Regulation on application of integration environment – FGIS MDLP Sandbox-integrated OMS/test environment OMS

Moscow 2019

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Introduction

1. Document purpose

This document describes the order for integration testing of software solutions developed by the integrators

in the following environments of Operator-CRPT LLC:

1. integration environment - FGIS MDLP Sandbox-integrated OMS

2. test environment OMS (no integration with FGIS MDLP Sandbox)

All actions in these environments do not have a legal value and performed exclusively for the purpose of

integration testing and debugging of software solutions developed by the integrators for pharmaceutical entities.

2. Document objectives

2.1. Development of the unified approach for application of the integration/test environment;

2.2. Determination of integration testing stages (hereinafter - integration testing) for software solutions

developed by the integrators with a link to FGIS MDLP-integrated OMS/test OMS;

2.3. Determination of the order for notifying the integrators on scheduled and unscheduled maintenance for

the integration environment - FGIS MDLP Sandbox-integrated OMS;

2.4. Familiarization of the integrators with the work on actual updates in releases of FGIS MDLP, OMS.

3. Terms and abbreviations

GTIN – Global Trade Item Number — goods barcode

SGTIN

SNTIN

–

–

Serialised Global Trade Item Number - goods serial number consisting of GTIN

and the serial number proper

Serialised Notional Trade Item Number is the full marking number, including

SGTIN, verification code (crypto tail) and application identifiers.

BO – business order for marking codes

FGIS MDLP Sandbox – the test version (“Sandbox”) of the Medicine track and trace government

information system

Integrator – the organization developing software solutions for integration of automated

process control systems for pharmaceutical entities with a link to FGIS MDLP-

OMS

Integration

environment

– test versions set of information systems intended for simulation of processes

identical to the productive environment that do not have a legal value and

performed for testing/debugging the integration with the software of

pharmaceutical entities

Marking code, MC – a unique sequence of characters including a Serialised Global Trade Item

Number and a verification code

UA – user account

PA – personal account

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Productive environment – a set of productive (“live”) versions of information systems intended for

implementation of processes with a legal value

Identification means, IM – marking code represented in machine-readable form or using another means

(technology) of automated identification generated for application on a

package by the methods that do not allow undamaged separation of

identification means and (or) material mediums containing the identification

means from a medicine package.

OMS – Order Management Station

EDMS – electronic document management system

RC – registration certificate

RF – the Russian Federation

GG

Test environment OMS

–

–

goods group

test version of the Order Management Station (OMS) intended for simulation

of processes that are identical to the productive environment, do not have legal

value and are performed to test/debug the integration with the software of

pharmaceutical entities. This environment is not integrated with FGIS MDLP

Sandbox.

EQES – enhanced qualified electronic signature

Pharmaceutical entity – an entity of the medicine turnover, a legal entity or an individual entrepreneur

performing the turnover of medicines in the Russian Federation.

Note: under this document the “pharmaceutical entity” and “integrator” terms

can be used as equivalents since the integrator is not a pharmaceutical entity

but performs in the integration environment the activities for

testing/debugging of own software solutions as a pharmaceutical entity

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Description of integration process testing

4. Content of integration process testing

The integration testing process includes the following basic1 sub-processes:

integrator’s request for registration in one of the environments of Operator-CRPT LLC;

business order creation and application of identification means via OMS interface;

business order creation and application of identification means via OMS API;

payment for marking codes.

The content of the integration testing process can be modified and supplemented by Operator-CRPT LLC.

5. “Integrator’s request for registration in the integration environment” sub-process;

5.1. The integration environment of FGIS MDLP Sandbox – integrated OMS is configured for connectivity of

these systems, which allows debugging/testing the entire commodity distribution chain, including the

issuance of marking codes, their receipt and sending of reports on application of marking codes by means

of OMS. This will be followed by the verification of availability and correctness of reports, SGTINs in FGIS

MDLP Sandbox.

