Release 4.55.0 MDLP August 26, 2023

Installed on the Sandbox test environment: 17/08/2023

Installed on the production environment: 26/08/2023

XSD-schemes version: 1.38

Changes in line with Decree of the Government of the Russian Federation No. 1556

Prohibition of reverse order for the medicines

In accordance with paragraph 3 of Clause 44 of Decree of the Government of the Russian Federation No.1556, in case of circulation of the medicines with international non-proprietary name "Ethanol" and medicines which contain narcotics, psychotropic substances, and their precursors, pharmaceutical entities engaged in circulation of such medicines shall submit information to the Track and Trace System by direct order of data submission for medicine circulation according to paragraphs four and five of Clause 44 of Decree of the Government of the Russian Federation No. 1556.

For such medicines, the schemes of reverse acceptance with "Return" and "Receipt" posting/acceptance operation types are prohibited:

• 702 "Registration in MDLP IS of information on posting";

• 416 "Registration in MDLP IS of information on acceptance of medicines at the receiver’s warehouse";

• 473 "Registration in MDLP IS of information on acceptance of medicines by agent under agency contract".

If an attempt is made to carry out operations, a document will be processed with error 29 "The operation cannot be executed for medicines of these categories".

"Misgrading" operation type is allowed for such medicines.

Restriction on the batch in monoaggregates

In accordance with Clause 40 of Decree of the Government of the Russian Federation No.1556, when aggregating those medicines, which have the same global trade item number and the same production batch number, a pharmaceutical entity shall apply the identification code of tertiary (shipping) medicine package on the tertiary (shipping) medicine package and shall submit those data, which are stipulated in Clause 1 of Appendix 5 of Decree of the Government of the Russian Federation No.1556, to the Track and Trace System before providing any data on further handling of such medicine"

For operations:

• 911 "Registration in MDLP IS of information on aggregation of medicine packages into tertiary (factory, shipping) package";

• 915 "Registration in MDLP IS of information on aggregation into multiple tertiary (factory, shipping) packages"

it is checked that all SGTINs relate to the same batch. If the specified SGTINs relate to different batches, a document will be processed with error 3013 "Aggregation is denied – trying to aggregate ICMs with different batches of the medicines".

When 1st level SSCC is aggregated into 2nd level SSCC, there is no check for monobatch.

For operations:

• 914 "Registration in MDLP IS of information on additional insertion of packages into tertiary (factory, shipping) package";

• 916 "Registration in MDLP IS of information on additional insertion into multiple tertiary (factory, shipping) packages"

it is checked that SGTINs which have been previously nested into the SSCCs and SGTINs which are to be added, relate to the same batch. If the SGTINs relate to different batches, a document will be processed with error 3013 "Aggregation is denied – trying to aggregate ICMs with different batches of the medicines".

The boxes created before September 01, 2023, will not be forcibly disaggregated, and their further movement will be acceptable.

Uploading of instructions for medicines

From September 01, 2023, in accordance with Clause 33 of Decree of the Government of the Russian Federation No.1556, it will be possible for the circulation participants which are issuers of the identification means or are marketing authorization holders/owners which have registered the medicines in the MDLP FGIS user account, to upload instructions and medicine package images to the MDLP FGIS. Instructions and images to be uploaded shall be accurate at the time of introduction of the medicines into civil circulation.

Instructions and images can be uploaded both by using the MDLP FGIS API methods and via the participant’s UA.

Instructions can be uploaded in JSON and PDF formats, and package images can be uploaded in PNG format. Uploading of JSON instructions is mandatory.

When working with instructions and images, the following features are available to circulation participants:

1. uploading of instructions and images;

2. viewing and downloading;

3. editing;

4. as well as configuring connection of instructions and images with GTIN or medicine production batch number.

Uploaded instructions and medicine package images will be available to consumers in Chestny ZNAK.

More detailed information can be found at link.

 Automatic introduction into circulation

In accordance with Clauses 35, 37(1), 38(1) of Decree of the Government of the Russian Federation No.1556, from September 01, 2023, a status of the medicines for which information on introduction into civil circulation is received by the MDLP FGIS from the Roszdravnadzor AIS, will be automatically changed to "In circulation". Thus, there will be no need for the circulation participants to submit schemes 313/342/363 in order to change a medicine status to "In circulation".
More detailed information on a process of automatic introduction of the medicines into circulation can be found in the document which is published on the official website of "Chestny ZNAK", as well as in the "Help" section in the Participant’s UA.

