Tatmeen is a Ministry of Health and Prevention digital platform that enables the tracking and tracing of all pharmaceutical products in the United Arab Emirates.
Serialisation is the application of a GS1 approved 2D Matrix barcode and human readable information onto all drug secondary packing.
Tatmeen became operational 18 months after the issuance of the Decree by the Ministry of Health for the serialization of all pharmaceuticals in the UAE, which was on December 13th, 2022
A Global Location Number (GLN) is a 13-digit code used to identify the physical locations of businesses or organizations worldwide. In Tatmeen, GLNs are used to track the location of pharmaceutical products by linking them to the serialized medicines that exist in that location.
Pharmaceutical supply chain partners are companies or organizations that collaborate to move pharmaceutical products from the manufacturer to the end consumer. These partners are responsible for ensuring that drugs and other pharmaceutical products are available to patients who need them. The primary pharmaceutical supply chain partners are: Marketing Authorization Holders (MAHs) are companies that hold the marketing authorization for a drug or other pharmaceutical product and are responsible for sending commissioning messages to Tatmeen. MAHs may have scientific offices located in the country or in a free zone. Licensed Agents are companies that have obtained a license or certification from MoHAP to import and distribute pharmaceutical products into the UAE. They are responsible for obtaining the shipping permit that will be used by MAHs for commissioning, in addition to other product transfer processes. 3PL companies store and distribute medicines, whether in the UAE mainland or in the Free Zone. They are responsible for sending shipping messages into and out of their warehouses. Dispensaries include pharmacies, hospitals, clinics, or rehabilitation centers that dispense products to final consumers (patients) and are responsible for sending dispensing messages on Tatmeen
The Tatmeen Decree applies to all supply chain participants that produce, transport, store, or dispense pharmaceutical products
As per the serialization guidelines published by the Ministry of Health and Prevention, Conventional and Biological Medicines are included in the first phase of the Tatmeen roll-out. Other product types will be included at a later stage, and the ministry will announce that as it happens
The application of 2D Matrix barcodes applies to both registered and unregistered drugs and is mandatory for all drugs imported or produced in the UAE
The Ministry of Health and Prevention published guidelines for serialization to help the industry comply with the legislation. The guidelines can be found here in English and here in Arabic
Ministry of Health and Prevention will announce the fees associated with Tatmeen at a later stage, the final decision pertaining to the fees is still pending.
Tatmeen does not require any special software, however companies that have an ERP system, or WMS system, or POS system can connect their system to Tatmeen using the business to business capability that Tatmeen provides. However, companies that do not have any of these software can still use Tatmeen using a web browser or mobile application.
Any supply chain partner can share their credentials with any external service provider (for example IT companies) to handle the connection process on Tatmeen. However, partners (MAHs, Licensed Agents, 3PL, Dispensaries) would still be responsible for all the activities that is performed using their credentials. We recommend that only the technical user credentials be shared (if required) with an external party and not the SPOC credentials
The first step in registering with Tatmeen is obtaining a GLN from GS1. Once obtained Tatmeen platform will receive the GLN details from GS1 and release the registration link to the single point of contact of that GLN who can proceed with the registration.
Yes. Registration and obtaining a unique Global Location Number is mandatory for all sites licensed to produce, store, and dispense drugs in the UAE.
Products and product information cannot be uploaded to Tatmeen directly. They need to be uploaded to Brandsync and Tatmeen will receive these details from Brandsync only.
Yes, all protocols for the registration of scientific offices, medical stores, and drugs will remain the same as they are today
The MAH can choose to use either the original manufacturer GLN or the local Scientific Office GLN. Both GLNs are acceptable
No. If the MAH has already registered the master data for products, then the Licensed Agent is not required to create these records again on BrandSync
Third Party Logistic Companies, although not registered with the ministry of health and prevention, have still to register with GS1 and obtain a GLN because they are part of the supply chain of pharmaceutical products
The Ministry of Health and Prevention is committed to supporting industry members in their transition to the Tatmeen platform. As part of this commitment, comprehensive training material and regular workshops will be provided to ensure successful implementation and use of the platform
Yes. In addition to serving as the primary source for updates and announcements related to the Tatmeen platform, the Tatmeen website will also provide industry members with access to guidelines, manuals, and informative videos to assist with onboarding to the platform.
Yes, there will be no changes to any reporting of information to those government entities you currently have to mandatorily report too.
Only licensed agents can apply for shipping permits, while local manufacturers can only apply for local sales permits. The commissioning process, performed by the MAH, requires the shipping permit reference for imported medicines or the local sales permit for locally manufactured ones. These permits can be obtained by using the MoHAP Permit Services available on www.mohap.gov.ae
Yes, if the Licensed Agent GLN is associated with the product being commissioned in the drug department master data, then either that specific licensed agent or the MAH can handle the commissioning of serial numbers
No. 3PL companies are not allowed to register products under their name in the drug registration system of the ministry of health, and therefore cannot send commissioning messages. Only the MAH or the licensed agent can send commissioning messages
No, only pharmaceutical products intended for the local UAE market need to be reported to Tatmeen. Products received in free trade zones that will be exported outside the UAE are not within Tatmeen's scope
Products need to be commissioned to Tatmeen prior to the import customs clearance into the UAE local market.