5.2. The access to integration environment (FGIS MDLP Sandbox + integrated OMS) can be provided only to

the Integrator.

The access to OMS in the integration environment can be provided to the pharmaceutical entity, if such

entity has access to the user account in FGIS MDLP Sandbox, in which the participant registers on its own

by submitting the request to https://sb.mdlp.crpt.ru/#/auth/signup/.

5.3. To initiate the process of registration in the integration environment it is required to send a request to

support@crpt.ru

The email with the request shall have the following subject: The request for access to the Pharma

integration environment

The request shall specify the following data:

INN/ITIN

OGRN/OGRNIP

Organization name

Registration number in FGIS MDLP Sandbox (to be specified if UA in FGIS MDLP Sandbox is available)

Type of participant: Integrator

Type of access: for a resident/non-resident of RF (one option shall be specified)

Last name, first name, patronymic (if any) of the contact person

Contact phone

Email

Environment: Pharma integration environment

List the medicines manufacturers that you represent as the Integrator

5.4. The GG makes a decision on provision or denial to provide the access to the integration environment;

1Basic sub-processes mean sub-processes, without the performance of which the integration environment cannot be accessed as well as the process of issuing MCs and sending the report on their application.

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5.5. In the event of a negative decision, the Integrator is notified of the access denial via email from

support@crpt.ru;

5.6. In case of incomplete data provided in the request, the Integrator can be requested missing data;

5.7. During the registration in the integration environment to perform the testing the following test (fictive)

entities/data can be created/specified in the FGIS MDLP Sandbox UA:

INN/ITIN

OGRN/OGRNIP

KPP

license number for pharmaceutical activity

license number for medicine production;

setting of “7VZN” attribute for a pharmaceutical entity (for residents of RF);

medicines (GTIN) with 7VZN attributes (for residents of RF), VED (for residents of RF) and without

the attribute (for residents and non-residents of RF);

business place;

safe storage place;

contract on service for marking codes provision (for residents of RF);

the personal account of entity replenished with funds (or residents of RF)

entity’s accounting systems;

EQES certificate (pfx format) to login the UA in the MDLP FGIS (for residents)

5.8. During the registration in the integration environment the test emission registrar (hereinafter - ER)

connects to the integrated OMS to perform testing;

5.9. Once the registration2 completed, a pharmaceutical entity is notified of access granting to the integration

environment and provided with the login account data via support@crpt.ru.

5.10. When registering as the resident of the Russian Federation, Operator-CRPT LLC provides the test EQES

certificate for the Integrator. Once the provided certificate expired, you need to contact the technical

support service to re-issue it.

For this purpose, proceed as follows:

send an email with the subject “Integrator. Re-issue of EQES test certificate”;

attach to the letter the expired EQES certificate;

specify in the email the name of your organization (from the UA in “Sandbox” MDLP FGIS) and the

registration number from the UA in “Sandbox” MDLP FGIS.

6. The "Submitting a request for registration in the test environment OMS" sub-process

6.1. The test environment OMS does not have connectivity with FGIS MDLP Sandbox. This environment is

intended for testing and debugging the direct interactions with OMS (UI/API).

2 If access is granted to two systems: FGIS MDLP Sandbox and CPS-integration, then a notification is sent to the participant after registration is completed in both systems

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6.2. The access to the test environment OMS can be provided both to the Integrator and the pharmaceutical

entity.

6.3. To initiate the registration process in the test environment OMS, it is necessary to submit a request to

support@crpt.ru.

