C.3.2 - As of when are the new criteria (for determining the corresponding initial investigation and surveillance fees) for Production Organisation approvals applicable?
The new criteria are applicable for all applications received after 1 January 2020 and for all valid (existing) approvals at the entry into force as from the next billing cycle starting after the entry into force of the Implementing Regulation 2019/2153. Approvals issued after 1 January 2020 are also subject to the fees stipulated in Table 10 of the Annex to the Implementing Regulation 2019/2153.
