Release 4.59.0 MDLP March 2, 2024

25 июня 2024 21:27

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

Installed on the Sandbox test environment: 27/02/2024

Installed on the production environment: 02/03/2024

XSD-schemes version: 1.38

Provision of data to MA Holder as part of delegation

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

This process includes delegation of rights to view and obtain data of analytical reports and rights to manage analytical reports for MA holders.

Remember that 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".

Additionally, the "Instruction on how to use delegation" document (in the GCP’s UA in the "Help" section, "Instructions and user guides" group) has been updated in terms of provision of data to MA Holder.

More detailed information can be found at link.

Procedure of automatic import of medicines to the territory of the Russian Federation

In accordance with paragraph 37 of Decree of the Government of the Russian Federation No.1556, from March 1, 2024, importers are not obliged to submit data on release of goods for domestic consumption to the MDLP (scheme 335 "Registration in MDLP IS of information on customs clearance results" with type 40 "Release for domestic consumption").

In this connection, a test launch of procedure of automatic change of the status of the medicines to "Declared" when importing foreign medicines to the territory of the Russian Federation is planned in release 4.59.0. A status of such medicines will be changed automatically by the MDLP FGIS upon receipt of information from FCS on issuance of the customs declaration for an information type - "Request for processing of information on released goods" 1.0.1.  

Please note that:

  1. Scheme 335 remains valid and will not be deleted from the current scheme set;

  2. You can independently submit scheme 335 "Registration in MDLP IS of information on customs clearance results" with type 40 "Release for domestic consumption" and it will be processed by the system in normal mode;

  3. As soon as a status of the medicine is changed to "Declared", notification 633 of results of automatic import will be sent to you, the medicines themselves will be available for further operations.

New document types: Reminder about the upcoming termination of the contract for MCs with/without renewal

The following new types of the documents were added into the "My documents" - "All documents" section:

  • Reminder about the upcoming termination of the contract for provision of marking codes (with renewal) (Figure 1);

  • Reminder about the upcoming termination of the contract for provision of marking codes (with non-renewal).

The documents are intended to inform participants about the upcoming termination of the contract for provision of marking codes by Operator-CRPT.

Signature of a participant is not required.

Figure 1. Reminder about the upcoming termination of the contract for provision of marking codes (with renewal)

Display of document processing status when viewing the SSCC history

"Document processing status" parameter was added into the section "Products" - "Search for SSCC" - "Operation History".
The parameter contains information about a processing status of the document for which SSCC operations were performed.

Additionally, a scheme number has been added for the "Operation type" parameter (Figure 2).

Figure 2. "Document processing status" and "Operation type"

Search by certificates when you sign in to your UA using EQES

A certificate search feature has been added to a certificate selection page when you sign in to your GCP’s UA using EQES (Figure 3).

 The following certificate parameters are used to search:

  • Organization;

  • INN;

  • Position;

  • Issued to.

Search is performed by entering at least 1 character into the search string.
When you add or remove characters, the results will be recalculated automatically.  

Search feature is available when a user has 3 or more certificates.

Figure 3. Сertificate search


API updates

  1. a note on the maximum number of values was added for the input parameter of "document_ids" ("Document identifiers") in the "Start of processing of documents group" method;

  2. possible values were added for an export field - "status_from_rzn" ("Status from Roszdravnadzor") in the section "Export from the registry of batches";

  3. a filtering parameter - "1158_IC_Agg_115_type_realiz" ("Aggregation type") was added into the "General pricing report" section.


Attention please,

analytical reports listed below will not be available in the participant’s user account and for export by means of API methods:  

  1. Report on remaining medicines;

  2. Report on medicine disposal;

  3. Report on movement of medicines introduced into circulation;

  4. Report on remains of imported medicines before introduction into civil circulation;

  5. Report on medicine prices. 
      

If you order and apply marking codes to the medicines for medical use, Operator recommends that you use the following main mechanisms to export analytical data:

  1. General pricing report;

  2. General report on disposal;

  3. General report on movement;

  4. General report on remaining items


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