The message with the request should include the following in the subject line: Request for access to the

test environment OMS Pharma

The request must include the following data:

INN/ITIN

Organization name

Registration number in FGIS MDLP Sandbox (indicate, if there is a user account in FGIS MDLP

Sandbox)

Type of pharmaceutical entity: Integrator/Pharmaceutical entity

Access type: for resident of the Russian Federation/for non-resident of the Russian Federation

(highlight only one)

Last name, first name, patronymic (if any) of the contact person

Contact telephone number

Email

Environment: test environment OMS

List the manufacturers of medicinal products that you represent as an Integrator (only for the type

of pharmaceutical entity: Integrator)

6.4. In the case of incomplete data submitted in the request, the Integrator/pharmaceutical entity may be

requested to provide missing data;

6.5. During the registration in the test environment for the purpose of testing, OMS will be connected to the

test ER;

6.6. Following the completion of the registration process, the Integrator/pharmaceutical entity is notified on

the provision of access to the test environment OMS and receives an email with account details sent from

support@crpt.ru.

7. “Business order creation and application of identification means via OMS interface” sub-process;

Preconditions:

The pharmaceutical entity is registered in the integration environment/test environment OMS

The pharmaceutical entity is provided with the test ER

Funds are credited to the personal account of the pharmaceutical entity (available funds on the

pharmaceutical entity’s PA is obligatory for order of charged MC)

In order to test the procedure for business order creation and application of identification means via

OMS interface, the following actions shall be performed in sequence:

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7.1. Login FGIS MDLP Sandbox (to be performed for the integration environment)

On the FGIS MDLP Sandbox login page click “Sign in with certificate” button and login by means of test

EQES (for residents of the Russian Federation) or log in using your login and password (for non-residents

of the Russian Federation);

7.2. Redirect to the Order Management Station (to be performed for the integration environment)

7.2.1. Redirect to the “Profile” section then click the “SGTIN Order” button.

7.2.2. When clicking the “SGTIN Order” button, FGIS MDLP Sandbox automatically

redirects the user to the Order Management Station interface (OMS), “Business orders”

section, the OMS login is performed with the Operator account.

7.3. Authorization in OMS (to be performed for the test environment OMS)

On the authorization page of OMS, enter your login and password specified in the email received

following the provision of access to OMS and press Enter.

7.4. Business order creation

The business order creation process can be tested with link to the marking codes payment process

described in clause 9 of this document, if all preconditions in clause 9 of this document are fulfilled.

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7.4.1. The “Create” button shall be clicked to create a business order.

7.4.2. The interface displays the order creation form.

The following fields shall be filled in (the requirement to fill in the field is determined by

the order creation form):

Field name Filling in rule

Step 1. General data

Entity To be filled in with the registration number of the pharmaceutical entity

from the Profile in FGIS MDLP Sandbox

Payment indication The field is used to define the payment criteria for marking codes.

The “payable” value shall be selected for the medicines that selling price

exceeds 20 roubles.

The “not payable value shall be selected for the medicines that selling

price does NOT exceed 20 roubles.

Payment type The field is used to select the type of payment for marking codes. The

field is mandatory if the “Payment criteria” field has the “MC payable”

value.

At payment upin application the funds are debited from the

pharmaceutical entity’s PA upon the receipt of MC application report by

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FGIS MDLP Sandbox (10311 form (residents of RF)/10319 form (non-

residents of RF).

At payment upon emission the funds on the pharmaceutical entity’s PA

are reserved at the moment of BO sending, and debited upon the receipt

of MC emission report by FGIS MDLP Sandbox (10300 form).

Step 2. Goods (you can go to Step 2 by pressing Go to goods)

Goods code To be filled in with the GTIN number for which the BO is generated.

MC quantity To be filled in with a required number of IM

Identification codes

template

The field is used to select the length (number of characters) of verification

code

Serial number

generation method

The field is used to select the serial number generation method

At the automatically method, serial numbers are generated by OMS

At the by user method, it is required to upload to OMS a csv-file containing

serial numbers generated by the pharmaceutical entity. For this purpose,

the “Upload CSV” button will be displayed in the interface.

Using this serial number generation method, the “List of serial number”

filed is filled in automatically with several serial numbers in the file.

The file must contain unique serial numbers (SGTINs) that were not used

by the pharmaceutical entity when creating orders. Otherwise, OMS will

generate an error.

