The Maldives Food and Drug Authority (MFDA) has introduced new drug regulations that impose fines of up to MVR 100,000 for importing medicines without the required authorization.

Under the regulations, published in the Government Gazette yesterday, individuals or businesses that import medicines without authorization face fines ranging from MVR 10,000 to MVR 100,000 and have their licences or permits suspended for 14 days.

The regulations also empower the MFDA to blacklist companies that provide false information when registering pharmaceutical products.

In addition, a pharmacy's licence may be temporarily suspended if it fails to begin operations within six months of registration. Pharmacies authorized to sell prescription medicines may also have their licences temporarily revoked if they cease operations for more than three months.

The regulations allow individuals to import medicines for personal use. Long-term users may import up to three months' supply of medication, while up to six months' supply may be imported if supported by the patient's medical records.

The new regulations will come into force 90 days after their publication in the Government Gazette. Drug importers and pharmacies will be required to re-register under the new framework.