Innovative Medicinal Product creation

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

The creation of a new Innovative Medicinal Product begins with a "basis for creation" regular/registered email message with the topic "New Innovative Medicinal Product":

  • regular/registered email message with an attachment "Decision to introduce a new Innovative Medicinal Product", sent when the results of previous Clinical Trial(s) justify the introduction of a new Innovative Medicinal Product

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Innovative Medicinal Product can be done in advance, before the beginning of structural definition and subsequently when the Innovative Medicinal Product has become a topic in the registered email correspondence.

Before the beginning of the structural definition

Gathering of documentation related to the creation of a new Innovative Medicinal Product is a process that can begin before the receipt of the "basis for creation"  registered email and subsequent beginning of the structural definition. During that period database record for the new Innovative Medicinal Product and directory tree of replacement narrative files does not exists in the Integral Information System and the only topic that can be used in the correspondence is "New Innovative Medicinal Product". Attached documents are classified and uploaded to the Corporate Documentation Cloud but they are not linked with the Innovative Medicinal Product that is being created. Nevertheless, linking of all correspondence to the newly created Innovative Medicinal Product is essential and it can be done after the structural definition is started.

After the beginning of the structural definition

The cmc entity person begins the process of  Innovative Medicinal Product structural definition right after receiving the "basis for creation" registered email. When selecting a "basis for creation" registered email on the "correspondence" sub-application form, all related correspondence previously received relating to the Innovative Medicinal Product being created should also be selected

During the insertion of the record into the Integral Information System a core sequence and a directory tree of replacement narrative files are generated and the newly defined Innovative Medicinal Product automatically becomes the topic of the "basis for creation" registered email and all selected previously received registered emails. That can be seen when inserting additional data on the "correspondence" sub-application form.

Previously received attachments/documents have to be manually assigned to the corresponding replacement files using the application form "Corporate Entity creation / Medicinal Product / Narrative data". The process is explained in the narrative definition section.

All correspondence from then on should be conducted using registered email messages and the newly-created Innovative Medicinal Product as the topic.

During the subsequent correspondence and classification of the attachment(s), attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement files.

Structural definition

In order to create and structurally define a new Innovative Medicinal Product following business processes must be performed in the following order:

  1. Generation/receipt of a "basis for creation" regular/registered email
  2. Selection of one "basis for creation" registered email message and related correspondence on the sub-application form "Correspondence" of the application form "Corporate Entity creation / Medicinal Product / Structural Data - Innovative MP"
  3. Definition of general structural data of the Innovative Medicinal Product
  4. Selection of designated person(s) for the Innovative Medicinal Product
  5. Creation of Innovative Medicinal Product information documents
  6. Definition of containers for the Innovative Medicinal Product
  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" registered email

The regular/registered email message with the attachment "Decision to introduce a new Innovative Medicinal Product" sent by a corporate person with the appropriate authority to the high-level cmc entity person.

The regular email message must be registered by the recipient.

If necessary, additional correspondence using the same topic and subtopic can be made in order to clarify certain details. 

When all details are clarified, the structural definition process can be started by choosing the menu item "Corporate Entity creation/Medicinal Product/Structural Data - Innovative MP" on the "Corporate Entities" application module.

2. Selection of one "basis for creation" registered email notification

The process is initiated by choosing the menu item "Corporate Entity creation / Medicinal Product / Structural Data - Innovative MP" on the "Corporate Entities" application module.

To create a new Innovative Medicinal Product, first, using the "Correspondence" sub-application form, a received "basis for creation" registered email relevant to the new Innovative Medicinal Product being created must be selected from the non-processed correspondence documents. In addition, all registered email messages classified as "related correspondence" pertaining to the same new Innovative Medicinal Product should also be selected in order to properly establish entity creation correspondence environment.

3. Definition of general structural data of the Innovative Medicinal Product

Since the Innovative Medicinal Product is completely new entity all structural characteristics have to be selected from the corresponding LoV. Following structural data are selected:

  • Active substance - from the LoV of innovative substances
  • Dosage form - from the LoV of dosage forms
  • Proposed Legal Status - from the LoV of legal statuses
  • Proposed Supply - from the LoV of supplies
  • Strength and unit of measure
  • Intended ATC Group - from the LoV of ATC groups
  • Route of administration - from the LoV of routes of administration
  • Indication(s) - from the LoV of indications

A minimal set of structural data is specified with the (*) and they are a prerequisite for the insertion of the record in the Integral Information System Database.

When the minimal structural data set criterion is met and the Innovative Medicinal Product is introduced into the Integral Information System, a core sequence, directory tree of replacement narrative files, and a registered email notification to the designated cmc entity person are generated.

During subsequent correspondence and classification of attachment(s), the attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement narrative files.

4. Selection of designated persons for the Innovative Medicinal Product

In order to completely cover all aspects of the Innovative Medicinal Product  and provide pre-clinical, clinical and quality overviews as needed, three qualified persons have to be nominated:

  • designated cmc entity person - covering quality aspect
  • designated clinical entity person - covering clinical aspect
  • designated pre-clinical entity person - covering pre-clinical aspect

5. Creation of the Innovative Medicinal Product information documents

The structure of Product Information Documents can be defined on a separate page.

6. Definition of containers for a Innovative Medicinal Product

For a Innovative Medicinal Product, one or more Containers can be defined along with shelf life and storage conditions.

At the insert of the record, a core sequence, a registered email notification to a designated cmc entity person, and directory trees of replacement narrative files are generated.

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 Innovative Medicinal Product is assigned the status "completely structurally defined".

At the same time following automatically generated registered email notifications are sent:

  • notification for a New Medicinal Product-Preparation Production Chain - top level cmc entity person

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 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 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 Innovative Medicinal Product from the LoV of incompletely defined Innovative Medicinal Products. Previous registered emails related to the selected entity 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 Innovative Medicinal Product is assigned the status "completely structurally defined" with the ability to be used to define corporate entities of the higher level.

Narrative definition

The designated cmc entity person is responsible for complete narrative definition of the Innovative Medicinal Product

The eCTD documents can be either:

  • created by the designated cmc entity person and manually uploaded to the Corporate Documentation Cloud
    and/or
  • collected from related Business Partners via email correspondence and automatically uploaded to the Corporate Documentation Cloud during the registered email processing of the Business Partner's regular email messages. 

Therefore, in order to narratively define a Innovative Medicinal Product following business processes must be performed:

  1. Creation of eCTD documents and manual uploading to the Corporate Documentation Cloud
    and/or
  2. Collection of eCTD documents via email and automatic uploading to the Corporate Documentation Cloud
  3. Completion of the process

1.Creation of eCTD documents and manual uploading to the Corporate Documentation Cloud

Using any regular text processor eCTD documents have to be created and pdf files generated for the uploading to the Corporate Documentation Cloud. If required, the process of verification by a senior manager can be included upon request.

The process is initiated by choosing the menu item "Corporate Entity creation / Medicinal Product / Narrative Data" on the "Corporate Entities" application module.

Other than that, the process is same as described in the "Substance - creation" page of this site, here.

2. Collection of eCTD documents via email and automatic uploading to the Corporate Documentation Cloud

In case the eCTD documents were originally generated by the Business Partner, they can be obtained via email correspondence. During the processing of such a Business Partner's regular email message by the Registered Email and using the email attachments classification, they are automatically uploaded to the Corporate Documentation Cloud.

The process is same as described in the "Substance - creation" page of this site, here.

3. Completion of the process

When all mandatory replacement files in the directory tree are replaced with the written eCTD files, the process ends automatically and the Innovative Medicinal Product is set to be "completely narratively defined".