UAE's new pharmacy law imposes fines up to AED 1 million for medicine violations

Federal Decree-Law No. 13 of 2024 imposes fines up to AED 1 million on pharmacies caught selling unlicensed or counterfeit medicines in the UAE.

The law, published in the Official Gazette in December 2024, replaces decades-old legislation and consolidates pharmaceutical oversight under the Ministry of Health and Prevention (MOHAP). Emirate-level regulators keep their licensing authority: the Dubai Health Authority (DHA) in Dubai and the Department of Health (DOH) in Abu Dhabi. The law takes effect 90 days from publication.

What the law covers

The decree-law sets a single regulatory standard for manufacturing, importing, exporting, storing, distributing, and dispensing pharmaceutical products across all seven emirates. It introduces mandatory electronic tracking of controlled substances, stricter cold-chain documentation requirements, and new rules for online pharmacy operations.

Penalties are tiered by severity:

• Operating a pharmacy without a valid licence: fines between AED 250,000 and AED 1 million
• Selling unregistered or counterfeit medicines: criminal prosecution plus financial penalties
• Dispensing prescription-only medications without a valid prescription: fines starting at AED 50,000
• Repeat offences: permanent licence revocation

The law also requires all pharmacies to employ at least one licensed pharmacist during operating hours. This targets the practice of pharmacy technicians dispensing medications unsupervised in smaller outlets. MOHAP data from 2023 showed the UAE had approximately 4,800 licensed pharmacies and 12,300 registered pharmacists.

Who bears the compliance burden

For hospital and clinic operators, the immediate concern is supply chain documentation. The law mandates end-to-end traceability for all pharmaceutical products from manufacturer to patient. Facilities that source medicines through parallel import channels or unlicensed distributors face the steepest penalties.

Pharmacy chains operating across multiple emirates will need to reconcile their compliance programmes with a single federal standard. Under the prior system, DHA, DOH, and MOHAP each ran separate pharmaceutical inspection regimes with varying enforcement intensity. The UAE pharmacy market was valued at approximately AED 14.2 billion in 2023, according to IQVIA data, with hospital pharmacies accounting for roughly 35% of total dispensing volume.

For health technology companies, the law's provisions on electronic prescriptions and digital pharmacy platforms impose new compliance requirements. Online pharmacy operators must now obtain a specific federal licence category, separate from their general trade licence, and maintain physical premises that meet MOHAP inspection standards. That same licensing structure opens a defined regulatory path for digital pharmacy entrants.

What comes next

MOHAP is expected to issue implementing regulations within six months of the law's effective date. These will cover pharmacy staffing ratios, controlled substance reporting formats, and technical standards for electronic prescription systems. The ministry has indicated it will establish a transitional compliance period, though the duration has not been specified.

Operators should begin auditing their pharmaceutical supply chains, prescription documentation processes, and pharmacist staffing levels now. The law sets a federal compliance baseline comparable to European Medicines Agency frameworks, and it applies to every facility that stores, handles, or dispenses medicines in the UAE.