The first Law Update of 2024 is here, and our first focus of the year spotlights Healthcare and Lifesciences, a sector that is undergoing significant growth and development across the MENA region.
Our focus provides an insight into some of the most important regulatory updates across the region, such as the UAE’s groundbreaking law on the use of human genome, Kuwait’s resolution on nuclear and radioactive materials, the new regulations for healthcare services in Qatar, Egypt’s healthcare regulatory framework, and the impact of the Saudi Civil Transactions Law on the healthcare and life sciences sector … and there is so much more!
Beyond the healthcare pages our lawyers share with you multi-sector insights where you will discover articles on Dubai’s DIFC regulatory framework for startups, Bahrain’s commercial agencies law, and we also shed light on Kuwaiti civil code and the advantages of setting up a joint stock company in Saudi Arabia.Read the full edition
In June 2021 the UAE Ministry of Health and Prevention (“MOHAP”) issued a pharmaceutical products traceability decree, which applies to all conventional medicines that are being traded in the United Arab Emirates (“UAE”).
There is a 6-month grace period, after which all pharmaceutical products imported into the UAE must comply with the decree by applying a 2D matrix barcode and human readable format, in accordance with GS1 standards; the deadline is 13 December 2021.
There is an 18-month period for serialization reporting and onboarding onto the Tatmeen platform. The deadline for this is 13 December 2022.
All sites that are licensed to dispense medicines in the UAE will be required to be registered with a GS1 global location number (“GLN”) within 18 months of the decree’s issuance, being 13 December 2022.
Pharmaceutical products already within the UAE prior to 13 December 2021 may continue to be sold without complying with the decree, until such time that the quantities in country runs out at the various trading points.
Products that are exempt from serialization include:
Tatmeen is a digital platform that enables the tracking and tracing of all pharmaceutical products in the UAE.
The marketing authorization holder, brand owner, manufacturer, or their subsidiaries must register and upload the required product master data on GS1 UAE’s platform (BrandSync). All supply chain actors located in the UAE must obtain a GLN from GS1 UAE to identify their organisation, location, and other required information.
Once operational, around December 2022, product information will need to be loaded into Tatmeen.
All secondary packaging must be barcoded with a GS1 DataMatrix. The application of these barcodes applies to both registered and non-registered drugs, and is mandatory for all drugs imported or produced in the UAE.
All secondary packaging sold, imported, produced and supplied to the UAE must be serialized. The required serialization and aggregation varies by the packaging level. For, example, secondary packaging must have the following data elements on it and encoded in a GS1 DataMatrix:
Logistic units must be aggregated and identified with a Serial Shipping Container Code (“SSCC“). Aggregation will be performed by the manufacturer on all applicable packaging levels to ensure ease of downstream reporting. Distributors, wholesalers and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the logistic units using their own SSCC codes. If, in addition to being a logistic unit, the item is regarded as a ‘Trade Item’ by the brand owner, it may additionally be identified with a GTIN.
The drug tracking system allows the identification and tracking drugs sold in the UAE from a central command centre, using the unique GS1 standard serialized bar codes. UAE inspectors will be able to scan bar codes in stores, pharmacies, and hospitals, and identify counterfeit and illegal drugs and service providers. The system will also enable supply chain stakeholders to track the movement of medicines and for hospitals and pharmacies to validate products on arrival and upon dispensing.
Similar to Saudi’s recent implementation of a consumer facing medicines tracking app (Tameni app), the UAE public will also be able to validate their medications using customized mobility solutions.
Al Tamimi & Company’s Healthcare & Life Sciences Sector Group regularly advises pharmaceutical companies on regulations and doing business in the Middle East. Please emails us at email@example.com or the author of this alert, should you require any support in the United Arab Emirates, or any of our nine jurisdiction across the Middle East.