Marketing authorisation: Main 
     principles (1)                                                  European Patients’ Academy 
                                                                      on Therapeutic Innovation
      A medicinal product may only be placed on the market in 
         the European Economic Area (EEA) after a marketing 
         authorisation (MA) has been issued by the competent 
         authority of that Member State (MS) or by the European 
         Commission after scientific assessment by the European 
         Medicines Agency (EMA).
      The process for obtaining a marketing authorisation is 
         very complex and is highly regulated.
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     Marketing authorisation: Main 
     principles (2)                                                  European Patients’ Academy 
                                                                      on Therapeutic Innovation
      The main principle underlying pharmaceutical legislation 
         is the protection of public health.
      MAs for medicinal products are dynamic; the dossier 
         supporting an MA must be regularly updated in order to 
         ensure that scientific progress and new regulatory 
         requirements are respected.
      Any new information that may influence the evaluation of 
         the benefits and risks of the medicinal product must be 
         promptly supplied to the competent authority. 
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     MA application dossier and Common 
     Technical Document (CTD)                                        European Patients’ Academy 
                                                                      on Therapeutic Innovation
      The applicant submits an MA application (MAA) dossier 
         to the competent authority which must demonstrate that 
         the medicinal product has the required quality, that it is 
         safe, and that it is efficacious.
      The dossier must adhere to the common technical 
         document (CTD), a set of specifications for the MAA 
         dossier. The CTD is an internationally agreed format that 
         must be followed for applications intended to be 
         submitted to regulatory authorities.
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      Common Technical Document (CTD)
                                                                                 European Patients’ Academy 
                                                                                  on Therapeutic Innovation
       The Common Technical Document (CTD):
           Determines an appropriate format for the data required in an 
              application
           Is applicable for all types of MAAs, irrespective of the type of 
              application or the procedure
           Is organised in five modules
                -  Modules 2-4 constitute the actual CTD; Module 1 differs according 
                   to region. 
           An eCTD guideline specifies how to construct an electronic 
              version of the CTD
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     Common Technical Document: 
     Modules (1)                                                     European Patients’ Academy 
                                                                      on Therapeutic Innovation
      1. Regional information
          Specific administrative data including application form
          Risk management plan (RMP)
          Summary of Product Characteristics (SmPC)
          Labelling and package leaflet (PL)
      2. Quality overall summary
          Non-clinical overview/summaries and clinical 
            overview/summaries
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