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Table 1 Milestones and product characteristics collected through the OpERA program

From: An evaluation of the Caribbean regulatory system centralized assessment process for medicines submitted 2017–2018 using the OpERA methodology

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