Pharmaceutical Product Registration in Sri Lanka

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Pharmaceutical product registration in Sri Lanka is regulated by the National Medicines Regulatory Authority (NMRA) under the NMRA Act No. 5 of 2015. All pharmaceutical products, including prescription drugs, over-the-counter (OTC) medicines, biologicals, and herbal preparations, must be registered with the NMRA before being imported, marketed, or sold in the country. The registration process involves a thorough review of the product’s safety, efficacy, and quality based on submitted dossiers, which typically follow the Common Technical Document (CTD) format. Applicants must also submit Good Manufacturing Practice (GMP) certificates, product samples, labeling details, and evidence of regulatory approval from recognized authorities such as the US FDA or EMA.