Instructions for Manufacturer (MAH, License Agent, Scientific Office)

1
Serialization Implementation User Guide
This document provides information regarding the GS1 System of Standards, its benefits for all stakeholders in the UAE pharmaceutical supply chain, and how stakeholders can become compliant with the UAE’s serialization requirement.
1
Register with GS1 to acquire a Global Location Number (GLN). GS1 contact: [email protected].
2
Update Master Data in GS1 systems:
  • Tatmeen must contain details of each partner (stakeholder) within the scope of the pharmaceutical product supply chain. Each business partner is represented in Tatmeen with unique Global Location Number (GLN). All supply chain partners in scope of Tatmeen such as Marketing Authorization Holders (MAHs), Licensed Agents, 3PLs, Warehouses, Hospitals, Pharmacies need to update their Partner Master in GS1 partner master system so it can be sent to Tatmeen. Information such as GLN, Geocoordinates, SPOC (single point of contact/administrator) for the location needs to be updated in the partner master.
  • Brand owners (Marketing Authorization Holders, Licensed Agents) also need to review and update their Product Master (registered drugs, unregistered drugs) on GS1 BrandSync system with information such as Global Trade Item Number (GTIN), MAH GLN, and Licensed Agent GLN, packing hierarchy master data, etc. After the required updates this data is sent to Tatmeen.
BrandSync
3
To use Tatmeen, users must first register with Tatmeen. Once Tatmeen receives the partner master data record, a registration email will be sent to the SPOC specified on the partner master data record. SPOC can then create and manage additional Service/Technical and Dialogue Users (Mobile/Portal users) in Tatmeen after completing registration.
  • SCP Single Point Of Contact (SPOC) - Each business partner location in the Tatmeen must have a Single-Point-of-Contact (SPOC) defined within the business partner master data. SPOC acts as an administrator for the specific business partner location (GLN) and are responsible to manage and handle users within their organization.
  • SCP Portal and Mobile - These are additional dialog users that are responsible to perform operational transactions in Tatmeen Portal and Mobile. All the dialog users for the organisation are created against the specific business partner location (GLN) that is administered by the SPOC.
  • SCP B2B Service - These are used to access predefined Tatmeen electronic Application Programming Interface (API) services. Then this user will register on Developer Portal to get API Key, which will then be used for B2B integration. (Please see Postman Collection in Next Step)

Documents

If you want to integrate with our sytem using B2B user. Use this API collection.
(CODE)

The purpose of this document is to define the technical onboarding for partners that expected to transact or connect electronically with the Tatmeen traceability system supporting the MoHAP regulations.
These instructions and guidelines are the first draft of this technical guide, and it is expected that additional content will be added in future versions of this document, as appropriate.
(Download in English)

The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by supply chain participants for the following processes:

  1. Importation to UAE
    1. Registered drugs
    2. Unregistered drugs
  2. Domestic Manufacturing for UAE

These processes are the first draft of this technical guide, and it is expected that additional processes (e.g., the process for importation of unregistered drugs) will be added in future versions of this document, as appropriate.

(Download in English)

The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by logistics supply chain participants involved in the movement of medical products for the following processes:

  1. Importation Into UAE: Initial Receipt of Goods for import clearance and customs release
  2. Sampling for Import Clearance and Customs Release / Market Release
  3. Domestic Manufacturing for UAE, staging for release
  4. Product transfer between stock holding owners and locations within the UAE
  5. Product hierarchy update within the UAE
  6. Product status update within the UAE
  7. Export of product from the UAE
  8. Destruction of product within the UAE

These processes are the first draft of this technical guide and it is expected that additional processes will be added in future versions of this document, as appropriate.

(Download in English)

This document is a presentation for the Onboarding of MAH, Licensed Agents and 3PLs.

(Download in English)

Technical Workshops

Tatmeen Onboarding Event (MAH, LA, 3PL)

Training Manuals & Videos

For Tatmeen Product master data and Partner master data are in scope. Master data refers to the characteristics and attributes of an object such as GTIN, product description, unit of measure, partner address, etc.

