MFDA Bans Unauthorized Online Medicine Sales and Retail Shop Distribution

The Maldives Food and Drug Authority (MFDA) has announced new regulations banning the unauthorized sale of medicines in general retail shops and restricting online delivery to approved providers. The new rules, which take effect on October 22, aim to tighten the oversight of how medicines are imported, stored, and distributed across the archipelago. Under the new framework, issued under the Health Services Act, general retail shops are prohibited from stocking or selling any product classified as a medicine without prior MFDA approval. This marks a significant shift from previous practices, where retail shops commonly sold various over-the-counter medicines for fever and common ailments without additional authorization. While some non-prescription medicines may still be sold in these shops, they will now be subject to strict conditions and MFDA clearance. The regulations also bring digital healthcare commerce under tighter control. Medicines may now only be sold or delivered online by MFDA-registered providers. Furthermore, online sales are strictly limited to medicines approved for import that do not require a doctor's prescription. To ensure professional standards, all pharmacies—whether operating within healthcare facilities or as standalone entities—must be registered with the MFDA. Pharmacy licenses will be issued for three-year periods. The MFDA now requires pharmacists to hold a valid Pharmacist Card to practice. In a move to ensure patient safety and clear communication, foreign pharmacists must provide documentation proving their proficiency in Dhivehi; otherwise, the pharmacy must employ a dedicated interpreter. Additional requirements include mandatory written notification to the MFDA for pharmacies storing vaccines or biological products, as well as strict new standards for prescription information and medicine labeling. To enforce these measures, the MFDA has been granted the authority to impose substantial financial penalties. Depending on the severity of the violation, offenders could face fines ranging from MVR 10,000 to MVR 100,000.