Delegation

In accordance with Clause 57 (1-1) of Decree of the Government of the Russian Federation No.1556, an issuer of the identification means is entitled to transfer access to analytical reports to the pharmaceutical entities which introduce medicines into civil circulation and/or to marketing authorization holders/owners if there is information on a taxpayer code of such holder/owner of the marketing authorization in the MDLP FGIS.

This process includes the delegation of rights to view analytical reports and rights to manage analytical reports.

When the rights to view the reports are delegated, a possibility to view the reports is reserved both for the circulation participant that has delegated the right and for the circulation participant that has obtained the right.
When the right to manage a report is delegated, the right to manage a report is reserved only for the circulation participant that has obtained the right to manage the report (a participant that has delegated the right, will not have the right to manage the report).

Delegation of the rights to reports will be carried out by using the functionality of the Participant’s UA.

Delegation is applied in respect of the following reports:

1. "General report on remaining items";

2. "General report on disposal";

3. "General report on movement";

4. "General pricing report";

5. "Report on remaining medicines";

6. "Report on medicine disposal";

7. "Remains of imported medicines before introduction into civil circulation";

8. "Report on medicine prices";

9. "Movement of medicines introduced into circulation",

as well as "SGTIN tracking" and "SGTIN archive" in the "Products" section.

Additionally, a new document "Instruction on how to use the delegation" has been added into the GCP’s UA in the "Help" section, "Instructions and user guides" group. The document describes the purpose of delegation, how to use the delegation, as well as describes the main scenarios of work with the delegation.

More detailed information can be found at link.

A text of notifications when accepting the application for registration in the MDLP FGIS has been corrected

In accordance with Clause 26 of Decree of the Government of the Russian Federation No.1556, registration (denial of registration) of pharmaceutical entities in the Track and Trace System is carried out within 5 business days from the date on which pharmaceutical entities submit data to the Track and Trace System. In connection with these changes, a notification sent to circulation participants at their registration in the MDLP FGIS has been corrected in terms of changing the deadline for sending the result of consideration of an application for registration in the MDLP FGIS from 14 days to 5 business days.

Machine-readable powers of attorney
 

New xml version for creating machine-readable powers of attorney (the machine-readable PoA)

The MDLP FGIS has moved to a new version of the machine-readable PoA called 003.

New fields were added:

• Document expiry date;

• Code of subdivision that has issued the document;

• Name of the authority that has issued the document.

A mandatory field has been removed:

• Document confirming powers.

The changes will affect only the creation of new machine-readable PoA.
There will be no need to re-issue the machine-readable powers of attorney that were created earlier.

We remind you that from September 01, 2023 a machine-readable PoA will be mandatory for the employees that have EQES of a physical entity.
In this regard, availability of the active machine-readable PoA will be checked for the EQES of a physical entity when authorizing in the MDLP FGIS. 

 Other improvements in the UA

• Information statement on how to use delegation has been added into the "Control of access to medicines reports" section, "Issued rights" and "Obtained rights" tabs;

• "Administration - Control of access to medicines reports" section has been opened to manage delegation;

• A new registry "Registry of instructions and images" has been added into the "Medicines" section.
   MANAGE_CONTAINERS - "Managing instructions and images" right is required to work with containers.

• "Registry of batches" registry has been moved to the "Medicines" section;

• "Container ID" column has been added into the "Medicines" section, in "Registry of medicines" and "Registry of batches". Changes are also supported in export to Excel;

• In the medicine card, in the registry of medicines, the "Default container" button has been added. The following parameters have been added as well:

• "Container ID". If the "Container ID" parameter is empty, "-" will be displayed;

• ""Default container" is used for the batches that do not have an assigned container identifier" - "Yes"/"No" is displayed.

• In the section "Products - SGTIN tracking" and "Products - SGTIN archive", display of operation 705 "Registration in MDLP IS of information on absence of the medicines on balance" is supported.

API updates

• The following methods have been implemented:

• creating a container - POST /reestr/containers;

• editing a container - PUT /reestr/containers/{container_id};

• downloading container files - GET /reestr/containers/{container_id}/download;

• getting data from containers registry - POST /reestr/containers/filter;

• sending a container for moderation - POST /reestr/containers/validate;

• creating a GTIN configuration - POST /reestr/med_products/assign_container;

• correction of connection between a container and batch - POST /reestr/batches/assign_container.

• The "Container ID" parameter was added into the input parameters of the fields available for export in the method for creation of task POST /export/tasks/{task_type} for task_type =batches_registry;

• The "Container ID" parameter was added into the output parameters in the method to receive result GET /export/tasks/{task_id}/result for task_type =batches_registry;

• An additional table with a list of task types to filter analytical data (TaskType) was added. A link was changed for the method Endpoint: POST //export/tasks/filter for the filter.task_type input parameter in a note for a new table.