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52009XX0923(04)
Opinion of the European Data Protection Supervisor on the proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, 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, and on the proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
OJ C 229, 23.9.2009, p. 19–26 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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32009L0120
Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance)
OJ L 242, 15.9.2009, p. 3–12 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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22009D0061
Decision of the EEA Joint Committee No 61/2009 of 29 May 2009 amending Annex II (Technical regulations, standards, testing and certification) and Protocol 37 to the EEA Agreement
OJ L 232, 3.9.2009, p. 13–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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32009L0035
Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance)
OJ L 109, 30.4.2009, p. 10–13 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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32007R1394R(01)
Corrigendum to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 ( OJ L 324, 10.12.2007 )
OJ L 87, 31.3.2009, p. 174–174 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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32004R0726R(02)
This corrigendum does not concern the English version.
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52008PC0664
Proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, 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 {SEC(2008) 2670} {SEC(2008) 2671}
/* COM/2008/0664 final - COD 2008/0257 */
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52008SC2671
Commission staff working document - Accompanying document to the :
Proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, 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 and the :
Proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Summary of the impact assessment {COM(2008) 664 final} {COM(2008) 665 final} {SEC(2008) 2670}
/* SEC/2008/2671 final */
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52008SC2670
Commission staff working document - Accompanying document to the :
Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, 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 and the :
proposal for a directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
Impact assessment {COM(2008) 664 final} {COM(2008) 665 final} {SEC(2008) 2671}
/* SEC/2008/2670 final */
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52008XC0924(01)
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
OJ C 243, 24.9.2008, p. 1–12 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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