Introduction
The UAE government recently issued a new Federal Decree-Law No. 38 of 2024 to regulate pharmaceutical establishments, the pharmacy profession, and medical products (new pharmaceutical law). Federal Law No. 8 of 2019 on medical products, pharmacy profession, and pharmaceutical establishments has been superseded by the new pharmaceutical law. On January 2, 2025, the new pharmaceutical law came into Effect.
Scope of the New Pharmaceutical Law
The new pharmaceutical law regulates pharmaceuticals, medical devices, preparations, healthcare, biological products, supplements, cosmetics, genetically modified organisms, chemical predecessors, pharmaceutical establishments, and biobanks. Contract research organizations and genetically modified organisms were included in the new pharmaceutical law.
Furthermore, the new pharmaceutical law applies to all pharmacy professionals who practice in the UAE, including free zones. Emirates Drug Establishment (EDE) replaces the Ministry of Health and Prevention (MOHAP) as the centralised regulatory authority responsible for the management of medical approvals and pharmaceutical surveillance.
Important Provisions Under the New Pharmaceutical Law
A pharmaceutical product is defined as one that contains active ingredients that fulfil its stated purpose through biological effects in accordance with Article 1. It is used for disease diagnosis, treatment, cure, relief, prevention, restoration, renewal, modification, or correction and includes biological products, nutritional supplements, and cosmetic preparations. The same article explains that pharmaceuticals made from living things are known as biological products. They consist of growth factors, vaccines, monoclonal antibodies, blood and plasma derivatives, therapy medications, and allergy detection products.
Furthermore, the law defines a biobank as a licensed establishment that collects, preserves, stores, and distributes biological samples such as blood, tissues, and cells, as well as associated information for future use. The umbilical cord blood banks, stem cell storage facilities and independent mobile blood banks are all included in this.
Marketing Approval for All Medical Products
According to Article 5, marketing approval is required for all medical products unless exempted to ensure quality, safety, and efficacy. The establishment may grant exclusive marketing rights as per Article 4 for specific products as well as conditional marketing approval as per Articles 8-10. In addition to this, an establishment may allow emergency use authorization for rare diseases, life-threatening conditions, or health emergencies under strict monitoring, which is described under Articles 11-13. Marketing approval is valid for 5 years and is renewable as per Article 7. However, according to Article 15, if there is an extensive change in the product, it is required to take reapproval. The establishment may also have the right to cancel the approval if the product is unsafe, unavailable, or obtained fraudulently.
Pharmaceutical Policy Committee
According to Article 36, the newly established pharmaceutical policy committee has the right to oversee pricing and circulation policies and monitoring of medical products. In accordance with Article 39, it is legally prohibited to use counterfeit, defective, or expired products. Furthermore, the new pharmaceutical law regulates the import and export of medical products. Pharmacy activities must be licensed in accordance with Articles 71–80. The ministry and health authorities are responsible for approving and maintaining national and local registers.
Pharmacists must follow ethical and professional guidelines that ensure accuracy, confidentiality, and patient safety. Article 75 prohibits pharmacists from engaging in unfair practices, such as selling duplicate or expired medicines, altering prescriptions, or dispensing restricted drugs without authorization. In addition to this, Article 76 says that all medical prescriptions must be clear, properly formatted, and include patient and doctor details. Pharmacists cannot modify prescriptions without a doctor’s written consent and must verify any errors with the prescribing physician. All controlled substance prescriptions must be recorded in the national tracking system (Article 81). Additionally, as per Article 82, healthcare professionals are restricted from prescribing controlled drugs for themselves or close relatives.
Penalties Under the New Pharmaceutical Law
The new pharmaceutical law implemented strict rules and regulations for pharmaceutical companies, biobanks, and pharmacists. The new law specifies various disciplinary penalties for pharmaceutical companies and pharmacists who violate rules. In accordance with Article 160, authorities may impose temporary suspensions, license cancellations, warnings, and fines between AED 1,000 and AED 1,000,000. Additionally, licensed pharmacists may face similar penalties, including fines of up to AED 500,000 and suspension from services for up to one year. As per Article 162, the affected parties may appeal penalties within 15 days, and decisions are made within 30 days. However, disciplinary actions do not exempt violators from criminal or civil liability. As per Article 168, courts may authorise the imposition of additional penalties like business closures or confiscation of illegal products.
In addition, the criminal penalties may apply to serious violations like forgery, illegal pharmacy operations, and handling unauthorized substances (Articles 164–167). Punishments include jail sentences from six months to 5 years and fines from AED 50,000 to AED 1,000,000. Selling duplicate medicine, smuggling, or using prohibited chemicals can lead to life imprisonment. Operating a pharmacy without a license or working without proper approval may also carry fines and jail sentences, and repeat offenders may face severe penalties.
Conclusion
The new pharmaceutical law seeks to improve the country’s role in the medical and pharmaceutical sectors. Its main priorities are controlling pharmaceutical practices, guaranteeing regular supplies of vital medications, and promoting invention. In order to maintain the highest standards in healthcare services, the new law also specifies fines and license suspensions for violations.
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