Contents
Article 1Subject matter and scope#
1.This Regulation lays down rules concerning:
(a)the fees and charges levied by the European Medicines Agency (the ‘Agency’) for assessment activities relating to obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products, and for other services provided or tasks carried out by the Agency, as provided for in Regulations (EC) No 726/2004 and (EU) 2019/6;
(b)the corresponding remuneration payable by the Agency to the competent authorities of the Member States for the services provided by rapporteurs and, where applicable, co-rapporteurs from competent authorities of the Member States, or by persons performing other roles considered as equivalent for the purposes of this Regulation, as referred to in the Annexes to this Regulation; and
(c)the monitoring of the costs of activities and services provided by the Agency and the monitoring of the costs of the remuneration referred to in point (b).
2.This Regulation also lays down the following:
(a)the amounts of the fees and charges referred to in paragraph 1, point (a), established on a cost-based evaluation; and
(b)the corresponding amounts of remuneration referred to in paragraph 1, point (b), established on a cost-based evaluation.
3.Medicinal products for human use which are authorised to be placed on the market in accordance with Article 126a of Directive 2001/83/EC shall not be subject to the fees for pharmacovigilance activities set out in the Annexes to this Regulation.
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