How many days after the start of the DCP Assessment Step I should the reference member state supply the draft labeling?

In the context of the Decentralized Procedure (DCP), the reference member state is required to provide the draft labeling within a specific timeframe after the commencement of the Assessment Step I. This is crucial as the draft labeling plays a significant role in the submission process, aligning the marketing authorization application with the requirements of the involved member states.

The correct timeframe is 120 days after the start of the DCP Assessment Step I. During this period, the reference member state must prepare and distribute the draft labeling to allow for the appropriate review by the concerned member states. This timeline ensures sufficient opportunity for input and collaboration among the member states, facilitating a harmonized approval process.

The other options suggest shorter or longer timelines that do not align with the regulatory requirements for the DCP. Maintaining adherence to the 120-day timeframe is vital for keeping the assessment process on track and ensuring that all necessary documentation is finalized efficiently.