Product owners (MAHs, Licensed Agents) need to add their products in relevant MoHAP systems. All the supply chain entities that are part of Tatmeen scope such as MAH, Licensed Agent, Distributors, 3PLs, Hospital, Warehouse, and Pharmacy are responsible for registering their partner master data in the relevant MoHAP systems. MoHAP systems send all required product and partner master data to BrandSync GS1 where additional master data attributes are entered. BrandSync GS1 then makes this data available to Tatmeen.

(Download in English)

To access Tatmeen, the user must first register in Tatmeen. For supply chain partners the process start with defining the SPOC in the partner master data in BrandSync. Once SPOC is registered in Tatmeen, he/she can create additional Portal and mobile users and Service (B2B) users.

(Download in English) | (Watch in English)New

In addition to using APIs (B2B connectivity), Tatmeen portal can also be used to share Commissioning and Aggregation events using File Upload functionality. Using this feature, authorized users (MAH / Licensed Agent) will be able to upload a CSV file, containing commissioning and aggregation events.

(Download in English) | (Watch in English)New

Mobile commissioning functionality will be available for MAH or Licensed Agents to manually commission a SGTIN for a product they’re authorized to manufacture and/or import. This functionality is to be used by entities that due to small product volumes or technical capabilities is not in position to report commissioning events via the B2B API as described in the Technical Guide for Manufacturers. Please consider that this functionality will only commission the product, but it will still be necessary to pack it using the Hierarchy Change -> Pack functionality of Tatmeen.

Supply Chain actors that don’t have the capability to generate SSCC themselves, will have option in Tatmeen to generate/request new SSCC codes (Serial Shipping Container Codes) and print SSCC labels for logistics unit.

(Download in English) | (Watch in English - SSCC Request)New | (Watch in English - Mobile Commissioning)New

Hierarchy Change indicates a change in packaging as the goods move through the distribution process and it involves Pack, Unpack, Unpack all transactions.

(Download in English) | (Watch in English)New

Each serialized item (SGTIN/SSCC) that is currently registered into Tatmeen is given a status. From the initial status of “Commissioned”, this value will be changed as the product moves through the supply chain until it is finally dispensed.

(Download in English)

The Product Transfer functionality refers to the movement of a product from its current location to a new location. All Supply Chain entities can perform product transfer and must report product transfer events. Product transfer involves Shipping, Receiving, Return Shipping, Return Receiving transactions.

(Download in English)

The status and detailed information of any serialized item can be checked at any time using Product Verification functionality. Based on a user's security level users will be able to see:

  • Product Verification – The user will be able to see basic information about serialized/aggregated items and aggregation hierarchy if any exists.
  • Product verification with a journey – The user will be able to see basic information about serialized/aggregated items and the aggregation hierarchy if any exists. The User will also have access to the detailed journey of the products, status changes, users and locations where the status changes happened, and movements between different GLN locations.
(Download in English)

Message Log functionality will show the users details about the operations performed by them within Tatmeen. Successful processing of events such as product transfer documents and product status updates will be shown immediately. The outcome of other events such as EPCIS uploads will be available once their processing has been completed. To access the Message Log, select Message Log in the navigation menu in the Portal or Mobile to access the message log.

(Download in English)

The Batch Recall functionality is used for managing the recall of product batches deemed unsuitable throughout the supply chain. The Batch Recall process has three steps:

  • Batch recall initiation
  • Batch recall initiation approval (or rejection) by MoHAP
  • Batch recall completion

The batch recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the batch are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiating entity once the process is completed. After completion, all items related to that batch are decommissioned in Tatmeen.

(Download in English)

The Product Recall functionality is used to manage the recall of products deemed unsuitable. The Product Recall process has three steps:

  • Product recall initiation
  • Product recall initiation approval (or rejection) by MoHAP
  • Product recall completion

The product recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the product are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiation entity once the process is completed. After completion, all items related to that product are decommissioned in Tatmeen.

