Q&A guide to the commercialisation of healthcare in the United Arab Emirates
- What is the definition of medicine (or equivalent) in your jurisdiction?
"Medical products" are defined in UAE law as "all drugs, medical devices or healthcare products".
"Drug" is defined as "any product that contains an active ingredient or a group of active ingredients that have an intended biological effect on or in humans or animals. Drugs are products which are manufactured, sold or made available to be applied for the:
- Diagnosis, treatment, cure, relief, or prevention of illness.
- Restoration, renovation, modification or correction of organ functions.
(Article 1, Federal Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments (Pharmaceutical Law)).
- What authorities are responsible for regulating the manufacture, marketing and advertising of medicines?
The UAE Ministry of Health and Prevention (MOHAP) is the primary regulatory authority that regulates all healthcare services for the Northern Emirates. The MOHAP supervises the healthcare policies, all medicinal products, manufactured and imported, as well as the licensing and registration for all medical products and institutions. Additionally, the Emirates Health Authority (EHA) also regulates public healthcare services.
In addition to the MOH, the following regulatory authorities oversee the UAE:
- Health Authority Abu Dhabi (HAAD), which supervises all healthcare in the capital of the UAE (Abu Dhabi) and was established under Abu Dhabi Law No. 1/2007.
- Dubai Health Authority (DHA), which runs the medical necessities in the Emirate of Dubai and was established under Dubai Law No. 13/2007.
- Sharjah Health Authority (SHA), which oversees all healthcare needs in Sharjah and was established under Federal Law No. 13/2009.
- Abu Dhabi Health Services Company (SEHA), which manages and owns, either indirectly or directly, public health facilities and other services approved by HAAD in the Emirate of Abu Dhabi.
- What notifications, registrations, approvals and licences are required to manufacture and market medicines and their active pharmaceutical ingredients?
A medical product cannot be manufactured in the UAE without obtaining the approval of the MOHAP, provided that it is manufactured by a licensed or approved factory in the UAE according to the standards and criteria issued by a resolution of the Minister (Article 22, Pharmaceutical Law). The process is as follows:
- The companies must seek prior approval from the relevant authorities (that is, the MOHAP or the relevant health ministry) (see Question 2), before establishing a manufacturing unit or setting up factories to produce medical products.
- Individuals must apply to the Board of the MOHAP to obtain a licence.
- Applications must be submitted with all necessary documents to support the application.
- Companies must also:
- provide all proposals and full details of any machinery to be installed in the unit;
- give details of all medicinal products to be manufactured in such a factory and any other vital information required by the MOHAP.
- The Minister or their deputy must cancel the medical product manufacturing authorisation licence in the UAE if:
- it is proved that the manufacturing authorisation or factory's accreditation is based on false documents;
- a resolution has been issued to prohibit product manufacturing in the country or the country of origin or any of the reference entities approved by MOHAP;
- it is proved that the factory does not apply the principles of good manufacturing practice, which affects the quality of the medical product;
- the product is found unsafe or has repeatedly failed to comply with the approved quality standards at the time of laboratory tests performed in the accredited laboratories in the country. The Minister must specify by resolution the number of failures that require cancellation of manufacture authorisation; or
- a resolution is issued to ban the factory's activities in the country, country of origin or any of the reference entities approved by the MOHAP.
(Article 24, Pharmaceutical Law)
There are no exceptions concerning the requirements as the Pharmaceutical Law explicitly lays down that no clinical studies of a medical product may be conducted on humans, unless approval from the MOHAP or the concerned authority has been obtained. Any company which complies with the following requirements is entitled to hold the required approvals and licences and undertake approved activities:
- The company must meet required sanitary manufacturing standards.
- Full quality control of the whole pharmaceutical product must be assured.
- An MOHAP-approved qualified pharmacist or other suitable professional must supervise the manufacturing process of the medicinal products.
Individuals and companies are not permitted to circulate or advertise medical products without obtaining a marketing authorisation or exclusive marketing authorisation licence and approval from the MOHAP (Pharmaceutical Law). Also, under Federal Law No. 15/1980 regarding the regulation of Publications, companies and individuals cannot distribute publications without prior approval from the MOHAP or relevant health ministry. Additionally, UAE Cabinet Resolution No. 7/2007 states that anyone that does not have MOHAP approval and an issued licence is forbidden from advertising and promoting medical products.
