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)
- In force
- CELEX number: 32006R1901
- Official Journal: JOL_2006_378_R_0001_01
- Form: Regulation
- Procedure number: 2004/0217(COD), 2004/0217/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - December 12, 2006
- December 27, 2006
- January 26, 2007
- Entry into force - Date pub. + 30 See Art 57.1
- July 26, 2007
- Partial application - See Art 57.2
- July 26, 2008
- Partial application - See Art 57.2
- January 26, 2009
- Partial application - See Art 57.2
Modified by
Modified by:
- Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use (Text with EEA relevance) - detail
- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance - detail
- Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance ) - detail
- Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance) - detail
Amendment proposed by:
- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
- Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
All documents based on this document:
Modifies
Modifies:
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
- Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
Affected by case
- Judgment of the Court (Second Chamber) of 21 June 2018. Pfizer Ireland Pharmaceuticals, Operations Support Group v Orifarm GmbH. Request for a preliminary ruling from the Landgericht Düsseldorf. Reference for a preliminary ruling — Intellectual and industrial property — Patent law — Acts of Accession to the European Union of 2003, 2005 and 2012 — Specific Mechanism — Whether applicable to parallel imports — Regulation (EC) No 469/2009 — Product protected by a supplementary protection certificate in a Member State and marketed by the holder of the basic patent in another Member State — Exhaustion of intellectual and industrial property rights — No basic patent in the new Member States — Regulation (EC) No 1901/2006 — Extension of the protection period. Case C-681/16.
- A36P1
- Judgment of the Court (Second Chamber) of 8 December 2011. Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt. Reference for a preliminary ruling: Bundespatentgericht - Germany. Intellectual and industrial property - Patents - Regulation (EEC) No 1768/92 - Article 13 - Supplementary protection certificate for medicinal products - Possibility of granting that certificate where the period that has elapsed between the date of the lodging of the basic patent application and the first marketing authorisation in the European Union is less than five years - Regulation (EC) No 1901/2006 - Article 36 - Extension of the duration of the supplementary protection certificate. Case C-125/10.
- A36
- Case C-681/16: Request for a preliminary ruling from the Landgericht Düsseldorf (Germany) lodged on 27 December 2016 — Pfizer Ireland Pharmaceuticals, Operations Support Group v Orifarm GmbH
Legal basis
- Treaty establishing the European Community (Nice consolidated version) Part Five: Institutions of the Community Title I: Provisions governing the institutions Chapter 2: Provisions common to several institutions Article 251 Article 189b - EC Treaty (Maastricht consolidated version)
- Treaty establishing the European Community (Nice consolidated version) Part Three: Community policies Title VI: Common rules on competition, taxation and approximation of laws Chapter 3: Approximation of laws Article 95 Article 100a - EC Treaty (Maastricht consolidated version)
EuroVoc Vocabulary
- Paediatrics
- Medical research
- Market approval
- Public health
- Proprietary medicinal products
- Medicinal products
- Drug surveillance
- Plant health legislation
- Medicinal product
- European Medicines Agency
- Testing
- Technical barriers