7.4.3. Once the business order form is completed, the Save button shall be clicked. Once

this button is clicked, the order confirmation form will be displayed in the interface (the

sub-process of MC payment is described in clause 9 of this document). If all order

parameters are entered correctly it is required to check the box: “I confirm the

correctness of the entered data” and click the “Send request” button.

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7.4.4. Clicking this button initiates the business order sending for verification and its further

generation. Once the order is assigned with “Available” status, the receipt of marking codes

can be started.

You can read more on the status model of orders for marking codes in the specification of OMS API

posted on the official website at https://chestnyznak.ru/en/. In the Medications section , go to

"Documents for MDLP", then go to "To developers".

Upon receipt of the “Available” status by the order, the report “10300-Issue of Marking Codes” is

automatically generated and sent to the MDLP FGIS Sandbox.

7.5. Receiving the marking codes

7.5.1. To receive the marking codes as well as to view the detailed information on the

order/commodity, click the order ID. This will open the order form consisting of 2 tabs:

General data and Goods.

To obtain the marking codes, go to the Goods tab and click icon on the right in the

commodity line.

7.5.2. This will open the form for obtaining the marking codes.

Fill in the following fields (the requirement to fill in the fields is determined by the form for

obtaining MCs):

Field names Filling in rule

Format Format of the file, in which the printed marking codes are placed

Template Template of the label, on which it is necessary to print the marking codes

Quantity This indicates the number of MCs to print

7.5.3. After filling in all fields, press the Print button. This will initiate the download of the

file with marking codes to the user browser.

7.5.4. When printing, marking codes are converted to identification means. From one

order it is possible to print the number of codes that does not exceed the number

specified at the order generation. The ordered number of marking codes is shown in

“Total codes” fields on the "Goods" tab.

The number of already printed marking codes is shown in the “Received” field.

The number of codes available for printing is displayed in the “Codes in buffer” field.

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7.6. Sending a report on using (applying) the marking codes.

7.6.1. To create and send the report, go to the Application section.

7.6.2. Pressing button opens the form of report on application. In the form of

report, the General data block indicates the following read-only data:

commodity group of pharmaceutical entity – Medicines for medical use

type of marking code usage – Application of MC verified.

In this form, fill in the following fields (the requirement to fill in the fields is determined by the

form of report on application):

Field name Filling in rule

Expiry date Expiry date of a marked medicine shall be specified

Production order

type

Production order type shall be specified (own or contract production),

this field is filled in only if the medicinal product is manufactured within

the Russian Federation

Business place ID At medicine production in RF: 14-character identifier of the entity

business place as per the license, assigned upon the business place

registration by the entity in FGIS MDLP Sandbox

At medicine production outside RF. When the medicinal product is

manufactured outside the Russian Federation: 36-character number is

assigned to the holder of the registration certificate (or its

representative) upon its registration in FGIS MDLP Sandbox

Owner ID To be filled in with an owner registration number in RC (foreign

contractor) from “Foreign contractors register” section in FGIS MDLP

Sandbox if the “Production order type” has the “Contract production”

value

Production series

number

The production series number of the marked medicine shall be specified

ID of the producer

that performed

To be filled in with a registration number of a producer that performed

packing/prepacking in secondary (tertiary) package (foreign contractor)

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packing/prepacking

in the

secondary/tertiary

packaging

from “Foreign contractors register” section in FGIS MDLP Sandbox, if the

medicinal product is manufactured outside the Russian Federation.

ID of the producer

that performed

release quality

control

To be filled in with a registration number of the producer that

performed the release quality control (foreign contractor) from “Foreign

contractors register” section in FGIS MDLP Sandbox. This field may be

filled in, if the medicinal product is manufactured outside the Russian

Federation.

This field is mandatory only if the medicinal products is marked in the

customs zone.

Identified of the

location of goods in

the customs control

zone

To be filled by 36-character identifier of commodity location from the

register of locations in the customs zone in FGIS MDLP. The field must

be filled in, if the medicinal products are marked in the customs zone.