(Download in English)

The destruction functionality is used to manage the destruction of products deemed unsuitable in the UAE supply chain. Destruction has three steps:

  • Destruction initiation
  • Destruction initiation approval (or rejection) by MoHAP
  • Destruction completion

Destruction is first initiated by a supply chain entity. After destruction is initiated, all items are blocked from any transfer and dispensation. After completion of destruction, all items are decommissioned.

(Download in English)

Test Execution

This document provides information regarding the test scenarios, which are required for the onboarding of B2B.

(Download in English)

This document is a template, which will be filled by the partner after executing the test scenarios result. This is a prerequisite step for partners for the onboarding of B2B.

(Download in English)

FAQ(s)

Instructions for Distributor (3PL, Warehouse, Wholesaler)

1
Serialization Implementation User Guide
This document provides information regarding the GS1 System of Standards, its benefits for all stakeholders in the UAE pharmaceutical supply chain, and how stakeholders can become compliant with the UAE’s serialization requirement.
1
Register with GS1 to acquire a Global Location Number (GLN). GS1 contact: [email protected].
2
Update Master Data in GS1 systems:
  • Tatmeen must contain details of each partner (stakeholder) within the scope of the pharmaceutical product supply chain. Each business partner is represented in Tatmeen with unique Global Location Number (GLN). All supply chain partners in scope of Tatmeen such as Marketing Authorization Holders (MAHs), Licensed Agents, 3PLs, Warehouses, Hospitals, Pharmacies need to update their Partner Master in GS1 partner master system so it can be sent to Tatmeen. Information such as GLN, Geocoordinates, SPOC (single point of contact/administrator) for the location needs to be updated in the partner master.
  • Brand owners (Marketing Authorization Holders, Licensed Agents) also need to review and update their Product Master (registered drugs, unregistered drugs) on GS1 BrandSync system with information such as Global Trade Item Number (GTIN), MAH GLN, and Licensed Agent GLN, packing hierarchy master data, etc. After the required updates this data is sent to Tatmeen.
BrandSync
3
To use Tatmeen, users must first register with Tatmeen. Once Tatmeen receives the partner master data record, a registration email will be sent to the SPOC specified on the partner master data record. SPOC can then create and manage additional Service/Technical and Dialogue Users (Mobile/Portal users) in Tatmeen after completing registration.
  • SCP Single Point Of Contact (SPOC) - Each business partner location in the Tatmeen must have a Single-Point-of-Contact (SPOC) defined within the business partner master data. SPOC acts as an administrator for the specific business partner location (GLN) and are responsible to manage and handle users within their organization.
  • SCP Portal and Mobile - These are additional dialog users that are responsible to perform operational transactions in Tatmeen Portal and Mobile. All the dialog users for the organisation are created against the specific business partner location (GLN) that is administered by the SPOC.
  • SCP B2B Service - These are used to access predefined Tatmeen electronic Application Programming Interface (API) services. Then this user will register on Developer Portal to get API Key, which will then be used for B2B integration. (Please see Postman Collection in Next Step)

Documents

If you want to integrate with our sytem using B2B user. Use this API collection.
(CODE)

The purpose of this document is to define the technical onboarding for partners that expected to transact or connect electronically with the Tatmeen traceability system supporting the MoHAP regulations.
These instructions and guidelines are the first draft of this technical guide, and it is expected that additional content will be added in future versions of this document, as appropriate.
(Download in English)

The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by logistics supply chain participants involved in the movement of medical products for the following processes:

  1. Importation Into UAE: Initial Receipt of Goods for import clearance and customs release
  2. Sampling for Import Clearance and Customs Release / Market Release
  3. Domestic Manufacturing for UAE, staging for release
  4. Product transfer between stock holding owners and locations within the UAE
  5. Product hierarchy update within the UAE
  6. Product status update within the UAE
  7. Export of product from the UAE
  8. Destruction of product within the UAE

These processes are the first draft of this technical guide and it is expected that additional processes will be added in future versions of this document, as appropriate.

(Download in English)

This document is a presentation for the Onboarding of MAH, Licensed Agents and 3PLs.

