New regulations have been established regarding the import, storage, and sale of medicines in the Maldives. Under these rules, parties in violation may face fines of up to MVR 100,000 and the suspension of their licenses. According to the regulation, the Maldives Food and Drug Authority (MFDA) is required to compile a registry of medicines used in the Maldives within 30 days. Additionally, all entities, from pharmaceutical manufacturers to pharmacies, are now mandated to register with the MFDA and obtain specific permits.
The regulation stipulates that controlled drugs can only be imported and sold under special authorization, and the importation of unregistered medicines is strictly prohibited. For those who breach these regulations, authorities are empowered to issue warnings, impose fines ranging from MVR 10,000 to MVR 100,000, and take further action such as the temporary suspension of permits or blacklisting. Individuals importing medicine for personal use are permitted to bring up to a six-month supply, provided they present valid medical records. This regulation will come into effect 90 days after its publication in the Government Gazette.
