006

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 53.
Article 54.
Article 55.
CHAPTER 3. Final provisions
Article 56.
Article 57.

27.12.2006

Official Journal of the European Union

L 378/1

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)

THE EUROPEAN PARLIAMENT AND THE

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