Creating Corporate Entities

second step

There are six classes of Corporate Entities whose structural definition can be initiated/completed in the second step of the corporate entity hierarchy creation process:

  • Substance track

    • Marketed Substance - first level entity - initiated automatically or by decision and structurally completed

    • Marketed Substance - Production Chain - second level entity - initiated automatically and structurally incomplete

  • Medicinal Product track

    • Pre-Clinical Tests - third level entity - initiated automatically or by decision and structurally incomplete

    • Clinical Trial with Generic Investigational Medicinal Product - fourth level entity - initiated automatically or by decision and structurally incomplete

    • Medicinal Product based on the Reference MP - first level entity - initiated automatically and structurally completed

For the two classes of Corporate Entities, the structural definition is initiated and completed in this step.

For the three classes of Corporate Entities, the structural definition is initiated but not completed in this step.

For the five classes of Corporate Entities, 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 second 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, a 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 creation of a Corporate Entity begins with a structural definition on the appropriate application form for 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.

In the second step of creating a hierarchy of Corporate Entities, two creation tracks are initiated:

  • Substance track
  • Medicinal Product track

Both tracks meet several times in the next entity creation steps in order to create several Medicinal Product Preparation Production Chains.

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Marketed Substance

initiated by decision or automatically and structurally completed

Marketed substances are substances that can be purchased on the market. Their composition is defined in accordance with international standards or internal standards of the manufacturer.

The creation of a Marketed Substance entity in the eCTD Integral Information System must be instigated with a "basis for creation"  type of document, sent via Enriched Email as a:

  • Enriched email automatic notification sent to the cmc entity person who was responsible for the creation and definition of the distribution Organization with:
    • Topic - "New Marketed Substance"
    • Subtopic - "Introduction of a New Marketed Substance"
    • Subject - "The notification to introduce a new Marketed Substance" 
    • Initiator - enriched email that was used as a basis for the creation/change of the substance distributing Organization sent when the new distributing Organization is introduced/changed into the Integral Information System

The Organization can be:

  • New Organization with the corresponding Substance in the GDP certificate distribution list
    or
  • Existing Organization with an addition of the corresponding Substance in the GDP certificate distribution list

Also, in the following situations, an enriched email message is sent by a top-level cmc entity person:

  • If a Substance, with an established distributing Organization(s) and Marketed Specification(s), already exists in the eCTD Integral Information System, but there is a need for a Marketed Substance with different marketed specification, top-level cmc entity person initiates the "basis for creation" enriched email message for the creation of a new Marketed Substance:
    • Enriched email message sent to the cmc entity person:
      • Topic - "New Marketed Substance"
      • Subtopic - "Introduction of a New Marketed Substance"
      • Subject - Instruction for the introduction of a new Marketed Substance 
  • If the Marketed Substance with a different specification cannot be procured from the existing distributing Organization(s),  the top-level cmc entity person must be notified to initiate a "basis for creation" enriched email message for the introduction of a new distributing Organization: 
    • Enriched email message sent to the cmc entity person:
      • Topic - "New Organization"
      • Subtopic - "Introduction of a New Organization"
      • Subject - Instruction for the introduction of a new distributing Organization 

The enriched email automatic notification generated after the introduction of a new distributing Organization should be processed on the application form   "Corporate Entity creation/Marketed Substance/Structural Data", where for the new Marketed Substance, a new top of the supply chain can be defined with the new distributing Organization. 

  • If there is a need for a new distributing Organization for the existing Marketed Substance, the top-level cmc entity person must be notified to initiate "basis for creation" enriched email message for the introduction of a new distributing Organization:
    • Enriched email message sent to the cmc entity person:
      • Topic - "New Organization"
      • Subtopic - "Introduction of a New Organization"
      • Subject - Instruction for the introduction of a new distributing Organization

The enriched email automatic notification generated after the introduction of the new distributing Organization should be processed on the application form "Corporate Entity change/Marketed Substance/Structural Data", where for the existing Marketed Substance, a new top of the supply chain can be defined with the new distributing Organization. 

  • If there is a need for a new supply chain with the existing distributing Organization, the top-level cmc entity person must be notified to initiate "basis for change" enriched email message for the change of the existing Marketed Substance:
    • Enriched email message sent to the cmc entity person:
      • Topic - "Change of the Marketed Substance"
      • Subtopic - "General - Development"
      • Subject - Instruction for the introduction of a new Marketed Substance Production Chain

The enriched email message should be processed on the application form "Corporate Entity change/Marketed Substance/Structural Data", where a new top of the supply chain can be defined for the existing distribution Organization. A new supply chain with the existing distribution Organization can not be created for Marketed Substances produced in accordance with the manufacturer's  Active Substance Master File (ASMF).

