Dossier/Dossier Extension - MP based on the Ref. MP - creation

  • Gathering of the documentation/data
  • Structural definition
  • Narrative definition

Creation of a new Dossier/Dossier Extension for Medicinal Products based on the Ref. MP, also referred to as a Regulatory Dossier, begins with a "basis for creation" enriched email message with the topic "New Dossier/Dossier Extension - Medicinal Products".

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Dossier/Dossier Extension - Medicinal Product based on the Ref. MP can be done in advance, before the beginning of structural definition and subsequently when the Dossier/Dossier Extension - Medicinal Product based on the Ref. MP become a topic in the enriched email correspondence.

Before the beginning of the structural definition

Gathering of documentation related to the creation of a new Dossier/Dossier Extension - Medicinal Product based on the Ref. MP is a process that can begin before the receipt of the "basis for creation" enriched email message and subsequent beginning of the structural definition. During that period database record for the new Dossier/Dossier Extension - Medicinal Product based on the Ref. MP does not exists in the eCTD Integral Information System and the only topic that can be used in the correspondence is "New MP Dossier/Dossier Extension". Attached documents are classified as "related documents" and uploaded to the Corporate Documentation Cloud but they are not linked with the Dossier/Dossier Extension - Medicinal Product based on the Ref. MP that is being created/extended. The Regulatory Dossier does not require narrative entity definition documents for its definition. Nevertheless, linking all correspondence to the newly created Regulatory Dossier is essential and can be done when the decision is made and the structural definition started.

After the beginning of the structural definition

The cmc entity person begins the process of structural definition of the Regulatory Dossier or its' extension right after receiving the "basis for creation" enriched email. When selecting a "basis for creation" enriched email on the "correspondence" sub-application form, all related correspondence previously received relating to the Regulatory Dossier  being created or extended should also be selected.

During the insertion of the record into the eCTD Integral Information System the initial submission directory tree with documents is automatically generated consisting of the entity definition documents and project initial submission documents and the Regulatory Dossier automatically becomes the topic of the "basis for creation" enriched email and all selected previously received enriched emails. At the same time, the Marketing Authorization/Extension Application Project(s) is initiated and the regulatory project person(s) is notified with an automatically generated enriched email notification.

All correspondence from then on should be conducted using enriched email messages and the newly initiated All correspondence from then on should be conducted using enriched email messages and the newly initiated Marketing Authorization/Extension Application Project .

Structural definition

The structural definition of the Regulatory Dossier is done using the "Corporate Projects - Medicinal Products" application module. The following business processes must be performed in the following order:

  1. Generation/receipt of a "basis for creation" regular/enriched email
  2. Selection of one "basis for creation" enriched email message and related correspondence on the sub-application form "Correspondence"
  3. Definition of general structural data of the new/extended Regulatory Dossier
  4. Selection of the Medicinal Product of the new/extended Regulatory Dossier
  5. Selection of Preparation Production Chain(s)
  6. Selection of Stock-Keeping Unit(s)
  7. Completion of the structural definition
    1. Complete structural definition during the first session
    2. Complete structural definition in several sessions

1. Generation/receipt of a "basis for creation" enriched email

The decision to open/extend a Regulatory Dossier is finalized by a regular/enriched email message with the attachment "Decision to open/extend a Regulatory Dossier" sent by a corporate person with the appropriate authority to the regulatory project person.

The regular email message must be registered by the recipient.

To open/extend a new/existing Regulatory Dossier, the process is initiated by choosing the menu item:

  • MP Dossier creation / New application / Structural Data
    or
  • MP Dossier creation / Extension / Structural Data
    or
  • MP Dossier creation / Repeat use / Structural Data
    or
  • MP Dossier creation / Repeat use - new application / Structural Data
    or
  • MP Dossier creation / MRP - new application / Structural Data

on the "Corporate Projects - Medicinal Products" application module.

2. Selection of one "basis for creation" enriched email message

To open a new Regulatory Dossier, the process is initiated by choosing the menu item "MP Dossier creation / Extension / Structural Data" on the "Medicinal Products - Regulatory Projects" application module.

Using the "Correspondence" sub-application form, a received "basis for creation" enriched email message relevant to the Regulatory Dossier being created must be selected from the non-processed correspondence. In addition, all enriched email messages classified as "related correspondence" pertaining to the same Regulatory Dossier creation should also be selected in order to properly establish entity creation correspondence environment.

To extend an existing Regulatory Dossier, the process is initiated by choosing the menu item "MP Dossier creation / Extension / Structural Data" on the "Medicinal Products - Regulatory Projects" application module.

