- The MFDA's new Regulation for Medicinal Drugs, published 25 July, takes effect 90 days later, requiring all premises selling medicines to register with the authority.
- The regulation mandates licensed premises, authorised personnel, valid prescriptions for prescription medicines, and an annually reviewed Approved Drug Register limiting imports.
- Violations carry fines from MVR 10,000 to MVR 100,000, plus warnings, licence suspensions of 14 days to one year, or cancellation.
The Maldives Food and Drug Authority (MFDA) has introduced a new regulation governing the import, sale, manufacture, prescription and distribution of medicinal drugs, prohibiting the sale of medicines at unregistered premises and imposing penalties of up to MVR 100,000 for violations.
The Regulation for Medicinal Drugs was published in the Government Gazette on 25 July and will come into force 90 days after its publication.
Issued under the Health Services Act, the regulation establishes rules for the registration and licensing of medicines, pharmacies and other businesses dealing in medicines. It also sets standards for importing, exporting, manufacturing, prescribing, storing, transporting and handling medicines in the Maldives.
Under the new rules, all premises selling medicines must be registered with the MFDA before they can operate. Applications must be submitted through the authority’s online portal and include a floor plan, location plan and business registration documents.
Registered pharmacies will also be required to have a responsible pharmacist present whenever medicines are being dispensed and throughout operating hours.
The regulation states that all medicines may only be sold or dispensed at licensed premises by authorised personnel. Prescription medicines can only be sold with a valid prescription, while over-the-counter (OTC) medicines listed in the MFDA’s Approved Drug Register may be sold without one.
The MFDA will publish and maintain an Approved Drug Register listing medicines permitted to be imported and sold in the Maldives. The register, which will be reviewed at least once a year, will classify medicines into medicinal drugs and traditional or alternative medicines. Importing medicines that are not included in the register will be prohibited.
Medicinal drugs covered by the regulation include prescription medicines, OTC medicines, controlled drugs, biological products, vaccines under the national immunisation programme, contrast media and dialysis solutions.
The regulation also introduces new dispensing requirements. Pharmacies must provide labels with usage instructions, supply information on storage and possible side effects, and issue receipts containing details such as the medicine’s name, strength, batch number, expiry date, quantity, price and the name of the person who dispensed it.
Pharmacies will be charged MVR 1,500 to register as a Grade 1 medicine seller and MVR 1,000 to renew the registration. Registration for Grade 2 medicine sellers will cost MVR 1,000, while renewal will cost MVR 500.
Under the enforcement provisions, the MFDA may issue warnings requiring corrective action, impose fines ranging from MVR 10,000 to MVR 100,000, suspend licences for between 14 days and one year, or cancel licences altogether, depending on the severity of the violation.
