Release 4.69.0 MDLP June 22, 2025

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

Installed on the Sandbox test environment: 17.06.2025

Installed on the production environment: 22.06.2025

XSD-schemes version: 1.38

Modifications

Added the ability to return medicines into circulation

After the “Withdrawal from circulation for various reasons” operation (scheme 552) of 19 (control sampling under quality control) or 20 (retention sampling) type it is allowed to return medicines into circulation by using the “Re-introduction of the medicine into circulation” document (scheme 391).

The following new type of the reason for withdrawal from circulation (withdrawal_reason) was added to make such a return: 17 “withdrawn from circulation as part of the selection of quality control/retention samples”.
This return feature is available for the medicines of good quality (return reason 1 — “Return of proper quality”) and substandard medicines (return reason 2 — “Return of improper quality”).

After the medicines are returned into circulation with a reason of 17 “withdrawn from circulation as part of the selection of quality control/retention samples”, the medicines will have the statuses assigned to them before withdrawal from circulation.

Medicines of good quality can change their status from “sample selected” (“lp_sampled”) to:

• awaiting release (“marked”);

• awaiting introduction into circulation by owner (“waiting_for_release”);

• in circulation (“in_circulation”);

• awaiting transfer to the owner (“released_contract”);

• admitted to the warehouse from the customs-controlled area (“declared_warehouse”);

• declared (“declared”);

• imported to the Russian Federation (“arrived”) - only for a type of withdrawal — 19.

Substandard medicines: change their status from “sample selected” (“lp_sampled”) to “paused circulation” (“paused_circulation”).

Please note that the following conditions must be met to succeed in uploading the document:

• the document is submitted by a current owner of the medicines;

• the medicine is unexpired;

• after withdrawal from circulation, no decision to suspend circulation of such medicines has been received from regulatory authorities.

Import of medicines under the mutual recognition

As part of mutual recognition of the marking codes with the Republic of Uzbekistan, a new document — “Import of medicines under the mutual recognition” (scheme 338) and a new emission type value (emission_type) — 5 (“mutual recognition”) were added.

Information about the changes in the documents: “Passports of Processes”, “Description of XSD Schemas”, schemes examples as archive and “Description of API of Government Medicine Track and Trace Information System” (it is published in a user account on the production environment) will be published upon the release.

Added new field into the “Registry of medicines”

To display current INN (or analog) of a marketing authorization holder, a new field “INN (or analog) of the MA holder” was added into the “Medicines” section, the “Registry of medicines” tab. The “INN (or analog) of the MA holder” field:

• added into an export of Excel format of the registry of medicines;

• can be edited by submitting a request for medicine data correction. The request form is supplemented with the “Attach a scanned copy of the extract from commercial register of your country” button. The button is mandatory only when the field is edited;

• added to the “Registry of requests for medicine data correction” tab of the “Medicines” section.

“7VZN” was renamed to “VZN”

• The “7VZN” was renamed to “VZN” in interface elements (filters, tooltips, displays), as well as on the following tabs:

• “Organization data” of the “Profile” section;

• “Registry of medicines”, “Registry of batches”, “General register of registered medicines” of the “Medicines” section;

• “SGTIN registry”, “Display window of products by SGTIN”, “Registry of SGTINs emitted before 2021-03-28” of the “Products” section;

• “Registry of suspended medicines” of the “Products temporarily withdrawn from circulation” section.

Prohibition of reverse acceptance schemes for the medicine with “Controlled substances” attribute

Schemes of reverse acceptance with “Return” and “Receipt” posting/acceptance operation types are now prohibited in the MDLP FGIS for the medicines with controlled substances, as defined by the order of the Ministry of Health of the Russian Federation:

• "Registration of information on posting" (scheme 702, exception is type 3 “misgrading”);

• "Registration of information on acceptance of medicines at the receiver’s warehouse” (scheme 416);

• "Registration of information on acceptance of medicines by agent under agency contract" (scheme 473).

If an attempt is made to carry out operations mentioned above, a document will be processed with error 29 "The operation cannot be executed for medicines of these categories". An operation of type 3 “misgrading” of the "Registration of information on posting" document (scheme 702) remains permitted for such medicines.

We remind you that in accordance with paragraph 3 of Clause 44 of the Decree of the Government of the Russian Federation No.1556 dated December 14, 2018, in case of circulation of the medicines which contain narcotics, psychotropic substances and their precursors (a medicine that has a “Controlled substances” attribute), pharmaceutical entities engaged in circulation of such medicines shall submit information to the Track and Trace System by using direct order of data submission (schemes 415/472).

API modifications

Changes in parameters names and descriptions

The following names and descriptions of the parameters were changed:

• Description of the “reg_status” parameter was changed from “Registration certificate validity status” to “ESKLP code status (Drug Code)” in the “EsklpFilter data structure” subsection of the “Receiving information from the ESKLP” section.

• A name and description of the parameter were changed from “7vzn” (“7 VZN”) to “vzn” (“VZN”) in the “Fields available for export” subsection of the “Export from the registry of batches” section.

The “Description of API of Government Medicine Track and Trace Information System” document is published in a user account on the production environment.