CRED ERP 25

11. Duplicate Licenses

Applicants may multiply or duplicate their applications through the MRP or DCP procedures.

However, there is no definition of “ duplicate ” in the current pharmaceutical legislation.

CMDh has published a guidance document on duplicates: Recommendations on Multiple/Duplicate Applications in Mutual Recognition and Decentralised Procedures (https://www.hma.eu/human medicines/cmdh/procedural-guidance/application-for-ma.html). A duplicate is an independent authorised medicinal product. The possibility of duplicating the application for further approval should be discussed with the RMS. The duplicate application of a MA is defined as follows: • Same product dossier (Modules 1, 2, 3, 4 and 5) • Same legal basis according to the MPD 2001/83/EC • Different trade name • Same or different applicant/MAH