Creating Corporate Entities

third step

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

  • Substance track

    • Marketed Substance - Production Chain - second level entity - structurally completed

  • Medicinal Product track

    • Generic Investigational Medicinal Product - first level entity - initiated and structurally completed

    • Medicinal Product based on the Ref. MP - Preparation Production Chain - third level entity - automatically initiated but structurally incomplete

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 is initiated and completed in this step.

For one Corporate Entities class the structural definition is initiated but not completed in this step.

For the two classes of Corporate Entities, 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 third 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 automatic 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 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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Marketed Substance - Production Chain

structurally completed

Top of the  Marketed Substance - Production Chain, namely distribution Organization, is defined in the previous second step of entity creation. In this step, all preceding manufacturing and quality control operations involving starting material, reagents, catalysts and intermediate products remain to be defined. The enriched email notification to proceed with the rest of the creation process is sent

when the structural definition of the Marketed Substance is completed:

  • Registered email automatic notification with:
    • Topic - "<Name of the Marketed Substance-Production Chain>"
    • Subtopic - "Introduction of a New Marketed Substance-Production Chain"
    • Subject - "The notification to define <Name of the Marketed Substance-Production Chain> "
    • Initiator - enriched email that was used as a basis for creation of the Marketed Substance

This enriched email automatic notification is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Marketed Substance - 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.

Marketed Substance - Production Chain - structural definition

In the third step of creating the hierarchy of corporate entities, the second part of the structural definition of Marketed Substance - Production Chain can be completed.

Since the Marketed Substance - 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.

Structural definition - second part

The complete structural definition of the Marketed Substance - Production Chain can be done on the application form "Corporate Entity creation/Marketed Substance - Production Chain/Structural Data".

Creation of additional manufacturing Organization(s) can be initiated on the application form by clicking the button "New Manufacturer". An automatically generated "basis for creation" enriched email notification is initiated:

  • Enriched email automatic notification with:
    • Topic - "New Organization"
    • Subtopic - "General - Development"
    • Subject - "The notification to define new manufacturer for <Name of the Marketed Substance-Production Chain> "
    • Initiator - enriched email that was used as a basis for creation of the Marketed Substance

which can be used on the "Correspondence" sub-application form of the application form "New Corporate Entity/Organization/Structural Data", to create a new Organization that participates in the Marketed Substance - Production Chain.

When all structural data are completely defined Marketed Substance - Production Chain is assigned a status "completely structurally defined" and can be used to define Corporate Entities of the higher level. At that point, depending on the business rules:

  • if the Substance is an Innovative Active Substance, an automatic enriched email notification is sent to:
    • either the pre-clinical entity persons responsible for the definition of the first Pre-Clinical Tests or the
    • cmc entity person responsible for the definition of the  Innovative Medicinal Product - Preparation Production Chain 
      with the information that the       new Marketed Substance-Production Chain is completely structurally defined
  • if the Substance is (Generic) Active Substance of the Ref. Medicinal Product, an automatically generated enriched email notification is sent to:
    • either the cmc entity person responsible for the definition of the Generic Investigational Medicinal Product - Preparation Production Chain or the
    • cmc entity person responsible for the definition of the Medicinal Product based on Ref. MP - Preparation Production Chain
      with information that the new Marketed Substance - Production Chain is completely structurally defined

It is important to note that the structural definition of the Marketed Substance - Production Chain represents the finalization of the substance track, which latter merges with the medicinal product track to define the Medicinal Product - Preparation Production Chain.

The Medicinal Product - Preparation Production Chain is the main component used to initiate, extend or change the Medicinal Product Regulatory Dossier.

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

Marketed Substance - Production Chain - narrative definition

Since the Marketed Substance - Production Chain 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 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.

Business rules

For the creation of the narrative documents, beside the basic eCTD specification related to Marketed Substance - Production Chain, following business rules are used:

  • For the manufacturers from the third countries replacement documents for the quality statement given by the distributing Organization are created
  • For the manufacturers from USA, Canada, EU, UK and Japan replacement documents for the GMP certificate are created

New or changed documents are uploaded using the application form "Corporate Entity creation/Marketed Substance - Production Chain/Narrative Data"

When all replacement documents are replaced with newly created narrative documents, status of the new Marketed Substance-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 Marketed Substance - Production Chain has been completely defined.

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

Generic Investigational Medicinal Product

initiated and structurally completed

For the realization of the Clinical Trial one or more Generic Investigational Medicinal Products are required. 

The creation of a Generic Investigational Medicinal Product(s) entity in the eCTD Integral Information System is instigated with one of the "basis for creation"  type of documents sent to the top-level cmc entity person via Enriched Email:

  • Enriched email automatic notification with:
    • Topic - "New Generic Investigational Medicinal Product"
    • Subtopic - "Introduction of a New Generic Investigational Medicinal Product"
    • Subject - "The notification to introduce a new Generic Investigational Medicinal Product"
    • Initiator - The enriched email that was used as the basis for the creation of a Clinical Trial with Generic Investigational Medicinal Product(s)

The top-level cmc 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/Medicinal Product/Structural Data - Generic Investigational MP” 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 Investigational Medicinal Product - structural definition

A Generic Investigational Medicinal Product is based on a Reference Medicinal Product whose structural data are used for its definition. Depending on the legal basis, certain changes are allowed.