Under Article 7 of the Pharmaceutical Law, the medical product marketing authorisation applicant must:
- Appoint one or more qualified persons residing in the country according to a resolution from the Minister.
- Provide a medical warehouse to carry out the import, storage, distribution and wholesale of marketing approved products.
- Monitor medical products through distribution channels.
- Provide the necessary capabilities and systems to comply with the requirements of the medical product marketing authorisation.
- Monitor the performance of the licensed medical product and receive reports from pharmaceutical facilities about its effectiveness, safety, usage and quality.
- Inform the MOHAP and the concerned authority within 15 days of the date of noticing any unexpected side effects or adverse effects or critical side effects or adverse effects reported or monitored during circulation or local or global clinical researches conducted on the product(s).
- Monitor procedures of medical product withdrawal.
- Monitor product patent and manufacture right protection.
There are no exceptions to the requirements as the Pharmaceutical Law explicitly lays down that no clinical studies of a medical product may be conducted on humans, without obtaining approval from MOHAP or the relevant authority.
The MOHAP governs and regulates all manufacturing, advertising and sale of medical products in the UAE and is the only authority that issues licences for these activities. However, specific Emirates have authorities that regulate the policies and overall healthcare quality, for example, the:
- DHA governs all policies, rules and regulations applicable in the Emirate of Dubai.
- HAAD governs all policies, rules and regulations applicable in the Emirate of Abu Dhabi.
- SEHA manages and owns, either indirectly or directly, public health facilities and other strategies approved by HAAD in the Emirate of Abu Dhabi.
- What are the differences between the regulation of new innovative medicines and generic or biosimilar versions of those medicines?
There are no differences in the regulation of new innovative medicines and generic or biosimilar versions of those medicines regarding the registration, advertising and manufacturing of medical products. The medical products must be licensed in accordance with the guidelines set out in the Pharmaceutical Law (see Question 3). The MOHAP regulates licences and approvals for obtaining, advertising and selling medical products and healthcare products. Additionally, the Higher Committee of Drug Policies is a committee under the supervision of the MOHAP which is in charge of the development of medical product circulation, pricing and control policy in the UAE.
- What are the differences between the regulation of prescription and over-the-counter medicines?
"Prescribed products" are regulated under Article 31 of the Pharmaceutical Law. These are medical products that require a medical prescription and which cannot be sold, displayed, stored or circulated by non-pharmaceutical facilities.
Non-pharmaceutical facilities are defined as a facilities licensed to operate in any pharmacy, pharmacy chain, medical warehouse, marketing office, marketing consultation office, pharmaceutical laboratory, pharmaceutical research offices, factory and other facilities stipulated by the executive decree of the Pharmaceutical Law.
The prescription must be a written or electronic document issued by a healthcare professional duly licensed to dispense medicines. An oral order issued by a healthcare professional is deemed a prescription, as long as it is documented later under the terms of a ministerial resolution.
However, non-pharmaceutical facilities are allowed to sell, display, store or circulate medical products that can be dispensed without a prescription and which are the over-the-counter medicines under Article 32 of the Pharmaceutical Law.
- Are there fewer or different requirements for the approval of medicines that have already been licensed or approved in another jurisdiction?
Under the Pharmaceutical Law, companies must obtain a licence for selling or manufacturing medical products. However, there are a few exceptions, which usually involve emergency medical products that must be flown into the UAE or sporadic forms of medication that are required at short notice.
An applicant wishing to obtain medical products from another country in an unregistered way must submit an application to the MOHAP. Only specific bodies such as hospitals and health authorities can import in this manner. All other medical products must pass through the standard licensing process whether or not they have been approved in another country.
- Is it possible to sell medicines to or buy medicines from other jurisdictions?
