Fees payable / European Medicines Agency

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Tuairimí a glacadh on 16/10/2013
Reference
INT/712-EESC-2013-5169
Opinion Type
Referral
Referral
COM(2013) 472 final - 2013/0222 (COD)
Official Journal
OJ C 67, 6.3.2014, p. 92
Rapporteur
Ms Renate Heinisch
Civil Society Organisations - GR III
Germany
Plenary session number
493
-
Pharmaceuticals
Download — EESC opinion: Fees payable / European Medicines Agency
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Key points

The EESC welcomes:

  • the Commission proposal, which makes an important contribution to the further improvement of medicinal product safety and the transparency of the assessment processes.the principle that the marketing authorisation holder will not have to pay fees twice for the same pharmacovigilance activity. It calls on the Commission to ensure that, simultaneously with the introduction of the new fees, national fees charged for the same activity are abolished.
  • the proposal that the EMA will levy an annual flat-rate fee from marketing authorisation holders for pharmacovigilance activities. The Committee suggests that the flat-rate fee be suspended pending availability of these services.
  • the proposal that fees should be shared as fairly as possible between all market authorisation holders affected and suggests that the proposed approach involving "chargeable units" should be reconsidered.


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