The Maldives Food and Drug Authority (MFDA) has amended the regulations governing medicines, introducing stricter penalties for unauthorised imports, including fines of up to MVR 100,000 and the suspension of licences.

The amended regulations, published by the MFDA yesterday, set out the procedures governing the import, export, manufacture, donation, sale and dispensing of medicines. They also outline the requirements for registering and licensing pharmacies and other establishments involved in handling medicines, as well as standards for the storage of medicines at every stage of the supply chain.

The regulations aim to ensure that medicines available to the public are safe, effective and of good quality, while preventing the misuse of medicines and unauthorised pharmaceutical activities. They also seek to prevent the import of medicines unsuitable for human use and counterfeit medicines into the Maldives.

In addition, the regulations require pharmacies and healthcare facilities to maintain stocks of essential medicines. They also establish licensing requirements for medicine importers and pharmacies, require inspections to ensure compliance with the regulations, and mandate that medicine manufacturers comply with Good Manufacturing Practices.

Under the regulations, anyone found importing medicines in violation of the rules may be fined between MVR 10,000 and MVR 100,000, while their licence may be suspended for 14 days. The MFDA is also authorised to blacklist companies that provide false information when registering medicines. Blacklisted companies may only apply for registration again after six months.

The regulations also specify circumstances under which pharmacy licences may be revoked. These include supplying medicines that are not considered safe for public health, failing to commence operations within six months of pharmacy registration, and keeping a pharmacy closed for more than three months after obtaining a licence to dispense prescription medicines. Licences may also be cancelled if medicines are handled by individuals who are not authorised to do so, or if poor cleanliness at medicine storage facilities raises concerns about the safety of the medicines stored there.

The amended regulations also set limits on the quantity of medicines individuals may import for personal use. A person may import up to a three-month supply of medicine for personal use, while a supply of up to six months may be imported upon submission of the patient's medical records.

The regulations will be implemented by the Maldives Food and Drug Authority on the advice of the National Pharmaceutical Board.