The creation of a new Marketed Substance begins with a "basis for creation" regular/enriched email message/notification with the topic "New Marketed Substance":

Other "basis for creation" documents that may be necessary for structural and narrative definition of the Marketed Substance are:

• Certificate of Suitability - CEP

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

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 / Marketed Substance / 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 Marketed Substance 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.

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

Depending on the role of the Substance, five types of Marketed Substance directory trees with replacement narrative files are defined:

• active substance directory tree with replacement narrative files
• novel excipient directory tree with replacement narrative files
• non novel - non compendial excipient directory tree with replacement narrative files
• compendial excipient directory tree with replacement narrative files
• directory tree with replacement narrative files and with an additional specification test(s)

These documents/files are placed in the "common area" of the Corporate Documentation Cloud and are automatically used to generate initial submissions whenever the Marketed Substance is present in the manufacturing process of a Medicinal Product. 

The five types of directory tree with replacement narrative files are presented below:

In addition to the basic eCTD files associated with the Marketed Substance, the following business rules are used to create the narrative files required for a complete narrative definition:

• if the quality standard is defined by the EU Pharmacopeia replacement narrative file for the CEP is created (annex-10)
• if the quality standard is defined by ASMF related replacement narrative files are not created at this instance. They are created at the time of Corporate Project launch when the regulatory agency to which the letter of accession (Annex-10) and the letter of confirmation for notification of changes (Annex-11) are to be sent.

For compendial chemicals these files are used to generate submissions and fill-in electronic application form to the Certification of Substances Department (DCEP) of the EDQM to obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).

The specification for the Marketed Substance is defined using the dedicated sub-application form "Specification" on the "Corporate Entity creation / Marketed Substance / Structural Data" application form.

Separate blocks are provided for Composition and Physicochemical properties. An analytical method is defined for each property and at the insert of the record an analytical Quality Control Analysis is defined. The Analysis is later used to initiate quality control of the Marketed Substance during the purchasing receiving procedure.

Analytical Quality Control is supported by a separate "Analytica Quality Control" application module that can be added on request.

One or more distributing Organizations can be defined for each Marketed Substance. Distributor is selected from the List of Values of GDP distributing Organizations of the Substance in question.

For each distributor, an initial rudimentary Marketed Substance - Production Chain is defined, consisting only of the distributing Organization. A further, more elaborate, definition of the Marketed Substance - Production Chain is made on the application form "Corporate Entity creation / Marketed Substance-Production Chain / Structural Data".

The cmc entity persons responsible for the definition and subsequent development of each Marketed Substance - Production Chain are also defined and automatically generated enriched email notifications are sent. 

At the same time, first set of replacement narrative files for the narrative definition of the Marketed Substance - Production Chain are generated. They can be seen on the application form "Corporate Entity creation / Marketed Substance - Production Chain / Narrative Data".

During subsequent correspondence, Marketed Substance - Production Chain(s) can be used as a topic. With the classification of the attachments, the attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement narrative files.

The designated cmc entity person is responsible for the complete narrative definition of the Marketed Substance.

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

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 Client and using the email attachments classification, attachments are automatically uploaded to the Corporate Documentation Cloud.

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

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