Creating Corporate Entities
seventh step
There are three classes of Corporate Entities whose structural definition can be initiated/completed in the seventh step of the process of creating a hierarchy of corporate entities:
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Medicinal Product track
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Generic Medicinal Product - first level entity - initiated by decision and structurally completed
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Innovative Investigational Medicinal Product - fifth level entity - automatically initiated and structurally completed
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Promotional Material Production Chain - OTC Medicinal Product(s) - sixth level entity - automatically initiated and structurally completed
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For the three classes of Corporate Entities the structural definition can be initiated and completed in this step.
For one Corporate Entities class the narrative definition is initiated in this step by the automatic creation of the appropriate directory structures with the replacement documents.
For the two classes of Corporate Entities the project initial submission is initiated in this step by the automatic creation of the appropriate directory structures with the replacement initial submission documents and entity definition documents .
To initiate the structural definition of a Corporate Entity in the seventh 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 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 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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Generic Medicinal Product
initiated by decision and completed
Creation of a Generic Medicinal Product with a Legal Basis:
- Article 10(1) generic application
- Article 10(3) hybrid application
- Article 10(4) similar biological application
- Article 10b fixed combination application
must be justified by the results of previously conducted Clinical Trial(s)
The creation of a Generic 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 Generic Medicinal Product"
- Subtopic - "Introduction of a New Medicinal Product"
- Subject - "The decision to introduce a new Generic 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 Generic Medicinal Products introduction
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.
This enriched email is displayed on the sub-application form "Correspondence" on the “New Corporate Entity/Medicinal Product/Structural Data - Generic 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 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 - Generic MP" and they are a prerequisite for the insertion of the record into the eCTD Integral Information System Database.
Since the Generic Medicinal Product has the similar structural definition as the corresponding Reference Medicinal Product, the Reference Medicinal Product's structural data, intended legal basis and intended use are utilized to define the Generic Medicinal Product:
- 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
- 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 and use declared in the decision to introduce or re-use an existing Reference Medicinal Product, the corresponding Generic Medicinal Product can be completely defined in the first session.
After the insertion of the record into the eCTD Integral Information System Database, Generic 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 Generic Medicinal Product with the information that the Generic Medicinal Product-Preparation Production Chain has to be also created using the newly defined Generic Medicinal Product.
Also, a core sequence is automatically generated and all subsequent narrative definition actions are associated with that sequence. The designated cmc entity person is set as a "designated follower" of all enriched email messages related to the newly introduced Generic 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 Medicinal Product 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.
A detailed description of a similar structural definition process is presented here.
Generic Medicinal Product - narrative definition
When the Generic 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.
When all replacement documents are replaced with newly created narrative documents, status of the new Generic 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 newly Generic Medicinal Product has been completely defined.
Innovative Investigational Medicinal Product
automatically initiated and structurally completed
The creation of a Investigational Innovative Medicinal Product 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 notification sent by clicking on the "Investigational MP" button on the application form "New Corporate Entity/Clinical Trial/Structural Data" with:
- Topic - "New Innovative Investigational Medicinal Product"
- Subtopic - "Introduction of a New Medicinal Product"
- Subject - "The decision to introduce New Innovative Investigational Medicinal Products"
- The requested dosage form, strength, ATC code, route of administration
- Initiator - enriched email that was used as a basis for creation of the Clinical Trial entity
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.
This enriched email notification is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Medicinal Product/Structural Data - Innovative 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.
Innovative Investigational Medicinal Product - structural definition
Investigational Innovative Medicinal Product is defined by the following lower-level Corporate Entities and structural data:
Investigational Innovative Medicinal Product is defined by the following lower-level Corporate Entities and structural data:
- Active substance(s)
previously defined global/basic Corporate Entity(s) - Pre-Clinical Tests Dossier - status "at least one Pre-Clinical Tests corporate project completed"
previously defined fourth level Corporate Entity - cmc entity person responsible
- Dosage form
- Strength - a quantity and a unit of measure
- Route of administration
- Indication(s)
A minimal set of structural data is specified with the (*) on the application form "New Corporate Entity/Medicinal Product/Structural Data - Innovative Investigational MP" 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 Investigational Innovative Medicinal Product.
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 notification. Also, at the same time, the designated clinical entity person is set as a follower of all enriched email messages related to the newly introduced Investigational Innovative Medicinal Product.
During the definition of the minimal set of structural data of the Investigational Innovative Medicinal Product, an editable unique "var" abbreviation "iimedprod" is automatically generated which is later used as a part of template directory paths and document names.
When all structural data are completely defined Investigational Innovative Medicinal Product is assigned a status "completely structurally defined" and can be used to define Corporate Entities of the higher level. At that point, to preserve the entity creation correspondence chain, an automatically generated enriched email notification is sent to the cmc entity person designated for the definition of the Investigational Innovative Medicinal Product with the information that the Investigational Innovative Medicinal Product - Preparation Production Chain has to be also created using the newly defined Investigational Innovative Medicinal Product.
Innovative Investigational Medicinal Product - narrative definition
The Investigational Innovative Medicinal Product does not require additional narrative documents for its definition.
Narrative definition of Investigational Innovative Medicinal Product related to its characteristics and handling is done during the definition of the Clinical trial in the following documents:
- Clinical Trial Protocol
- Investigator's Brochure
- Instructions for handling of Investigational Medicinal Product(s)
- Investigational Medicinal Product(s) Certificate of Analysis normal value(s)/range(s)
- Decoding Procedures for Blinded Clinical Trials
Promotional Material Production Chain - OTC MP(s)
automatically initiated and structurally completed
Under development
Promotional Material Production Chain - structural definition
Under development
Promotional Material Production Chain - narrative definition
Under development
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