To extend an existing Regulatory Dossier, first, appropriate Regulatory Dossier must be selected from the LoV of existing Regulatory Dossiers. Using the "Correspondence" sub-application form, a received "basis for creation" enriched email message relevant to the extension of the selected Regulatory Dossier must be selected from the non-processed correspondence. In addition, all enriched email messages classified as "related correspondence" pertaining to the same extension of the selected Regulatory Dossier should also be selected in order to properly establish entity creation correspondence environment.

3. Definition of general structural data of the new/extended Regulatory Dossier

First, from the LoV of Active Substances, Active Substance of the new Regulatory Dossier is selected. For the extension of the existing Regulatory Dossier, the Active Substance has already been defined and the process starts with the selection of a new Medicinal Product.

Than, general structural data such as:

  • Procedure type
  • Referent member state/country
  • Marketing Authorization Holder (MAH) in the ref. member state/country
  • Applicant (optional)
  • Concerned member states (optional)

are selected from the appropriate LoVs.

4. Selection of the Medicinal Product of the new/extended Regulatory Dossier

In the case of a new Regulatory Dossier, the first Medicinal Product is selected from the LoV of  Medicinal Products for the selected Active Substance from the Regulatory Dossier.

In the case of an existing Regulatory Dossier, the case of an Extension procedure the Medicinal Product is selected from the LoV of Medicinal Products that are not present in the current Regulatory Dossier.

For Repeat use, Repeat use - new application and Mutual Recognition procedures, similar application forms have been developed.

After the selection of the Medicinal Product, structural data of the Medicinal Product, such as:

  • indication(s)
  • Legal basis
  • Reference Medicinal Product (optional)

 are transferred to the application form.

5. Selection of Preparation Production Chain(s)

For the selected Medicinal Product, the Medicinal Product - Preparation Production Chain is selected from the LoV of Preparation Production Chains of the selected Medicinal Product.

Several Preparation Production Chains can be selected if the possibility exist.

6. Selection of Stock-Keeping Unit(s)

For each selected Medicinal Product - Preparation Production Chain several Stock-Keeping Units can be selected if the possibility exist.

The selection of Stock-Keeping Units, one or more for each Medicinal Product - Preparation Production Chain, is the last requirement to fulfill the minimal structural data set criterion for defining the Regulatory Dossier.

When the minimal structural data set criterion is met and the Medicinal Product based on the Reference MP Regulatory Dossier  is introduced 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
  • the topic of the "basis for creation" enriched email is replaced with the newly created Medicinal Product based on the Reference MP Regulatory Dossier 
  • 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 "designated followers" of the respective Registered Email topics
  • 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 corresponding 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.

7. Completion of the structural definition

The structural definition process can be completed in two ways:

  1. In one session when all structural data are defined
  2. in several sessions where
    1. in the first session only minimal data set and maybe some of the additional data are defined
    2. in the  next session(s) where remaining additional data are defined

Upon completion of the structural definition process, the Medicinal Product based on the Reference MP Regulatory Dossier  is assigned the status "completely structurally defined".

7.1 Complete structural definition during the first session

The minimal data set denoted with (*) is prerequisite for the insertion of the record into the eCTD Integral information System.

If the minimal data set requirement is met, then confirmation of the complete structural definition is prompted. If the complete structural definition is confirmed the record is inserted into the database of the eCTD Integral Information System with the status "completely structurally defined" and with the ability to be used to define corporate entities of the higher level.

7.2 Complete structural definition in several sessions

In the first session only the minimal data set and maybe some additional data are defined. At the end of the session, confirmation of the complete structural definition is prompted. If the answer is negative, the record is inserted and the status of the entity is set to "incompletely structurally defined". 

Additional data can be added on the same application form by clicking on the "Additional data" button and selecting the required MP Regulatory Dossier from the LoV of incompletely defined MP Regulatory Dossiers. Previous enriched emails related to the selected MP Regulatory Dossier can be seen on the "correspondence" sub-application form.

The structural definition is completed when a positive response is given to the prompt for a complete structural definition.

The MP Regulatory Dossier is assigned the status "completely structurally defined" with the ability to be used to define corporate entities of the higher level.

Narrative definition

The Dossier itself does not require a narrative definition, but the project initial submission documents must be created prior to the realization of the initiated Corporate Project.

The designated regulatory project person is responsible for the creation and upload of the project initial submission document files.

Those business processes are supported in the "Corporate Projects - Medicinal Products" application module and are fully described here.