Import of medicines. Medical products and the raw materials contained in them cannot be imported, exported or re-exported without the MOHAP's approval (Article 26, Pharmaceutical Law). Individuals and companies must adhere to the specific requirements of the MOHAP. The following rules must be considered before selling medical products from other jurisdictions:
- Only medical products listed as permitted under the Pharmaceutical Law can be imported into the UAE.
- Individuals who do not have a MOHAP approved permit cannot import permitted medical products.
A marketing authorisation holder must appoint one pharmaceutical establishment as an importer and appoint one or more distributors to distribute the medical products within the UAE. The importers and distributors must be duly licensed by the MOHAP to ensure oversight and security of supply chains and their appointment by the marketing authorisation holder must also be approved by the ministry.
Export of medicines. Companies must adhere to different rules to sell pharmaceuticals to other jurisdictions. Pharmaceutical products cannot be sold to other jurisdictions if such products have not been registered under the appropriate authorities. A manufacturer which holds authorisation in its home jurisdiction and a local representative from the UAE must apply jointly for registration. The local representative can only act as an authorised representative with the manufacturer's authorisation. The local representative oversees each element needed to market the product, which includes:
- A document of proof stating that the products are manufactured using manufacturing processes that adhere to the relevant laws.
- A "free-of-sale" certification, that is, clearance for sale certification required to certify that the pharmaceuticals are freely sold in the exporting country.
- A document of proof stating that the appropriate goods can be manufactured and exported from the specific country.
- Authorisation for the location where the product was produced.
- Approval indicating that the laws of the manufacturing country have approved the product.
- Proof that the product meets and is approved by all safety laws of the manufacturing country.
- All instructions and labelling for the products.
- A detailed plan of financial activity and marketing prospects.
However, parallel imports of medical products are not allowed in the UAE.
- How is medicine promotion and advertising activity regulated, and what are the general requirements to advertise medicines?
A medical product dispended by a medical prescription cannot be publicised or advertised to the public by any means (Article 39(1), Pharmaceutical Law).
The following are permitted with the MOHAP's approval:
- Announcing, advertising or promoting a medical product in magazines or scientific resources intended for healthcare practitioners.
- Announcing, advertising or promoting to the public any non-prescription medicine or healthcare product that has marketing authorisation.
(Article 39(2), Pharmaceutical Law)
The marketing authorisation holder must ensure that medical product advertisements and promotions comply with the terms and conditions set out by the MOHAP.
The principal legislation that governs the medical industry's advertisements is Regulation No. 430/2007 of the Health Advertisement Regulations. Additionally, Federal Law No. 15/1980 concerned with Publications and Public Matters (Article 83) states that advertisements are prohibited without the prior approval of the MOHAP. Advertisements for medicines must:
- Be in line with the law and must not breach any rules in the UAE.
- Not undermine UAE traditions, Islamic beliefs and customs.
- Be clear and concise and must not misdirect individuals.
- Not disrupt public morale.
- Not promote the unwanted and excessive use of medicinal products.
- must not be accompanied by the giving of samples.
(Federal Law No. 15/1980.)
Some medical advertising is explicitly prohibited because of its content. It is an offence to advertise the following products and services:
- Embryo freezing.
- Products that are proven to be harmful to individuals.
- Treatment or preventing the following diseases: cancer, sexually transmitted diseases (STDs), Acquired Immune Deficiency Syndrome (AIDS), hepatitis, mental and psychological disorders.
(Federal Law No. 15/1980.)
Pharmaceutical products can be advertised on the internet. However, they must not be advertised online if they do not have professional approval from the appropriate authority. Breach of the approval requirement results in penalties, including imprisonment (Federal Law No. 15/1980).
- Are there additional or alternative regulations for special types of medicines or medicines intended for particular types of patients or diseases?
The Department of Health (DoH) Standard on Stem Cell Therapies and Products & Regenerative Medicine, approved in July 2019, applies to all DoH-licensed healthcare professionals, providers and suppliers of:
- Stem cell products and laboratories engaged in the provision of stem cells.
- Stem-cell based-products, and related cellular therapies.
- Somatic-cell therapy and tissue-engineered products and regenerative medicine products for the purpose of human use.
This standard also applies to insurers, third party administrators (TPAs) and Medical Billing Offices.
