Our first edition of 2022 focuses on Healthcare and Life Sciences. It is a sector that will once again have the spotlight on it this year as we continue to tackle COVID-19 and its subsequent variants. While the pandemic continues to challenge the sector, governments across the region forge ahead with their plans to expand and upgrade healthcare systems and develop robust world-class healthcare infrastructure.
For the region, healthcare is a vital pillar in diversifying its economies, both locally and as medical tourism hubs. To underpin this, healthcare authorities across the region continue to implement frameworks and regulations that provide structure and accountability.
In this edition, you have unique access to great insights and expert commentary on a number of pertinent healthcare regulatory developments. You will find a topical mix of articles; for example, our lawyers discuss vaccines and returning to work during the pandemic. They take you through several other areas, including stem cell research in Bahrain, clinical research laws in Egypt, and Saudi medical device and pharmaceutical laws.Take a read of the edition
Bassam Al Azzeh
The new resolution has approved standard No UAE.S/GSO 1926:2009 as technical regulations rather than standard regulations which will require all suppliers to seek registration of energy drinks with ESMA.
By the deadline date of June 14, 2012, all suppliers including manufacturers, agents, distributors, commercial representatives and legal representatives would need to have completed registering their energy drinks at ESMA. This deadline has been fixed by the resolution which gives suppliers a grace period of six months to comply with the technical regulations in standard UAE.S/GSO 1926:2009.
ESMA established in 2001 the Emirate Conformity Assessment Scheme (ECAS) taking on responsibility of issuing registration certificates for approved products. Energy drinks are now required to meeting the following conditions:
– The Energy drink should comply with Standard No. UAE.S/GSO 1926:2009 for Recommendation of Handling Energy Drinks.
– Evidence of approval for general safety of the energy drink from other conformity assessment bodies, if the production is conducted out of the UAE.
– The label of the should state the following warning [translated]:
“This product is not permitted for pregnant women, or women breast feeding, children under 16 years of age, persons susceptible to allergy by caffeine, or persons suffering from heart disease or athletes during sport practice”
There are language conditions on the warning as well as other conditions that relate to labeling requirements. The ingredients will need to adhere to Islamic Sharia.
In addition, Halal Certificate is one of the complementary requirements (متطلبات تكميلية) for the Standard No. UAE.S/GSO 1926:2009, where suppliers should also seek to register their product under standard No. UAE.S /GSO 1931 :2009 for general requirements for producing, supplying, storing, and consuming Halal products.
The resolution confirmed that suppliers can be either companies/factories working in the UAE or agents and representatives for companies/factories out of the UAE. Agents in such conditions should provide a letter attesting that they are representing the foreign company/factory and hold the responsibility for supplying the product.
Energy drinks are granted ECAS certificate when completing compliance with Standard UAE.S/GSO 1926:2009 and receiving an acceptable lab result. The registration number of ECAS should be recorded at the bottle/can in clear font.
ECAS certificate is valid for one year and can be renewed within two months before expiry, and any adjustment to the product should be notified to ESMA.
The resolution prohibits energy drinks sales at school cantinas and to persons mentioned in the warning, and it further regulates the inspection in the local market and at all entry points in the UAE.
This resolution has significant compliance changes and imposes more stringent measures on energy drinks and is in harmony with the GCC standards for energy drinks.