How does delegation work?

13 июля 2024 15:34

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 that 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 Honest Mark labeling system for medicines.

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 the 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.

Functionality description

You can adjust the delegation in the "Administration - Control of access to medicines reports" section.

Please note that MANAGE_ACCESS_REPORT – "Control of access to medicines reports" right is required to use delegation.

The delegation is intended for issuers and participants that have obtained the rights to manage GTIN/GTIN+Batch.

Rights to the reports are delegated as follows:

1. By providing rights to view reports in terms of "GTIN"/"GTIN and Batch":

a. A participant that has delegated a right, and a participant that has received the right, will be able to generate reports.

b. A participant that has delegated a right, may revoke the right.

c. A participant that has received the right, may waive the right.

2. By providing rights to manage reports in terms of "GTIN"/"GTIN and Batch":

a. A participant that has delegated a right, will not be able to generate reports (only a participant that has received a management right, will be able to manage the reports).

b. A participant that has received the right, may waive the right to manage reports.

c. A participant that has delegated a right, cannot revoke the right to manage the reports (to revoke the right, a participant that delegated the right, must contact Technical Support Service).

2 tabs were implemented in the "Control of access to medicines reports" section:

  1. "Issued rights". The tab displays a table with a list of all rights which have been issued by a participant authorized in the system to other participants.

  2. "Obtained rights". The tab displays a table with a list of all rights which have been received by a participant authorized in the system from other participants.

The "Add right" button has been implemented on the "Issued rights" tab. Clicking on the button will open a modal window with steps to fill in parameters to delegate rights.

Step 1

Enter "INN" of the circulation participant to which a right will be delegated.

Step 2

Fill in one of the following values:

  • "MA No.";

  • "GTIN";

  • "Batch";

  • Select a delegation type by selecting the checkbox "Refuse to view the reports on specified "GTIN", "GTIN+Batch"".

One of the mandatory fields must be filled in: "MA No." or "GTIN".

Rules for filling the fields:

  • If the "GTIN" field is not filled in, the "MA No." field is mandatory. If the "GTIN" field is filled in, the "MA No." field is blocked. If the "MA No." field has been filled in, in Step 3 all GTINs included in the specified "MA No." for which a participant is the issuer or for which a participant has the rights to manage and for which the participant has not previously transferred the right to anyone else, will be displayed.

  • If the "MA No." field is not filled in, the "GTIN" field is mandatory. If the "MA No." field is filled in, the "GTIN" field is blocked. The "GTIN" field has an input mask of 14 characters.

  • If the "GTIN" field is filled in, you can enter a value into the "Batch" field. The "Batch" field is optional.

The "Refuse to view the reports on specified "GTIN", "GTIN+Batch"" checkbox is required to select a type of delegation:

  1. Delegation of the right to view;

  2. Delegation of the right to manage.

By default, the checkbox is not selected. When you select a checkbox, the following notification will be displayed in Step 3: "Please note that after saving the changes, the possibility of forming a report and information on the rights will be unavailable (except for this record of delegation). Ability to manage and previously issued rights will be transferred to the organization specified".

Step 3

Check the data specified in Step 1 and Step 2:

1. "Organization name" – a name of the organization which corresponds to "INN" specified in Step 1.

a. If the "INN" specified is not found in the MDLP FGIS, an error will be displayed.

2. "GTIN" or "GTIN + Batch" – data that have passed the system checks and are available for delegation to the organization specified.
 System checks for delegation:

a. A participant that delegates the right is the issuer of the specified data and has not previously delegated a right to manage these data to other participants.

b. A participant that delegates the right is not the issuer of the specified data, but this participant has the rights to manage these data, the participant has sent a scheme on introduction into civil circulation for the specified data and the participant has not previously delegated the right to manage these data to another participant.

Check result:

If all system checks have been passed and the data are correctly indicated, save the changes.

If at least one system check is not passed during the delegation for "GTIN"/"GTIN+Batch", the corresponding errors will be displayed.

If in case of delegation for "MA No."(by GTIN group), one part of GTINs being part of the "MA No." has passed the system checks, and another part of GTINs being part of the "MA No." has failed the system checks, the errors will be displayed for the GTINs that have not passed the system check. And the right can be delegated only for those GTINs that have passed system check. A list of such GTINs will be displayed in the system check results in Step 3.

The delegated previously rights to view can be extended or narrowed. For example, first delegate a right to view for "GTIN+Batch", and then delegate a right to view for "GTIN" to the same participant. This will result in extending the rights to view data

Previously delegated rights to manage cannot be extended or revoked. For example, if the right to manage has been delegated for "GTIN", further attempt to delegate the right to manage for "GTIN+Batch" will result in error.

Use of obtained rights

Once the rights to view/manage have been received for "GTIN"/"GTIN+Batch", a participant can generate the analytical reports in the user account.

Delegation is applied in respect of the following analytical reports:

  1. "General report on remaining items";

  2. "General report on disposal";

  3. "General report on movement";

  4. "General pricing report".

Delegation also applies to "SGTIN tracking" and "SGTIN archive" in the "Products" section.

Remove rights to view reports

After a participant has delegated the rights to view, the participant that issued the rights, can remove them. To do this, in the section "Administration - Control of access to medicines reports - Issued rights", find a string with the rights, click the "Remove right" button and confirm the action in the opened modal window. A record telling that a right to view "GTIN"/"GTIN+Batch" has been previously added, will become inactive. This record will be unavailable in the "Issued rights" and "Obtained rights" tabs.

After delegation of the rights to view, a participant that has received the rights, may waive them. To do this, in the section "Administration - Control of access to medicines reports - Obtained rights", find a string with the rights, click the "Remove right" button and confirm the action in the opened modal window. A record telling that a right to view "GTIN"/"GTIN+Batch" has been previously added, will become inactive. This record will be unavailable in the "Issued rights" and "Obtained rights" tabs.

Remove rights to manage reports

After a participant has delegated the rights to manage, the participant that issued the rights, cannot remove them. To remove a right to manage, a participant that issued the right, shall contact to the Technical Support Service.

After delegation of the rights to manage, a participant that has received the rights, may waive them. To do this, in the section "Administration - Control of access to medicines reports - Obtained rights", find a string with the rights, click the "Remove right" button and confirm the action in the opened modal window. A record telling that a right to view "GTIN"/"GTIN+Batch" has been previously added, will become inactive. The participants will not see this record in the "Issued rights" and "Obtained rights" tabs. The rights to manage for "GTIN"/"GTIN+Batch" will be returned to the participant that has previously delegated them.

Please note that Instruction on how to use delegation can be found in the participant’s UA in the "Help" section.

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