Information about the content of the release in Russian can be found at this link.
Installed on the Sandbox test environment: 25.07.2022

Installed on the production environment: 30.07.2022

XSD-schemes version: 1.38

2. Modifications

2.1. Set of schemes 1.38

Within release, a version of xsd schemes has been increased to 1.38. Updating of the schemes set will extend the functional possibilities of the MDLP FGIS business processes. The set of schemes 1.38 and updated business processes are backward compatible with the current version of schemes 1.37. A feature for submitting the schemes of ver. 1.34, 1.35, 1.36 and 1.37 remains. A description of the changes can be found at link.

2.2. Changes in business processes:

• a return of the medicine to a supplier by using schemes 415 (Medicine shipment from warehouse) / 416 (Medicine acceptance to warehouse) has been implemented for cases when this medicine was previously posted by uploading scheme 702 (Posting);
• a new attribute - “Shipped by sender” has been added. This attribute will be displayed for the medicines after uploading scheme 705 (Registration in MDLP FGIS of information on absence of the medicines on balance). When uploading this scheme, medicines, which are out of stock (in view of the shipment to another goods circulation participant), are specified. The operation is available only for the medicines with “In circulation” or “Shipped” status.

  “Shipped by sender” attribute with “Yes” and “Unfilled” valid values will be displayed in the following sections:

  • “Display window of products by SGTIN”;
  • “SGTIN registry”;
  • “Registry of SGTINs emitted before 2021-03-28”.
• sending of notifications on suspension / resumption of medicine circulation has been implemented in the MDLP FGIS.

  The notification contains the following information:

  • decision number;
  • decision date;
  • effective date of the decision.

2.3. Modifications in the user account:

• in the “Registries and classifiers” section, a new registry — “Registry of declarations” was added. This registry will contain information on introduction into civil circulation in terms of declarations. To work with this registry, the following rights are required: “Receiving information from the registry of solutions on introduction of batches into civil circulation” (VIEW_LP_IN_CIRCULATION_DECISIONS) or “Viewing of general information on a participant from the registries” (REESTR_ALL).

  A list of the registry data:

  The filtering is available in the declaration registry for the following parameters: “GTIN”, “Batch No.”, “Declaration No.”, “Document processing date”. Data can be exported from the registry in a document of * .xlsx format;

  • “GTIN” — it is filled out in line with the data of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Batch No.” — it is filled out in line with the data of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Declaration No.” — it is filled out in line with the data of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Owner ID” — it is filled out in line with the data of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Volume specified in the importation document in line with the declaration” — it is filled out in line with the data of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Identifier of the record in RZN” — it is filled out in accordance with a permit to introduce into civil circulation received from the Federal Service for Surveillance in Healthcare (the RZN);
  • “Date from importation document” — it is filled out in line with the data of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Document processing date” — it is filled out as an actual time of processing of scheme 335 (Registration in MDLP FGIS of information on customs clearance results);
  • “Volume permitted for introduction into civil circulation” — it is filled out in accordance with a permit to introduce into civil circulation received from the RZN;
  • “Number of the permission to introduce into circulation” — this parameter is for immunobiologicals, it shall be fill out in accordance with a permit to introduce into civil circulation received from the RZN;
  • “Number of SGTINs introduced into circulation” — it is filled out in line with the results of automatic introduction.

​The filtering is available in the declaration registry for the following parameters: “GTIN”, “Medicine batch number”, “Customs declaration No.”, “Document processing date”. Data can be exported from the registry in a document of * .xlsx format;​Рисунок 7. Registry of customs declarations (import medicines)

• in the “Registries and classifiers” section, a new registry — “Registry of shipments” was added. This registry will contain information on introduction into civil circulation in terms of shipments of medicines from the Eurasian Economic Union (the EEU). To work with this registry, the following rights are required: “Receiving information from the registry of solutions on introduction of batches into civil circulation” (VIEW_LP_IN_CIRCULATION_DECISIONS) or “Viewing of general information on a participant from the registries” (REESTR_ALL).

  A list of the registry data:

  The filtering is available in the registry for the following parameters: “GTIN”, “Batch No.”, “Shipment No.”, “Shipment date”, “Document processing date”. Data can be exported from the registry in a document of * .xlsx format;

  • “GTIN” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Batch No.” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Shipment No.” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Shipment date” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Owner’s identifier” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Shipment volume under import document” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Identifier of the record in RZN” — it is filled out in accordance with a permit on introduction into civil circulation received from the RZN;
  • “Date from importation document” — it is filled out in line with the data of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information) which accepts scheme 361 (Medicine shipment in the Russian Federation from EEU) / scheme 362 (Registration in MDLP FGIS of information on import of medicines from the EEU countries and medicine acceptance at the buyer’s warehouse);
  • “Document processing date” — it is filled out as an actual time of processing of scheme 360 (Registration in MDLP FGIS of information on import of own medicines to the Russian Federation from EEU countries) or scheme 701 (Registration in MDLP FGIS of confirmation (acceptance) of information);
  • “Volume permitted for introduction into civil circulation” — it is filled out in accordance with a permit on introduction into civil circulation received from the RZN;
  • “Number of the permission to introduce into circulation” — this parameter is for immunobiologicals, it shall be filled out in accordance with a permit to introduce into civil circulation received from the RZN;
  • “Number of SGTINs introduced into circulation” — it is filled out in line with the results of automatic introduction.

