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In brief

On 1 October 2024, the UAE Government has issued a new Federal Decree-Law No. 38 of 2024 to regulate medical products, the pharmacy profession and pharmaceutical establishments (the “Law“).

The Law replaces Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments including its later amendments (hereafter, “Federal Law of 2019“).  However, its implementing regulations remain in effect to the extent they do not contradict with the Law.

The Law was first published on the UAE government website on 29 December 2024. It has been published in the official gazette dated 14 October 2024 and circulated on 8 January 2025. It came into force on 2 January 2025 (“Effective Date“).

Entities and individuals to which the law applies are granted a one-year grace period starting from the Effective Date, to make the necessary changes to comply with its provisions. Such a period can be extended by a Cabinet decision. 


Contents

  1. Objectives
  2. Scope
  3. Import, distribution and warehousing
  4. Marketing Offices
  5. Other changes

Objectives

The Law aims to consolidate legislation governing medical products and pharmaceutical establishments at a federal level, to facilitate the take-over of responsibilities by the Emirates Drug Establishment (EDE) from the Ministry of Health and Prevention, and to further solidify the UAE’s position as a globally trusted hub for the pharmaceutical and medical industries.

The Law further focuses on enhancing supply chain security and streamlining the development, approval, manufacturing, marketing, and distribution of medical products. Additionally, the Law seeks to attract investments and encourage innovation in line with the vision and objectives of the UAE government.

Scope

The Law clarifies and expands its scope regulating medical products, the pharmacy profession, pharmaceutical establishments and biobanks. Biobanks which were not previously covered by the regulations are now regulated by the Law but not as pharmaceutical facilities. The Law introduced new (sub) categories of products and establishments such as genetically modified organisms for medical use and contract research organizations.

Products:

  • Medical Products: pharmaceuticals, medicines, medical devices, healthcare products, biological products, nutritional supplements, cosmetics, genetically modified organisms for medical use.
  • Other Products: chemical precursors, controlled substances, semi-controlled substances, hazardous and toxic products and materials for human and veterinary use.

Pharmaceutical Establishments:

  • Public pharmacies and pharmacy chains.
  • Non-clinical and clinical research entities.
  • Bioequivalence centers.
  • Pharmaceutical laboratories.
  • Contract factories and companies for manufacturing medical products.
  • Contract companies for research and development.
  • Marketing offices.
  • Pharmaceutical consulting offices.
  • Compounding pharmacies.
  • Medical store (logistics and sales) and medical warehouse (only logistics).

Import, distribution and warehousing

Import and distribution remains reserved for medical stores and is now clearly distinguished from warehousing. As per the new definitions, medical stores can engage in logistics and have title in the products. They may be licensed to carry out the importation, distribution or re-export whereas a medical warehouse is licensed to only store medical products but cannot engage in distribution or sales. The specific activities will need to be authorised by the EDE and will be further clarified in the executive regulations together with related requirements. The local ownership requirements for onshore entities remain within the remit of local authorities responsible for corporate affairs in the relevant Emirate.

The Law maintains the changes introduced last year by Law No. 11 of 2023 amending the Federal Law of 2019. The marketing authorisation holder is still required to appoint at least two importers and one or more distributors (Article 22).

The Law further clarifies the concept of importer and distinguishes it from distribution activities. Import only relates to the activity of bringing medical products from outside the country or its free zones to the mainland or within the country through customs ports after obtaining the necessary approvals. However, it will need further clarification through the anticipated executive regulations to understand the implications under the Commercial Agency Law.

There is no longer a need to file two regulatory applications, instead, the marketing authorisation holder must designate one main pharmaceutical establishment among its designated establishments to handle regulatory affairs, vigilance and quality. This entity is responsible for managing a product’s entire lifecycle in the UAE. A marketing authorisation holder may be exempted from these requirements through a Cabinet decision. However, such exemption must be based on a proposal of the EDE president, indicating the limited and strategic nature of the exemption.

Further conditions and controls for the implementation of Article 22 will be adopted through executive regulations.

Marketing Offices

Under the Federal Law of 2019, marketing offices remained regulated through the scientific office decree of 2016. Similar requirements are transferred into the Law such as the requirement to appoint a person licensed in the health or pharmacy profession in charge of the management of the marketing office. The marketing office must have obtained a commercial license for an activity within the field of the pharmacy profession.

As for the medical warehouses and stores, local ownership requirements for onshore entities remain within the remit of local authorities responsible for corporate affairs. Further conditions and requirements will be set forth in executive regulations which may further steer away from the current scientific office regulations.

Other changes

The Law contains further changes which we will address in separate alerts where we will shed some light on the innovation protection, research activities and authorisation pathways.

It is clear that the UAE is steaming ahead to fulfil its ambitions as a global innovative player whilst focusing on supply chain security to protect the health of its population. What better way to start a new year!

Author

Hani has been practicing since 2007 with a focus on M&A, joint ventures, corporate reorganizations and post-acquisition integration as well as corporate structuring, foreign direct investment and market entry in the Middle East with a particular focus on the UAE and Qatar. His experience also covers general commercial contracts such as agency and distribution and advice on corporate governance, compliance and competition matters.
Hani focuses on the healthcare, technology and the retail sectors but he also gained substantive experience advising both companies and government agencies in the defense sector and had significant exposure assisting governmental authorities with developing their internal structures and drafting legislations.
Hani is also the lead Pro Bono partner in the UAE and the Middle East.
Hani holds an MBA degree and a Masters in Management alongside his law degree. He is fully trilingual and practices in English, French and Arabic, all three at a professional level.
Prior to joining Baker McKenzie’s UAE offices in April 2012, Hani worked as a corporate associate at an international law firm in both Dubai and Doha between 2008 and 2012 and prior to that worked at an FMCG company and a private equity group in Kuwait.

Author

Laya Aoun-Hani is a counsel and senior member of the EMEA Baker McKenzie International Commercial & Trade Practice Group. With over 18 years of experience in the Middle East, Laya regularly advises multinational clients from different industries on regulatory matters, commercial transactions, multijurisdictional distribution and agency arrangements and restructurings, commercial disputes settlements, competition law, trade compliance, export controls, trade sanctions and customs matters. She is the Middle East co-lead for the Baker McKenzie Consumer Goods and Retail and the Healthcare and Life Sciences Industry Groups. Laya has also extensive experience in the Telecommunications sector.
Laya trained at one of the largest law firms in Lebanon and one of the largest international law firms in London before she joined Baker McKenzie in Dubai in 2013. She was a lecturer and coordinator of a Business Law course for five years at the Faculty of Business at Antonine University in Lebanon. Laya is currently a lecturer in the continuous Legal Professional Development Program at the Dubai Legal Affairs Department and a regular speaker at Mecomed

Author

Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.

Author

Rony has extensive corporate and commercial experience in the Middle East with 14 years in the UAE.
He is experienced in corporate and commercial transactions, joint ventures, mergers and acquisitions, distribution and commercial agency arrangements, corporate reorganizations, foreign direct investment, regulatory matters and local laws. Rony also advises on market entry and structuring of companies in the UAE including within the free zones.
Having been seconded to the in-house team of one of Dubai's leading pharmaceutical companies, Rony has a practical and commercial approach to advising clients and understanding their needs.