Depending on the scenario, one of those enriched emails is displayed on the sub-application form "Correspondence" on the "Corporate Entity creation/Marketed Substance/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.

Marketed Substance - structural definition

A minimal data set is specified with the (*) on the application form "Corporate Entity creation/Marketed Substance/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  correspondence in order to collect other data required to completely structurally and narratively define Marketed Substance.

The Marketed Substance is defined by the following lower-level Corporate Entities and structural data:

  • Substance
    previously defined global/basic Corporate Entity
  • Organization
    previously defined global/basic Corporate Entity performing:
    • distribution operation
  • cmc entity person responsible
  • Quality Standard for marketed substances
    • American Chemical Society (ACS) grade
    • US Pharmacopeia grade (USP)
    • EU Pharmacopeia grade (EP)
    • Japan Pharmacopeia grade (JP)
    • British Pharmacopeia grade (BP)
    • Active Substance Master File (ASMF)
    • Laboratory grade (p.a.)
    • Technical grade
    • None

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 automatic notification.

Also, at the same time,  the topic of the "basis for creation" enriched email is replaced with the newly created Marketed Substance and the designated cmc entity person is set as a "designated follower" of all enriched email messages related to the newly introduced Marketed Substance. 

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.

In the case that an enriched email message is used as a “basis for creation”, using the business rules for this situation, the entity creation chain of correspondence is established and the original initiating enriched email is automatically inserted into the new “basis for creation” enriched email message.

During the definition of the minimal set of structural data of the Marketed Substance, an editable unique "var" abbreviation "mrktsubst" is automatically generated which is later used as a part of template directory paths and documents names.

For Marketed Substances sold on the basis of a "manufacturer's specification" and/or designated for quality control upon receipt, the specification, together with quality control techniques and methods, must also be specified. When inserting a record, quality control analysis is automatically generated and later used whenever the Marketed Substance is received in the purchasing receiving area.

During the process of structural definition of a Marketed Substance, the top of the Marketed Substance - Production Chain, namely the distributing Organization, is also defined, making it possible to use the chain as a topic in Enriched Email correspondence.

When all structural data are completely defined Marketed Substance is assigned the 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 designated cmc entity person with the information that the Marketed Substance - Production Chain has to be completely defined for the newly defined Marketed Substance.

It is important to note that the structural characteristics of the Marketed Substance such as main substance ID, substance role, standard, etc. are used to navigate the correspondence chain for the Substance track as well as during the automatic generation of initial submission for Marketing Authorization Application projects. 

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

Marketed Substance - narrative definition

If the minimal set of the Marketed Substance structural data is satisfied, and the record is inserted in the eCTD Integral Information System Database, directory structure with replacement documents annotated with (*) is automatically created.

In addition to the basic eCTD documents associated with the Marketed Substance, the following business rules are used to create the narrative documents required for the complete narrative definition of the Marketed Substance:

  • if the quality standard is defined by the EU Pharmacopeia replacement file for the CEP is created (annex-10)
  • if the quality standard is defined by ASMF related replacement files are not created. They are created at the time of MAA project launch when the regulatory agency, to which the letter of accession (Annex-10) and the letter of confirmation for notification of changes (Annex-11) are to be sent, is known.

The designated cmc entity person is responsible for the creation and subsequent changes of narrative documents and is automatically granted the necessary system privileges. 

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

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

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

Marketed Substance-Production Chain

initiated automatically and structurally incomplete

To enable the use of Marketed Substance-Production Chain entity as a topic in Enriched Email correspondence as soon as possible, its creation is initiated in the second step of creating a hierarchy of Corporate Entities, together with the creation of a Marketed Substance entity.

Every "basis for creation" enriched email received for the creation of a Marketed Substance is also the basis for initiating the creation of the Marketed Substance-Production Chain.

Marketed Substance-Production Chain - structural definition

Marketed Substance-Production Chain is defined by the following lower-level Corporate Entities and structural data:

  • Marketed Substance
    previously defined first level Corporate Entity
  • Organization(s)
    previously defined global/basic Corporate Entity performing:
    • manufacturing operations
    • quality control operations
    • distribution operation
  • cmc entity person responsible
  • Distribution operations
    defined by the Good Distribution Practice
  • Manufacturing operations
    defined by and used in the the eAF application form
  • Quality control operations
    defined by and used in the the eAF application form
  • Stability data
    experimentally determined by the manufacturer
  • Starting materials and intermediates
    defined by the manufacturer

In order to enable the use of Marketed Substance-Production Chain entity as a topic in Enriched Email correspondence as soon as possible, the structural definition process is divided in two parts.