​The filtering is available in the registry for the following parameters: “GTIN”, “Medicine batch number”, “Shipment number”, “Shipment date”, “Document processing date”. Data can be exported from the registry in a document of * .xlsx format;

Рисунок 8. Register of shipments imported from EEU

• a switch to “Registry of shipments” and “Registry of declarations” is available from the “Registry of solutions on introduction of batches into civil circulation”. To switch to a registry, it is necessary to click on a value in the “Batch No.” column in the “Registry of solutions on introduction of batches into civil circulation”;
• a new parameter — “Number of related RZN decisions” was added into the “Registry of solutions on introduction of batches into civil circulation” in the “Registries and classifiers” section. The parameter will contain the number of decisions to introduce into civil circulation:
  • for medicines from EEU — the number of permits for shipments in a batch;
  • for imported medicines (not EEU) — the number of permits for declarations in a batch.

​Рисунок 9. Registry of solutions on introduction of batches into the civil circulation

• when receiving information from external agencies that a participant’s status is “Eliminated”, a license status will be changed to “Invalid”. Business places /Responsible storages will change their status to “Suspended”;
• in the “SGTIN tracking” section, a display of the prices was corrected for issuers for the following schemes:
  • 702 — “Posting”;
  • 415 — “Medicine shipment from warehouse”;
  • 416 — “Medicine acceptance to warehouse”;
  • 254 — “Information update”;
  • 361 — “Medicine shipment in the Russian Federation from EEU”;
  • 362 — “Medicine import into the Russian Federation from EEU”;
  • 441 — “Shipment of medicines to unregistered place”;
  • 461 — “Shipment of medicines to EEU”;
  • 470 — “Medicine transfer within the state medicine provision”;
  • 511 — “Retail sale”;
  • 512 — “Dispensing of medicines other than indicated in the register receipt”;
  • 10511 — “Retail sale using CRE”.
• a new parameter - “Narcotic Drugs/Psychotropic Substances” was added into the following sections:
  • “Medicines” → “Registry of medicines”;
  • “Medicines” → “Registry of medicines” → “GTIN card”;
  • “Medicines” → “General registry of registered medicines”.
• a new parameter - “A name of the measurement units of weight/volume in the primary packing” was added into the following sections:
  • “Medicines” → “Registry of medicines”;
  • “Medicines” → “Registry of medicines” → “GTIN card”;
  • “Medicines” → “General registry of registered medicines”;

​Рисунок 10. Registry of medicines

• a new parameter - “A name of the measurement units of weight/volume in the primary packing” was added into the following sections:
  • “Medicines” → “Registry of medicines”;
  • “Medicines” → “Registry of medicines” → “GTIN card”;
  • “Medicines” → “General registry of registered medicines”;

• a possibility to update an enhanced qualified electronic signature (the EQES) without involving an administrator has been added for a user which does not have rights to view / edit users.

  For this purpose, before EQES expiration date, proceed as follows:

  • log in to the MDLP FGIS;
  • go to the “Administration” section;
  • go to user card;
  • in the opened form, go to the “Certificates” tab;
  • click the “Add certificate from media” button or “Add certificate from the file system” button depending on the EQES location.

​

Рисунок 11. Certificates

• “Phone number” and “Brand name” columns were added into the section “Profile” → “Addresses” → “Business places”;
• “Update contact” button was added into the section “Profile” → “Addresses” → “Business places”. Clicking the button will open a modal window to specify / edit/ delete a phone number and a brand name of one business place or a group of the business places. Phone number input mask: +7XXXXXXXXXX;
• In the section “Profile” → “Addresses” → “Branches”, an “Adding contact” caption has been added, clicking on this caption will hide / open the notification: “The specified phone number and brand name will be displayed in the “Search of medicines” section of the “Chestny Znak” application to ensure prompt communication of the application users with the employees of the pharmacies on the balance of which the medicines are recorded”.

​Рисунок 12. Business places

2.4. API modifications

• a new response parameter - “is_narcotic” (“Narcotic drugs or psychotropic substances”) was added into the following methods:
  • “Method of searching by the registries of ICM by the list of values” (the identification and control mark) (POST /reestr/sgtin/sgtins-by-list);
  • “Method for obtaining detailed information about the ICM and related medicines from the ICM registries” (GET /reestr/sgtin/{sgtin});
  • “Method for obtaining detailed information about the ICM in the long-term storage and a related medicine” (GET /reestr/sgtin/archive/{sgtin});
  • "Method for obtaining information from the registry of medicines manufactured by the company" (POST reestr/med_products/current);
  • "Method for obtaining detailed information about a medicine manufactured by the company" (GET reestr/med_products/{gtin});
  • "Method for searching public information in the registry of manufactured medicines" (POST /reestr/med_products/public/filter);
• a new response parameter - “mass_volume_name” (“Measurement unit”) was added into the methods:
  • "Method for searching public information in the registry of manufactured medicines" (POST reestr/med_products/current);
  • "Method for obtaining detailed information about a medicine manufactured by the company" (GET reestr/med_products/{gtin});
  • "Method for searching public information in the registry of manufactured medicines" (POST /reestr/med_products/public/filter);
• a new response parameter - “not_on_my_balance” (“A sign to indicate that a sender does not have a medicine”) was added into the methods:
  • “Method for searching by the ICM registries” (POST /reestr/sgtin/filter);
  • “Method of searching by the registries of ICM by the list of values” (POST /reestr/sgtin/sgtins-by-list);
  • “Method for obtaining detailed information about the ICM and related medicines from the ICM registries” (GET /reestr/sgtin/{sgtin});
  • “Method for receiving information on ICM in tertiary packing” (POST /reestr/sscc/{sscc}/sgtins);
• “phone_number” (“Phone number”) and “brand_name” (“Brand name”) parameters were added into response and request of the "Method for searching information about business places by filter" (POST /reestr/branches/filter);
• number of uploaded documents was increased from 50 to 300.