Creating Corporate Entities

eleventh step

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

  • Medicinal Product track

    • Innovative Medicinal Product - initiated by decision and completed

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

For one class 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 eleventh 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.

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

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

The narrative definition can begin as soon as the "minimal data set" is inserted in the eCTD Integral Information System Database because an appropriate directory tree with replacement 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.

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Innovative Medicinal Product

initiated by decision and completed

Creation of a Innovative Medicinal Product must be justified by the results of previously conducted Clinical Trial(s)

The creation of a Innovative Medicinal Product entity in the eCTD Integral Information System is instigated with a "basis for creation"  type of document sent to the top-level cmc entity person via Enriched Email:

    • Enriched email message with:
      • Topic - "New Innovative Medicinal Product"
      • Subtopic - "Introduction of a New Innovative Medicinal Product"
      • Subject - "The decision to introduce a new Innovative 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 the results of previous Clinical Trial(s) justify the initiation of a new Innovative Medicinal Products introduction

    This enriched email is displayed on the sub-application form "Correspondence" on the “New Corporate Entity/Medicinal Product/Structural Data - Innovative 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.

    Innovative Medicinal Product - structural definition

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

    • Innovative Active Substance - same Active Substance used for Innovative Investigational 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
    • Legal basis - Article 8(3) full application 
    • Dosage form
    • Strength - a quantity and a unit of measure
    • ATC code
    • Route of administration
    • Indication(s)

    Since the Innovative Medicinal Product is completely structurally defined in the "Decision document", Innovative Medicinal Product can be completely defined in the first session.

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

    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 designated cmc entity person is set as a follower of all registered email messages related to the newly introduced Innovative Medicinal Product.

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

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

    Innovative Medicinal Product - narrative definition

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

    Designated cmc entity person responsible for creation and upload of narrative files is informed about its new assignment via an automatically generated enriched email notification. This person, responsible for uploading newly generated documents, is also responsible for their subsequent changes, and is automatically granted the necessary system privileges. New or changed documents are uploaded using the application form "New Corporate Entity/Generic Medicinal Product/Narrative Data".

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