Reference Medicinal Product creation

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

The creation of a new Reference Medicinal Product begins with a "basis for creation" regular/enriched email message with the topic "New/New use - Reference Medicinal Product" and with an attachment "Decision to introduce a new Reference Medicinal Product" or "Decision on the new use of the existing Reference Medicinal Product".

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Reference Medicinal Product can be done in advance, before the beginning of structural definition and subsequently when 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 Reference Medicinal Product 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 Reference Medicinal Product does not exists in the eCTD Integral Information System and the only topic that can be used in the correspondence is "New/New use Reference Medicinal Product". Attached documents are classified and uploaded to the Corporate Documentation Cloud but they are not linked with the Reference Medicinal Product that is being created. Nevertheless, linking of all correspondence to the newly created Reference Medicinal Product 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  Reference Medicinal Product structural definition right after receiving the "basis for creation" enriched email. When selecting a "basis for creation" registered email on the "Correspondence" sub-application form, all related correspondence previously received relating to the Reference Medicinal Product being created should also be selected.

During the insertion of the record into the eCTD Integral Information System a core sequence is generated and the newly defined Reference 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 Reference Medicinal Product as the topic.

Structural definition

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

  1. Generation of regular or enriched email message with the appropriate "basis for creation" document as an attachment
  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 - Reference MP".
  3. Definition of general structural data of the Reference Medicinal Product
  4. Definition of the Marketing Authorization Holder data and the intended legal basis for the first use of the Ref. MP
  5. 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" regular/enriched email

Message is sent by a corporate person with the appropriate authority to the high level cmc entity person. If the message is a regular email message a cmc entity person is responsible for proper registration of the email. 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 next step can be initiated by choosing the menu item "Corporate Entity creation / Medicinal Product / Structural Data - Reference MP" on the "Corporate Entities" application module.

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

To create a new Reference Medicinal Product using sub-application form "Correspondence", only one of the "basis for creation" enriched email messages must be selected from the non-processed correspondence documents. In addition, all enriched email messages  classified as "related correspondence" pertaining to the same new Reference Medicinal Product should also be selected in order to properly establish entity creation correspondence environment.

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

The general structural data defining Reference Medicinal Products are defined using predefined Lists of Values (LoVs) for INNs, dosage forms, units of measures, Legal status of supply, Supply, ATC codes, routes of administrations and indications.

4. Definition of the Marketing Authorization Holder data and the intended legal basis for the first use of the Ref. MP

Using free text fields the structural data on the Marketing Authorization Holder (MAH) are entered defining all the data necessary for the automatic creation of the electronic Application Form (eAF).

The intended legal basis, which the Pharmaceutical Corporation intends to use first, is defined by selecting one of:

  • generic application (Article 10(1))
  •  hybrid application (Article 10(3))
  • Article 10(4) similar biological application
  • Article 10a well-established use application
  • Article 10b fixed combination application
  • Article 10c informed consent application
  • Article 16a traditional use for herbal medicinal product application

Also, short description of the intended use is also defined using the free text field.

5. 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 Reference Medicinal Product is assigned the status "completely structurally defined".

When the Reference Medicinal Product is completely defined an automatically generated enriched email notification is sent.

Depending on whether the Substance for the INN of the Reference Medicinal Product already exists in the eCTD Integral Information System an enriched email notification is sent to the appropriate entity person to:

  • create a Substance if it does not exist in the eCTD Integral Information System - cmc entity person
    or if the Substance already exist to
  • create a Clinical Trial if the Reference Medicinal Product is not administered directly into the bloodstream - clinical entity person
    or to
  • create a Generic Medicinal Product if the Reference Medicinal Product is administered directly into the bloodstream - cmc entity person
    or to
  • create a Generic Medicinal Product if the intended legal basis for the Reference Medicinal Product is "Article 10a well-established use application" - cmc entity person
  • create a Medicinal Product if the intended legal basis for the Reference Medicinal Product is "Article 10c informed consent application" - cmc entity person

5.1 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.

5.2 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 Reference Medicinal Product from the LoV of incompletely defined Reference Medicinal Products. 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 Reference 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

There is no need to narratively define Reference Medicinal Product.