Changing Corporate Entities

  • Starting the Process
  • Defining the appropriate Variation
  • Defining Structural Changes
  • Defining Narrative Changes

Since Pharmaceutical Corporations operate in today's dynamic business environment, changes in Corporate Entities are frequent, and controlling those changes is of utmost importance. 

All changes in Corporate Entities are made using predefined "Variations" where each Variation represents a specific change to one of the characteristics of the Corporate Entity.

The change of each Corporate Entity consists of a process of structural change definition and a process of narrative change definition. 

In the business environment of the Pharmaceutical Corporation, most changes to Corporation Entities are classified and defined according to the eCTD Variations specification. For other entity changes that are not within the scope of the eCTD specification for Variations, a similar structure has been developed so that the entire process is unified in terms of structure of changes and procedure for implementing changes.

The change in a Corporate Entity in the eCTD Integral Information System must be instigated with at least one of the required "basis for change" documents legislatively defined in the:

"Guidelines on the details of the various categories of variations..."   EUR-Lex Document 52013XC0802(04 and generated within the Pharmaceutical Corporation or by a third party.

The "basis for change" document(s) must be sent to one of the corporate entity persons via:

  • Registered email message as attached and appropriately classified document(s). The details and justification of such a business move together with the necessary resources should be provided in a separate document and signed by a corporate person with the appropriate authority.
  • Regular email message as attached document(s). The recipient is responsible for the proper processing of the regular email message with the Enriched Email Client and the adequate classification of attachments

Changes can be structural and/or narrative and they are all initiated on sub-application form "Correspondence" of one of the entity change application forms for Corporate Entity change.

When the record is inserted into the eCTD Integral Information System a new core sequence is generated and all structural and narrative document changes are related to that sequence.

Change of a Corporate Entity with the status “completely defined - draft” generates a new core sequence and all structural and narrative documents changes are related to that sequence.

Change of a Corporate Entity with the status “completely defined - engaged” generates a new core sequence with the same consequences but it also generates start of a Corporate Project(s) in order to implement and approve/notify changes with Health Authorities and/or other Business Partners.

In an attempt to use the same approach to all Corporate Entities, Variations for Pre-Clinical Tests and Clinical Trials are also defined.

Variations for Pre-Clinical Tests and Clinical Trials with "basis for change" documents are presented here.

Starting the Process

The process is initiated by the receipt of an email message with one or more "basis for change" type documents attached and its processing by the Enriched Email Client. The correct classification of the attached "basis for change" documents is of utmost importance.

All these processed email messages are displayed on the sub-application form "Correspondence" on the appropriate “Corporate Entity Change/<Corporate Entity>/Structural Data” application form.

Choosing the appropriate combination and returning to the application form starts the entity change process.

Defining the appropriate Variation

All "basis for change" documents and their combinations representing the "basis for change" of the corresponding Corporate Entity are predefined in the eCTD Integral Information System. As soon as enough "basis for change" documents are received in order to unequivocally define corresponding Variation, "basis for change" documents are checked, Variation is selected and process returned on the main "Corporate Entity Change" application form.

A selection of the Variation is applied, a core sequence is initiated and structural and narrative definition of changes can begin.

Defining Structural Changes

The process is performed using one of the “Corporate Entity Change/<Corporate Entity>/Structural Data” application forms, where the structural data defining the Corporate Entity are changed and recorded into the eCTD Integral Information System. 

During the structural change definition process, a "directory tree of entity definition documents" potentially necessary to narratively define the Corporate Entity change is automatically created.

When a record is inserted into the eCTD Integral Information System during the process of structural changes, using the Hierarchy of Structural Levels of Corporate Entities and the corresponding regulatory rules, all Dossiers in which changes must be reported/approved by Health Authorities are determined and initial submissions are automatically generated. The appropriate corporate project persons are notified by automatically generated enriched email notifications.

Defining Narrative Changes

The process consists of changing the required narrative "entity definition documents" to define the change and uploading them to the Corporate Documentation Cloud. Uploading is done using the "directory tree with replacement entity definition documents",  previously automatically created during the structural definition process, and the application form for uploading changed entity definition documents.

The narrative change definition process must be fully completed to submit initial submissions in Dossiers where Corporate Projects have to be conducted for the change to be authorized/reported by/to Health Authorities and/or Business Partners. At the same time, core sequences for each Corporate Project are created. However, the narrative  change process must be completed for the Corporate Entity to be part of the eCTD initial submission used as the documentary basis of the Corporate Project.