duplicate
- Guideline or reference source
- CMDh/064/2006/Rev1 CMDh POSITION PAPER ON SUNSET CLAUSE AND ITS APPLICATION TO MARKETING AUTHORISATIONS GRANTED IN MORE THAN ONE MEMBER STATE
- Definition
- A definition of a duplicate (multiple application, copy) is lacking in pharmaceutical legislation. The former MRFG (now CMDh) agreed that 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 marketing holder. The above mentioned definition concerns an application for a duplicate. If a duplicate marketing authorisation (MA) is varied in a way that it deviates from the ´original ´ MA it automatically will be outside the definition of a duplicate.
- Related Term
- marketing authorization application
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