United Arab Emirates Regulatory Compliance

General Overview

The UAE’s Ministry of Health and Prevention – MoHAP has published legislation that defines the Serialisation and Track and Trace (T&T) requirements for all participants involved in manufacturing, distributing, and dispensing pharmaceutical products.

 

This legislation is driven by the need to maintain and improve patient safety whilst at the same time reducing counterfeits within the UAE.

 

Tatmeen is the Information Technology (IT) regulatory system that will support the UAE T&T legislation for the pharmaceutical industry. All products placed on the UAE market need to display a serialized unique identifier on the product secondary packaging. Also aggregated packaging (aggregated homogenous products or logistics units) must display a serialized unique identifier. The appropriate serialized identifiers must be used to record the operational and transactional movements of the products throughout the supply chain and during dispensing to the patient/consumer.

 

The information recorded by the participants must be transmitted to the Tatmeen traceability system where it is stored. The stored data is made available for regulatory purposes to the authorities of the UAE MoHAP departments.

 

The user environment for the Tatmeen solution consists of Dialog users and Service (also called B2B) Users for business partners.

 

Each business partner entity in the Tatmeen solution must have a Single-Point-of-Contact (SPOC) defined within the business partner master data.

Regulatory Requirements

Regarding serialization requirements, the product must be labelled with four data points in a GS1 Data Matrix code:

 

GTIN (Global Trade Item Number)

Randomized serial number – up to 20 characters

Expiry date – YYMMDD format

Batch/ lot number

 

As for aggregation, the manufacturer is responsible for labelling all logistic units with GS1-128 barcodes encoded with SSCC (Serial Shipping Container Code).

Exemptions

Products that are exempt from serialization are:

 

  • Free samples of pharmaceutical products;
  • Pharmaceutical products imported for personal use only;
  • Medical devices and supplies;
  • GSL products.

Technical Onboarding Process

The technical onboarding follows the process

 

1. Request Technical User

2. Tatmeen Staging Onboarding

3. Tatmeen Staging Qualification

4. Tatmeen Production Onboarding

 

* Technical onboarding is dependent on the nature of the organisation represented by the business partner. Many organisations will choose to share electronic records with the Tatmeen system to meet the UAE MoHAP legislation and will need to follow the process.

Dialog Users

  • Business Partner Single-Point-of-Contact (SPOC).
  • Business Partner operational users, being those users at a specific business partner location where they conduct/capture transactions for the Tatmeen solution.
  • MoHAP and UAE Government Agency users that only view Tatmeen information.
  • Tatmeen Administrator users.

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