    Structural definition - first part

    In the first part, during the second step of creating the hierarchy of Corporate Entities, only the top of the supply chain, i.e. the distributing Organization, is defined, and the cmc entity person is designated. In this way, prerequisites for data gathering necessary for structural and narrative definition via Enriched Email correspondence are provided.

    The minimal set of structural data is specified with the (*) on the sub-application form "Distributors" of the application form "Corporate Entity creation/Marketed Substance/Structural Data" and they are a prerequisite for the insertion of the record in the eCTD Integral Information System Database.

    The record contains following minimal data set of structural data:

    • Marketed Substance
    • Distributing Organization
    • cmc entity person responsible

    The other Organizations participating in the production of the Marketed Substance are not defined.  The record, since it contains only 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 Client to collect other data required to completely structurally and narratively define Marketed Substance-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 automatic notification - with:
      • Topic - "New Marketed Substance Production Chain"
      • Subtopic - "Introduction of a New Marketed Substance Production Chain"
      • Subject - "The notification to complete the structural definition of the newly introduced Marketed Substance Production Chain"
      • Initiator - enriched email used as a basis for the creation of the Marketed Substance

    Also, at the same time, the designated cmc entity person is set as a "designated follower" of all enriched emails  related to the newly introduced Marketed Substance-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 Marketed Substance-Production Chain structural data, an editable unique "var" abbreviation "substprodchain" is automatically generated and later used as a part of the template directory paths and documents names. 

    A detailed description of the first part of the process of structural and narrative definition is presented here.

    Marketed Substance-Production Chain - narrative definition

    When the Marketed Substance-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 the narrative definition documents.

    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 newly Marketed Substance-Production Chain has been completely defined.

    A detailed description of a narrative definition process is presented here

    Pre-Clinical Tests

    initiated automatically or by decision and structurally incomplete

    To enable the use of Pre-Clinical Tests entity as a topic in Enriched Email correspondence as soon as possible, its creation is initiated in the second step of creating a hierarchy of Corporate Entities.

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

    • Enriched email automatic notification with:
      • Topic - "New Pre-Clinical Tests"
      • Subtopic - "Introduction of a New Pre-Clinical Tests"
      • Subject - "The notification to introduce a new set of Pre-Clinical Tests" 
      • Initiator - enriched email that was used as a basis for creation of the Substance

    sent when the corresponding Active Substance, whose proposed legal basis for future marketing authorization is in accordance with Article 8(3), is completely structurally defined

    • Enriched email message with
      • Topic - "New Pre-Clinical Tests"
      • Subtopic - "Introduction of a New Pre-Clinical Tests"
      • Subject - "The decision to introduce a New Pre-Clinical Tests" 
      • Attachment - "Decision document"
        Details and justification for such a business move along with necessary resources must be provided in this (template) document and should be signed by a corporate person with the appropriate authority

    sent when there is a need for additional Pre-Clinical Tests for an innovative Active Substance, Generic Active Substance, novel excipients and non-novel non-compendial excipients.

    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.

    Depending on the scenario, one of enriched emails 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 begin.

    Pre-Clinical Tests - structural definition

    Since Pre-Clinical Tests are defined by the first and second level Corporate Entities and structural data:

    • Active Substance
      previously defined global/basic Corporate Entity
    • Organization(s) 
      previously defined global/basic Corporate Entity performing:
      • pre-clinical tests
      • statistical support
      • ...
    • pre-clinical entity person responsible
    • Test type
      defined by health legislation
    • Marketed Substance-Production Chain
      previously defined second level Corporate Entity

    their structural definition process is divided in two parts. In the second 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 Active Substance and Organization, are completely structurally defined.

    Structural definition - first part

    The minimal set of structural data, based only on the global/basic Corporate Entities,  is specified with the (*) on the application form "Corporate Entity creation/Pre-Clinical Tests/Structural Data" and they are a prerequisite for the insertion of the record in the eCTD Integral Information System Database.

      The record contains following minimal set of structural data:

      • Active Substance
      • Lead Sponsor - Organization
      • Study Classification
      • pre-clinical entity person responsible
      • Official Title
      • Indication(s)

      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 to collect other data required to completely structurally and narratively define Pre-Clinical Tests.

      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 pre-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 Pre-Clinical Tests and the designated pre-clinical entity person is set as a "designated follower" of all enriched emails  related to the newly introduced Pre-Clinical tests. 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.

