Laws Governing the Pharmacists Sector and Drug Registration in the UAE
People are accustomed to the convenience of acquiring medicines from pharmacies for various common ailments, such as headaches, inflammation, and muscle spasms. These medications are readily available for purchase when needed, and individuals often keep them in their bags or homes. However, it is crucial to recognize that medicines, their licenses, importation, registration, and the regulations governing pharmacists are all vital aspects directly related to public safety. To ensure proper regulation, various laws and regulatory bodies have been established.
Is access to medicines by companies and pharmacies as simple as obtaining them from a regular pharmacy?
What is medicine from the perspective of the Ministry of Health?
How can a potential importer determine whether their product requires registration under Article 65?
There are several governing laws and regulatory authorities related to the pharmaceutical sector in the United Arab Emirates (UAE).
Some of these laws and rules include:
- Federal Law No. 5 of 1984: This law focuses on the regulation and registration of physicians, pharmacists, and other healthcare professionals working in both public and private healthcare institutions.
- Federal Laws No. 7 of 1975 and Resolution No. 2 of 1996: These laws outline the specific requirements for establishing and licensing medical laboratories, clinics, as well as public and private hospitals in the UAE.
- Federal Law No. 14 of 1995: This law, known as the “Counter-measures against narcotic drugs and psychotropic substances,” regulates the import of medicines into the UAE.
The definition of medicine is provided by the Pharmacy Act, which states that medicine is “any drug that contains one or more ingredients intended for the treatment or protection of humans and animals.” The Guide to Pharmacy further explains that medicine refers to any chemical substance intended for medical diagnosis, treatment, or disease prevention.
The regulatory authorities responsible for pharmaceuticals in the UAE include:
- UAE Ministry of Health (MOH)
- Health Authority – Abu Dhabi (HAAD)
- Dubai Health Authority (DHA)
- Emirates Health Authority (EHA)
These authorities oversee the licensing of pharmacists and pharmacies, drug registration, and drug advertising guidelines. The Ministry of Health sets national health policies and regulates the healthcare market in the Northern Emirates.
Previously, before the formation of the UAE Health Authority in 2009, the healthcare system in the northern emirates was under the jurisdiction of the Ministry of Health. However, with the establishment of the UAE Health Authority through Federal Law No. 13 of 2009, the healthcare system in these emirates gained an independent regulatory entity. The EHA was primarily created to facilitate interdepartmental cooperation between authorities, and its headquarters are located in Sharjah.
Registration of substances that have an anesthetic property
According to the Medicine Law of 1983, any substance with an anesthetic property must undergo registration with the Ministry of Health prior to its importation into the UAE market. This registration process is mandatory and ensures compliance with regulatory requirements and standards.
Under the Medicines Act of 1983, it is strictly prohibited for any individual to engage in the profession of pharmacy without a valid license. The term “pharmacy profession” encompasses various activities such as the preparation, formulation, separation, manufacturing, packaging, sale, or distribution of drugs or pharmaceutical preparations for the prevention or treatment of diseases in humans or animals (Section 1, Medicines Act 1983).
Pharmacists who practice without a valid license or violate the terms of their license may face disciplinary measures, as outlined in Question 8.
Engaging in fraudulent practices, such as submitting false documents or statements to obtain a license, or illegally practicing as a pharmacist, is considered a serious offense. Violators may be subject to imprisonment for a period of up to one year and/or fines (Sections 83 and 84, Medicines Law 1983).
Furthermore, offenses involving adulterated or counterfeit materials carry even stricter penalties. Offenders can face imprisonment for up to three years and/or fines of up to Dh10,000 (Article 86, Pharmacy Law 1983).
Drug Registration Laws:
The pharmaceutical market comprises a wide range of healthcare products, including not only common and prescription drugs but also various nutritional supplements, cosmetic products, and other related items that may not fall strictly under the definition of “medicine.”
According to Federal Law No. (4) of 1983, known as the Pharmacy Law, all medicines, including imported pharmaceuticals, must undergo registration with the Ministry of Health to be legally sold in the UAE. Even if a product is approved or registered in its country of origin, its registration in the UAE is subject to the Ministry of Health’s discretion, as outlined in Article 65. Unfortunately, the specific criteria for making registration decisions are not publicly available, which means that entities seeking product registration may have limited guidelines to increase their chances of success.
Articles 63-67 of the Pharmacy Law primarily address the registration of pharmaceuticals, indicating that manufacturers may not be extensively involved in the registration process. Complementary regulations, such as the Community Pharmacy Licensing and Pharmaceutical Practices in the DHA Guide from February 2013, focus more on licensing and protocols for institutions and professionals rather than industry products.
