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05

Ago

EMA publishes revised implementing rules, explanatory note for fees payable to agency

The European Medicines Agency (EMA) has published revised rules for the implementation of the fees payable regulation, increasing its rates across the board and revising some text on when the payments are required.
 
EMA previously set the fees in a document that took effect in January. The latest update, which sets the fees as of 1 August, increases the fees set in the older document. For example, the fee for the extension of marketing authorizations for medicinal products for human use has increased from €89,000 to €94,000. The Type II variation fee has risen by the same amount.
 
The agency has also revised the text on the situations in which companies need to pay the fee for canceling formally notified distinct inspections. EMA has added a new scenario in which the fee is payable, explaining it will request €11,800 when an inspection is canceled due to “the notification of the non-submission of the intended application by the prospect applicant, for cases where the inspection was requested on the basis of a “letter of intent to submit” (i.e. prior to the actual submission of an application for a marketing authorisation or rolling review).” EMA tweaked the wording of other points.
 
EMA published the revised rules alongside its explanatory note on general fees payable to the agency. The note discusses the reduced fee level for veterinary medicinal product variations requiring assessment. [EMA - RAPS]

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