EMA publishes Explanatory note on general fees payable to the Agency

Documents contains fees payable to European Medicines Agency.

Link to documents is as below:

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/explanatory-note-general-fees-payable-european-medicines-agency_en.pdf

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.