The structural definition of Generic Investigational Medicinal Products depends on the related Clinical Trial and the Reference Medicinal Product. The “Corporate Entity creation/Medicinal Product/Structural data - Generic Investigational MP” application form contains already defined data from the related Clinical Trial and the Reference Medicinal Product:

  • Active Substance(s) - from Clinical Trial
    previously defined global/basic Corporate Entity
  • Dosage form - from Reference Medicinal Product
  • Strength - from Reference Medicinal Product
  • Generic name - from Reference Medicinal Product
  • ATC code - from Clinical Trial
  • Route of administration - from Clinical Trial
  • Indication - from Clinical Trial
  • intended legal basis - from Clinical Trial
  • intended use - from Clinical Trial

Depending on the incorporated business rules certain changes are allowed:

  • Dosage form - for hybrid legal basis
  • Strength - for hybrid legal basis
  • Route of administration - for hybrid legal basis

Since most of the structural data are already defined in the related Clinical Trial or Reference Medicinal Product, a Generic Investigational Medicinal Product can be completely defined in the first session. After the insertion of the record into the Integral Information System Database, the Generic Investigational Medicinal Product is assigned a 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 the top level cmc entity person with information that Generic Investigational Medicinal Product - Preparation Production Chain has to be created using newly defined Generic Investigational Medicinal Product. The recipient the enriched email automatic notification decides whether to initiate the creation process himself or to forward the message to another cmc entity person under his jurisdiction.

When the record is inserted into the eCTD Integral Information System a core sequence is automatically generated and all subsequent narrative definition actions are associated with that sequence. The designated clinical 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  and the designated clinical entity person is set as a "designated follower" of all enriched email messages related to the newly introduced Generic Investigational Medicinal Product. 

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 Generic Investigational Medicinal Product structural data, an editable unique "var" abbreviation "gimedprod" is automatically generated and later used as a part of the template directory paths document names.

Detailed description of the structural definition process is presented here.

At the end of the structural definition process, Generic Investigational Medicinal Product is assigned a status "completely structurally defined".

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

The recipient of the above enriched email automatic notification decides whether to initiate the creation process himself or to forward the notification to another corporate entity person under his jurisdiction.

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

Generic Investigational Medicinal Product - narrative definition

When the Generic Investigational  Medicinal Product 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 application form "Corporate Entity creation/Generic Investigational Medicinal Product/Narrative Data".

When all replacement documents are replaced with newly created narrative documents, status of the new Generic Investigational  Medicinal Product 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 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 presented here

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

automatically initiated but structurally incomplete

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

For the three types of Medicinal Product based on the Reference MP created in the previous step, the Medicinal Product - Preparation Production Chain can be created in this step of Corporate Entity creation.

To create a Medicinal Product - Preparation Production Chain, a Medicinal Product must be created first and, in order to finish the creation, the related Marketed Substance - Production Chain must also be created.

The creation of a Medicinal Product - Preparation Production Chain  entity in the eCTD Integral Information System must be instigated with the "basis for creation"  type of documents sent via Enriched Email to the cmc entity person designated for the definition of the corresponding Medicinal Product based on the Reference MP:

  • Enriched email automatic notification with:
    • Topic - "New Medicinal Product - Preparation Production Chain "
    • Subtopic - "Introduction of a New Medicinal Product - Preparation Production Chain"
    • Subject - "The notification to create a new Medicinal Product - Preparation Production Chain"
    • Initiator - enriched email that was used as a basis for the creation of the Medicinal Product based on the Reference MP

sent when a Medicinal Product based on the Reference MP is completely structurally defined

    The top-level cmc 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 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 begin.

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

    Since a Medicinal Product based on the Reference MP - Preparation Production Chain is completely defined by the first and second level Corporate Entities and structural data:

    •  Medicinal Product based on the Reference MP
      previously defined first level Corporate Entity
    • Marketed Active Substance - Production Chain(s)
      previously defined second level Corporate Entity
    • Marketed Excipients - Production Chain(s)
      previously defined second level Corporate Entity
    • Organization(s)
      previously defined global/basic Corporate Entity performing:
      • distribution
      • required technological unit operations
    • CMC entity person responsible

    its structural definition process is divided in two parts. In the third step of creating a hierarchy of Corporate Entities, only the first part of the structural definition can be done when only the global/basic entities, Generic Medicinal Product and Organization, are completely structurally defined.

    Structural definition - first part

    A minimal set of structural data is specified with the (*) on the application form "Corporate Entity creation/Preparation Production Chain/Structural Data" and they are a prerequisite for the insertion of the record in 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 Enriched Email in order to collect other data required to completely structurally and narratively define Medicinal Product based on the Reference MP - Preparation Production Chain.

    When the record is inserted into the eCTD Integral Information System a core sequence is automatically 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 automatic notification.

    Also, at the same time, the topic of the "basis for creation" enriched email is replaced with the newly created Medicinal Product based on the Reference MP - Preparation Production Chain and the designated cmc entity person is set as a "designated follower" of all enriched email messages related to the newly introduced Medicinal Product based on the Reference MP - 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 Medicinal Product based on the Reference MP - Preparation Production Chain structural data, an editable unique "var" abbreviation "gmedprodchain" is automatically generated and later used as a part of the template directory paths and documents names.

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

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

    If the minimal set of the Medicinal Product based on the Reference MP - Preparation Production Chain structural data requirement is satisfied, and the record is inserted in the eCTD Integral Information System Database, directory structure with replacement documents annotated with (*) is automatically created.

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

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

    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 narrative definition process is presented here.