2 Amendments of Alojz PETERLE related to 2013/0222(COD)
Amendment 41 #
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 110 #
Proposal for a regulation
Annex – part IV – paragraph 3
Annex – part IV – paragraph 3
3. Holders of marketing authorisations for medicinal products (other than authorised homeopathic medicinal products) referred to in Article 7(5) shall pay 80 % of the amount applicable to the chargeable units corresponding to those products. Holders of marketing authorisations for homeopathic medicinal products shall pay the percentage equivalent to the ICT services applicable to the chargeable unit corresponding to those products.