Creating Corporate Entities

fourth step

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

  • Medicinal Product track

    • Pre-Clinical Tests - third level entity - structurally completed

    • Generic Investigational Medicinal Product - Preparation Production Chain - third level entity - automatically initiated and structurally completed

    • Medicinal Product based on the Reference MP - Preparation Production Chain - third level entity - structurally completed

For the two incompletely defined classes of Corporate Entities the complete structural definition can be done as their related lower-level Corporate Entities are completely structurally defined in the previous step.

For one Corporate Entities class the structural definition is 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 structure with the replacement documents.

To initiate the structural definition of a Corporate Entity  in the fourth 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 entities must be completely structurally defined.

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

The 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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Pre-Clinical Tests

structurally completed

One of the prerequisites for complete definition of the Pre-Clinical Tests entity is complete structural definition of the corresponding Marketed Substance-Production Chain. When that entity is completely structurally defined, enriched email automatic notification is sent to the pre-clinical entity person responsible for the definition of the first corresponding Pre-Clinical Tests:

  • Registered email automatic notification with
    • Topic - <"Name of the Pre-Clinical Tests">
    • Subtopic - " Introduction of a New Pre-Clinical Tests"
    • Subject - "The notification that Marketed Substance-Production Chain <Name> is completely structurally defined"
    • Initiator - enriched email that was used as a basis for creation of the Marketed Substance - Production Chain 

sent when a Marketed Substance-Production Chain is completely structurally defined

This enriched email automatic notification is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Pre-Clinical Tests/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 be completed.

Pre-Clinical Tests - structural definition

In the fourth step of creating the hierarchy of corporate entities, the second part of the structural definition of Pre-Clinical Tests can be completed.

Structural definition - second part

The second part of the structural definition of a Pre-Clinical Tests can be completed only when the corresponding Marketed Substance Production Chain - second level entity is defined in the III step of entity creation.

Prior to that, the collection of other data regarding Investigational Sites Organization(s), other participating Organizations, data for protocol development, acquisition of peer review, etc. can be done. All correspondence in regards to that data collection should be done by Enriched Mail using the appropriate Pre-Clinical Tests as a topic.

If all remaining entities and data such as:

  • Marketed Substance Production Chain
  • Investigational sites - Organization(s)
  • Species
  • route of administration
  • ...

are defined the process of structural definition can be completed.

Upon completion, the Pre-Clinical Tests entity is assigned status "completely structurally defined" with the ability to be used to define Corporate Entities of the higher level. At that point, an automatically generated enriched email notification is sent to top-level pre-clinical entity person with the information that a Pre-Clinical Tests Dossier or Dossier extension is created.

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

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

Pre-Clinical Tests - narrative definition

Since the Pre-Clinical Tests entity has already been introduced into the eCTD Integral Information System Database in the previous step, the designated pre-clinical entity person have been notified and the directory structure with replacement documents annotated with (*) have already been created. Since than, the pre-clinical entity person has been able to use this entity as a topic in Enriched Email correspondence to collect the remaining data necessary for structural and narrative definition.

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

At that point, an automatically generated enriched email notification is sent to the top-level pre-clinical entity person with the information that the new Pre-Clinical Tests has been completely defined.

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

Generic IMP - Preparation Production Chain

automatically initiated and structurally completed

The cmc entity person designated for the definition of the Generic Investigational Medicinal Product is also in charge for the definition of the corresponding Generic Investigational Medicinal Product - Preparation Production Chain.

The Generic Investigational Medicinal Product - Preparation Production Chain is a unique combination of  Generic Investigational Medicinal Product-Production Chain and Marketed Substance - Production Chain.

The creation of an Generic Investigational Generic Medicinal Product - Preparation Production Chain  entity in the eCTD Integral Information System must be instigated with the "basis for creation"  type of document sent to the designated cmc entity person via Enriched Email:

  • Enriched email automatic notification with:
    • Topic - "New Generic IMP - Preparation Production Chain "
    • Subtopic - "Introduction of a New Medicinal Product - Preparation Production Chain"
    • Subject - "The notification to introduce a new Generic Investigational Medicinal Product - Preparation Production Chain"
    • Initiator - enriched  email that was used as a basis for creation of the Generic Investigational Medicinal Product

sent when the Investigational Generic Medicinal Product is completely structurally defined

    This enriched email automatic notification is displayed on the sub-application form "Correspondence" on the “New Corporate Entity/Preparation Production Chain/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.

