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Medicines stocked inside a pharmacy - Photo: Maazy Chemist

The Maldives Food and Drug Authority (MFDA) has published new pharmaceutical regulations establishing hefty fines of up to MVR 100,000, 14-day license suspensions, and corporate blacklisting for unauthorized medicine imports.

The newly gazetted framework outlines strict procedures for medicine disposal, confiscation, prohibited activities, and legal penalties aimed at guaranteeing public health safety across the pharmaceutical supply chain.

Under the new regulations, any entity importing pharmaceuticals without proper authorization faces a fine ranging between MVR 10,000 and MVR 100,000, along with a mandatory 14-day suspension of their import permit or license. Additionally, the MFDA now holds explicit authority to blacklist companies that provide false information during medicine registration.

Once blacklisted, an importer or company must wait a minimum of six months before becoming eligible to reapply for service registration. The new regulation will officially take effect 90 days from its publication date.

Key Regulatory Guidelines & Penalties

• Unauthorized Import Fine: MVR 10,000 to MVR 100,000.

• License Suspension: 14-day suspension for import violations.

• Blacklisting Re-application Wait Period: 6 months after being blacklisted for providing fraudulent registration information.

• Personal Medicine Imports: Limited to a maximum 3-month supply (extension up to 6 months allowed upon submitting verified patient medical records).

• Pharmacy Permit Cancellation Triggers:

  • Failure to start services within 6 months of pharmacy registration.

  • Remaining inactive or closed for more than 3 consecutive months after receiving a prescription medicine sales permit.

  • Unsanitary storage conditions that compromise

    medicine safety.

  • Transactions conducted by unauthorized or unlicensed personnel inside pharmacy premises.

• Implementation Timeline: Comes into force 90 days after gazetting

Strengthening Public Health Safeguards

The regulation empowers authorities to immediately revoke or suspend licenses if pharmaceutical transactions endanger public safety or breach regulatory standards.

Pharmacies failing to maintain adequate hygiene standards, risking the safety of stored medicines, will face immediate permit cancellation. Furthermore, any transaction carried out by personnel lacking proper authorization to dispense medicines will result in the immediate revocation of the establishment's permit.

For individuals bringing in pharmaceuticals for personal use, the rule sets a standard limit of a three-month supply. However, patients who present official medical records can request permission to import up to a six-month supply.