Documents contains fees payable to European Medicines Agency.
Link to documents is as below:
Changes introduced in this version (1 April 2021)
- Removal of maximum period for fee incentives applying to certain post-authorisation activities for pandemic post-authorisation applications in heading 5.6.2 (human medicines).
- Introduction of fee incentives for post-authorisation applications relating to certain human vaccines authorised under exceptional circumstances for preparedness against biological agents that might be used as weapons of bioterrorism in heading 5.11.2 (human medicines).
- Clarification that consultations on medical devices shall be charged to the medical device
manufacturer in heading 1.4. - New footnote for heading 5.1.2. with regard to SME incentives for consultations on medical
devices. - Minor editorial changes.