      To complete the structural definition, the related Marketed Substance - Production Chain must also be completely structurally defined, and when that happens, an enriched email automatic notification is sent to the designated cmc entity person:

      • Enriched email automatic notification with:
        • Topic - "<NAME of the Generic Investigational Medicinal Product  -Preparation Production Chain> "
        • Subtopic - "Introduction of a New Medicinal Product - Preparation Production Chain"
        • Subject - "The notification that the <NAME of the Marketed Substance - Production Chain> is completely structurally defined
        • Initiator - enriched email that was used as a basis for creation of the Marketed Substance - Production Chain
          sent when Marketed Substance - Production Chain is completely structurally defined

      Generic IMP - Preparation Production Chain - structural definition

      Since an Investigational Generic Medicinal Product - Preparation Production Chain - is completely defined by the first and second level Corporate Entities and structural data:

      • Generic Investigational Medicinal Product
        previously defined first level Corporate Entity defined in the III step
      • Marketed Active Substance - Production Chain(s)
        previously defined second level Corporate Entity defined in the III step
      • Marketed Excipients - Production Chain(s)
        previously defined second level Corporate Entity defined in the III step
      • Organization(s)
        previously defined global/basic Corporate Entity performing:
        • distribution
        • required technological unit operations
      • cmc entity person responsible 

      the definition of a Generic Investigational  Medicinal Product - Preparation Production Chain can be completed only when the corresponding Marketed Substance Production Chains - second level entities for the active substance(s) and excipients are defined.

      Prior to that, the collection of other data regarding Manufacturing Organization(s), and other participating Organizations can be done. All correspondence in regards to this data collection should be done by Registered Mail using appropriate Generic Investigational  Medicinal Product - Preparation Production Chain as a topic.

      A minimal set of structural data is specified with the (*) on the application form "New Corporate Entity/Preparation Production Chain/Structural Data" and they are a prerequisite for the insertion of the record into the eCTD Integral Information System Database. Record with a minimal set of structural data can not be used to define entities of the higher level but can be chosen as a topic in the Registered Email correspondence to collect other data required to completely structurally and narratively define Generic Investigational Medicinal Product - Preparation Production Chain.

      When the record is inserted into the eCTD Integral Information System a core sequence is generated and all subsequent structural and narrative definition actions are associated with that sequence. The designated cmc entity person is informed of the new assignment through an automatically generated enriched email notification. Also, at the same time, the topic of the "basis for creation" enriched email is replaced with the newly created Generic Investigational  Medicinal Product - Preparation Production Chain and the designated cmc entity person is set as a "designated follower" of all enriched emails related to the newly introduced Generic Investigational  Medicinal Product - Preparation Production Chain. The "designated follower" is responsible for the complete structural definition and subsequent structural changes and is automatically granted the necessary system privileges with the ability to delegate the assigned rights to an Assistant or Agent using the features of the Enriched Email Client.

      During the definition of the minimal set of structural data of the Generic Investigational  Medicinal Product  -Preparation Production Chain, an editable unique "var" abbreviation "igmedprodchain" is automatically generated which is later used as a part of template directory paths and documents names.

      When all structural data are completely defined,  Generic Investigational  Medicinal Product - Preparation Production Chain is assigned a "completely structurally defined" with the ability to be used to define Corporate Entities of the higher level.

      At that point, an automatically generated enriched email notification is sent to the designated clinical entity person with information that the complete structural definition of the Clinical Trial entity can be completed using the newly created Generic Investigational Medicinal Product - Preparation Production Chain(s).

      The process of structural definition is similar to the process of structural definition of a Medicinal Product based on Ref. MP - Preparation Production Chain presented here.

      Generic IMP-Preparation Production Chain - narrative definition

      When the Generic Investigational  Medicinal Product - Preparation Production Chain record is inserted in the eCTD Integral Information System Database, directory tree with replacement narrative documents annotated with (*) is automatically created.

      The designated cmc entity person is responsible for the creation and subsequent changes of narrative definition documents.

