- Подготовка производственной площадки к маркировке
- Сроки внедрения маркировки для производителей: что нужно знать малым, средним и крупным?
- Оборудование для маркировки: какое нужно и что пригодится из того, что у вас уже есть?
- Состав кода маркировки молочной продукции
How to work with instructions for medicines in the Participant’s UA
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 that are issuers of the identification means or are marketing authorization holders/owners that have registered the medicines in the marking system user account, to upload instructions and medicine package images to the Honest Mark labeling system for medicines. 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 marking system API methods and via the participant’s UA.
Functionality description
To work with instructions and images, go to the section "Medicines - Registry of instructions and images". The registry displays all containers with instructions and images that have been created by an issuer (Figure 1). The issuer can see containers of his/her organization only.
In this registry, you can:
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Create a container;
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Change a container;
-
Send for moderation;
-
Download a container;
-
View all containers.
Figure 1 Display of medicine instruction registry
Container composition
Each container may have:
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Container name;
-
JSON instruction;
-
PDF instruction;
-
Medicine package image.
Container status model:
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"Draft" - this status is assigned to all created containers by default;
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"Currently being moderated" - a container with this status is sent for moderation;
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"Confirmed" - means that a container has been checked. Information on an instruction and medicine package images will be displayed in Chestny ZNAK app;
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"Rejected" - moderation has not been passed, a participant shall correct the container composition.
Container creation
To create a container, click the "Create container" button (Figure 2).
Figure 2 Display of button to create a container
Clicking the "Create container" button will open the "Creating a container" modal window (Figure 3, Figure 4).
Figure 3 Display of parameters to create a container - fields are not filled with data
Figure 4 Display of parameters to create a container - fields are filled in
Parameters in the window of creating a container:
|
|
Parameter name |
Description |
|---|---|---|
|
1 |
Container name |
A container name in any form. The container name is not checked for uniqueness. Maximum number of characters to enter - 64. Mandatory parameter. |
|
2 |
JSON instruction |
There are two ways to fill out JSON instruction:
When adding a JSON file, data from a file attached by a participant are distributed between form fields in line with mapping. Data that do not correspond to the mapping, are not transferred to the form. If uploaded file does not correspond to JSON or the system fails to recognize any parameter from the file, the following error will be displayed: "File upload failed. Please check if the format of uploaded file is JSON" Mandatory parameter. |
|
3 |
PDF instruction |
Maximum file size - 5 MB. Optional parameter. |
|
4 |
Medicine package image |
Maximum number of attachments: 5 images. A size of one file — no larger than 2 MB. Optional parameter. |
Mapping of parameters from JSON file to form fields
|
|
JSON parameter |
Field on form |
Data requirements |
|---|---|---|---|
|
1 |
regNum |
Number of marketing authorization |
Maximum number of characters to enter - 50 At least one non-space character must be filled in. Mandatory field |
|
2 |
regDate |
Date of medicine state registration |
Date format: DD.MM.YYYY Mandatory field |
|
3 |
regHolder |
Marketing Authorization Holder |
Maximum number of characters to enter - 500 At least one non-space character must be filled in. Mandatory field |
|
4 |
tradeName |
Trade name |
Maximum number of characters to enter - 500 At least one non-space character must be filled in. Mandatory field |
|
5 |
prodFormName |
Dosage form |
Maximum number of characters to enter - 500 At least one non-space character must be filled in. Mandatory field |
|
6 |
mnn |
Active substance |
Maximum number of characters to enter - 500 At least one non-space character must be filled in. Mandatory field |
|
7 |
composition |
Composition |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
8 |
description |
Description of appearance of the medicine for medical use |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
9 |
physicochemicalCharacteristics |
Physical and chemical properties (for radiopharmaceuticals) |
Maximum number of characters to enter - 4,000 Optional field |
|
10 |
pharmacotherapeuticGroup |
Pharmacotherapeutic group |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
11 |
Object pharmacologicalProperties parameter pharmacodynamics |
Pharmacological properties → Pharmacodynamics |
Maximum number of characters to enter - 4,000. Mandatory field. At least one non-space character must be filled in. |
|
12 |
Object pharmacologicalProperties parameter pharmacokinetics |
Pharmacological properties → Pharmacokinetics |
Maximum number of characters to enter - 4,000. Mandatory field. At least one non-space character must be filled in. |
|
13 |
indicationsForUse |
Indications for use |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
14 |
contraIndication |
Contra indications |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
15 |
withCare |
With caution |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
16 |
useDuringPregnancy |
Use during pregnancy and lactation |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
17 |
dosage |
Dosage and administration |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
18 |
sideEffects |
Side effects |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
19 |
overDosage |
Overdose |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
20 |
interaction |
Interaction with other medicines |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
21 |
releaseForm |
Release form |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
22 |
Object specialInstruction parameter specialPatientGroups |
Special warnings → Special patient groups |
Maximum number of characters to enter - 4,000 Optional field |
|
23 |
Object specialInstruction parameter disposalInstructions |
Special warnings → Disposal instruction |
Optional field |
|
24 |
doctorsActions |
Description (if necessary) of actions of doctor (physician assistant) and (or) patient when skipping receiving one or more doses of the medicine for medical use |
Maximum number of characters to enter - 4,000 Optional field |
|
25 |
effectsOnAbilityDriveVehicles |
Effects of the medicine on ability to drive and use machines |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
26 |
expirationInterval |
Expiration date |
Maximum number of characters to enter - 500 At least one non-space character must be filled in. Mandatory field |
|
27 |
storageCondition |
Storage conditions |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
28 |
storageConditionOutChildren |
Indication to store medicines for medical use out of reach of children |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
29 |
precautionsDestruction |
Indication (if necessary) of special precautions for the disposal of unused medicines for medical use |
Maximum number of characters to enter - 4,000 Optional field |
|
30 |
pharmDelivery |
Conditions of sale in pharmacies |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
31 |
manufacturer |
Manufacturer |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
|
32 |
support |
Support service |
Maximum number of characters to enter - 4,000 At least one non-space character must be filled in. Mandatory field |
Editing a container
To edit a container, click the "Edit container" button (Figure 5).