(Download in English)

Technical Workshops

Tatmeen Onboarding Event (MAH, LA, 3PL)

Tatmeen Technical Workshop for Distributors

Training Manuals & Videos

For Tatmeen Product master data and Partner master data are in scope. Master data refers to the characteristics and attributes of an object such as GTIN, product description, unit of measure, partner address, etc.

Product owners (MAHs, Licensed Agents) need to add their products in relevant MoHAP systems. All the supply chain entities that are part of Tatmeen scope such as MAH, Licensed Agent, Distributors, 3PLs, Hospital, Warehouse, and Pharmacy are responsible for registering their partner master data in the relevant MoHAP systems. MoHAP systems send all required product and partner master data to BrandSync GS1 where additional master data attributes are entered. BrandSync GS1 then makes this data available to Tatmeen.

(Download in English)

To access Tatmeen, the user must first register in Tatmeen. For supply chain partners the process start with defining the SPOC in the partner master data in BrandSync. Once SPOC is registered in Tatmeen, he/she can create additional Portal and mobile users and Service (B2B) users.

(Download in English) | (Watch in English)New

Hierarchy Change indicates a change in packaging as the goods move through the distribution process and it involves Pack, Unpack, Unpack all transactions.

(Download in English) | (Watch in English)New

TSupply Chain actors that don’t have the capability to generate SSCC themselves, will have option in Tatmeen to generate/request new SSCC codes (Serial Shipping Container Codes) and print SSCC labels for logistics unit.

(Watch in English)New

Each serialized item (SGTIN/SSCC) that is currently registered into Tatmeen is given a status. From the initial status of “Commissioned”, this value will be changed as the product moves through the supply chain until it is finally dispensed.

(Download in English)

The Product Transfer functionality refers to the movement of a product from its current location to a new location. All Supply Chain entities can perform product transfer and must report product transfer events. Product transfer involves Shipping, Receiving, Return Shipping, Return Receiving transactions.

(Download in English)

The status and detailed information of any serialized item can be checked at any time using Product Verification functionality. Based on a user's security level users will be able to see:

  • Product Verification – The user will be able to see basic information about serialized/aggregated items and aggregation hierarchy if any exists.
  • Product verification with a journey – The user will be able to see basic information about serialized/aggregated items and the aggregation hierarchy if any exists. The User will also have access to the detailed journey of the products, status changes, users and locations where the status changes happened, and movements between different GLN locations.
(Download in English)

Message Log functionality will show the users details about the operations performed by them within Tatmeen. Successful processing of events such as product transfer documents and product status updates will be shown immediately. The outcome of other events such as EPCIS uploads will be available once their processing has been completed. To access the Message Log, select Message Log in the navigation menu in the Portal or Mobile to access the message log.

(Download in English)

The Batch Recall functionality is used for managing the recall of product batches deemed unsuitable throughout the supply chain. The Batch Recall process has three steps:

  • Batch recall initiation
  • Batch recall initiation approval (or rejection) by MoHAP
  • Batch recall completion

The batch recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the batch are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiating entity once the process is completed. After completion, all items related to that batch are decommissioned in Tatmeen.

(Download in English)

The Product Recall functionality is used to manage the recall of products deemed unsuitable. The Product Recall process has three steps:

  • Product recall initiation
  • Product recall initiation approval (or rejection) by MoHAP
  • Product recall completion

The product recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the product are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiation entity once the process is completed. After completion, all items related to that product are decommissioned in Tatmeen.

(Download in English)

The destruction functionality is used to manage the destruction of products deemed unsuitable in the UAE supply chain. Destruction has three steps:

  • Destruction initiation
  • Destruction initiation approval (or rejection) by MoHAP
  • Destruction completion

Destruction is first initiated by a supply chain entity. After destruction is initiated, all items are blocked from any transfer and dispensation. After completion of destruction, all items are decommissioned.

(Download in English)

Test Execution

This document provides information regarding the test scenarios, which are required for the onboarding of B2B.

(Download in English)

This document is a template, which partner should use for the test scenarios (which are required for the onboarding of B2B) result.

