BETA

Activities of Philippe JUVIN related to 2008/0257(COD)

Shadow opinions (1)

OPINION 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
2016/11/22
Committee: IMCO
Dossiers: 2008/0257(COD)
Documents: PDF(195 KB) DOC(500 KB)

Amendments (6)

Amendment 8 #
Proposal for a regulation – amending act
Recital 7
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk- Benefit Assessment Advisory Committee. That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance audit.
2010/02/12
Committee: IMCO
Amendment 12 #
Proposal for a regulation – amending act
Article 1 — point 1
Regulation (EC) No 726/2004
Article 5 – paragraph 2
For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk- Benefit Assessment Advisory Committee referred to in Article 56(1)(aa).
2010/02/12
Committee: IMCO
Amendment 25 #
Proposal for a regulation – amending act
Recital 7
(7) In order to ensure the availability of the necessary expertise and resources for pharmacovigilance assessments at Community level, it is appropriate to create a new scientific committee within the Agency, the Pharmacovigilance Risk- Benefit Balance Assessment Advisory Committee. That committee should be composed of independent scientific experts with competence in the safety of medicines including the detection, assessment, minimisation and communication of risk, and the design of post-authorisation safety studies and pharmacovigilance audit. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
2010/03/01
Committee: ENVI
Amendment 35 #
Proposal for a regulation – amending act
Article 1 – point 1
Regulation EC/726/2004
Article 5 – paragraph 2
(1) In Article 5(2) the following sentence is added: ‘For the fulfilment of its pharmacovigilance tasks, it shall be assisted by the Pharmacovigilance Risk Assessment Risk-Benefit Balance Advisory Committee referred to in Article 56(1)(aa)’. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
2010/03/01
Committee: ENVI
Amendment 37 #
Proposal for a regulation – amending act
Article 2 – paragraph 1
1. The requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by Directive …/…/EC, which applies to medicinal products authorised pursuant to Regulation (EC) No 726/2004 by virtue of its Article 9(4)(a) and (d), shall apply to a marketing authorisation granted before the date set out in the second paragraph of Article 3 of this Regulation from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.deleted
2010/02/12
Committee: IMCO
Amendment 85 #
Proposal for a regulation – amending act
Article 2 – paragraph 1
1. The requirement for the inclusion of a summary of the essential information necessary to use the medicine safely and effectively in the summary of the product characteristics and the package leaflet provided for in point 3a of Article 11 and in point (aa) of Article 59(1) of Directive 2001/83/EC as amended by Directive …/…/EC, which applies to medicinal products authorised pursuant to Regulation (EC) No 726/2004 by virtue of its Article 9(4)(a) and (d), shall apply to a marketing authorisation granted before the date set out in the second paragraph of Article 3 of this Regulation from renewal of that authorisation or from the expiry of a period of three years starting from that date, whichever is the earliest.deleted
2010/03/01
Committee: ENVI