      In the case that a enriched email message without initiator is used used as a “basis for creation”, using the business rules for this situation, the entity creation chain of correspondence is established and the original initiating enriched email is inserted into the “basis for creation” enriched email message.

      During the definition of the minimal set of Pre-Clinical Tests structural data, an editable unique "var" abbreviation "pclt" 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 presentedhere.

      Pre-Clinical Tests - narrative definition

      If the minimal set of the Pre-Clinical Tests 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 pre-clinical 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/Pre-Clinical Tests/Narrative Data".

      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 cmc entity person with the information that the newly Pre-Clinical Tests has been completely defined.

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

      Clinical Trial with a Generic Investigational MP(s)

      initiated automatically or by decision and structurally incomplete

      To enable the use of Clinical Trials with a Generic Investigational Medicinal Product(s) as a topic in Enriched Email correspondence as soon as possible, their creation is initiated in the second step of creating a hierarchy of Corporate Entities.

      The creation of a Clinical Trial with 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 clinical entity person via Enriched Email:

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

      sent when a Generic Active Substance, intended for generic application (Article 10(1), with Reference Medicinal Product not administered directly into the bloodstream, is completely structurally defined

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

      sent when an Active Substance, intended for hybrid application (Article 10(3), is completely structurally defined

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

        sent, if the Generic Active Substance has already been introduced into the eCTD Integral Information System, and its new Reference Medicinal Product intended for generic application (Article 10(1) which is not administered directly into the bloodstream is completely structurally defined

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

        sent, if the Generic Active Substance has already been introduced into the eCTD Integral Information System, and its new Reference Medicinal Product intended for hybrid application (Article 10(3) is completely structurally defined

          • Enriched email message with:
            • Topic - "New Clinical Trial"
            • Subtopic - "Introduction of a New Clinical Trial"
            • Subject - "The decision to introduce a new Clinical Trial with a Generic Investigational Medicinal Products" 
            • Attachment - "Decision document"
              Details 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

          sent when there is a need for additional Clinical Trial with Generic Investigational Medicinal Products

          The top-level 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.

          Depending on the scenario, one of those enriched emails is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Clinical Trial-Generic IMP/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.

          Clinical Trial with Generic Investigational MP - structural definition

          Since a Clinical Trial with Generic Investigational MP is completely defined by the first and third level Corporate Entities and structural data:

          • Active Substance
            previously defined global/basic Corporate Entity
          • Organization(s) 
            previously defined global/basic Corporate Entity performing:
            • sponsorship
            • clinical trials
            • statistical support
            • ...
          • clinical entity person responsible
          • Trial type
            defined by health legislation
          • Generic Investigational Medicinal Product
            previously defined first level Corporate Entity defined
          • Generic Investigational MP-Preparation Production Chain
            previously defined third level Corporate Entity

          its structural definition process is divided in two parts. In the second 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 Active Substance and Organization, are completely structurally defined.

          Structural definition - first part

          The minimal set of structural data, based only on the global/basic Corporate Entities, is specified with the (*) on the application form "Corporate Entity creation/Clinical Trial/Structural Data" and they are a prerequisite for the insertion of the record into the eCTD Integral Information System Database.

          The record contains following minimal set of structural data:

          • Generic Active Substance - same INN as the Reference Medicinal Product
          • Lead Sponsor - Organization
          • Study Classification
          • clinical entity person responsible
          • Official Title
          • Indication(s)
          • Objective(s)
          • Trial Type and Phase

          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 automatic notification. Also, at the same time, the topic of the "basis for creation" enriched email is replaced with the newly created Clinical Trial and the designated clinical entity person is set as a "designated follower" of all enriched email messages related to the newly introduced Clinical Trial. 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.

          In the case that a enriched email message 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.

          In the case that an enriched email message 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 registered email is inserted into the “basis for creation” enriched email message.

          During the definition of the minimal set of Clinical Trial structural data, an editable unique "var" abbreviation "cltgimp" is automatically generated and later used as a part of the template directory paths and documents names. 

          Generic Investigational Medicinal Product(s)

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

          By clicking on the button "Investigational MP" a "basis for creation " enriched email notification is generated for the creation of one Generic Investigational Medicinal Product. After the required dosage form and strength are specified, enriched email notification is sent to the top- level cmc entity person for creating one Generic Investigational Medicinal Product. Its structural definition can be done on the "Corporate Entity creation/Medicinal Product/Structural Data - Generic Investigational MP" application form.

          The instigation of the creation of Generic Investigational Medicinal Product(s), completes the first part of the structural definition of a Clinical Trial.

          A Clinical Trial entity is assigned the status "incompletely defined".