(Download in English)

FAQ(s)

Instructions for Hospital & Pharmacy

1
Serialization Implementation User Guide
This document provides information regarding the GS1 System of Standards, its benefits for all stakeholders in the UAE pharmaceutical supply chain, and how stakeholders can become compliant with the UAE’s serialization requirement.
1
Register with GS1 to acquire a Global Location Number (GLN). GS1 contact: [email protected].
2
Update Master Data in GS1 systems:
  • Tatmeen must contain details of each partner (stakeholder) within the scope of the pharmaceutical product supply chain. Each business partner is represented in Tatmeen with unique Global Location Number (GLN). All supply chain partners in scope of Tatmeen such as Marketing Authorization Holders (MAHs), Licensed Agents, 3PLs, Warehouses, Hospitals, Pharmacies need to update their Partner Master in GS1 partner master system so it can be sent to Tatmeen. Information such as GLN, Geocoordinates, SPOC (single point of contact/administrator) for the location needs to be updated in the partner master.
  • Brand owners (Marketing Authorization Holders, Licensed Agents) also need to review and update their Product Master (registered drugs, unregistered drugs) on GS1 BrandSync system with information such as Global Trade Item Number (GTIN), MAH GLN, and Licensed Agent GLN, packing hierarchy master data, etc. After the required updates this data is sent to Tatmeen.
BrandSync
3
To use Tatmeen, users must first register with Tatmeen. Once Tatmeen receives the partner master data record, a registration email will be sent to the SPOC specified on the partner master data record. SPOC can then create and manage additional Service/Technical and Dialogue Users (Mobile/Portal users) in Tatmeen after completing registration.
  • SCP Single Point Of Contact (SPOC) - Each business partner location in the Tatmeen must have a Single-Point-of-Contact (SPOC) defined within the business partner master data. SPOC acts as an administrator for the specific business partner location (GLN) and are responsible to manage and handle users within their organization.
  • SCP Portal and Mobile - These are additional dialog users that are responsible to perform operational transactions in Tatmeen Portal and Mobile. All the dialog users for the organisation are created against the specific business partner location (GLN) that is administered by the SPOC.
  • SCP B2B Service - These are used to access predefined Tatmeen electronic Application Programming Interface (API) services. Then this user will register on Developer Portal to get API Key, which will then be used for B2B integration. (Please see Postman Collection in Next Step)

Documents

If you want to integrate with our sytem using B2B user. Use this API collection.
(CODE)

The purpose of this document is to define the technical onboarding for partners that expected to transact or connect electronically with the Tatmeen traceability system supporting the MoHAP regulations.
These instructions and guidelines are the first draft of this technical guide, and it is expected that additional content will be added in future versions of this document, as appropriate.
(Download in English)

The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by logistics supply chain participants involved in the movement of medical products for the following processes:

  1. Importation Into UAE: Initial Receipt of Goods for import clearance and customs release
  2. Sampling for Import Clearance and Customs Release / Market Release
  3. Domestic Manufacturing for UAE, staging for release
  4. Product transfer between stock holding owners and locations within the UAE
  5. Product hierarchy update within the UAE
  6. Product status update within the UAE
  7. Export of product from the UAE
  8. Destruction of product within the UAE

These processes are the first draft of this technical guide and it is expected that additional processes will be added in future versions of this document, as appropriate.

(Download in English)

The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by dispensing participants such as pharmacies, hospitals, and clinics for the following process:

  1. Dispensing medical products within the UAE
(Download in English)

The purpose of this document is to define the information regarding the onboarding process of medical stores

(Download in English)

Technical Workshops

Tatmeen Technical Workshop for Hospitals

Tatmeen Technical Workshop for Pharmacies

Training Manuals & Videos

For Tatmeen Product master data and Partner master data are in scope. Master data refers to the characteristics and attributes of an object such as GTIN, product description, unit of measure, partner address, etc.

Product owners (MAHs, Licensed Agents) need to add their products in relevant MoHAP systems. All the supply chain entities that are part of Tatmeen scope such as MAH, Licensed Agent, Distributors, 3PLs, Hospital, Warehouse, and Pharmacy are responsible for registering their partner master data in the relevant MoHAP systems. MoHAP systems send all required product and partner master data to BrandSync GS1 where additional master data attributes are entered. BrandSync GS1 then makes this data available to Tatmeen.