      New or changed documents are uploaded using the "New Corporate Entity/Preparation Production Chain/Narrative Data" application form .

      When all replacement documents are replaced with newly created narrative documents, status of the new Generic Investigational  Medicinal Product - Preparation Production Chain entity  is set to “completely defined - draft”.

      At that point, an automatically generated enriched email notification is sent to the top-level cmc entity person with the information that the new Generic Investigational  Medicinal Product - Preparation Production Chain has been completely defined.

      The process of narrative definition is similar to the process of narrative definition of a Medicinal Product based on Ref. MP - Preparation Production Chain presented here.

      MP based on the Ref. MP - Prep. Production Chain

      structurally completed

      The Medicinal Product based on the Reference MP - Preparation Production Chain is a unique combination of Medicinal Product based on the Reference MP and Marketed Substance - Production Chain.

      One of the prerequisites for complete definition of the Medicinal Product based on the Reference MP - Preparation Production Chain entity is complete structural definition of the corresponding Marketed Substance - Production Chain. When that entity is completely structurally defined, enriched email notification is sent to the cmc entity person responsible for the definition of the corresponding Medicinal Product based on the Reference MP - Preparation Production Chain:

      • Enriched email automatic notification with
        • Topic - <"Name of the Medicinal Product based on the Reference MP - Preparation Production Chain">
        • Subtopic - "Introduction of a New Medicinal Product based on the Reference MP - Preparation Production Chain"
        • Subject - "The notification that Marketed Substance-Production Chain <Name> is completely structurally defined"
        • Initiator - enriched email that was used as a basis for creation of the Marketed Substance - Production Chain 

      sent when a Marketed Substance - Production Chain is completely structurally defined

      This enriched email automatic notification is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Preparation Production Chain/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 be completed.

      MP based on the Ref. MP - Prep. Production Chain - structural definition

      Since the Medicinal Product based on the Reference MP - Preparation Production Chain is already introduced into the eCTD Integral Information System Database, designated cmc entity person can use it as a topic in the Enriched Email correspondence to collect other data required for its structural and narrative definition.

      In the fourth step of creating the hierarchy of corporate entities, the second part of the structural definition of the Medicinal Product based on the Reference MP - Preparation Production Chain can be completed.

      Structural definition - second part

      After receiving the enriched email automatic notification that the Marketed Substance - Production Chain is completely structurally defined, designated cmc entity person using the application form "New Corporate Entity/Preparation Production Chain/Structural Data" and by clicking the button "Additional data", selects the appropriate incompletely structurally defined Medicinal Product based on the Reference MP - Preparation Production Chain.

      On the sub-application form, "Correspondence" selects a enriched email automatic notification with the information that the corresponding Marketed Substance - 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.

      On the application form, selects the newly defined Marketed Substance - Production Chain and completes the structural definition of the Medicinal Product based on the Reference MP - Preparation Production Chain entity.

      When all structural data are completely defined Medicinal Product based on the Reference MP - Preparation Production Chain is assigned a status "completely structurally defined" and can be used to define Corporate Entities of the higher level. 

      At that point, an automatically generated enriched email notification is sent to the top-level management with information that Medicinal Product Dossier or its' extension can be created.

      It is important to note that the choice of registration domains and what specifically to register in which domain  is within the responsibility and competence of the sales business function.

      Structural data of Medicinal Product based on the Reference MP - Preparation Production Chain(s) are used during the generation of initial submission for Marketing Authorization Project  and automatic generation of electronic Application Form (eAF).

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

      MP based on the Ref. MP - Prep. Production Chain - narrative definition

      Since the Medicinal Product based on the Reference MP - Preparation Production Chain entity has already been introduced into the eCTD Integral Information System Database in the previous step, the designated cmc entity person have been notified and the directory structure with replacement narrative documents annotated with (*) have already been created. Since than, the cmc entity person has been able to use this entity as a topic in Enriched Email correspondence to collect the remaining data necessary for structural and narrative definition.

      When all replacement documents are replaced with newly created narrative documents, status of the new Medicinal Product based on the Reference MP - Preparation Production Chain entity  is set to “completely defined - draft”.

      At that point, an automatically generated enriched email notification is sent to the top-level cmc entity person with the information that the new Medicinal Product based on the Reference MP - Preparation Production Chain has been completely defined.

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