The main aim is to set DOH’s criteria for the provision of safe, effective and quality stem cells, stem-cell based-products and related cellular therapies, somatic-cell-therapy and tissue-engineered products and regenerative medicine products for the purpose of human use in Abu Dhabi.
- What controls apply to medicines or components of medicines that derive from humans or animals or incorporate modified genetic material?
The MOHAP, along with other health regulatory authorities, issues all policies for medical products. If a product contains an ingredient (active or excipient, for instance, magnesium or calcium stearate, stearic acid, gelatin, lactose) that is, or potentially is, of animal origin, or comes into contact with the material of animal origin during manufacture, the source of the material (or contact) must be declared, and evidence must be provided that the product is free from viruses, other micro-organisms and Transmissible Spongiform Encephalopathy (TSE) agents.
The European Pharmacopoeia Commission Certificate of Suitability (CEP) is acceptable as evidence of freedom from TSE agents.
In the UAE the following information must be submitted for the General Sales List (GSL), that is medicines that can be sold at non-pharmaceutical facilities such as supermarkets:
- Statement issued by the principal company showing that the product is devoid from hormones, heavy metals, antibiotics, steroids, derivatives of pork and any natural and chemical ingredients having harmful effects on human biological and behavioral functions.
- If the product contains an ingredient from an animal source, the kind of animal and part extracted from it must be specified.
- The percentage of alcohol if any must be mentioned together with reasons for its inclusion.
- Halal certificate issued by recognisable organisations and authorities.
- What is the definition of biological medicines in your jurisdiction and what are the main laws that specifically apply to them (if any)?
See Question 1 for the definition of medical products and drugs.
Under Ministerial Decision No. 1412 of 2017, the definition of "medical products" includes pharmaceutical products, including original drugs, generic drugs, herbal drugs, biological products and vaccines. There is no specific definition of biological medicines. .
- Are there any additional or alternative regulations that apply specifically to biological medicines?
Biological medicines are considered as medical products and all regulations that apply to medical products (see Questions 2 to 10) also apply to the biological medicines under the Pharmaceutical Law and the other relevant regulations.
- What is the definition of medical device (or equivalent) in your jurisdiction? What is the significance of any legal classifications?
A medical device is defined as a medical product that contains any element, instrument, tool, machine, appliance, implant, in vitro reagent, calibrator or a system, including its accessories and operating software, which achieves the intended purpose to be applied in or on humans or animals, without pharmacological, immunological or metabolic effect.
A medical device is intended by the manufacturer to be used, alone or with something else, for humans, for one or more of the following purposes:
- Diagnosis, treatment, cure, relief, monitoring or prevention of illness, injury or disability.
- Investigation, replacement or modification of an anatomical condition.
- Contraceptive control.
Medical devices come within the definition of Medical Products (Article 1 of Pharmaceutical Law). The medical device definition incorporates the idea that a drug can be used for more than its intended purpose, for example, for an anatomical position as well as pregnancy control.
- What authorities are responsible for regulating the manufacture, marketing and advertising of medical devices?
The MOHAP’s Higher Committee of Drug Policies is in charge of medical product circulation, pricing and control, including of medical devices. The DHA regulates the policies and overall healthcare quality in the Dubai. The HAAD governs all policies, rules and regulations to be administered in Abu Dhabi.
- What notifications, registrations, approvals and licences are required to manufacture and market medicinal devices?
The classification system for medical devices must be undertaken by the manufacturers according to the system set out by the Global Harmonisation Task Force on Medical Devices (GHTF) and the International Medical Devices Regulations Forum (IMDRF).
The regulatory authorities set out the responsibilities to be followed by manufacturers, such as the design, process of manufacturing, advertising and marketing of medical devices. Manufacturers must conform with the relevant guidelines to assure safe use of the particular medical devices. Further, classification of the medical devices must be undertaken carefully following the GHTF and IMDRF system, where Class A, represents the lowest level of risk to patients, and Class D represents the highest level.
The primary classification requirements followed by the UAE for medical devices follow those of other countries, such the US Food and Drug Administration's Regulations and the following EU Directives:
- Directive 93/42/EEC concerning medical devices (Medical Devices Directive).
- Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive).
- Directive 90/385/EEC on active implantable medical devices (Active Implantable Medical Devices Directive).
Under the GHTF, medical devices must meet specific requirements such as essential safety standards and design and manufacturing requirements. Manufacturers must also adhere to all UAE health and safety and other laws.
They must also meet all expectations of the MOH at the registration process to obtain approval for the production process.
Manufacturers of medical devices must be registered with the Higher Committee of Drug Policies before marketing the products in the UAE.
Documentation required for registering is as follows:
- Application form (in Arabic and English to the MOH).
- Proof of conformity.
- Authorisation of company registration.
- Prices to be charged.
- Evidence of essential principles (safety regulations, quality management).
- Manufacturing process.
- Labelling and samples.
- Risk assessment.
- Are there fewer or different requirements for medical devices that have already been licensed or approved in another jurisdiction?
The MOHAP is the authority in charge of all medical products and devices within the UAE. They cover all matters set out in the Pharmaceutical Law.
All medical devices must be registered and licensed whether including those registered in other jurisdictions. This is so that the MOHAP is aware of and has ensured that all medical devices that are available to be sold in the UAE are safe and documented.
The only exception to the above requirement is if a medical device is required in an emergency or on short notice in which case only a health authority or hospital is permitted to order the device(s), and they must complete the necessary application.
- Is it possible to sell devices to or buy devices from other jurisdictions?
To sell products in the UAE, the company must be legally established in the UAE. Additionally, companies wishing to sell these devices must either contact a local representative already registered with the MOHAP to sell devices or use a company in which they have a shareholding. If using a company, the seller wishing to sell the products in the UAE the local or the foreign company must begin the registration process. Companies must also ensure that they have a trade licence in the UAE (see Question 7).
- What are the general requirements to advertise medical devices?
Advertising of medical devices is regulated and supervised by the Higher Committee of Drug Policies of the MOHAP. Advertisers must adhere to the rules provided by the MOHAP, including that advertisers cannot advertise without MOHAP approval, which is only granted if all necessary requirements are met (see Question 8).
All related medical products must first receive an approval from the MOHAP before they can be advertised. Once the product receives the approval and licence(s), it can move to the next stage. The UAE has not passed any federal law governing the advertisements for medical products or devices. However, the UAE has passed numerous resolutions and decisions on pharmaceutical products. This includes laws such as the printing and publication law, and national media council regulations. Federal Law No. 15/1980 relates to printing and publication and under this law specific strict guidelines must be adhered to before anything can be published, including advertisements. Companies must:
- Send two copies of all upcoming publications to the competent department in the MOHAP.
- Seek adequate approvals from the appropriate ministry department before publishing any journal. If approved, notification of approval will be given within 14 days of applying.
(Articles 11 and 12, Federal Law No. 15/1980)
On receiving approval, a company can publish in the relevant journal. Additionally, companies in the UAE must ensure that advertisements do not cause any negative impact on society. Advertisements must not be offensive to any religious groups and must be mindful of countries' cultures and ways.
- What product marking is required for authorised medical devices?
Medical device approvals or clearances from a recognised regulatory authority (US, Canada, Japan, or Europe) can be used to abridge the evaluation process for medical devices to be marketed within the UAE. Evidence of regular approval or clearance of a medical device in the form of certification and relevant, authenticated documents must be submitted. For devices not certified in the US, Canada, Japan, or Europe, these will be examined, and if approved, will be exempted from recognised country certification for Class A devices (those devices which require the lowest level of regulation and pose the lowest level of risk to patients).
- Does your jurisdiction recognise combination products? What are the main laws that specifically apply to them (if any)?
The MOHAP is responsible for the regulation of combination products in the UAE. Under the Pharmaceutical Law, all medical products must be registered by the MOHAP before they are imported into the UAE for sale and distribution. A medical product manufacturer must successfully register with the MOHAP before its medical products can be registered in the UAE.
- Are there any additional or alternative regulations that apply specifically to combination products?
See Questions 13 to 19 . The same regulations apply to the commercialisation of combination products.