Production date To be filled with the date and time of actual manufacturing of medicinal

product. This field is optional.

Attention! The date and time indicated in this field must not be earlier

than the issuance of marking codes. Otherwise, it will violate the history

of events.

Goods code Download csv file containing the applied SNTINs (full marking codes). To

do this, press

7.6.3. Once the form of report on marking codes printing form is completed, the “Print” button shall be

clicked. The list of reports in the Application section will display the saved report with Pending status.

7.6.4. To send the report, go to the Reports section.

All reports available for sending have Pending status. To send a report, tick the box in the line of

required report (you can select several reports simultaneously) or select the action Send without

signature.

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Once these steps are completed, the report acquires Ready for sending status.

If the report was successfully sent, its status will change to Sent, “10311-Packing completion

(emission registrar)” reports for residents of RF / “10319-Medicine release outside RF (emission

registrar)” for non-residents of RF will be generated and sent to FGIS MDLP Sandbox.

In the case of an error when sending a report, the status will change to Rejected.

You can read more on the status model of reports in the specification of OMS API posted on the

official website at https://chestnyznak.ru/en/ In the section Medications, go to Documents for

MDLP, then go to To developers.

7.6.5. To view the detailed information on the report, click the icon of commodity group in the

Reports section. This will open the form of reports consisting of 2 tabs: General information and

Production.

The General information tab indicates the data included in the report when it was generated.

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The Production tab indicates all marking codes included in the report on application.

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Please note that on this tab the marking codes are indicated without the verification code (crypto

tail). The codes also include the usage identifiers: identifier "01" before the value of GTIN, identifier

"21" before the value of the serial number of medicinal product.

When searching for MC data in the user account of FGIS MDLP Sandbox, first remove the usage

identifiers from MC because FGIS MDLP Sandbox conducts the search by SGTIN.

7.7. Business order closure

7.7.1. Completely used orders are closed automatically. The number of active codes can not

exceed 100.

7.7.2. You can manually close the order with remaining unused marking codes by using various

methods. You can use any method from the list below:

In the order list press the Close order the order button in the required order line.

Go to detailed information about the order (by clicking the order identifier in the

list of orders), next click Close order.

Go to detailed information about the order (by clicking the order identifier in the

list of orders), next go to the Goods tab, click the Close button in the commodity

line.

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This step will close the array (pool) of marking codes within the order. Since for

Pharma 1 the order can include only 1 commodity (GTIN), the order will be closed

automatically after closing the array (pool) of MCs.

7.7.3. To close the order (array of MCs), confirm this action by clicking the Close the order button

in the dialog box.

When you close the order in the integration environment, OMS will automatically generate and

send to FGIS MDLP Sandbox a report on rejected marking codes (scheme 10305 – Rejection), which

will include all MCs that remained unused in the order at the time of its closure.

7.7.4. Closed business orders disappear from the Active tab in the Orders section and are

displayed in the History of orders section.

8. “Business order creation and application of identification means via OMS API” sub-process

Preconditions:

The pharmaceutical entity is registered in the integration/test environment OMS

The pharmaceutical entity has information on omsId and clientToken

The pharmaceutical entity is provided with the test ER

Funds are credited to the personal account of the pharmaceutical entity (available funds in the

pharmaceutical entity’s PA is obligatory for the order of charged MC)

To test the procedure for business order creation and application of identification means via OMS API,

the following OMS API methods shall be called in sequence:

check OMS availability;

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create a business order for marking codes emission;

receive the status of MC array from the business order;

receive the MC from the business order;

send a MC usage report;

close the sub-order for the specified GTIN. (This method is called when it is necessary to close an

order with unused marking codes. Fully used orders are closed automatically.)

