Creating Corporate Entities

fifth step

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

  • Medicinal Product track

    • Clinical Trial - Generic Investigational Medicinal Product(s) - fourth level entity - structurally completed

    • Pre-Clinical Tests Dossier - fourth level entity - initiated automatically and structurally completed

    • Medicinal Products based on Ref. MP - Regulatory Dossier - fourth level entity - 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 the two classes of Corporate Entities, the structural definition is initiated and completed in this step.

For the two classes of Corporate Entities, the  project initial submission is initiated in this step by the automatic creation of the appropriate directory structures with the replacement initial submission documents and entity definition documents .

To initiate the structural definition of a Corporate Entity  in the fifth 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 a 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 narrative 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 is submitted.

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    Clinical Trial with Generic Investigational MP(s)

structurally completed

When each Generic Investigational Medicinal Product - Preparation Production Chain  is completely structurally defined in the fourth entity creation step, an enriched email 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 Generic Investigational Medicinal Products - Preparation Production Chain> is completely structurally defined"
    • Initiator - enriched email that was used as a basis for creation of the Generic Investigational Medicinal Products - Preparation Production Chain

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

    Those enriched email notifications are displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/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 fifth step.

    Clinical Trial with Generic Investigational MP(s) - structural definition

    Since the Clinical Trial with Generic Investigational Medicinal Product is already introduced into the eCTD Integral Information System 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 Email using the appropriate Clinical Trial as a topic.

    Structural definition - second part

    After receiving the enriched email notification(s) that the Generic 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 notifications with the information that the corresponding Generic 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:

    • Generic 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)/Dossier extension(s) is automatically created
    • first Clinical Trial Authorization Project(s) is automatically launched
    • 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 Authorization Project(s) launched
    • an automatically generated enriched email notification(s) is sent to the clinical project person(s) with the information that a Clinical Trial Authorization Project is launched in their domain of responsibility

    A detailed description of a structural definition process is presented here.

    Clinical Trials with Generic Investigational MP(s) - narrative definition

    When the Clinical Trial record was inserted in the eCTD Integral Information System Database in the second step of entity creation, the directory structure with replacement documents annotated with (*) was 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".

    When all replacement documents are replaced with newly created narrative documents, status of the new Clinical Trial  entity  is set to “completely defined - draft”.

    At that point, an automatically generated enriched email notification is sent to the top-level clinical entity person with the information that the new Clinical Trial has been completely defined and that the initial submission for Clinical Trial Authorization Project can be made.

    A detailed description of a narrative definition process is presented here.

          Pre-Clinical Tests Dossier

    initiated automatically and structurally completed

    The Pre-Clinical Tests Dossier contains all the data on the realization of Pre-Clinical Tests Projects for a particular Innovative Active Substance at the global level.

    The creation of a Pre-Clinical Tests Dossier entity in the eCTD Integral Information System must be instigated with a "basis for creation"  type of document sent to the top-level pre-clinical entity person via Enriched Email as a:

    • Enriched email automatic notification with
      • Topic - "New Dossier/Dossier Extension - Pre-Clinical Tests"
      • Subtopic - "Introduction of a New Dossier/Dossier Extension - Pre-Clinical Tests"
      • Subject - "The notification to create a Pre-Clinical Tests Dossier"
      • Initiator - enriched email that was used as a basis for creation of the first Pre-Clinical tests entity

    sent when the first Pre-Clinical Tests entity for an Innovative Active Substance is completely structurally defined.

    The top-level pre-clinical entity person can choose to initiate the definition process themselves or to forward the email to one of their subordinate colleagues taking into account the required professional skills and security classification of the meter in question.

    The enriched email automatic notification is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Pre-Clinical Tests Dossier/Structural Data” 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.

    Pre-Clinical Tests Dossier - structural definition

    Pre-Clinical Tests Dossier is automatically created and opened when the first Pre-Clinical Tests Project is launched. At that point, following structural data used to define first Pre-Clinical Tests entity, are utilized to structurally define the Pre-Clinical Tests Dossier and launch the first Pre-Clinical Tests Project:

    • Pre-Clinical Tests Dossier
      • Innovative Active substance of the Dossier
        previously defined global/basic Corporate Entity

      • Dossier project type

    • Pre-Clinical Tests Project
      • Pre-Clinical Tests entity
        previously defined third level Corporate Entity
      • Organization(s) participating in the project
        • Sponsor
          previously defined global/basic Corporate Entity
        • Investigational Institution(s)
          previously defined global/basic Corporate Entity(s)
      • pre-clinical project person responsible for the conduct of the project

    The next Pre-Clinical Tests Projects are treated as an extensions of the Pre-Clinical Tests Dossier.

    The designated pre-clinical project person responsible for the conduct of the project is informed of the new assignment through an automatically generated enriched email notification.

    Also, at the same time, the designated pre-clinical project person is set as a "designated follower" of all enriched email messages related to the newly introduced Pre-Clinical Tests Project. The "designated follower" is responsible for the initial and all related project submissions and overall project implementation and is automatically granted the necessary system privileges with the ability to delegate the assigned rights to an Assistant and/or Agent using the features of the Enriched Email Client.

    It is important to note that the structural data of the Pre-Clinical Tests Dossier is used to generate initial submissions for Clinical Trial Projects and Marketing Authorization Projects.

    Pre-Clinical Tests Dossier - narrative definition

    The Pre-Clinical Tests Dossier does not require narrative entity definition documents for its definition.

    Narrative definition of a Pre-Clinical Tests Project consists of creation and upload of project initial submission documents required by the Pre-Clinical Tests Project template. Upload of project submission documents for all types of "active" Corporate Projects can be done using "Corporate Projects/Submission documents - upload" application form .

    Medicinal Products based on Ref. MP 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 route of administration and legal basis of the first Generic Medicinal Product is intravenous and generic application (Article 10(1)), the Generic Medicinal Product Regulatory Dossier can be created and the first  MAA Project launched as early as the fifth step. This is also the case for the legal basses well-established use application (Article 10a) and informed consent application (Article 10c).

    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 Medicinal Product based on Ref. MP 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 “Corporate Entity creation/Medicinal Products 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.

    Medicinal Products based on Ref. MP - Reg. Dossier - structural definition

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

    • Medicinal Product Regulatory Dossier
      • Active substance of the Dossier
        previously defined global/basic Corporate Entity
      • State/Country(s) of the Dossier
      • Country of the first national MA (for MRP)
      • Organization(s) participating in the dossier's projects
        • Health Authority
        • MAA Holder(s)
        • Applicant(s)
    • Medicinal Product MAA Project
      • First Medicinal Product(s) - to be registered
        previously defined first level Corporate Entity
        • indication(s) to be registered
        • route(s) of administration to be registered
      • 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
    • the topic of the "basis for creation" enriched email is replaced with the newly created Medicinal Product based on the Reference MP Regulatory Dossier 
    • 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 "designated followers" of the respective Registered Email topics
    • since an enriched email 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 corresponding initiating enriched email is inserted into the “basis for creation” registered 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

    It is important to note that structural data of Medicinal Product based on the Reference MP Regulatory Dossier are used during the generation of initial submission for Marketing Authorization Application Project  and automatic generation of electronic Application Form (eAF).

    A detailed description of a structural definition process is presented here.

    Medicinal Products based on Ref. MP Reg. 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".

    A detailed description of a narrative definition process is presented here.