Activities of Linda McAVAN related to 2013/0222(COD)
Reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use PDF (277 KB) DOC (355 KB)
Amendments (4)
Amendment 22 #
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. 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, including fees for follow-on variations to marketing authorisations.
Amendment 37 #
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
1. ‘'Chargeable unit’' means each individual entry in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004 based on information from the list of all medicinal products for human use authorised in the Union referred to in Article 57(2) thereof. a unit defined by the following data set from the medicinal products information included in the database referred to in Article 57(1)(l) of Regulation (EC) No 726/2004: (a) marketing authorisation holder; (b) country of authorisation; (c) active ingredient(s); (d) pharmaceutical form.
Amendment 72 #
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. Where a Member State voluntarily initiates a referral, and is appointed rapporteur or co-rapporteur, they shall only receive 50% of their remuneration.
Amendment 101 #
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 45 100 when 1 or 2 active substances are involved. This fee is increased by 15% for every additional active substance involved in the procedure. The corresponding remuneration of the rapporteur and co-rapporteur(s) is EUR 78 400. This remuneration is increased by 15% for every additional active substance assessed.