The detailed description of OMS API methods, their calling procedure via OMS API to generate a business

order for marking codes as well as the description of transmitted parameters and response codes are set

forth in the documentation available on website http://chestnyznak.ru/en/ (“Medications” section, then

“Documents for MDLP”, then “To developers”)

9. “Payment for marking codes” sub-process (to be performed for integration environment)

Preconditions:

The pharmaceutical entity is registered in the integration environment

The pharmaceutical entity is a resident of RF;

The following medicines are registered in FGIS MDLP Sandbox:

- from the 7VZN list (the MC for the medicines that in FGIS MDLP Sandbox have “7VZN” attribute=Yes,

payable)

- from the VED list with selling price less than 20 roubles (the MC for the medicines included into the

VED list with selling price less than 20 roubles are not payable until 01.01.2020 and after 01.01.2020)

- from the 7VZN and VED lists with selling price less than 20 roubles (the MC for the medicines that in

FGIS MDLP Sandbox have “7VZN” attribute=No or “VED”=Yes, but their selling price more than 20

roubles, are not payable only until 01.01.2020)

The pharmaceutical entity is provided with the test ER

Funds are credited to the personal account of the pharmaceutical entity

To test the marking codes payment process, the following actions shall be performed in sequence:

9.1. Login FGIS MDLP Sandbox

9.1.1. On the FGIS MDLP Sandbox login page click “Sign in with certificate” button and

login by means of test EQES (for residents of the Russian Federation) or log in using your

login and password (for non-residents of the Russian Federation);

9.2. Redirect to the Order Management Station

9.2.1. Redirect to the “Profile” section then click “SGTIN Order” button.

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9.2.2. When clicking the “SGTIN Order” button, FGIS MDLP Sandbox automatically

redirects the user to the Order Management Station interface (OMS), “Business orders”

section, the OMS login is performed with the Operator account.

9.3. Business order creation

9.3.1. Create the business order for marking codes as per clause 7.4 of this document.

9.3.2. Depending on the combination of values of “Payment criteria” and “Type of

payment” fields, the testing scenarios can be the following:

Payment indication=Payable

Payment type=Payment upon application

Means that the marking codes are ordered for a medicine that cost more than 20

roubles.

The pharmaceutical entity’s PA is to be debited after the receipt of identification means

application report by FGIS MDLP Sandbox: “10311-Packing completion (emission

registrar)” for residents of RF / “10319-Medicine release outside RF (emission

registrar)” for non-residents of RF.

At payment upon application the identification means shall be applied within 180 days

from the moment of display of this BO in the OMS UA of the pharmaceutical entity

(exact date and time are specified in “operation_date” attribute in “10300-Marking

codes emission” report).

After 180 days unused MC can no longer be printed.

Until July 1, 2020, the following form is displayed in the interface at confirmation of the

business order creation:

After July 1, 2020, the text in the dialog box for order confirmation will be changed for

the text that corresponds to paid marking codes.

Payment indication =Payable

Type of payment=Payment upon emission

Means that the marking codes are ordered for a medicine that cost more than 20

roubles.

The funds in the pharmaceutical entity’s PA are reserved when sending the business

order. If there are not enough funds in the personal account to create a reserve, the

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operation is rejected. After verification for errors in the business order, the marking

codes are available for application. The reserved funds are debited from the

pharmaceutical entity’s PA upon the receipt of “10300-Marking codes emission” report

on the marking codes emission by FGIS MDLP Sandbox.

At payment upon emission the marking codes can be used without any time limit.

Until July 1, 2020, the following form is displayed in the interface at confirmation of the

business order creation:

After July 1, 2020, the text in the dialog box for order confirmation will be changed for the

text that corresponds to paid marking codes.

Payment criteria=Not payable

Means that the marking codes are ordered for a medicine that cost less than 20 roubles.

In this case, the “Type of payment” field value is not processed by the system.

The pharmaceutical entity's PA is not debited.

The marking codes can be used without any time limit.

