Importing medicines without permit to carry fines of up to MVR 100,000
Medicines may only be imported if they are registered with the MFDA and an import permit has been issued.
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The Maldives Food and Drug Authority (MFDA) has introduced new regulations governing the import, sale, storage and disposal of medicines, including fines of up to MVR 100,000 for importing medicines without the required authorisation.
The regulation, published last week, establishes national requirements for pharmaceutical products and businesses operating within the sector.
According to the MFDA, the regulation aims to ensure that medicines available in the Maldives are safe, effective and of the required quality, while preventing misuse and unauthorised trade.
Under the regulation, the MFDA must compile and publish a list of medicines approved for import and sale within 30 days of the regulation coming into force. The list must be reviewed at least once each year.
The regulation prohibits the import or attempted import of medicines that are not included on the approved list.
Approved medicines include prescription medicines, alternative medicines and traditional Maldivian medicine (Dhivehi beys). The regulation also prohibits the import or sale of unregistered alternative medicines and products marketed as treatments or intended to alter body functions unless they are included in the alternative medicine register.
Pharmaceutical manufacturers, importers, suppliers, warehouse operators, wholesalers, retailers and pharmacies are required to register with the MFDA and obtain the necessary approvals.
Medicines may only be imported if they are registered with the MFDA and an import permit has been issued.
Applications to register medicines may only be submitted by Maldivian citizens or companies with Maldivian shareholding. Import and sales permits will only be issued after the MFDA has assessed and approved the manufacturer.
The MFDA is also required to publish a register of approved pharmaceutical manufacturers within 90 days of the regulation taking effect.
The regulation gives the MFDA the authority, on the advice of the National Pharmaceutical Board, to suspend or blacklist manufacturers if medicines are recalled because of quality or safety concerns or if their use results in health risks.
It also prohibits the import of medicines from unregistered suppliers or manufacturers.
The regulation requires foreign pharmacists working in the Maldives to hold a Maldivian language proficiency certificate issued by the MFDA. Where such certification is not available, an interpreter must be present at the pharmacy.
Penalties for breaches of the regulation include warnings with a period to rectify non-compliance, fines ranging from MVR 10,000 to MVR 100,000, suspension of permits for periods between 14 days and one year, and cancellation of licences issued under the regulation.
The regulation will take effect 90 days after its publication. Medicines, businesses and facilities already registered or licensed before the regulation comes into force will continue to be recognised, provided they comply with the new requirements.