(Download in English)

To access Tatmeen, the user must first register in Tatmeen. For supply chain partners the process start with defining the SPOC in the partner master data in BrandSync. Once SPOC is registered in Tatmeen, he/she can create additional Portal and mobile users and Service (B2B) users.

(Download in English) | (Watch in English)New

Hierarchy Change indicates a change in packaging as the goods move through the distribution process and it involves Pack, Unpack, Unpack all transactions.

(Download in English) | (Watch in English)New

Each serialized item (SGTIN/SSCC) that is currently registered into Tatmeen is given a status. From the initial status of “Commissioned”, this value will be changed as the product moves through the supply chain until it is finally dispensed.

(Download in English)

Supply Chain actors that don’t have the capability to generate SSCC themselves, will have option in Tatmeen to generate/request new SSCC codes (Serial Shipping Container Codes) and print SSCC labels for logistics unit.

(Watch in English)New

The Product Transfer functionality refers to the movement of a product from its current location to a new location. All Supply Chain entities can perform product transfer and must report product transfer events. Product transfer involves Shipping, Receiving, Return Shipping, Return Receiving transactions.

(Download in English)

Pharmacies, hospitals, and clinics, among others, where drugs are dispensed, are required to capture an exit event - dispensing.

The dispensing process starts with providing a list of the item(s) intended to be dispensed within Tatmeen.

The state of the serialized products, in order to be successfully dispensed, can only be “Commissioned”. Products that are decommissioned for any reason, for instance, expired products, won’t be allowed to be dispensed.

(Download in English) | (Watch in English)New

The status and detailed information of any serialized item can be checked at any time using Product Verification functionality. Based on a user's security level users will be able to see:

  • Product Verification – The user will be able to see basic information about serialized/aggregated items and aggregation hierarchy if any exists.
  • Product verification with a journey – The user will be able to see basic information about serialized/aggregated items and the aggregation hierarchy if any exists. The User will also have access to the detailed journey of the products, status changes, users and locations where the status changes happened, and movements between different GLN locations.
(Download in English)

Message Log functionality will show the users details about the operations performed by them within Tatmeen. Successful processing of events such as product transfer documents and product status updates will be shown immediately. The outcome of other events such as EPCIS uploads will be available once their processing has been completed. To access the Message Log, select Message Log in the navigation menu in the Portal or Mobile to access the message log.

(Download in English)

The Batch Recall functionality is used for managing the recall of product batches deemed unsuitable throughout the supply chain. The Batch Recall process has three steps:

  • Batch recall initiation
  • Batch recall initiation approval (or rejection) by MoHAP
  • Batch recall completion

The batch recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the batch are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiating entity once the process is completed. After completion, all items related to that batch are decommissioned in Tatmeen.

(Download in English)

The Product Recall functionality is used to manage the recall of products deemed unsuitable. The Product Recall process has three steps:

  • Product recall initiation
  • Product recall initiation approval (or rejection) by MoHAP
  • Product recall completion

The product recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the product are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiation entity once the process is completed. After completion, all items related to that product are decommissioned in Tatmeen.

(Download in English)

The destruction functionality is used to manage the destruction of products deemed unsuitable in the UAE supply chain. Destruction has three steps:

  • Destruction initiation
  • Destruction initiation approval (or rejection) by MoHAP
  • Destruction completion

Destruction is first initiated by a supply chain entity. After destruction is initiated, all items are blocked from any transfer and dispensation. After completion of destruction, all items are decommissioned.

(Download in English)

Test Execution

This document provides information regarding the test scenarios, which are required for the onboarding of B2B.

(Download in English)

This document is a template, which partner should use for the test scenarios (which are required for the onboarding of B2B) result.

