Release 4.63.0 MDLP August 31, 2024

Information about the content of the release in Russian can be found at this link

Installed on the Sandbox test environment: 27.08.2024

Installed on the production environment: 31.08.2024

XSD-schemes version: 1.38

Modifications

Return into circulation of good quality medicines after write-off of “hanging” remaining items

To support return of the medicines that were withdrawn by means of document 552 “Registration in MDLP IS of information about medicinal drugs withdrawal from circulation for various reasons” with a type of withdrawal from circulation (withdrawal_type) = 23 (“Write-off of the medicines with no information according to BP”), the following new value of the reason for withdrawal from circulation (withdrawal_reason) was added into document 391 “Registration in MDLP IS of information on re-introduction of medicine into circulation”:

• 16 — withdrawn from circulation in view of the write-off when there is no information according to BP.

When returning such SGTINs, it is checked that:

• document 391 was submitted by a current SGTIN owner;

• SGTIN is not expired;

• SGTIN was withdrawn by means of document 552 with “withdrawal_type” = 23;

• SGTIN is returned by means of document 391 with “withdrawal_reason” = 16 as a medicine of good quality (“reason_return” = 1);

• no decision has been received from the state authorities to suspend circulation of the medicines since withdrawal from circulation of the medicines.

After an operation of return of such SGTINs is performed, these SGTINs will be returned into “In circulation” status (in_circulation).

Validity of the EQES issued to an employee of the organization was limited

According to changes in 63-FZ “On Electronic Signature”, activities of the employees (which use certificates that contain data about the organization) of the organizations will be limited from September 1, 2024. Limitations will be applied when you sign in to your user account and when adding such certificates for existing or new employees.

To work in a user account, employees should use a qualified electronic signature issued to a natural person with the use of the machine-readable power of attorney.

Such an electronic signature shall not contain:

• OGRN / OGRN of individual entrepreneur;

• TIN (INN) of the legal entity;

• Name of the organization.

Signing of the documents on behalf of the company will be available to:

• CEO;

• an employee that uses a certificate of a natural person with the use of the machine-readable power of attorney;

• an employee by means of impersonal EQES (such an EQES can be used only via API).

Number of the fields in the signup form was increased for representative offices of a foreign MAH and MAHs of a foreign manufacturer

New fields were added into the medicine circulation participant signup form for the “Representative office of a foreign MAH” and “MAH of a foreign manufacturer” participant types:

• “Marketing authorization number”;

• “Trade name”.

The fields have been added in order that participants provide more valid data, and as a result to speed up moderation of the requests for registration in the MDLP FGIS on the part of Roszdravnadzor

A banner about the need to migrate to version 3 of the OMS API was added

In view of the migration to a new OMS API version a banner has been added. The banner will be displayed to all participants emitted marking codes. The banner can be hidden by clicking on the checkbox “Do not show again”.

Banner text:

Participants using an API must switch to the OMS API v3 methods by September 1, 2024!

The API methods of OMS 2.0 will be disabled on September 1, 2024 (order\obtainment of MCs, submission of application reports, status request and etc. — all the methods that have /api/v2..). It is only possible to work with the goods groups via OMS API v3. For a description of the OMS API v3 documents, go to the Help section of the MDLP user account (the production environment).

“My virtual warehouse (new)” report was updated

In the “My virtual warehouse (new)” report:

• “Number of packages under scheme 705” and “Date of updating information” fields were added;

• “Consider the shipped medicines” filter was deleted.

Creation of the “Medicines without movement for the last N days (705)” report

A new report — “Medicines without movement for the last N days (705)” was added into the “Reports” section in a medicine circulation participant’s user account.

Access to the report is available to distributors (users that have a license for wholesale trade) and manufacturers (users that have a license for the production) with a new right “MEDICINES_WITHOUT_MOVEMENT_INFORMATION_705” (Medicines w/o movement for the last N days (705)).

In this report, a user has a possibility to submit scheme 705 “Registration in MDLP IS of information on absence of the medicines on balance” for the displayed SGTINs (up to 5,000 pcs) by clicking the “Withdraw from my balance” button, as well as to submit scheme 705 selectively for the SGTINs selected by clicking the “Withdraw selected items from my balance”. Based on the data from the reports, an export in the * .csv format is available.

Expanding the functionality of the “Medicines without movement for the last N days” report

A name of the report was changed from the “Medicines without movement for the last N days” to “Medicines without movement for the last N days (552/23)” in a user account → “Reports”. Functionality of the report has been preserved, as well as it becomes possible to write off with the use of scheme 552/23 by using checkboxes in the report (for this purpose a SGTIN filter was added).

Parameters were added into description of the medicines

The “Name of the OKEI (All-Russia Classifier of Measurement Units) unit of the consumer unit of the medicine” and “Mass/volume of the substance in a primary packaging” parameters were added into the following sections:

• “Registry of medicines” (GCP’s user account → “Medicines” → “Registry of medicines”);

• “General register of registered medicines” (GCP’s user account → “Medicines” → “General register of registered medicines”);

• “View GTIN” (GCP’s user account → “Medicines” → “Registry of medicines” → “View GTIN”).

API modifications

New fields were added into analytical export “My virtual warehouse” (new)

Fields available for export of the “My virtual warehouse” (VIRTUAL_WAREHOUSE_REPORT) were extended:

• “Number of packages under scheme 705”;

• “Date of updating information”.

Changes in filtering parameters:

• “Consider the shipped medicines” filtering parameter (0611_IC_Agg_MDLP_shipped) was deleted.

Modifications in API methods 8.3

“vzn_drug”, “gnvlp”, “is_narcotic”, “is_pku” output parameters were marked as deprecated in the following methods:

• 8.3.1. “Method for searching by the ICM registries”;

• 8.3.2. “Method of searching by the registries of ICM by the list of values”;

• 8.3.5. “Method for obtaining detailed information about the ICM and related medicines from the ICM registries”;

• 8.3.6. “Method for obtaining detailed information about the ICM in the long-term storage and a related medicine”;

• 8.3.9. “Method for searching for all records with the status 'Turnover suspended ' through the ICM registries”.

An input parameter — “is_narcotic” was added into the following methods:

• 8.6.1. “Method for obtaining information from the registry of medicines manufactured by the company”;

• 8.6.3. “Method for searching public information in the registry of the manufactured medicines”.

The “false” value will be always returned in the “is_narcotic”, “is_pku” output parameters in the following methods:

• 8.3.1. “Method for searching by the ICM registries”;

• 8.3.2. “Method of searching by the registries of ICM by the list of values”;

• 8.3.5. “Method for obtaining detailed information about the ICM and related medicines from the ICM registries”;

• 8.3.6. “Method for obtaining detailed information about the ICM in the long-term storage and a related medicine”;

• 8.3.9. “Method for searching for all records with the status 'Turnover suspended' through the ICM registries”.