Out-Law News | 20 Jul 2021 | 9:24 am |
A new law introduced in the UAE requires businesses selling pharmaceutical products in the state to log information that will enable those products to be traced through a new electronic system.
The ministerial resolution on tracking pharmaceutical products resolution was signed in June and came into force on 1 July 2021, but businesses have until 1 January 2022 to update their product information and apply the new coding system before the law is enforced.
The information to be submitted includes the Global Trade Item Number (GTIN) for pharmaceutical products, their batch number, the drug expiration date, and the serial number of each individual package. These details must be entered on a specific platform – ‘Tatmeen’ – which will be used to track the medicine from the manufacturing stage until the medicine reaches the consumer.
The new logging requirements apply to all pharmaceutical companies that manufacture, produce or distribute pharmaceutical products in the UAE. The law applies regardless of whether the medicines have been manufactured locally or imported from other countries. Businesses can apply for an exemption from the requirements, though the conditions of exemption are limited. Exemptions are issued at the discretion of the Department of the Ministry of Health and Community Protection.
"The passing of the new pharma law demonstrates that regulators in the UAE are keen to maintain international standards and best practice,” said Alexandra Aikman of Pinsent Masons, the law firm behind Out-Law.