Release 4.62.0 MDLP July 20, 2024

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

Installed on the Sandbox test environment: 16.07.2024

Installed on the production environment: 20.07.2024

XSD-schemes version: 1.38

Modifications

Movement of medicines to quarantine area by using document 552

To support a process of movement of the medicines to quarantine area, a new type of withdrawal from circulation (withdrawal_type) was added into document 552 “Registration in MDLP IS of information on withdrawal of medicines from circulation for various reasons”:

• 27 — movement to quarantine area.

Movement to a quarantine area is available for the SGTINs that have the following statuses:

• “In circulation” (in_circulation);

• “Partially sold at retail” (in_partial_sale);

• “Partially released by subsidized prescription” (in_partial_discount_prescription_sale);

• “Partially issued for medical use” (in_partial_medical_use);

• “Partially issued under documents” (in_partial_dispensing_by_document);

• “Partially withdrawn from circulation” (in_partial_ooc).

After the operation of movement to quarantine area, SGTIN will change its status to “Paused circulation” (paused_circulation).

An operation of return into circulation by means of document 391 “Registration in MDLP IS of information on re-introduction of medicine into circulation” will be available for SGTINs of proper quality. To return such SGTINs, the following new possible value of the reason of withdrawal from circulation (withdrawal_reason) was added into document 391:

• 15 — withdrawn from circulation as a result of movement to quarantine area.

However, if from the moment of movement of the medicines to quarantine a decision has been received from the state authorities to suspend circulation of the medicines, it will not be possible to return such SGTINs to circulation, error 13 — “Error of acceptance or return of paused ICMs” will be returned for them.

Destruction of medicines by manufacturer w/o assistance by means of document 552

To support a process of destruction of SGTIN by a manufacturer without assistance, a new type of withdrawal from circulation (withdrawal_type) was added into document 552 “Registration in MDLP IS of information on withdrawal of medicines from circulation for various reasons”:

• 28 — destruction w/o assistance.

Also, to support this process, the following new optional parameters were added into document 552:

• “Destruction method” (destruction_method) — possible parameter values are similar to those used in document 542 “Registration in MDLP IS of information on destruction of medicines”;

• “Reason for destruction” (reason_for_destruction) — possible parameter values are similar to those used in document 541 “Registration in MDLP IS of information on transfer of medicines for destruction”.

To register document 552 that has a type of withdrawal from circulation “Destruction w/o assistance”, the following conditions shall be observed:

• a document is submitted by a manufacturer of the SGTIN (on a business place there must be a valid license for production);

• the following parameters are transferred in the document:

° “Document registration number” (doc_num);

° “Document registration date” (doc_date);

° “Reason for destruction” (reason_for_destruction);

° “Destruction method” (destruction_method).

Destruction without assistance is available for SGTINs that have the following statuses:

• “In circulation” (in_circulation);

• “Applied” (marked);

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

• “Imported to the Russian Federation” (arrived);

• “Accepted to the warehouse from CCA” (declared_warehouse);

• “Paused circulation” (paused_circulation);

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

• “Partially sold at retail” (in_partial_sale);

• “Partially released by subsidized prescription” (in_partial_discount_prescription_sale);

• “Partially issued for medical use” (in_partial_medical_use);

• “Partially issued under documents” (in_partial_dispensing_by_document);

• “Partially withdrawn from circulation” (in_partial_ooc);

• “Declared” (declared);

• “Awaiting shipment to the Russian Federation” (released_foreign).

After the operation of destruction without assistance is performed by a manufacturer, SGTIN will change its status to “Disposed” (disposed).

Information about SGTINs destroyed without assistance will be transferred to Roszdravnadzor as part of a type of information “Information about destroyed medicines”, and parameters of destruction will be filled in as follows:

• “Address of destruction site” (АктУничтож.АдрМестоУничтож) — an address of the business place (subject_id) that is specified in document 552;

•  “Number and date of certificate of destruction” (АктУничтож.НомерАкт and АктУничтож.ДатаАкт) — doc_num and doc_date parameters taken from document 552;

• “Date of medicine destruction” (СведЛП.ДатаУничтож) — an operation date (operation_date) from document 552;

• “Method and reason of the medicine destruction” (СведЛП.СпособУничтож and СведЛП.ПричинаУничтож) — destruction_method and reason_for_destruction parameters taken from document 552;

• “Grounds for destruction” (СведЛП.ОснованиеУничтож) — by the decision of the owner;

• “Organization that has destroyed the medicine” (ОрганУничтожЛП.НаимОрг, ОрганУничтожЛП.ИННЮЛ, ОрганУничтожЛП.КПП) — an organization that owns a business place (subject_id) from document 552.

Process of return by means of document 417 has been extended

A possibility of return of the medicines directly to those who introduced medicines into circulation, has been added into document 417 “Registration in MDLP IS of information on return of suspended medicines”.

To implement this feature, the following new optional parameter was added into the document:

• “Return type” (turnover_type).

Possible parameter values:

• 2 — return;

• 3 — return to manufacturer.

If a return type is NOT specified in the document, or return type = 2 is explicitly specified — an attempt will be made during the document processing to return to the previous participant of the supply chain.

If return type = 3 is explicitly specified in the document, an attempt will be made during the document processing to return to a participant that introduced medicines into circulation.

A return to a participant that introduced into circulation, is unavailable for the SGTINs emitted in the CCA, or outside the territory of the Russian Federation (when trying to return to those who introduced such SGTINs into circulation, error 17 - “Return operation is restricted” will be returned).

Information about SSCC was added to make a decision to take into balance sheet

A new tab - “SSCC contents” was added into the form “SSCC information” on the following pages:

• “Products. SGTIN registry”;

• “Products. Registry of SGTINs emitted before 2021-03-28”;

• “Products. Display window of products by SGTIN”

The tab contains the following information about SSCC:

•  “GTIN”;

• “Batch number”;

• “Number of SGTINs in SSCC”.

SSCC_CHECK right is required to get access to the tab.

Change of certificate selection logic when signing documents

Logic of selection of certificates when signing Contractual documents has been changed in the “My documents” service.

Earlier, before signing, it was suggested to select a certificate that would be used for signing. At the moment, to sign the Contractual documents a certificate used to log into goods circulation participant’s UA is automatically selected. Before signing, you will see the basic information about the certificate which will be used for signing:

 Figure 1. Document signing

Creation of new report “Expired medicines”

A new report — “Expired medicines” is available in a user account → “Reports”.

Access to the report is available to distributors (“Medical organization” and “Pharmaceutical company” rights groups) that have a new right - EXPIRED_MEDICINES_INFORMATION (“Expired medicines”).

In this report a user can submit scheme 552/13 (“Writing off without transfer for destruction”) for displayed SGTINs (up to 5000 pcs) when clicking the button “Write off remaining items”. Based on the data from the report, an export in the * .csv format can be done.

API modifications

Method to get information about SSCC to make a decision to take into balance sheet

“Method to get information about SSCC to make a decision to take into balance sheet” method (GET /reestr/sscc/{sscc}/sscc_check) was added. The method allows to obtain the following information about SSCC:

• “GTIN”;

• “Batch number”;

• “Number of SGTINs in SSCC”.

SSCC_CHECK right is required to use the method.