Legislation Details
- Full Title: Federal Decree-Law On the Establishment of the UAE Drug Corporation
- Law Type: Federal Decree-Law
- Law Number: [number] of 2023
- Issued Date: 25 Sep 2023
- Effective Date: 30 Sep 2023
- Official Gazette: No. 760
- Sector: Government Affairs
- Status: Active
- Number of Articles: 37
- Chapters/Parts: 0
- Amendments: 0
Summary
This Federal Decree-Law establishes the UAE Drug Corporation, a federal institution with independent legal personality, financial and administrative independence, and the legal capacity to carry out all legal acts and transactions. The Corporation aims to contribute to improving public health levels and making the UAE a trusted global center for the pharmacological and medical industries. It regulates a wide range of medical products, including pharmacological products, medical equipment, pharmaceutical products, health care products, biopharmaceutical products, food supplements, cosmetics, veterinary products, fertilizers, agricultural amendments, plant growth regulators, pesticides, and genetically modified organisms. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 1-2)
What is the scope and purpose of this law?
The scope of this Decree-Law covers a broad range of medical products in the UAE, including pharmacological products, medical equipment, pharmaceutical products, health care products, biopharmaceutical products, food supplements, cosmetics, veterinary products, fertilizers, agricultural amendments, plant growth regulators, pesticides, and genetically modified organisms. The Cabinet may also add any other medical products to this list. The purpose of the law is to establish the UAE Drug Corporation, which aims to contribute to improving public health levels and making the UAE a trusted global center for the pharmacological and medical industries. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 2)
What are the key definitions under this law?
The law provides the following key definitions:
- State: United Arab Emirates
- Ministry: Ministry of Health and Prevention or Ministry of Climate Change and Environment
- Corporation: The UAE Drug Corporation
- Board of Directors (BOD): The Corporation Board of Directors
- Chairman: Corporation Chairman of the Board of Directors
- Director General: Director General of the Corporation
- Health Authorities: Federal and local government authorities concerned with health affairs
- Medical Product: The product described in Article 2
- Pharmacological Product: Any product that contains an active substance or group of substances that achieves the intended purpose of use thereof in or on the human or animal body through a biological effect
- Medical Equipment: A medical product that contains a substance, device, instrument, engine, implant, detector, or system, including accessories, and operating software thereof
- Health Care Product: Any medical product that is used for the general health care of humans or is not intended for the diagnosis, treatment, cure, or prevention of any disease
- Pharmaceutical Product: A medical product manufactured in a specific pharmaceutical form and has specific uses in humans or animals
- Veterinary Product: A substance, a composition of substances, or a material intended for the treatment, prevention, or diagnosis of medical conditions in animals
- Fertilizers: Materials that are used in any way to provide plants with their nutritional needs, improve growth, increase productivity, and improve the quality of products thereof
- Agricultural Amendments: Materials that work to restore the soil, improve properties, and increase productivity thereof
- Plant Growth Regulators: Compounds with physiological effects that regulate the biological processes in the plant and products thereof
- Pesticides: Any chemical, biological or organic substance or mix of substances that contains the active ingredient and the additive in order to prevent, expel, reduce the spread of the pest, control or regulate growth thereof
- Genetically Modified Organism (GMO): A living organism that has a new genetic composition that differs from original composition thereof, obtained by using modern biotechnology
- Alternative Product: A pharmaceutical product that is similar to another pharmaceutical product, having the same qualitative and quantitative composition of active ingredients, the same pharmaceutical form, and being bioequivalent thereto
- Innovative Product: Pharmacological products that contain a new active ingredient in whole or in part, and the owner of which holds a patent document
- Pharmacogenomics: A branch of pharmacology that deals with the impact of genetic variation on drug response in patients
- Personalized Medicine: A model of precise medicine that takes into account the variation in genes, environment, and lifestyle to determine the treatment and prevention of disease
- Controlled Products: Products and substances whose medical and commercial circulation requires control actions
- Semi-controlled Products: Substances or drugs that are not classified as narcotic or psychotropic substances, but circulation thereof in the state shall be controlled because their misuse may lead to harm to public health
- Chemical Precursors: A chemical substance that is used in any stage of the manufacturing or production of narcotic or psychotropic substances, dangerous substances, psychoactive substances, or toxic substances
- Batches: A specific quantity of a medical product that has been manufactured in a single batch and carries a unique identification number as well as a manufacturing date
- Non-clinical Trials: Toxicology and pharmacological studies to assess the safety of a medical product
- Clinical Trials: Controlled trials or research on a specific medical product that are conducted on groups of humans
- Marketing Approval: The approval granted by the Corporation to a legal entity licensed in the State to market a specific medical product
- Contract Development and Manufacturing Organizations (CDMOs): Companies contracted to re-engineer and accelerate the processes of innovation, development, and manufacturing of medical products
(Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 1)
What are the main obligations and requirements?