Natural health products
- Is there a category for natural health products (or equivalent) (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?
"Healthcare products" are defined in the Pharmaceutical Law as any medical product used for general human health and not specific for diagnosis, treatment or cure, which do not require a prescription on dispensing or direct medical supervision when applied.
Natural health products are covered by the MOHAP and their guidelines, in the same way as any other healthcare product. However, depending on the purpose or effect of the product. the regulations may vary slightly.
The Dubai public health and safety department manages vitamins and minerals and other health supplements.
- What authorities are responsible for regulating the manufacture, marketing and advertising of natural health products?
The bodies responsible for the regulation of manufacturing, advertising and sales of natural health products are mostly the same as those responsible for general health products and medical products (see Question 2, Regulatory authorities).
- What notifications, registrations, approvals and licences are required to manufacture and market natural health products?
Generally, the processes and legislation applicable to manufacturing natural health goods are the same as for conventional health products. A licence must be obtained to produce the goods. The process to apply for the licence and its requirements include the following requirements:
- The applicant must be a citizen of the UAE.
- A licensed pharmacist must be managing the production factory.
- The nearest road between the subject of the licence, and the closest pharmacy must be no more than 200 metres away.
- The pharmacy must follow the technological and health conditions as determined by the Minister.
(Chapter 6, Federal Law No. 4/1983)
A factory to manufacture healthcare products can be set up when these conditions are fulfilled.
Similar to medical products, no healthcare product can be circulated within the UAE without obtaining marketing authorisation or exclusive marketing authorisation from the MOHAP according to the terms and procedures set out by a ministerial resolution (Article 3, Pharmaceutical Law) (see Question 3).
- Are there fewer or different requirements for natural health products that have already been licensed or approved in another jurisdiction?
The requirements for marketing/selling natural health products licensed or approved outside the UAE are no different from those that are licensed in the country.
Such products must be accompanied by the necessary import licence/authorisation documents (see Question 26) on their arrival into the UAE.
There are two methods of entry for imported products:
- Mainland entry points. Entry into the mainland incurs the standard tariffs of importing into the country as stated in the Gulf Co-operation Council Common Customs Law.
- Free zone entry points. Importing a product into one of the country's free zones will not incur the above tariffs.
- Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?
Natural healthcare products must be registered to be allowed to enter the country or to be sold online. This includes approval and licensing by the MOHAP. Once a product is approved, the requirements for natural healthcare products under the Pharmaceutical Law must be met. This means that at least the following must be present on the bottle in both Arabic and English:
- Name of the medicine or preparation and its registration number in the MOHAP, mentioning the pharmacopeia or scientific or cultural references according to which the medication was prepared, if any.
- Names and amounts of the active natural substances that are used in the composition of the medicine.
- Date of production of the medicine or preparation, and expiry date if validity is time-barred.
- Name of the manufacturer of the drug or preparation.
- The instructions and warnings associated with the use of the medication or preparation.
.When a product is approved, licensed and is fully legally compliant, it can be sold within the UAE.
Imported products can only be sold in the UAE if they meet the necessary requirements and must enter the country with all required paperwork present on entry.
Companies may face several difficulties in selling medicines online. Certain products such as vitamin and mineral tablets can be purchased online as long as they are approved by the MOHAP. However, other controlled substances are not permitted to be sold online. They must be prescribed to an individual and collected from a pharmacy. Controlled medical substances and products include:
- Toxic substances and plants.
- Prohibited veterinary substances.
- Narcotic and psychotropic substances, whether in form of raw materials or incorporated in a medical product.
- Hazardous medical products.
- What are the general requirements to advertise natural health products?
Advertising of natural health products in the UAE is permissible provided the products being advertised are licensed in the UAE from the relevant ministry. When the licence is issued, the advertisement must be sent to the MOHAP to receive approval. The import, manufacture, market or export medicines and preparations derived from a natural source or sources is not permitted unless the product has obtained a licence from the MOHAP. The company must apply to the MOHAP for their approval. The MOHAP will review the application according to the requirements of the Pharmaceutical Law and the printing and publishing laws (see Question 8).