Warehouse operations must share receiving messages with Tatmeen whenever they receive goods. They must also share messages for any other activities they perform, including packing, unpacking, shipping out, sampling out, damage, and loss. For more information, please refer to the Logistics Technical Guide
Locally manufactured pharmaceutical products follow the same process as imported ones, but instead of a shipping permit, the MAH must use the local sales permit for commissioning.
Drug stores that trade in pharmaceutical products in the UAE or within a regional geographical area are required to report any movement of these products into and out of their facilities in addition to any packing/unpacking that they perform.
In such cases, MoHAP customs will reject the products, and the MAH will have to decommission the wrong serial numbers and commission the correct ones instead
Products that are sold to patients from dispensaries will have their status changed to "Decommissioned - Dispensed" and will be automatically decommissioned from Tatmeen
If these are Conventional Medicines or Biological Medicines, then yes, they have to be reported to the Tatmeen platform, except certain cases that are defined in the serialization guideline document. Please note that there are clear message types on Tatmeen for free samples
Product verification is a process used to confirm that a product is genuine and authentic. It will also show the status of the product and whether it was commissioned to Tatmeen or not, as well as any hierarchy (packaging) created for that product
The product recall process can be initiated by the MAH, Licensed Agent, or a government regulatory agency depending on the specific circumstances. In some cases, the decision to recall a product may be voluntary by the manufacturer or distributor, while in other cases it may be required by law or ordered by a government regulatory agency
SPOC refers to the Single Point of Contact nominated by the company and responsible for all activities on Tatmeen including the creation of other users. Every location whether a MAH, Licensed Agent, 3PL, or Dispensary will have one SPOC only
Mobile / Portal user (also called Dialogue user) is a username created for any human who wants to access Tatmeen, either via the portal or by mobile. B2B User (Also called Service user or technical user) is created to generate an API Key that will be used to create any B2B connectivity with Tatmeen. Support user is a user type associated with a B2B user to allow for human users to view the history log of the B2B transactions.
The SPOC user can perform all the tasks of the mobile/portal user, but it is recommended to create mobile/portal users for other users within the organization to avoid sharing the SPOC account with others. However, the SPOC cannot perform the functionalities of a B2B user, so if a B2B connectivity is to be established then the SPOC has to create at least one B2B user.
Tatmeen has an independent staging (testing) system that can be used for testing the integration and familiarizing oneself with Tatmeen's functionalities before transitioning to the production (live) system.
The type of messages that each participant must send depends on the role of that participant in the supply chain. There are four main categories of messages, and these categories might have sub-processes within the same category. These are: commissioning, aggregation, shipping, and status change
Yes, the best and most efficient way is to use B2B connectivity (API), where the MAH system can be directly connected with Tatmeen. However, if the MAH does not have the technical capability to do so, they can utilize the file upload feature available on the Tatmeen portal or opt for mobile commissioning
Yes, the commissioning message will fail if it does not contain an import permit number or local sales permit number
Commissioning and aggregation messages can be combined in one message if it’s a B2B message, but they can also be combined in one csv file if the file upload feature is used.
B2B connectivity enables businesses to electronically connect and exchange data. Tatmeen offers a B2B connectivity option for supply chain partners who want to integrate their own systems with Tatmeen to automate the process of reporting activities related to their pharmaceutical products on the Tatmeen platform
API refers to Application Programming Interface (not to be confused with Active Pharmaceutical Ingredient) API is a set of protocols, routines, and tools used by software applications to communicate with each other
Once the SPOC registers with Tatmeen, the SPOC has to create a B2B user. The B2B user needs to register to Tatmeen and create a password that will be used to access Tatmeen Developer Portal only (the B2B user cannot access Tatmeen portal) and subscribe to the required API to get an API Key
There are two ways to check the status of these messages, either via the message status query or using the message log on the portal which is accessible for support user types only.
Downloading data or generating reports features are not provided for supply chain participants. Users can only view product data and partner data, but they cannot download records of products, serial numbers or batches from the Tatmeen platform
No, the United Arab Emirates requires you to follow the decrees and regulations issued by the Ministry of Health and Prevention in relation to drugs serialisation and the Tatmeen platform.
Yes, all protocols for the registration of scientific offices, medical stores, registration of drugs will remain as they are today.
For your queries
Serialization or BrandSync
Queries tied to Serialization or BrandSync will be sent to GS1 and will be answered within 4 business days
BUSINESS PROCESSES, THE TATMEEN PLATFORM, OR program timelines
Queries related to Business processes, the Tatmeen Platform, or program timelines will be directed to the Tatmeen program team.
TATMEEN WEBSITE, APIS, AND MOBILE APPLICATION
Queries of a technical nature regarding the Tatmeen website and portal, APIs, and Tatmeen mobile application will be directed to the Tatmeen technical support team.
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