Creating Corporate Entities
eighth step
There are two classes of Corporate Entities whose structural definition can be initiated/completed in the eight step of the process of creating a hierarchy of corporate entities:
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Medicinal Product track
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Innovative Investigational Medicinal Product - Preparation Production Chain - sixth level entity - automatically initiated and structurally completed
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Generic Medicinal Product-Preparation Production Chain - third level entity - automatically initiated and structurally completed
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Marketing Campaign Dossier/First Marketing Campaign Project - OTC Medicinal Product(s) - sixth level entity - automatically initiated and structurally completed/launched
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For the three classes of Corporate Entities the structural definition can be initiated and completed in this step.
For the three 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 eight 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.
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Innovative IMP - Preparation Production Chain
automatically initiated and completed
The Innovative Investigational Medicinal Product - Preparation Production Chain is a unique combination of a Innovative Investigational Medicinal Product - Production Chain and the related Marketed Substance-Production Chain.
The creation of an Innovative Investigational Medicinal Product - Preparation Production Chain 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 cmc entity person via Enriched Email:
- Enriched email automatic notification with:
- Topic - "New Innovative IMP - Preparation Production Chain"
- Subtopic - "Introduction of a New Medicinal Product - Preparation Production Chain"
- Subject - "The notification to introduce a new Innovative Investigational Medicinal Product - Preparation Production Chain"
- Initiator - enriched email that was used as a basis for creation of the Innovative Investigational Medicinal Product
sent when corresponding Innovative Investigational Medicinal Product is completely structurally defined
- Enriched email message with
- Topic - "New Innovative Investigational Medicinal Product - Preparation Production Chain"
- Subtopic - "General - Administrative"
- Subject - "The decision to make additional Innovative Investigational Medicinal Product - Preparation Production Chain"
- Attachment - "Decision document"
Details and justification for such a business move along with the necessary resources must be provided in this document and should be signed by a corporate person with the appropriate authority
sent when the need arose to make additional Innovative Investigational Medicinal Product-Preparation Production Chain
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 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.
Innovative IMP-Preparation Production Chain - structural definition
Investigational Innovative Medicinal Product-Preparation Production Chain - defined by the following lower-level Corporate Entities and structural data:
- Investigational Innovative Medicinal Product
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
- Stock Keeping Units - SKU
- cmc person responsible
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 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 Investigational Innovative Medicinal Product - 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 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 Investigational Innovative Medicinal Product - Preparation Production Chain.
During the definition of the minimal set of structural data of the Investigational Innovative Medicinal Product - Preparation Production Chain, an editable unique "var" abbreviation "iimedprodchain" is automatically generated which is later used as a part of template directory paths and documents names.
When all structural data are completely defined Investigational Innovative Medicinal Product - 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 clinical entity person designated for the definition of the related Clinical Trial.
A detailed description of a similar structural definition process is presented here
Innovative IMP-Preparation Production Chain - narrative definition
If the minimal set of the Investigational Innovative Medicinal Product - Preparation Production Chain 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.
Designated cmc entity person responsible for creation and upload of narrative documents 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/Medicinal Product/Narrative Data".
A detailed description of a similar narrative definition process is presented here.
Generic Medicinal Product - Prep. Production Chain
automatically initiated and structurally completed
The Generic Medicinal Product-Preparation Production Chain is a unique combination of a Generic Medicinal Product - Preparation Production Chain and the related Generic Marketed Substance - Production Chain.
For the four types of Generic Medicinal Product created in the seventh step of Corporate Entity creation, the Generic Medicinal Product - Preparation Production Chain can be created in this step.
To create a Generic Medicinal Product - Preparation Production Chain, a Generic Medicinal Product must be created first and, in order to finish the creation, the related Generic Marketed Substance - Production Chain must also be completely structurally defined.
The creation of a Generic 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 previously designated for the definition of the corresponding Generic Medicinal Product:
- Enriched email automatic notification with:
- Topic - "New Generic Medicinal Product - Preparation Production Chain "
- Subtopic - "General - Development"
- Subject - "The notification to create a new Generic Medicinal Product - Preparation Production Chain"
- Initiator - enriched email that was used as a basis for the creation of the Generic Medicinal Product
This registered email 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.
Generic Medicinal Product-Prep. Production Chain - structural definition
In case that the existing Generic Marketed Substance-Production Chain used to manufacture Generic Investigational Medicinal Product(s) is not suitable for the manufacture of a large quantity of Generic Medicinal product top-level cmc entity person is notified that a new Generic Marketed Substance - Production Chain is needed. Detailed description of the process is given in the second step of the Corporate Entity creation. In this case only the first part of the structural definition can be done.
If the existing Generic Marketed Substance - Production Chain can be used to manufacture Generic Medicinal Product the whole structural definition process can be finished in this step of the Corporate Entity creation.
Generic Medicinal Product - Preparation Production Chain is completely defined by the first and second level Corporate Entities and structural data:
- Generic Medicinal Product
previously defined first level Corporate Entity - Generic 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
Structural definition - first part
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 in the eCTD Integral Information System Database.
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 notification.
Also, at the same time, the topic of the "basis for creation" enriched email is replaced with the newly created Generic Medicinal Product - Preparation Production Chain and the designated cmc entity person is set as a follower of all enriched email messages related to the newly introduced Generic Medicinal Product - Preparation Production Chain.
During the definition of the minimal set of 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.
Detailed description of the structural definition process is presented here.
Structural definition - second part
After receiving the enriched email automatic notification that the Generic 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 Generic Medicinal Product - Preparation Production Chain.
On the sub-application form, "Correspondence" selects an enriched email automatic notification with the information that the corresponding Generic 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 Generic Marketed Substance - Production Chain and completes the structural definition of the Generic Medicinal Product - Preparation Production Chain entity.
When all structural data are completely defined Generic Medicinal Product - 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 marketing entity person with information that Medicinal Product Dossier or its' extension can be created.
The choice of registration domains and what specifically to register is within the responsibility and competence of the marketing business function.
A detailed description of a similar structural definition process is presented here.
Generic Medicinal Product-Prep. Production Chain - narrative definition
If the minimal set of the Generic Medicinal Product - 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.
Designated cmc entity person responsible for creation and upload of narrative documents 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/Preparation Production Chain/Narrative Data".
A detailed description of a similar narrative definition process is presented here.
Marketing Dossier - First Marketing Campaign Project - OTC MP(s)
automatically initiated and structurally completed/launched
Under development
Marketing Dossier - First MC Project - structural definition
Under development
Marketing Dossier - First MC Project - narrative definition
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