CRED 8 Presentations

08/07/2024

MRP/DCP offers flexibility (2/2)

● Procedure can be repeated, after withdrawal or in new member states (Repeat use, second wave, third wave, etc)

● Allowed to submit duplicate/copy applications immediately, or after a procedure is finalised

● In some cases possible to add a copy/duplicate application or a CMS during clock stop (see CMDh “Position Paper concerning Applicants’ request of submission of multiple applications during ongoing decentralised procedures or inclusion of new CMS or additional strength(s) in an already ongoing decentralised procedure (DCP)”)

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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Duplicate licences

● There is no definition of a “duplicate” in the pharmaceutical legislation

● Duplicate is an independent authorised medicinal product

● For practical purpose, a duplicate application is defined by reference to the first application or marketing authorisation as follows: – 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

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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