Spring Intro 2023

03/03/2023

Strategic Considerations Centralized Procedure (CP) 90 days to address questions at Day 120 clock-stop 30 days to address questions at Day 180 clock-stop Element of national review – CHMP members do have input into assessment in addition to Rapp/Co Rapp

Decentralised Procedure (DCP)

6 months to address questions during clock-stops, (if required)

Individual country-specific MAA requirements (especially Module 1 documentation).

Multiple assessments (each MS may conduct its own full MA assessment) and complex administration procedures. Can be difficult to reconcile all CMSs questions/issues, as there may be opposing views between MS. Reduced likelihood of rejections and withdrawals being made public (dependent on RMS).

All EMA rejections or company withdrawals (once the procedure has started) are made public and EPAR will be placed on the EMA website Patent extension is dated from the EU approval

Patent extension is dated from RMS approval

Application fee reductions and deferrals for SME status companies

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Strategic Considerations

Centralized Procedure (CP)

Decentralised Procedure (DCP)

Timeframe to address translation issues in final MA issue phase is 5 days

National phase targeted at 30 days, but can be protracted

Obtaining the final MA for each Member State can be problematic and delayed, as some countries require a local presence Post-approval submissions have individual country-specific application requirements Expensive MAA and post-licence variations costs if MAA is submitted to all CMSs especially if the product is not marketed in all MS. Costs are lowered if a reduced number of CMSs are selected, and language requirements are easier to manage

Defined post-approval submission schedule, therefore more time and project management issues (less flexibility to submit ad-hoc variations) Expensive MA and post-licence variations cost, including the need to provide translations of all product information in all 24 official EU languages, especially if the product is not marketed in all MS.

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