Tobacco Ingredients Esignature

/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
General Affairs
Information systems

EUCEG system: Workflow to submit the different types of xml

Document Control Information

Settings / Value
Document Title: / Technical Analysis on the management of the files linked to the submission
Project Title: / EUCEG
Document Author: / Christophe DUMONT
Project Owner:
Project Manager: / Markus KALLIOLA
Solution Provider: / Herman BRAND
Doc. Version: / 1.0
Sensitivity: / public
Date: / 29/02/2016

Document Approver(s) and Reviewer(s):

NOTE: All Approvers are required. Records of each approver must be maintained. All Reviewers in the list are considered required unless explicitly listed as Optional.

Name / Role / Action / Date
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Document history:

The Document Author is authorized to make the following types of changes to the document without requiring that the document be re-approved:

· Editorial, formatting, and spelling

· Clarification

To request a change to this document, contact the Document Author or Owner.

Changes to this document are summarized in the following table in reverse chronological order (latest version first).

Revision / Date / Created by / Short Description of Changes
0.1 / 18/02/2016 / dumonch / Creation of the document
0.2 / 26/02/2016 / Fabrece / Review and update

Table of Contents

1. Subject 4

2. Pre-requisite steps 4

3. Steps to submit a full product 4

4. Submit the "xml submitter" 5

5. Submit the "xml attachment" 5

6. Submit the "xml product" 6

7. Sequence diagram 7

7.1. For the user using the standalone client interface 7

7.2. For the user using system to system 8

1. Subject

The purpose of this document is to explain the different steps that are required to submit the XML for tobacco and e-cigarettes products.

2. Pre-requisite steps

Before to submit XML to the EUCEG system you must have been received a Submitter ID from the European Commission (The process to officially request this identifier will be explain in another document). If you don't have this ID you will not be able to submit any XML to EUCEG system.

The way to submit the products are the same for the enterprises using the system-to-system process (eDelivery/domibus) and for the enterprises using the standalone client interface (eTrustEx Web Access UI).

3. Steps to submit a full product

All data related to a product (tobacco product or e-cigarette) are submitted using several xml's. These different types of xml have to be sent in a specific order.

First step: Send the submitter details in a specific xml "XML SUBMITTER".

Second step: Send the files. For each file, a specific xml "XML ATTACHMENT" is created and sent.

Third step: Send the product (tobacco product or e-cigarette) "XML PRODUCT", in which the submitter is identified by the submitter id and each file by a different reference provided by the company.

4. Submit the "xml submitter"

The xml file contains the following data:

1. the submitter id

2. the name

3. the SME

4. the HasVatNumber flag

5. the VAT number (if the HasVatNumber flag is true)

6. the address

7. the country

8. the phone

9. the email

XML example:

<Name>Test Submitter Details</Name>

<Sme>false</Sme>

</SubmitterDetails>

Sending this information to the EUCEG system is the first step in the process and it is required before to send any other XML type.

This XML has to be sent only once before submitting any products. If some modifications have to be done, an update has to be sent.

The system needs to have this information before in order to identify the company. (The registration process to the European Commission will allow the company to get its unique submitter ID. This field is required in the XML submitter).

If you try to submit other XML before sending the XML submitter the EUCEG system will return an error message.

5. Submit the "xml attachment"

XML attachments are files that can be attached to the product submission (technical documents, studies on market research, product pictures, files related to toxicology data …)

The xml attachment contains the following data:

1. reference (assigned by the company and must be unique by company)

2. filename

3. confidential (true or false)

4. status (new or update)

5. content Type

6. content (the binary)

Example of XML attachment:

<Filename>sample_attachment.txt</Filename>

<ContentType>text/plain</ContentType>

</Attachment>

The reference of the attachment is in a specific format Universally Unique IDentifier (UUID) and must be given by the company themselves.

This unique reference will allow us to identify your document. With this mechanism the company can submit their documents only once, they will not be obliged to re-submit them each time they submit a new XML product. Using the file UUID within the XML product is sufficient.

The statuses (NEW or UPDATE) used in the XML attachment will allow EUCEG system to know if the submission is a new file or replace an existing file. The update will be done in all MS database where the first version of the file has been recorded.

For both NEW and UPDATED files, if after 6 hours no XML product submission is sent related to this XML file this one will be deleted.

In case an UPDATE with an file ID which doesn't exist an error message will be sent to the submitter.

6. Submit the "xml product"

In the xml product you have all the data related to a tobacco or e-cigarette product (2 different XML).

Example of information that you will find in the XML product:

Submitter (the submitter ID, the parent, affiliates …)

Submission type

General comment

Product

Product ID

Presentations

Tobacco ingredients

Other ingredients

…

Within the XML product, the submitter is referenced by his submitter ID and the related files by the UUID provided in the XML attachment submission (sent before).

7. Sequence diagram