16 Amendments of Dagmar ROTH-BEHRENDT related to 2013/0222(COD)
Amendment 25 #
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 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 should be based on average estimHowever, in order to ensure that activities linked to Union-wide pharmacovigilance procedures are only connected with the need to ensure patient safety, the rapporteur of a referral should not be the Member State which asked for that referral. Concerning the level of remuneration for the work carried out by rapporteurs and co-rapporteurs, the payment should be based on clear and transparent invoices, which provide a precise indications of the workload involvednumber of working hours spent on each assessment by the rapporteur and the co- rapporteur(s) and of the related costs, and should be taken into account in setting the level of the fees for Union-wide pharmacovigilance procedures.
Amendment 30 #
Proposal for a regulation
Recital 16
Recital 16
(16) Generic medicinal products, mMedicinal products authorised under the provisions relating to well-established medicinal use, authorised homeopathic medicinal products and authorised herbal medicinal products should be subject to a reduced annual flat fee as those products generally have a well-established safety profile. However, in cases where these products are part of any of the Union-wide pharmacovigilance procedures, the full fee should be charged in view of the work involved. As the legislation on pharmacovigilance encourages the conduct of joint post authorisation safety studies, marketing authorisation holders should share the applicable fee in case a joint study is submitted.
Amendment 32 #
Proposal for a regulation
Recital 18
Recital 18
(18) In order to avoid disproportionate administrative workload for the Agency, reductions and exemptions provided for in this Regulation should apply on the basis of a declaration of the marketing authorisation holder that claims to be entitled to the reduction or the exemption, and whose accuracy could be verified by the Agency. The submission of incorrect information should therefore be discouragstrongly prevented through an increase of the applicable amount of the fee.
Amendment 52 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. The Agency shall levy a fee for the assessment carried out in the context of a procedure initiated as a result of the evaluation of pharmacovigilance data under Articles 107i to 107k of Directive 2001/83/EC, under. Costs arising from procedures referred to in the second subparagraph of Article 31(1) thereof or underof Directive 2001/83/EC, or in Article 20(8) of Regulation (EC) No 726/2004 shall include a participation of the referring Member State.
Amendment 58 #
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. A reduced annual flat fee, as laid down in Part IV of the Annex, shall apply in respect of medicinal products referred to in Article 10(1) and Article 10a of Directive 2001/83/EC and in respect of authorised homeopathic medicinal products and authorised herbal medicinal products, as defined respectively in Article 1(5) and Article 1(30) of Directive 2001/83/EC.
Amendment 63 #
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, in order for the latter to be able to verify that these conditions are fulfilled.
Amendment 65 #
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 120% and the Agency shall levy the resulting full applicable amount or, as appropriate, the balance to the resulting full applicable amount.
Amendment 71 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point f
Article 9 – paragraph 1 – subparagraph 1 – point f
(f) where the Member State has appointed a member of the Pharmacovigilance Risk Assessment Committee who acts as rapporteur for the referrals referred to in Article 6. In that case, Member State(s) which triggered the referral shall provide all necessary data on signals, but shall not be chosen as rapporteur or co-rapporteur for that referral.
Amendment 73 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2
Article 9 – paragraph 1 – subparagraph 2
Where the Pharmacovigilance Risk Assessment Committee or the coordination group decides to appoint a co-rapporteur, the remuneration shall be divided between the rapporteur and the co-rapporteur. , on the basis of clear and transparent invoices, which provide a precise indication of the number of working hours spent on each part of the assessment by the rapporteur and co- rapporteurs, and of the related costs. This amount of working hours shall be presented in an understandable, justified and provable way.
Amendment 74 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The remuneration provided for in paragraph 1 shall be paid only after the final assessment report for a recommendation which is intended for adoption by the Pharmacovigilance Risk Assessment Committee has been made available to the Agency. This report shall be submitted in a fully and workable version translated into the working language of the Agency.
Amendment 76 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. If the purpose of the payment cannot be established, the Agency shall set a deadline by which the marketing authorisation holder shall and notify itied in writing of the purpose of the payment. If the Agency does not receive a notification of the purpose of the payment before expiry of the deadlineto the Agency within 30 days, the payment shall be considered invalid and the amount concerned shall be refunded to the marketing authorisation holder.
Amendment 87 #
Proposal for a regulation
Article 19 – paragraph 2 a (new)
Article 19 – paragraph 2 a (new)
2a. The annual flat fee referred to in Article 7 and Part IV of the Annex shall only enter into force six months after the date when Eudravigilance is declared by the Agency as fully functioning, in application of Article 24(2) third subparagraph of Regulation EC No 726/2004.
Amendment 93 #
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 120 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 97 #
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 120 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 105 #
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 120 % increase as provided for in Article 8(5), the remuneration of the rapporteur shall be adapted proportionally.
Amendment 111 #
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) shall pay 850 % of the amount applicable to the chargeable units corresponding to those products.