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

          Clinical Trial with Generic Investigational MP - narrative definition

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

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

          New or changed documents are uploaded using the application form "Corporate Entity creation/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 cmc entity person with the information that the newly Clinical Trial has been completely defined.

          A detailed description of a narrative definition process is presented here

          Medicinal Product based on the Reference MP

          initiated automatically and structurally completed

          With respect to their legal basis for marketing authorization, there are three types of Medicinal Product based on the Reference MP whose creation can be initiated in the second step of Corporate Entity creation. Their creation must be instigated by 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 Medicinal Product "
            • Subtopic - "Introduction of a New Medicinal Product"
            • Subject - "The notification to introduce a new Medicinal Product"
            • Initiator - enriched email that was used as a basis for the creation of the Substance

          automatically sent when
          Active Substance, intended for generic application (Article 10(1) with Reference Intravenous Medicinal Product administered directly into the bloodstream,

          or
          Active Substance intended for well-established use application (Article 10a),

          is completely structurally defined 

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

          automatically sent when Active Substance intended for informed consent application (Article 10c)
           is completely structurally defined 

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

          automatically sent if 
          Active Substance intended for generic application (Article 10(1) with Reference Intravenous Medicinal Product administered directly into the bloodstream,

          or
          Active Substance intended for well-established use application (Article 10a),

          has already been introduced into the eCTD Integral Information System, and its new Reference Medicinal Product is completely structurally defined

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

          automatically sent if 
          Active Substance intended for informed consent application (Article 10c)
          has already been introduced into the eCTD Integral Information System, and its new Reference Medicinal Product 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 matter in question.

          Depending on the scenario, one of enriched email notifications is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Medicinal Product/Structural Data - MP based on Ref. MP” application form. To preserve the entity creation chain of correspondence, that enriched email must be checked, and after returning to the main application form, the process of structural definition can begin.

          Medicinal Product based on the Reference MP - structural definition

          A minimal set of structural data is specified with the (*) on the application form "Corporate Entity creation/Medicinal Product/Structural Data - MP based on the Reference MP" and they are a prerequisite for the insertion of the record into the eCTD Integral Information System Database.

          Since the Medicinal Product based on Reference MP  has the same structural definition as the corresponding Reference Medicinal Product, the Reference Medicinal Product's structural data, the intended legal basis and the intended use are used to structurally define the Medicinal Product based on the Reference MP: 

          • Generic Active Substance - same INN as the Reference Medicinal Product
            previously defined global/basic Corporate Entity
            or
          • Fixed Combination of active substances
            previously defined global/basic Corporate Entity with quantity and a unit of measure for each active substance
          • CMC entity person responsible
          • Clinical entity person responsible
          • Pre-clinical entity person responsible
          • Legal basis
          • Dosage form
          • Strength - a quantity and a unit of measure
          • ATC code
          • Route of administration
          • Indication(s)

          Since the Reference Medicinal Product is completely structurally defined and the intended legal basis declared in the decision to introduce or re-use an existing Reference Medicinal Product, the corresponding Medicinal Product can be completely defined in the first session.

          Three entity persons are designated to cover all aspects of the Medicinal Product based on Reference MP.

          After the insertion of the record into the eCTD Integral Information System Database, Medicinal Product based on the Reference MP 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 cmc entity person designated for the definition of the Medicinal Product based on the Reference MP with the information that the Medicinal Product-Preparation Production Chain has to be created using the newly defined Medicinal Product based on the Reference MP. 

          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 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 Medicinal Product based on the Reference MP and the designated cmc entity person is set as a "designated follower" of all enriched email messages related to the newly introduced 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 Medicinal Product based on the Reference MP structural data, an editable unique "var" abbreviation "gmedprod" is automatically generated and later used as a part of the template directory paths and document names.

          It is important to note that the structural characteristics of the Medicinal Product based on the Reference MP such as substance ID, INN, indication, route of administration, MAH data, etc. are used to navigate the correspondence chain for the Medicinal Product track, as well as during the automatic generation of initial submissions for Preclinical Tests, Clinical Trial and Marketing Authorization Application projects. They are also used to automatically fill in electronic Application Form (eAF).

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

          Medicinal Product based on the Reference MP - narrative definition

          When the  Medicinal Product based on the Reference MP 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 the creation and subsequent changes of narrative definition documents.

          New or changed documents are uploaded using the application form "Corporate Entity creation/Medicinal Product/Narrative Data".

          When all replacement documents are replaced with newly created narrative documents, status of the new Medicinal Product based on the Reference MP  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 newly Medicinal Product based on the Reference MP has been completely defined.

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