Creating Corporate Entities

ninth step

There are two classes of Corporate Entities whose structural definition can be initiated/completed in the ninth step of the process of creating a hierarchy of corporate entities:

  • Medicinal Product track

    • Clinical Trial - Innovative Investigational Medicinal Product - structurally completed

    • Generic Medicinal Products Dossier/First Generic Medicinal Product MAA Project -  initiated by decision and structurally completed

For one incompletely defined Corporate Entities class the complete structural definition can be done as its related lower-level Corporate Entities are completely structurally defined in the previous step.

For one Corporate Entities class the structural definition can be initiated and completed in this step.

For one Corporate Entities class the narrative definition is initiated in this step by the automatic creation of the appropriate directory structures with the replacement documents.

To initiate the structural definition of a Corporate Entity  in the ninth step, the appropriate "basis for creation"  type of document must be sent to the relevant corporate entity person via Enriched Email and the lower-level Corporate Entities required for the "minimal data set" must be previously completely structurally defined.

To complete the structural definition of incompletely structurally defined Corporate Entities, all related lower-level Corporate Entities must be completely structurally defined.

Whenever a Corporate Entity is fully structurally defined, an enriched email notification is sent to the appropriate corporate entity person designated to define the related higher-level Corporate Entity with information that one of the prerequisites for the complete structural definition is provided.

The initiation and complete structural definition of a Corporate Entity can be done on the appropriate application form for New Corporate Entity Creation.

The narrative definition can begin as soon as the "minimal data set" is inserted in the eCTD Integral Information System Database because an appropriate directory tree with replacement documents is created in that instance . The narrative definition can be performed until the first initial submission  to the relevant Health Authorities and/or business Partners.

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Clinical Trial - Innovative Investigational MP

structurally completed

When each Innovative Investigational Medicinal Product-Preparation Production Chain  is completely structurally defined in the eighth entity creation step, an enriched email automatic notification is sent to the clinical entity person responsible for the definition of the corresponding Clinical Trial:

  • Enriched email automatic notification with
    • Topic - <"Name of the Clinical Trial">
    • Subtopic - "Introduction of a New Clinical Trial"
    • Subject - "The notification that <Name of the Innovative Investigational Medicinal Products - Preparation Production Chain> is completely structurally defined"
    • Initiator - enriched email that was used as a basis for creation of the Innovative Investigational Medicinal Products-Preparation Production Chain

sent when a Innovative Investigational Medicinal Products - Preparation Production Chain is completely structurally defined

    Those enriched email automatic notifications are displayed on the sub-application form "Correspondence" on the “New Corporate Entity/Clinical Trial/Structural Data” application form. To preserve the entity creation chain of correspondence, those enriched emails must be checked, and after returning to the main application form, the second part of the process of structural definition can be completed in the ninth step.

    Clinical Trial - Innovative Investigational MP - structural definition

    Since the Clinical Trial with Innovative Investigational Medicinal Product is already introduced into the eCTD Integral Information System Database in the second step of entity creation, the designated clinical entity person has been able to use it as a topic in the Enriched Email correspondence to collect other data required for its structural and narrative definition. The collection of data regarding Investigational Sites Organization(s), other participating Organizations, data for protocol development, acquisition of peer review, etc. can all be made. All correspondence regarding this data collection should be done by Enriched Mail using the appropriate Clinical Trial as a topic.

    Structural definition - second part

    After receiving the enriched email automatic notification(s) that the Innovative Investigational Medicinal Product - Preparation Production Chains are completely structurally defined, designated clinical entity person using the application form "New Corporate Entity/Clinical Trial/Structural Data" and by clicking on the button "Additional data", selects the related incompletely defined Clinical Trial. 

    On the sub-application form "Correspondence" checks all enriched email automatic notifications with the information that the corresponding Innovative Investigational Medicinal Product-Preparation Production Chain is completely structurally defined, and returns back to the application form. This process is necessary to preserve the entity creation chain of correspondence.

    If all remaining entities and data such as:

    • Innovative Investigational Medicinal Product - Preparation Production Chains
    • Other Sponsors and co-Sponsors - Organization(s)
    • Investigational Site Organization(s)
    • Trial type and Phase
    • Patient population data
    • ...

    are defined, the process of structural definition can be completed.

    Upon completion, the Clinical Trial entity is assigned status "completely structurally defined" with ability to be used to define Corporate Entities of the higher level. At that point, using data from the structural definition of the Clinical Trial:

    • The Clinical Trial Dossier(s) is automatically created
    • the first Clinical Trial Authorization Project(s) in each country is automatically launched by generating project initial submissions using business rules to select narrative definition documents of appropriate Clinical Trial and Pre-Clinical Tests
    • an automatically generated "basis for creation" enriched email announcement/notification(s) is sent to the top-level clinical entity person with the information that the Clinical Trial Dossier(s)/Dossier extension(s) is created and the Clinical Trial Project(s) launched
    • an automatically generated enriched email notification(s) is sent to the clinical project person(s) in each country with the information that a Clinical Trial Project is launched in their domain of responsibility

    Clinical Trial - Innovative Investigational MP - narrative definition

    When the Clinical Trial record is inserted in the eCTD Integral Information System Database in the sixth step of entity creation, the directory structure with replacement documents annotated with (*) is automatically created.