(Download in English)

FAQ(s)

Instructions for Government entities

1
Serialization Implementation User Guide
This document provides information regarding the GS1 System of Standards, its benefits for all stakeholders in the UAE pharmaceutical supply chain, and how stakeholders can become compliant with the UAE’s serialization requirement.
1
Register with GS1 to acquire a Global Location Number (GLN). GS1 contact: [email protected].
2
Update Master Data in GS1 systems:
  • Tatmeen must contain details of each partner (stakeholder) within the scope of the pharmaceutical product supply chain. Each business partner is represented in Tatmeen with unique Global Location Number (GLN). All supply chain partners in scope of Tatmeen such as Marketing Authorization Holders (MAHs), Licensed Agents, 3PLs, Warehouses, Hospitals, Pharmacies need to update their Partner Master in GS1 partner master system so it can be sent to Tatmeen. Information such as GLN, Geocoordinates, SPOC (single point of contact/administrator) for the location needs to be updated in the partner master.
  • Brand owners (Marketing Authorization Holders, Licensed Agents) also need to review and update their Product Master (registered drugs, unregistered drugs) on GS1 BrandSync system with information such as Global Trade Item Number (GTIN), MAH GLN, and Licensed Agent GLN, packing hierarchy master data, etc. After the required updates this data is sent to Tatmeen.
BrandSync
3
To use Tatmeen, users must first register with Tatmeen. Once Tatmeen receives the partner master data record, a registration email will be sent to the SPOC specified on the partner master data record. SPOC can then create and manage additional Service/Technical and Dialogue Users (Mobile/Portal users) in Tatmeen after completing registration.
  • SCP Single Point Of Contact (SPOC) - Each business partner location in the Tatmeen must have a Single-Point-of-Contact (SPOC) defined within the business partner master data. SPOC acts as an administrator for the specific business partner location (GLN) and are responsible to manage and handle users within their organization.
  • SCP Portal and Mobile - These are additional dialog users that are responsible to perform operational transactions in Tatmeen Portal and Mobile. All the dialog users for the organisation are created against the specific business partner location (GLN) that is administered by the SPOC.
  • SCP B2B Service - These are used to access predefined Tatmeen electronic Application Programming Interface (API) services. Then this user will register on Developer Portal to get API Key, which will then be used for B2B integration. (Please see Postman Collection in Next Step)

Documents

If you want to integrate with our sytem using B2B user. Use this API collection.
(CODE)

The purpose of this document is to define the technical onboarding for partners that expected to transact or connect electronically with the Tatmeen traceability system supporting the MoHAP regulations.
These instructions and guidelines are the first draft of this technical guide, and it is expected that additional content will be added in future versions of this document, as appropriate.
(Download in English)

The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by logistics supply chain participants involved in the movement of medical products for the following processes:

  1. Importation Into UAE: Initial Receipt of Goods for import clearance and customs release
  2. Sampling for Import Clearance and Customs Release / Market Release
  3. Domestic Manufacturing for UAE, staging for release
  4. Product transfer between stock holding owners and locations within the UAE
  5. Product hierarchy update within the UAE
  6. Product status update within the UAE
  7. Export of product from the UAE
  8. Destruction of product within the UAE

These processes are the first draft of this technical guide and it is expected that additional processes will be added in future versions of this document, as appropriate.

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The purpose of this document is to define the information that must be sent under the MoHAP regulations to the Tatmeen traceability system by dispensing participants such as pharmacies, hospitals, and clinics for the following process:

  1. Dispensing medical products within the UAE
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Training Manuals & Videos

For Tatmeen Product master data and Partner master data are in scope. Master data refers to the characteristics and attributes of an object such as GTIN, product description, unit of measure, partner address, etc.

Product owners (MAHs, Licensed Agents) need to add their products in relevant MoHAP systems. All the supply chain entities that are part of Tatmeen scope such as MAH, Licensed Agent, Distributors, 3PLs, Hospital, Warehouse, and Pharmacy are responsible for registering their partner master data in the relevant MoHAP systems. MoHAP systems send all required product and partner master data to BrandSync GS1 where additional master data attributes are entered. BrandSync GS1 then makes this data available to Tatmeen.