Advertisements must not be offensive and overly explicit, especially to religious groups and individuals. Additionally, advertisements must take local culture into account and must be sensitive towards the ways and customs of the UAE. When approval is received, the company can publish the advertisement in the public domain.
- What data and information laws must be complied with by life sciences businesses that collect, use or otherwise deal in patient data (including through health apps)?
The Federal Law No. 2 of 2019 regulates the use of information and communications technology in healthcare (ICT Law) throughout the UAE, including the free zones. The objectives of the ICT Law are to ensure:
- Optimal use of ICT in the health sector the security and safety of health data and information.
- That the bases, standards and practices adopted adhere to international standards.
- That the MOHAP can collect, analyse and maintain health information at the national level.
(Article 3, ICT Law)
Article 4 of the ICT Law prohibits the processing of data and information without authorisation, aiming to:
- Ensure the authenticity and credibility of health data and information by preventing its unauthorised destruction, variation, misrepresentation, deletion or addition.
- Allow health data and information to be available to authorised parties and make it accessible whenever needed by those parties.
Health data and information cannot be stored, processed, generated or transferred outside the UAE, other than through a resolution issued in favour of the healthcare data and information processors in co-ordination with the MOHAP (Article 13, ICT Law).
Under Article 16, data only be used and processed in relation to the patient's specific health matter unless the patient consents to the data being used processed for a different reason) or if exceptions apply. Exceptions include the data processing:
- Of health financing or health insurance services and benefits.
- Of clinical trial and research, provided that the identity of the patient is not disclosed.
- For taking preventive and treatment measures for public health or to maintain the safety and health of the patient or for supervision, inspection and maintaining public health at the request of the healthcare data and information processors.
- At the request of the judicial authorities.
- What restrictions and regulatory requirements apply to the testing of life sciences products on human and animal subjects?
No clinical or bio-equivalence or bio-availability studies of a medical product can be conducted on humans, without obtaining approval from the MOHAP or the relevant authority. In addition, the necessary medical investigations must be carried out on the human subjects of a clinical study to ensure their safety after obtaining written approval by the trial subjects for their part in the clinical study and acknowledging its potential risks (Article 13, Pharmaceutical Law).
Clinical trials and tests cannot be conducted on bio-samples of trials by any entities other than those approved under Article 13. The following types of bodies can be approved by the MOHAP or the relevant authority to conduct clinical trials:
- Public and private hospitals.
- Universities and specialised scientific research centres. Where clinical trials are not able to be conducted on such institutions' premises, trials can be conducted in authorised hospitals.
The entity that conducts the clinical trial is obliged to:
- Develop the trial plan to be performed, including scientific justifications.
- Provide licensed physicians to supervise the safety of subjects of the trial.
- Conclude an insurance contract at an insurer operating within the UAE to cover any damages that may result from the trial.
- Comply with the:
- code of good clinical trials practices adopted by the MOHAP;
- Higher Committee of Clinical Trials ethics.
- Are there any plans to reform the rules on the development, manufacture, marketing and advertising of life sciences products and services?
On 19 December 2019, the UAE adopted Federal Law No. 8 of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments and abrogated Federal Law No. 4 of 1983 and Federal Law No. 20 of 1995. The New Pharmaceutical Law modernises the legal framework for the regulation of medical products in the UAE. The legal and regulatory reforms contemplated in the UAE strongly convey the desire of the UAE to be at the forefront of medical care. The UAE is propelled to focus on its national agenda, which is to achieve a world-class healthcare system in the UAE. In the pharmaceutical sector, reform is directed at drastically increasing the manufacturing capacity, and for investing in pharmaceutical manufacturing and research and development. The UAE aims to manufacture and provide healthcare like the top countries in the world. This includes a renewed focus on research and development as well as attracting qualified medical professionals and researchers.
Simarata Randhawa, Trainee Associate
STA Law Firm
T +9712 694 8534
Professional qualifications. B.Com; LLB; LLM with emphasis on Corporate Law and Arbitration, Boston University.
Areas of practice. Corporate law; Healthcare.
Languages. English, Hindi and Punjabi.
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