Government Introduces Simplified Approach to Importing Medicines

Maldives government introduced its National Medicine Policy, a set of guidelines aimed at easing the importation of high-quality medications. Developed by the Maldives Food and Drug Authority (MFDA), the policy lays out a six-year plan to ensure accessible and discrimination-free availability of quality medicine.

A notable change involves simplifying import procedures for drugs originating from countries recognized by the World Health Organization as having strong drug regulatory systems. The MFDA will provide specific guidelines for implementation.

According to an MFDA representative, significant concessions are being considered for medication imports from these “Category 1” countries. The initial list includes 45 nations across Europe and Asia, such as Malaysia and Singapore, with 18 already holding Category 1 status.

Under the new policy, importers from Category 1 countries may only need to submit a Good Manufacturing Practice (GMP) license, drug stability documentation, and a sample. Current procedures often involve extensive paperwork, including confidential company information, causing concerns among pharmacy operators about hindrances in importing quality medicines.

An MFDA official highlighted that the existing process requires up to 45 documents and could take 90 days for approval. The new policy aims to significantly reduce the registration time frame to a maximum of 15 days.

Detailed guidelines from the MFDA are expected within a month. The anticipated result is an improved quality control system and a more efficient import process for medications in the Maldives.

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