{"id":7859,"date":"2022-11-15T14:30:00","date_gmt":"2022-11-15T06:30:00","guid":{"rendered":"https:\/\/credevo.com\/articles\/?p=7859"},"modified":"2023-05-31T20:22:51","modified_gmt":"2023-05-31T12:22:51","slug":"myanmar-nutraceutical-food-supplements-otc-products-regulatory","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2022\/11\/15\/myanmar-nutraceutical-food-supplements-otc-products-regulatory\/","title":{"rendered":"Myanmar Nutraceutical, Food Supplements & OTC Products Regulatory"},"content":{"rendered":"\n

Myanmar depends on imports for nutraceutical supplements and over-the-counter products. The nutraceutical supplements market in Myanmar is very competitive. Pharmaceutical spending is growing at double-digit growth, and researchers expect it to reach USD 1.1 billion valuations by 2023.<\/p>\n\n\n\n

\"Nutraceutical,<\/figure><\/div>\n\n\n\n

Considering the huge opportunities in Myanmar, many companies are showing interest in registering and marketing their products (particularly nutraceutical and over-the-counter). So let us understand the regulations to register nutraceutical and over-the-counter products in Myanmar.<\/p>\n\n\n\n

The regulatory authority in Myanmar<\/h2>\n\n\n\n

The Food and Drug Administration is the regulatory body in Myanmar<\/a>. The Myanmar FDA ensures to maintain the safety and quality of food, drugs, medical devices, and cosmetics.<\/p>\n\n\n\n

The food control division of the FDA oversees and is responsible for registering OTC and food supplement products.<\/p>\n\n\n\n

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Click here to find out the regulations to register your Pharmaceutical products & vaccines in Myanmar<\/a><\/p>\n\n\n\n

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Do you need a local resident for registration?<\/h2>\n\n\n\n

Yes, the applicant must be a Myanmar resident. Foreign manufacturers shall appoint and sign an agreement with the Myanmar resident to register their products in Myanmar.<\/p>\n\n\n\n

How Myanmar regulatory differentiates foods and drugs?<\/h2>\n\n\n\n

Whether a product comes under a drug or a food supplement depends on the manufacturer’s claims on the product labels, leaflets, or promotional materials. The Myanmar FDA considers the product a drug if the product claims to mitigate or treat disease.<\/p>\n\n\n\n

Registration of OTC & Food Supplements<\/h2>\n\n\n\n

Requirements for registration of OTC & Food Supplements<\/h3>\n\n\n\n
  • The sponsor needs to prepare the dossier in ASEAN Common Technical Dossier Format (ACTD)<\/li>
  • The dossier shall contain two parts
    • Administrative Part (Administrative documents and product information) & <\/li>
    • Quality part (Quality documents for drug substance and drug product).<\/li><\/ul><\/li><\/ul>\n\n\n\n

      The administrative part of documents include<\/h4>\n\n\n\n
      • Letter of Authorization<\/li>
      • Free Sale Certificate (Original) issued by the competent authority in the country of origin<\/li>
      • Properly endorsed\/ Legalization of Manufacturing License copy<\/li>
      • ISO Certificate (Standard)<\/li><\/ul>\n\n\n\n

        Quality part<\/h4>\n\n\n\n
        • Raw Material Specification, Source of raw material<\/li>
        • Raw Material quality control<\/li>
        • Master Formula<\/li>
        • Manufacturing process<\/li>
        • Finished product specification<\/li>
        • Reference Text<\/li>
        • Certificate of Analysis (Finished product)<\/li>
        • Stability test of the finished product<\/li><\/ul>\n\n\n\n

          Safety & efficacy data<\/h4>\n\n\n\n
          • The action of Active Ingredient, if any:<\/li>
          • Safety data of finished product<\/li>
          • Research Paper\/ Literature of Food Supplement (endorsed by a DFDA-Recognized Research Institute)<\/li><\/ul>\n\n\n\n

            Note: FDA accepts only a maximum file size of 3 MB for each file and 100 MB for the whole dossier. PDF files are preferable to upload<\/em><\/strong>.<\/p>\n\n\n\n

            Procedure for registration of OTC & Food Supplements<\/h2>\n\n\n\n
            • The applicant shall submit the finished product specification along with the LOA.<\/li>
            • Once the FDA approves the import permit, the manufacturer or the sponsor shall send the product samples with its COAs and submit them to the Myanmar FDA.<\/li>
            • The sponsor should note that the product shelf life shall be three \/ a fourth of the whole shelf life of the product applied for registration.<\/li>
            • The applicant shall submit the dossier along with a soft copy of the dossier to the Myanmar FDA.<\/li>
            • Once the FDA receives the dossier and the application, the applicant shall remit the assessment and laboratory fee.<\/li>
            • After payment of the fee, the applicant shall wait for a reply from the FDA. The FDA may ask for any additional requirements.<\/li>
            • If there are no requirements for the FDA, FDA goes for final evaluation.<\/li>
            • The FDA issues product approval and notifies the applicant.<\/li>
            • After remittance of the fee (which shall be done within three months, and failing to do so will cancel the application form), the applicant receives the DRC from the FDA.<\/li><\/ul>\n\n\n\n

              Fee for registration of OTC & Food Supplements<\/h2>\n\n\n\n
              Assessment fees<\/td>MMK 300,000<\/td><\/tr>
              Laboratory fees<\/td>MMK 130.000 \u2013 MMK 650,000 (Depending on the product)<\/td><\/tr>
              Registration fees<\/td>MMK 500,000<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

              Approval timeline<\/h3>\n\n\n\n

              The approval process takes about 18-24 months with a validity of 5 years.<\/p>\n\n\n\n

              Registration Dietary Supplement, Functional Food Supplement and Health Supplement Registration<\/h2>\n\n\n\n

              Requirements for registration Dietary Supplement, Functional Food Supplement, and Health Supplement Registration<\/h3>\n\n\n\n
              • Letter of Authorization<\/li>
              • Finished Product Specification<\/li>
              • List of Ingredients \/ Q and Q Formula<\/li>
              • Free Sale Certificate\/ GMP Certificate\/ Manufacturing License\/ Other Certificates<\/li>
              • Health Certificate or Certificate of Analysis (COA)<\/li>
              • Product Label Artwork<\/li><\/ul>\n\n\n\n

                Fee for registration<\/h3>\n\n\n\n

                The registration fee for Dietary Supplements, Functional Food Supplements, and Health supplements is MMK 500,000.<\/p>\n\n\n\n

                Import<\/h3>\n\n\n\n

                After approval, the FDA issues import recommendation letters for Dietary supplements, Functional Food supplements, and Health supplements.<\/p>\n\n\n\n

                Approval timeline<\/h3>\n\n\n\n

                The approval process takes about 3 months with a validity of 2 years.<\/p>\n\n\n\n

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                Do You Have More Questions About Nutraceutical & Food Regulatory In Myanmar?<\/h2>\n\n\n\n

                Do you need support to register your nutraceuticals and food supplements in Myanmar? Provide your required details below to connect with us and explore our services.<\/p>\n\n\n