EMA tarafından üstlenilen harçlar…
(ranging from 80,300€ to a maximum of 267,400€)
INTRODUCTION OF FEES TO BE CHARGED BY THE EMA FOR PHARMACOVIGILANCE CONCEPT PAPER
SUBMITTED FOR PUBLIC CONSULTATION
Deadline for replies to this Public Consultation: 15 September 2012
Contact: European Commission, DG Health and Consumers, Unit D5 ‘Medicinal products – authorisations, EMA’
E-mail: [email protected]
TABLE OF CONTENTS
1. INTRODUCTION………………………………………………………………………………………….4
2. LEGAL BASE……………………………………………………………………………………………….7
2.1. Fees Regulation …………………………………………………………………………………….7
2.2. The new pharmacovigilance legislation …………………………………………………… 7
2.3. General principles in proposing fees for pharmacovigilance………………………. 8
3. PROPOSED FEES …………………………………………………………………………………………9
3.1. Fee for assessments of Periodic Safety Update Reports …………………………….. 9
3.2. Fee for assessment of Post-Authorisation Safety Studies …………………………. 11
3.3. Fee for Assessment of Pharmacovigilance Referrals ……………………………….. 12
3.4. Pharmacovigilance Service Fee…………………………………………………………….. 14
3.4.1. New Pharmacovigilance Service Fee ………………………………………… 14
3.4.2. Current Annual Fee ………………………………………………………………… 15
3.5. Fee incentives for micro, small and medium-sized enterprises as
regards pharmacovigilance…………………………………………………………………… 16
3.5.1. Fee incentives for products involved in pharmacovigilance
procedures at EU level…………………………………………………………….. 17
3.5.2. Pharmacovigilance Service Fee………………………………………………… 17