Spring Intro 2023

03/03/2023

Duplicate DCP No definition of a “duplicate” in the legislation. However, for practical purposes, a duplicate wrt to an MA is ● same dossier (copy of modules 1, 2, 3, 4 and 5); ● same legal basis according to Directive 2001/83/EC, as amended; ● different tradename; ● same or different applicant/marketing authorisation holder. Application for a duplicate from the same MAH has to be submitted to the MS of the initial authorisation who become RMS Applications for duplicates result in independent MAs which can be varied independently. ● MAH are strongly encouraged to keep the SPC, PL and labelling of the duplicates harmonised, whenever possible.

CMDh Recommendations on Multiple/Duplicate Applications in Mutual Recognition and Decentralised Procedures (May 2016)

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Public Assessment Report (PAR) ● Details of MA and SmPC available to the public ● Public Assessment Report (PAR) - publicly accessible – without any information of a commercially confidential nature – a justification for each indication applied for shall be given – written and updated (Variations, Renewal) by the RMS for the CMS – consultation between RMS and Applicant on the content of the PAR (CMDh-BPG) ● Summary in lay language ● https://mri.cts-mrp.eu/Human/

The Organisation for Professionals in Regulatory Affairs

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