[ParlTrack]

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

Philippe JUVIN

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

Philippe JUVIN

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

Philippe JUVIN

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

Philippe JUVIN

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

Philippe JUVIN

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

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

Shadow opinions (1)

Amendments (6)

ParlTrack - 2011-2024