Medicinal Product based on the Ref. MP - creation

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

The creation of a new Medicinal Product based on the Reference Medicinal Product begins with a "basis for creation" enriched email notification with the topic "New Medicinal Product" or "New Generic Medicinal Product":

  • enriched email notification automatically sent after the structural definition of the new Substance
  • enriched email notification automatically sent after the structural definition of the Reference Medicinal Product

Other documents that may be necessary for the structural and narrative definition of the Medicinal Product are:

  • Certificate of the Pharmaceutical Product (CPP)

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Medicinal Product based on the Reference Medicinal Product can be done in advance, before the beginning of structural definition and subsequently when the Medicinal Product based on the Reference Medicinal Product has 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 Medicinal Product based on the Ref. MP is a process that can begin before the receipt of the "basis for creation"  enriched email and subsequent beginning of the structural definition. During that period database record for the new Medicinal Product and directory tree of replacement narrative files does not exists in the eCTD Integral Information System and the only topic that can be used in the correspondence is "New Medicinal Product based on Ref. MP". Attached documents are classified and uploaded to the Corporate Documentation Cloud but they are not linked with the Medicinal Product based on Ref. MP that is going to be created. Nevertheless, linking of all correspondence to the newly created Medicinal Product based on Ref. MP is essential and it can be done when the structural definition is started.

After the beginning of the structural definition

The cmc entity person begins the process of  Medicinal Product based on the Ref. MP structural definition 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 Medicinal Product based on the Ref. MP being created should also be selected.

During the insertion of the record into the eCTD Integral Information System a core sequence and a directory tree of replacement narrative files are generated and the newly defined Medicinal Product automatically becomes the topic of the "basis for creation" enriched email and all selected previously received enriched 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 enriched email messages and the newly-created 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 Medicinal Product based on the Ref. MP 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" of the application form "Corporate Entity creation / Medicinal Product /Structural Data - MP based on Ref. MP".
  3. Definition of general structural data of the Medicinal Product
  4. Selection of designated person(s) for the Medicinal Product
  5. Creation of Medicinal Product information documents
  6. Definition of containers for the 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" enriched email

The enriched email notification automatically sent to the high-level cmc entity person after the structural definition of:

  • the new Substance, provided that a corresponding Reference Medicinal Product has been previously defined
  • the Reference Medicinal Product, provided that related Substance was already introduced in the eCTD Integral Information System

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 - based on the Ref. MP" on the "Corporate Entities" application module.

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

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

To create a new Medicinal Product based on the Ref. MP, first, using the "Correspondence" sub-application form, a received "basis for creation" registered email notification relevant to the new Medicinal Product based on the Ref. MP 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 Medicinal Product based on Ref. MP should also be selected in order to properly establish entity creation correspondence environment.

3. Definition of general structural data of the Medicinal Product

Since the Medicinal Product based on the Ref. MP must have the same  or similar structural data as the corresponding Reference Medicinal Product, structural data of the Reference Medicinal Product are presented as the basis for the definition of the new Medicinal Product based on the Ref. MP. Depending on the intended legal basis declared in the decision to introduce or re-use an existing Reference Medicinal Product, certain changes of:

  • Strength
  • Route of administration
  • Indication

are allowed.

4. Selection of designated persons for the Medicinal Product

In order to completely cover all aspects of the Medicinal Product based on the Ref. MP 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 Medicinal Product information documents

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

6. Definition of containers for the Medicinal Product

For a 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 enriched email notification to a designated cmc entity person, and directory trees of replacement narrative files are generated.

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

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 Ref. MP is assigned the status "completely structurally defined".

At that point, an automatically generated enriched email notification is sent to top-level cmc entity person with the information that a New Medicinal Product-Preparation Production Chain is created.

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 Medicinal Product based on the Ref. MP from the LoV of incompletely defined Medicinal Products based on the Ref. MP. Previous enriched 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 Medicinal Product based on the Ref. MP  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 Medicinal Product based on Ref. MP.

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 enriched email messages. 

Therefore, in order to narratively define a Medicinal Product based on Ref. MP 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 correspondence 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 Enriched 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 Medicinal Product based on Ref. MP is set to be "completely narratively defined".