Until July 1, 2020, At confirmation of the business order creation the following form is

displayed in the interface at confirmation of the business order creation:

NOTE: If the medicine selling price at the first shipment exceeds 20 roubles, the

following goods movement will be blocked until the marking codes are paid.

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After July 1, 2020, the text in the dialog box for order confirmation will be changed for

the text that corresponds to free marking codes.

9.4. Verification of reports and payslips (to be performed for integration environment)

Availability of the reports on emission and marking codes application in the UA of a

pharmaceutical entity in FGIS MDLP Sandbox shall be verified.

9.4.1. Redirect to “Documents” section, click the “Sent” button. In the “Operation” filter

select one of the type of reports:

10300-Marking codes emission,

10311-Packing completion (emission registrar) – for residents of RF,

10319-Medicine release outside RF (emission registrar) – for non-resident of RF.

9.4.2. The report document and payslip can be downloaded by means of the buttons in

the right column of the report row.

The example of xml-report document “10300-Marking codes emission”

The example of xml-payslip document on operation “10300-Marking codes emission”

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The example of xml-report document “10311-Packing completion (emission registrar)”

The example of xml-payslip document on operation “10311-Packing completion (emission

registrar)”

The example of xml-report document “10319-Medicine release outside RF (emission

registrar)”

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The example of xml-payslip document on operation “10319-Medicine release outside RF

(emission registrar)”

9.4.3. Verification of SGTIN status

In the UA of pharmaceutical entity in FGIS MDLP Sandbox the SGTIN status from the order can

be verified. For this purpose, it is required to redirect to the “Goods” section, and then click the

“SGTIN register” button.

A particular SGTIN can be found using the filter.

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NOTE: If the paid marking codes were ordered, but funds in the pharmaceutical entity’s PA are

not enough, all SGTINs from the order will be assigned with “Waiting for release, not paid”

status.

Free or paid SGTINs are assigned with “Waiting for release” status (for residents of RF) or

“Waiting for shipment in RF” (for non-residents of RF).

10. The order for notifying integrators on scheduled and unscheduled maintenance in the integration environment

The integrators are notified on maintenance in the integration environment via one of the below channels

or simultaneously via all channels.

The channel for notification is selected on the side of Operator-CRPT LLC depending on the type of

scheduled maintenance.

Notification channel Type of works

1. An email to the contact person

specified when requesting the

registration in the integration

environment from support@crpt.ru

2. Telegram-channel “OMS-MDLP

notification”

Scheduled maintenance lasting more than

1 hour

Telegram-channel “OMS-MDLP notification”

Scheduled maintenance lasting more than

1 hour

Scheduled maintenance lasting less than 1

hour

Unscheduled maintenance

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List of changes

Version Change date List of implemented changes

1.0 19.11.2019 Original document version

1.1 18.02.2020 Section 5. Sub-process “Request submission for the registration in the integrated environment by the Integrator”, clause 5.1:

The clause on the necessity to submit the EQES certificate by the Integrator, registering as the resident of the Russian Federation, is excluded from the request for the access to the “Pharma” integrated environment.

The new clause is added to the request for access to the “Pharma” integrated environment on the need to submit the data (organization name) on medicines manufacturers represented by the Integrator.

Section 5. Sub-process “Submission of the request for registration in the integrated environment by the Integrator”, section 5.6:

A “test EQES certificate” for test (simulated actions) is added by Operator-CRPT LLC to provide the quality assurance in the MDLP FGIS UA.

Section 5. Sub-process “Submission of the request for registration in the integrated environment by the Integrator”, clause 5.9 on re-issue of a test EQES certificate is added.

2.0 08.05.2020 In the document text, the interface screenshots were replaced with their

updated versions (corresponding to OMS 3.1.10 and higher).

Changed the numbering of sections.

Made changes to sections 1, 2 and 3: added the definition of test

environment OMS.

Section 6 . Added the sub-process "Submitting the request for registration

in the test environment OMS"

In the document text, added the clarifications on availability of sub-

processes in environment of Operator-CRPT LLC.