Table 1 Milestones and product characteristics collected through the OpERA program

Key milestone dates

1a. Receipt of the dossier

1b. Acceptance to file

2a. Start of primary scientific assessment

2b. Completion of primary scientific assessment

3a. Primary assessment deficiency letter sent to applicant (if applicable)

3b. Response from applicant (if applicable)

4. Secondary assessment following deficiency letter response (if applicable)

5. Succeeding Advisory Committee Review (if applicable)

6. Completion of scientific assessment

7. Marketing Authorization outcome: granted/rejected

8. Final Acceptance by each Member State