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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)

OJ L 378, 27/12/2006, p. 1–19 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, SK, SL, FI, SV)
This document has been published in a special edition(s) ( BG, RO, HR)

OJ L 378, 27/12/2006, p. 1–19

Latest consolidated version:

28/01/2019

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE EVALUATION Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

SWD/2020/0164 final

COMMISSION STAFF WORKING DOCUMENT EVALUATION Joint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products

SWD/2020/0163 final

Decision of the EEA Joint Committee No 92/2017 of 5 May 2017 amending Annex II (Technical regulations, standards, testing and certification) and Annex XVII (Intellectual Property) to the EEA Agreement [2019/204]

OJ L 36, 07/02/2019, p. 41–43 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 36, 07/02/2019, p. 41–43

European Parliament resolution of 15 December 2016 on the regulation on paediatric medicines (2016/2902(RSP))

OJ C 238, 06/07/2018, p. 128–131 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ C 238, 06/07/2018, p. 128–131

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL State of Paediatric Medicines in the EU - 10 years of the EU Paediatric Regulation

COM/2017/0626 final

Council Decision (EU) 2017/715 of 27 March 2017 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement (Paediatric Regulation)

OJ L 105, 21/04/2017, p. 15–20 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ L 105, 21/04/2017, p. 15–20

Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical Regulations, Standards, Testing and Certification) and Annex XVII (Intellectual Property) to the EEA Agreement (Paediatric Regulation)

COM/2017/013 final - 2017/05 (NLE)

Case T-583/13: Order of the General Court of 3 September 2014 — Shire Pharmaceutical Contracts v Commission (Action for annulment — Medicinal products for paediatric use — Regulation (EC) No 1901/2006 — Article 37 — Extension of the period of market exclusivity of off-patent orphan medicinal products — Act not amenable to review — Inadmissibility)

OJ C 431, 01/12/2014, p. 23–23 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ C 431, 01/12/2014, p. 23–23

Communication from the Commission — Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies Text with EEA relevance

OJ C 338, 27/09/2014, p. 1–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

OJ C 338, 27/09/2014, p. 1–17