MFDA introduces stricter regulations for pharmacies and medicine sales
Maldives Food and Drug Authority (MFDA) has introduced new regulations that will tighten controls on the sale and distribution of medicines, including restrictions on retail and online sales, taking effect on 22nd October.
Issued under the Health Services Act, the Medicines Regulation establishes updated requirements for the import, storage, dispensing, and sale of medicines across the country.
Under the regulation, medicines classified by the MFDA may no longer be sold in general retail shops without prior approval from the authority.
Certain non-prescription medicines may still be sold, but only with MFDA authorization and under specified conditions.
The regulation also requires all pharmacies to be registered with the MFDA and licensed every three years.
Pharmacies storing vaccines or biological products must notify the authority, while licensed pharmacists are required to hold a valid MFDA-issued Pharmacist Card.
Foreign pharmacists must also meet the authority's Dhivehi language requirements or work with an interpreter.
Online sales and home delivery of medicines will be limited to MFDA-authorized providers.
Only medicines approved for import into the Maldives and those that do not require a prescription may be sold through online platforms.
The regulation also introduces new standards for prescriptions, medicine labeling, and pharmacy operations.
Violations may result in fines ranging from MVR 10,000 to MVR 100,000, depending on the nature and severity of the offense.