Creating Corporate Entities

thirteenth step

There is one class of Corporate Entities whose structural definition can be initiated/completed in the thirteenth step of the process of creating a hierarchy of corporate entities:

  • Medicinal Product track

    • Innovative Medicinal Products Dossier/First Innovative Medicinal Product MAA Project -  initiated by decision and structurally 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 thirteenth 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 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.

Add comment

Comments

There are no comments yet.

Innovative Medicinal Products Regulatory Dossier

initiated by decision and structurally completed

The Medicinal Product Regulatory Dossier contains all the data generated during the realization of Medicinal Products Regulatory Projects for a given Active Substance and for a specified regulatory domain.

Medicinal Product Regulatory Dossier is created and opened when the first Medicinal Product MAA Project is launched. For the first Innovative Medicinal Product the Medicinal Product Regulatory Dossier can be created and the first  MAA Project launched in the thirteenth step.

The creation of a Medicinal Product Regulatory Dossier entity in the eCTD Integral Information System must be instigated with a "basis for creation"  type of document sent to the top-level regulative project person via Enriched Email as a:

  • Enriched email message with
    • Topic - "New Dossier/Dossier Extension - Medicinal Products"
    • Subtopic - "Introduction of a New Dossier/Dossier Extension - Medicinal Products"
    • Subject - "The notification to create a Innovative Medicinal Product Regulatory Dossier for a specified domain"
    • Attachment - "Decision document"
      Details, such as the active substance, pharmaceutical form, dosage, route of administration, indication, registration domain, and justification for such a business move together with the required projected resources must be provided in this document and should be signed by a corporate person with the appropriate authority

This enriched email message is displayed on the sub-application form "Correspondence" on the “New Corporate Entity/MP Regulatory Dossier/MA Application” application form. 

To preserve the entity creation chain of correspondence, this enriched email must be checked, and after returning to the main application form, the process of structural definition can begin.

Innovative Medicinal Product Regulatory Dossier - structural definition

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

  • Medicinal Product Regulatory Dossier
    • Innovative Active substance of the Dossier
      previously defined global/basic Corporate Entity
    • State/Country(s)
    • Organization(s) participating in the dossier projects
      • Health Authority
      • MAA Holder
      • Applicant
  • Medicinal Product MAA Project
    • First Innovative Medicinal Product - to be registered
      previously defined first level Corporate Entity
      • indication to be registered
      • route of administration to be registered
    • Innovative Medicinal Product - Preparation Production Chain(s) and SKU(s)
      previously defined third level Corporate Entity
    • regulatory project person responsible for the conduct of the project

The following Medicinal Product Marketing Authorization Projects are treated as an extensions of the Medicinal Products Regulatory Dossier.

A minimal set of structural data is specified with the (*) on the application form "New Corporate Entity/MP Regulatory Dossier/MA Application" and they are a prerequisite for the insertion of the record in the eCTD Integral Information System Database.

When the record is inserted into the eCTD Integral Information System:

  • a core sequence is generated and all subsequent structural and narrative definition actions and project realization actions are associated with that sequence
  • automatically generated enriched email notifications are sent to MA Holder's marketing entity person and regulatory project person notifying them of new assignments and becoming followers of the respective Enriched Email topics
  • the topic of the "basis for creation" enriched email is replaced with the newly created Medicinal Product Regulatory Dossier 
  • since an enriched email message without initiator is used as a “basis for creation”, using the business rules for this situation, the entity creation chain of correspondence is established and the initiating enriched email is inserted into the “basis for creation” enriched email message
  • the initial submission directory tree with documents is automatically generated consisting of the entity definition documents and project initial submission documents.

The following criteria are used to automatically include entity definition documents in the submission:

  • For the Marketed Substance 
    • Substance role
    • Marketed Substance standard
  • For the Marketed Substance Production Chains
    • Substance role
    • Marketed Substance standard
    • Medicinal Product Preparation Chain(s) selected for the submission
  • For the Medicinal Product Production Chains
    • Medicinal Product Preparation Chain(s) selected for the submission
  • For the participating Marketed Active Substance Manufacturers
    • Organizations participating in the manufacture
  • For the design spaces of the participating Medicinal Product Manufacturers
    • Manufacturing activity
    • Pharmaceutical form of the Medicinal Product
  • For the Clinical Trial(s)
    • Clinical Trial classification
    • Route of administration of the Medicinal Product
    • Indication of the Medicinal Product
  • For the Pre-Clinical Tests(s)
    • Pre-Clinical Tests classification
    • Indication

Innovative Medicinal Product Regulatory Dossier - narrative definition

The Medicinal Product Regulatory Dossier does not require narrative entity definition documents for its definition.

Narrative definition of a Innovative Medicinal Product MAA Project, consists of creation and upload of project initial submission documents required by the Innovative Medicinal Product MAA Project template. Upload of project initial submission documents for all types of "active" Corporate Projects can be done using application form "Corporate Projects/Submission files - upload".