The law does not specify any direct obligations or requirements imposed on individuals or companies. However, it establishes the UAE Drug Corporation and outlines its purposes and powers, which include: 1. Promoting research and development in the pharmacological and medical products sector and attracting leading investments. 2. Strengthening the local industrial capacity in developing, producing, and exporting high-quality medical and pharmacological products. 3. Supporting medicine security in the UAE and ensuring the availability, quality, efficacy, safety, and reliability of medical and pharmacological products. 4. Effective national management of the procedures for developing, approving, manufacturing, marketing, and trading medical and pharmacological products. 5. Developing and implementing policies, strategies, and plans to achieve the Corporation's objectives. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 5)
What licensing, registration, or approval requirements exist?
The law does not specify any licensing, registration, or approval requirements for individuals or companies. However, it states that the Corporation will grant "marketing approval" to legal entities licensed in the UAE to market specific medical products. The approval will include details about the product, its composition, use, and other relevant information. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 1)
What rights and protections does this law provide?
The law does not explicitly mention any rights or protections granted to individuals, workers, businesses, or other parties. It is focused on establishing the UAE Drug Corporation and outlining its purposes and powers. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023)
Which authorities or bodies are responsible for enforcement?
The law establishes the UAE Drug Corporation as the main authority responsible for the regulation and management of medical products in the UAE. The key bodies and roles within the Corporation include: 1. Board of Directors (BOD): Responsible for setting the Corporation's policies, strategies, and plans. 2. Chairman: Chairs the BOD and represents the Corporation. 3. Director General: Manages the day-to-day operations of the Corporation. The law also mentions that the Corporation will coordinate with the Ministry of Health and Prevention and the Ministry of Climate Change and Environment, as well as other federal and local government authorities concerned with health affairs. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 7-9)
What are the penalties for non-compliance?
The law does not specify any penalties for non-compliance. It is focused on establishing the UAE Drug Corporation and outlining its purposes and powers. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023)
What fees, charges, or financial provisions are specified?
The law does not mention any specific fees, charges, or financial provisions. It states that the Corporation will have independent financial and administrative independence, but does not provide details on its financial resources or operations. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 3)
What exemptions or exceptions apply?
The law does not specify any exemptions or exceptions to its scope of application. It covers a broad range of medical products in the UAE, including those in free zones. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023, Art. 2)
How are disputes resolved under this law?
The law does not mention any dispute resolution mechanisms or procedures. It is focused on establishing the UAE Drug Corporation and outlining its purposes and powers. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023)
What are the key deadlines and time limits?
The law does not specify any deadlines or time limits. It states that the Decree-Law will come into effect on 30 September 2023, but does not mention any other deadlines or time periods. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023)
How does this law interact with other UAE legislation?
The law mentions the following related legislation: 1. Federal Law No. (1) of 1972 Concerning the Competences of Ministries and Powers of Ministers, as amended. 2. Federal Law No. (2) of 2019 Concerning the Information and Communication Technology in the Health Field. 3. Federal Law No. (8) of 2019 Concerning Medical Products, Profession of Pharmacy and Pharmaceutical Facilities, as amended. However, it does not specify how this Decree-Law interacts with or relates to these other laws. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023)
When did this law come into effect?
This Federal Decree-Law came into effect on 30 September 2023, as stated in the Effective Date section. It was published in the Official Gazette No. 760 on 29 September 2023. The law does not mention any transitional provisions. (Federal Decree-Law On the Establishment of the UAE Drug Corporation, 2023)
Source Documents
This article analyses Federal Decree-Law On the Establishment of the UAE Drug Corporation for legal research and educational purposes. For the purpose of interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text prevails. This does not constitute legal advice.