The Maldives Food and Drug Authority (MFDA) has introduced new regulations prohibiting the sale of medicines in general retail shops without its approval and restricting the online sale and delivery of medicines to authorised providers, with the rules set to take effect on 22 October.
The new Medicines Regulation, published by the MFDA, sets out the requirements for the import, storage and sale of medicines. Issued under the Health Services Act, the regulation also establishes standards governing the sale of medicines.
Under the regulation, any product classified as a medicine by the MFDA may not be stocked or sold in general retail shops without prior approval from the authority. However, the regulation allows certain non-prescription medicines to be sold in general retail shops, subject to MFDA approval and specified conditions.
Previously, general retail shops were permitted to sell selected over-the-counter medicines without obtaining additional approval. These shops commonly sold medicines used to treat fever and common illnesses.
The regulation requires all pharmacies selling medicines to be registered with the MFDA and sets out the standards they must meet. Pharmacies are classified into two categories: pharmacies operating within healthcare facilities and standalone pharmacies.
It also requires pharmacies that store vaccines or biological products to notify the MFDA in writing.
Licences to operate pharmacies will be issued for a period of three years. The regulation also requires pharmacy operators to notify the MFDA if pharmacy services are temporarily suspended or if there are any changes to the pharmacy during the licence period.
The regulation states that pharmacists must hold a valid Pharmacist Card issued by the MFDA to practise at a registered pharmacy.
Foreign pharmacists are also required to obtain documentation issued by the MFDA confirming their ability to communicate in Dhivehi. If they do not possess such documentation, the pharmacy must employ an additional staff member capable of providing interpretation services.
Under the new regulation, medicines may only be sold or delivered online by providers registered with the MFDA and authorised to offer the service. Online sales are limited to medicines that are approved for import into the Maldives and may be sold without a doctor's prescription.
The regulation also specifies the information that must be included on prescriptions and sets out the labelling requirements for medicines dispensed by pharmacies.
The MFDA has been granted the authority to impose fines ranging from MVR 10,000 to MVR 100,000 for violations of the regulation, depending on the severity of the offence.