The Pharmacy Law strictly mandates that all pharmaceutical products sold in the UAE must be registered with the Ministry of Health without any exceptions. However, the Ministry of Health has the authority to grant certain hospitals in Dubai and Abu Dhabi permission to import unregistered medicines under specific circumstances. These circumstances include emergency medications for immediate life-saving purposes, medications not currently available in hospitals (such as those used in cancer treatment) and not yet approved by the Ministry, as well as specialized narcotic and psychotropic substances. Any approval granted for over-the-counter drugs comes with the condition that the product remains within the respective institution and is proportionate to the hospital’s size and needs.
The Ministry of Health retains the power to revoke any license to import medicines in the event of any violations.
Regarding the content and scientific criteria for successful registration, there are limited available guidelines. To address this, the Ministry of Health issued Circular No. 20 of 2001, under the authority of the Director of the Drug Control Department. The Circular includes the General Sale List, which encompasses all registered pharmaceutical items in the UAE. Additionally, it specifies that “Dietary Supplements, Medicated Cosmetics, Antiseptics and Disinfectants, and miscellaneous products that contain pharmaceutical ingredients and/or a medical claim and cannot be classified as a drug” are included in the list. However, specific configuration standards are still not indicated in the Circular.
To successfully register a drug with the Ministry of Health, certain conditions and administrative requirements must be met. These include:
- Completion of the application form, which can be obtained from the technical section or downloaded from the Ministry of Health website, in either Arabic or English.
- Submission of a Certificate of Approval for the Pharmaceutical Product (CPP) according to the WHO control system or a Free Sale Certificate (FSC) issued by the competent legal authorities in the country of origin.
- Attestation of the certificate by the Foreign Aviation Department in the United Arab Emirates or any Gulf embassy in the country of origin.
- Provision of three (3) samples of the pharmaceutical preparation in its final packaging.
- Submission of a certificate of analysis for the batch of samples provided.
The application for registration must be accompanied by various supporting documents on the company’s letterhead, including but not limited to:
- A statement from the company confirms that the product is free from hormones, heavy metals, antibiotics, stimulants, pork derivatives, and any natural or chemical ingredients that may cause harm to humans.
- If the product contains an ingredient derived from an animal source, the company must specify the type of animal and the part from which it was extracted.
- A clear indication of the percentage of alcohol (if any) in the product, along with an explanation of why these ingredients have been combined.
- A Halal certificate issued by recognized organizations and authorities.
- Details of the medical storage facility licensed by the Ministry of Health, as per Circular No. 1 of 2006.
- Samples of the outer label, inner label, and product insert.
- A CD containing the artwork (external, inner label, and insert) of the product.
These requirements aim to ensure compliance with quality, safety, and regulatory standards for the registration of drugs with the Ministry of Health.
The Ministry of Health has issued registration guidelines for registering and regulating medical devices in the UAE. These guidelines align with international standards, particularly those outlined in the US Food and Drug Administration regulations and the EU Medical Devices Directive (Directive 93/42/EEC).
Companies intending to export medical devices to the UAE must appoint a local representative or distributor who holds a valid license for a medical store.
The registration guidelines categorize medical devices into four different categories based on risk factors, such as the duration and method of device usage.
The appointed local representative or distributor is responsible for submitting a medical device registration application form to the Drug Control Department of the Ministry of Health. The application must be accompanied by the required documents, which include:
- Regulatory approval, including certificates of regulatory approval and clearance to manufacture, import, or export the device from the country of export.
- Risk assessment reports.
- The regulatory status of the device in other countries.
- Device details, including instructions, warnings, and contraindications.
- Labeling information.
- Declaration of Conformity to Safety Standards and other safety-related data, including clinical studies.
- Manufacturing process details.
- Other miscellaneous requirements.
If the application is approved, a registration number is issued, allowing the import and sale of the medical device. The registration is valid for five years.
These registration guidelines ensure that medical devices meet the necessary safety and regulatory standards before they can be legally imported and sold in the UAE market.
Federal Law Number 4 of 1983, also known as The Medicines Act 1983, applies to the following:
- Pharmaceutical establishments
- Import, manufacture, and distribution of pharmaceutical products
According to this law:
- Permission is required for pharmacies, medical stores, and medical factories, and they must obtain registration and a valid license from the Ministry of Health (MOH).
- Only licensed medical warehouses and pharmacies are allowed to import and distribute pharmaceutical products. The applicants for a pharmacy or medical store license must be UAE nationals.
- Any medical company intending to market its products in the UAE must register with the Ministry of Health, based on the recommendation of the pharmaceutical companies and pricing committee.
- The registration requirements vary depending on the type of products being marketed. The classification committee of the Ministry of Health determines the requirements based on the information provided by the applicant.
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