18 Amendments of Michèle RIVASI related to 2013/0222(COD)
Amendment 21 #
Proposal for a regulation
Recital 8
Recital 8
(8) This Regulation should only refer to fees which are to be levied by the Agency, whereas the competence to decide on possible fees levied by the competent authorities of the Member States should remain with the Member States, notably for signal detection tasks. Marketing authorisation holders should not be charged twice for the same pharmacovigilance activity. Member States should therefore not levy fees for the activities which are covered by this Regulation.
Amendment 26 #
Proposal for a regulation
Recital 13
Recital 13
(13) Rapporteurs rely for their assessment on the scientific evaluation and resources of national marketing authorisation bodies, whilst it is the responsibility of the Agency to coordinate the existing scientific resources put at its disposal by the Member States. In view of that and to ensure adequate resources for the scientific assessments relating to the Union-wide pharmacovigilance procedures, the Agency should remunerate the scientific assessment services provided by the rapporteurs appointed by Member States as members of the Pharmacovigilance Risk Assessment Committee referred to in Article 56(1) (aa) of Regulation (EC) No 726/2004 or, where relevant, by rapporteurs and co-rapporteurs in the coordination group referred to in Article 27 of Directive 2001/83/EC. The level of remuneration for the work carried out by those rapporteurs and co-rapporteurs should be based on average estimations of the workload involved and should be taken into account in setting the level of the fees for Union-wide pharmacovigilance procedures.
Amendment 42 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall levy a fee for the assessment of periodic safety update reports referred to in 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation (EC) No 726/2004 with assessment criteria according to Annex I of Directive 2001/83/EC.
Amendment 64 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The Agency may request, at any time, evidence that the conditions for a reduction of fees or for an exemption from fees are fulfilled. In that case, the marketing authorisation holder claiming or having claimed to be entitled to a reduction or an exemption under this Regulation, shall submit to the Agency the information necessary to demonstrate compliance with the relevant conditions within seven calendar days from receipt of the Agency's request.
Amendment 67 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Where a marketing authorisation holder claiming or having claimed to be entitled to a reduction of or an exemption from fees under this Regulation fails to demonstrate that it is entitled to such a reduction or exemption, the amount of the fee laid down in the Annex shall be increased by 150% and the Agency shall levy the resulting full applicable amount or, as appropriate, the balance to the resulting full applicable amount.
Amendment 68 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point c
Article 9 – paragraph 1 – subparagraph 1 – point c
(c) where the Member State has appointed a member of the Pharmacovigilance Risk Assessment Committee who acts as rapporteur or co-rapporteur for the assessment of periodic safety update reports referred to in Article 4;
Amendment 69 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point d
Article 9 – paragraph 1 – subparagraph 1 – point d
(d) where the Member State has appointed a representative in the coordination group who acts as rapporteur or co-rapporteur in the context of the assessment of periodic safety update reports referred to in Article 4;
Amendment 70 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point e
Article 9 – paragraph 1 – subparagraph 1 – point e
(e) where the Member State has appointed a member of the Pharmacovigilance Risk Assessment Committee who acts as rapporteur or co-rapporteur for the assessment of post- authorisation safety studies referred to in Article 5;
Amendment 81 #
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. In view of the monitoring referred to in paragraph 4, the Commission may, where necessary, adjust the amounts of the fees and the amounts of the remuneration of rapporteurs and co-rapporteurs laid down in the Annex, in accordance with Article 16. Those adjustments shall take effect on 1 April following the entry into force of the corresponding amending act.
Amendment 86 #
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1 a (new)
Article 16 – paragraph 2 – subparagraph 1 a (new)
At the time of adoption of this Regulation, the number of chargeable units used as a basis for the calculations is [...].
Amendment 88 #
Proposal for a regulation
Annex – part I – paragraph 1
Annex – part I – paragraph 1
1. The fee for the assessment of periodic safety update reports is EUR 19 500 per procedure. The corresponding remuneration of the rapporteur is EUR 13 100 and the corresponding remuneration of the co-rapporteur is EUR 1.500.
Amendment 94 #
Proposal for a regulation
Annex – part I – paragraph 4
Annex – part I – paragraph 4
4. Where reductions and exemptions apply, the remuneration of the rapporteur shall be adapted proportionally. Where the Agency subsequently collects the full applicable amount including the 150 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 95 #
Proposal for a regulation
Annex – part II – paragraph 1
Annex – part II – paragraph 1
1. The fee for the assessment of a post authorisation safety study is EUR 43 000. The corresponding remuneration of the rapporteur is EUR 18 230.000 and corresponding remuneration of the co- rapporteur is EUR 10.000.
Amendment 98 #
Proposal for a regulation
Annex – part II – paragraph 4
Annex – part II – paragraph 4
4. Where reductions and exemptions apply, the remuneration of the rapporteur shall be adapted proportionally. Where the Agency subsequently collects the full applicable amount including the 150 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 100 #
Proposal for a regulation
Annex – part III – paragraph 1
Annex – part III – paragraph 1
1. The fee for the assessment of the procedure referred to in Article 6(1) is EUR 168 600. The corresponding remuneration of the rapporteur is EUR 45 170.000 and corresponding remuneration of the co-rapporteur is EUR 70.000.
Amendment 106 #
Proposal for a regulation
Annex – part III – paragraph 3 – subparagraph 3
Annex – part III – paragraph 3 – subparagraph 3
Where reductions and exemptions apply, the remuneration of the rapporteur shall be adapted proportionally. Where the Agency subsequently collects the full applicable amount including the 150 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 107 #
Proposal for a regulation
Annex – part IV – paragraph 1
Annex – part IV – paragraph 1
1. The annual flat fee is EUR 60XX per chargeable unit.
Amendment 112 #
Proposal for a regulation
Annex – part IV – paragraph 3
Annex – part IV – paragraph 3
3. Holders of marketing authorisations for medicinal products referred to in Article 7(5)10a of Directive 2001/83/EC shall pay 80% of the amount applicable to the chargeable units corresponding to those products. Holders of marketing authorisations for authorised homeopathic medicinal products and for authorised herbal medicinal products as defined respectively in Article 1(5) and Article 1(30) of Directive 2001/83/EC shall pay 80 25% of the amount applicable to the chargeable units corresponding to those products.