Figure 5 Display of button to edit a container
Clicking the "Edit container" button will open a modal window to edit container data (Figure 6).
Figure 6 Editing a container content
Parameters in the window of editing a container:
|
|
Parameter name |
Description |
|---|---|---|
|
1 |
Container name |
A container name in any form. The container name is not checked for uniqueness. Maximum number of characters to enter - 64. Mandatory parameter. |
|
2 |
JSON instruction |
There are two ways to fill out JSON instruction:
When adding a JSON file, data from a file attached by a participant are distributed by form fields in line with mapping. Data that do not correspond to the mapping, are not transferred to the form. If uploaded file does not correspond to JSON or the system fails to recognize any parameter from the file, the following error will be displayed: "File upload failed. Please check if the format of uploaded file is JSON" Mandatory parameter. A procedure for mapping of parameters from JSON file to form fields is the same as when creating a container - see clause "Creating a container - Mapping of parameters from JSON file to form fields" |
|
3 |
PDF instruction |
Maximum file size - 5 MB. Optional parameter. |
|
4 |
|
Maximum number of attachments: 5 images. A size of one file — no larger than 2 MB. Optional parameter. |
Containers can be edited if they have one of the statuses: “Draft”, “Confirmed”, “Rejected”. After editing, a container will have the "Draft” status.
Data of the container will be replaced with values specified in the form:
-
The old value will be updated if there is a new correct value.
-
The old value will be deleted if there is no new value.
All created containers shall pass the moderation on the part of Operator-CRPT.
Please note that JSON instruction can be downloaded in advance in the registry of instructions and images and upload again when editing
Sending for moderation
You can send for moderation the containers that have the "Draft" status. To send a container for moderation, click the "Send for moderation" button (Figure 7).
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The button will be available if at least one container has been selected by using checkboxes in the registry.
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You can select several checkboxes.
Figure 7 Sending a container for moderation
When clicking the "Send for moderation" button, the "Confirm sending for moderation" modal window will be opened to confirm your action. After confirming the action, all the containers sent for moderation will change their status to "Being moderated".
After moderation, the containers change their status to "Confirmed" or "Rejected" with an indication of a rejection reason.
-
The containers which have received the "Confirmed" status, are transferred to the mobile app and are displayed there.
-
The containers which have received the "Rejected" status, can be edited and re-sent for moderation.
Please note that MANAGE_CONTAINERS - "Managing instructions and images" right is required to work with the Registry.
Downloading a container
To download a container, click the "Download instructions and images" icon (Figure 8).
Figure 8 Display of button to download a container content
Container data are downloaded as an archive.
Setting the connection of a container with a medicine and batch
To set up connection with a medicine, go to the "Medicines" section, "Registry of medicines" and click the "Default container" button (Figure 9).
Figure 9 Display of medicine card and "Default container" button
Clicking the button will open the "GTIN settings" modal window to create a connection between a container and GTIN (Figure 10).
You need to fill in the following parameters in the modal window:
-
Default container ID - a drop-down list with all containers that have been created by the participant;
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Checkbox ""Default container" is used for the batches that do not have an assigned container identifier".
Figure 10 Setting connection between a container and medicine (GTIN)
One container can be specified as a default container for several GTINs.
If the default container is selected for the GTIN, a connection with this container will be automatically created for all new batches within this GTIN.
There is no automatic creation of the connection with a container for all old batches of GTIN. But if the checkbox has been selected, a container that is specified for the GTIN as a default container, will be displayed for old batch in the mobile app.
To set up connection with a batch, go to the "Medicines" section, "Registry of batches" and click the "Edit connection" button (Figure 11).
Figure 11 Display of batch card and "Edit connection" button
Clicking the "Edit connection" button will open the "Connection editing" modal window to edit connection of a batch and container (Figure 12).
You need to fill in the "Container ID" parameter in the modal window.
Figure 12 Setting connection between a container and Batch
Viewing a container in the medicine card
In the medicine card, in the registry of medicines, you can see:
-
"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.
Please note that MANAGE_CONTAINERS - "Managing instructions and images" right is required to set up the connection of a container with a medicine and batch.