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To access Tatmeen, the user must first register in Tatmeen. For supply chain partners the process start with defining the SPOC in the partner master data in BrandSync. Once SPOC is registered in Tatmeen, he/she can create additional Portal and mobile users and Service (B2B) users.

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All the products in scope of Tatmeen must be product cleared. In essence, for imported product, each shipment must have a valid shipment import permit (SHP), and follow the import process which consists of three steps:

  • Import Clearance, performed by the MoHAP Customs.
  • Custom Release, performed by Federal Customs.
  • Market Release, performed by MoHAP Empowerment.

Once the product is market released, it can be freely moved through the UAE supply. For products manufactured inside UAE, the shipment must have a valid local sales permit (LSP), and follow the Market Release process.

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Hierarchy Change indicates a change in packaging as the goods move through the distribution process and it involves Pack, Unpack, Unpack all transactions.

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Supply Chain actors that don’t have the capability to generate SSCC themselves, will have option in Tatmeen to generate/request new SSCC codes (Serial Shipping Container Codes) and print SSCC labels for logistics unit.

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Each serialized item (SGTIN/SSCC) that is currently registered into Tatmeen is given a status. From the initial status of “Commissioned”, this value will be changed as the product moves through the supply chain until it is finally dispensed.

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The Product Transfer functionality refers to the movement of a product from its current location to a new location. All Supply Chain entities can perform product transfer and must report product transfer events. Product transfer involves Shipping, Receiving, Return Shipping, Return Receiving transactions.

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The status and detailed information of any serialized item can be checked at any time using Product Verification functionality. Based on a user's security level users will be able to see:

  • Product Verification – The user will be able to see basic information about serialized/aggregated items and aggregation hierarchy if any exists.
  • Product verification with a journey – The user will be able to see basic information about serialized/aggregated items and the aggregation hierarchy if any exists. The User will also have access to the detailed journey of the products, status changes, users and locations where the status changes happened, and movements between different GLN locations.
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Message Log functionality will show the users details about the operations performed by them within Tatmeen. Successful processing of events such as product transfer documents and product status updates will be shown immediately. The outcome of other events such as EPCIS uploads will be available once their processing has been completed. To access the Message Log, select Message Log in the navigation menu in the Portal or Mobile to access the message log.

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The Batch Recall functionality is used for managing the recall of product batches deemed unsuitable throughout the supply chain. The Batch Recall process has three steps:

  • Batch recall initiation
  • Batch recall initiation approval (or rejection) by MoHAP
  • Batch recall completion

The batch recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the batch are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiating entity once the process is completed. After completion, all items related to that batch are decommissioned in Tatmeen.

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The Product Recall functionality is used to manage the recall of products deemed unsuitable. The Product Recall process has three steps:

  • Product recall initiation
  • Product recall initiation approval (or rejection) by MoHAP
  • Product recall completion

The product recall is first initiated by the MAH/Scientific Office/Licensed Agents or by MOHAP Drug Dept – Pharma-Co-vigilance/DOH Pharma-Co-vigilance/DHA Pharma-Co-vigilance.

After initiation, the recall must be approved by MoHAP PV. Once approved, all items of the product are blocked from dispensation, but transfer is still allowed.

As the last step, the recall is marked as completed by the initiation entity once the process is completed. After completion, all items related to that product are decommissioned in Tatmeen.

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The destruction functionality is used to manage the destruction of products deemed unsuitable in the UAE supply chain. Destruction has three steps:

  • Destruction initiation
  • Destruction initiation approval (or rejection) by MoHAP
  • Destruction completion

Destruction is first initiated by a supply chain entity. After destruction is initiated, all items are blocked from any transfer and dispensation. After completion of destruction, all items are decommissioned.

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Test Execution

This document provides information regarding the test scenarios, which are required for the onboarding of B2B.

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This document is a template, which partner should use for the test scenarios (which are required for the onboarding of B2B) result.

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FAQ(s)

Tatmeen mobile applications are available on the App Store (IOS) and Google Play (Android). Please click on the respective store button to download

Staging Applications
Production Applications

We have tested our applications on these additional devices