    While the Investigational Medicinal Products and their respective Preparation Production Chains are being defined, the designated clinical entity person responsible for the creation and upload of the narrative documents can collect the necessary data for the entity narrative definition. New or changed documents are uploaded using the application form "New Corporate Entity/Clinical Trial/Narrative Data".

    Generic Medicinal Products Regulatory Dossier

    initiated by decision and structurally completed

    The Medicinal Product Regulatory Dossier contains all the data generated during the realization of Medicinal Products Regulatory Projects for a given Active Substance and for a specified regulatory domain.

    Medicinal Product Regulatory Dossier is created and opened when the first Medicinal Product MAA Project is launched. If the legal basis of the first Generic Medicinal Product is Article 10(1) generic application, Article 10(3) hybrid application, Article 10(4) similar biological application Article 10b fixed combination application the Generic Medicinal Product Regulatory Dossier can be created and the first  MAA Project launched in the ninth step.

    The creation of a Medicinal Product Regulatory Dossier entity in the eCTD Integral Information System must be instigated with a "basis for creation"  type of document sent to the top-level regulative project person via Enriched Email as a:

    • Enriched email message with
      • Topic - "New Dossier/Dossier Extension - Medicinal Products"
      • Subtopic - "Introduction of a New Dossier/Dossier Extension - Medicinal Products"
      • Subject - "The notification to create a Generic Medicinal Product Regulatory Dossier for a specified domain"
      • Attachment - "Decision document"
        Details, such as the active substance, pharmaceutical form, dosage, route of administration, indication, registration domain, and justification for such a business move together with the required projected resources must be provided in this document and should be signed by a corporate person with the appropriate authority

    This enriched email message is displayed on the sub-application form "Correspondence" on the “New Corporate Entity/MP Regulatory Dossier/MA Application” application form. 

    To preserve the entity creation chain of correspondence, this enriched email must be checked, and after returning to the main application form, the process of structural definition can begin.

    Generic Medicinal Product Regulatory Dossier - structural definition

    Medicinal Product Regulatory Dossier is created and opened when the first Generic Medicinal Product Marketing Authorization Project is launched. At that point, following lower-level Corporate Entities and structural data are utilized to structurally define the Medicinal Product Regulatory Dossier and the first Medicinal Product MAA Project:

    • Medicinal Product Regulatory Dossier
      • Generic Active substance of the Dossier
        previously defined global/basic Corporate Entity
      • State/Country(s)
      • Organization(s) participating in the dossier projects
        • Health Authority
        • MAA Holder
        • Applicant
    • Medicinal Product MAA Project
      • First Generic Medicinal Product - to be registered
        previously defined first level Corporate Entity
        • indication to be registered
        • route of administration to be registered
      • Generic Medicinal Product - Preparation Production Chain(s) and SKU(s)
        previously defined third level Corporate Entity
      • regulatory project person responsible for the conduct of the project

    The following Medicinal Product Marketing Authorization Projects are treated as an extensions of the Medicinal Products Regulatory Dossier.

    A minimal set of structural data is specified with the (*) on the application form "New Corporate Entity/Medicinal Product Regulatory Dossier/MA Application" and they are a prerequisite for the insertion of the record in the eCTD Integral Information System Database.

    When the record is inserted into the eCTD Integral Information System:

    • a core sequence is generated and all subsequent structural and narrative definition actions and project realization actions are associated with that sequence
    • automatically generated enriched email notifications are sent to MA Holder's marketing entity person and regulatory project person notifying them of new assignments and becoming followers of the respective Enriched Email' topics
    • the topic of the "basis for creation" enriched email is replaced with the newly created Medicinal Product Regulatory Dossier 
    • since an enriched mail message without initiator is used as a “basis for creation”, using the business rules for this situation, the entity creation chain of correspondence is established and the initiating enriched email is inserted into the “basis for creation” enriched email message
    • the initial submission directory tree with documents is automatically generated consisting of the entity definition documents and project initial submission documents.

    The following criteria are used to automatically include entity definition documents in the submission:

    • For the Marketed Substance 
      • Substance role
      • Marketed Substance standard
    • For the Marketed Substance Production Chains
      • Substance role
      • Marketed Substance standard
      • Medicinal Product Preparation Chain(s) selected for the submission
    • For the Medicinal Product Production Chains
      • Medicinal Product Preparation Chain(s) selected for the submission
    • For the participating Marketed Active Substance Manufacturers
      • Organizations participating in the manufacture
    • For the design spaces of the participating Medicinal Product Manufacturers
      • Manufacturing activity
      • Pharmaceutical form of the Medicinal Product
    • For the Clinical Trial(s)
      • Clinical Trial classification
      • Route of administration of the Medicinal Product
      • Indication of the Medicinal Product
    • For the Pre-Clinical Tests(s)
      • Pre-Clinical Tests classification
      • Indication

    Generic Medicinal Product Regulatory Dossier - narrative definition

    The Medicinal Product Regulatory Dossier does not require narrative entity definition documents for its definition.

    Narrative definition of a Generic Medicinal Product MAA Project, consists of creation and upload of project initial submission documents required by the Generic Medicinal Product MAA Project template. Upload of project initial submission documents for all types of "active" Corporate Projects can be done using application form "Corporate Projects/Submission files - upload".