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.
Considering the huge opportunities in Mynamar, many companies are looking forward to 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.
Regulatory authority in Myanmar
The Food and Drug Administration is the regulatory body in Myanmar. It was established in 1995, The Mynamar FDA ensures the safety and quality of food, drugs, medical devices, and cosmetics.
The food control division of the FDA oversees and takes the responsibility for registering OTC and food supplement products.
Do you need a local resident for registration?
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.
How Myanmar regulatory differentiates foods and drugs?
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.
Registration of OTC & Food Supplements
Requirements for registration of OTC & Food Supplements
- The sponsor needs to prepare the dossier in ASEAN Common Technical Dossier Format (ACTD)
- The dossier shall contain two parts
- Administrative Part (Administrative documents and product information) &
- Quality part (Quality documents for drug substance and drug product).
Administrative part of documents include
- Letter of Authorization
- Free Sale Certificate (Original) issued by the competent authority in the country of origin
- Properly endorsed/ Legalization of Manufacturing License copy
- ISO Certificate (Standard)
- Raw Material Specification, Source of raw material
- Raw Material quality control
- Master Formula
- Manufacturing process
- Finished product specification
- Reference Text
- Certificate of Analysis (Finished product)
- Stability test of the finished product
Safety & efficacy data
- The action of Active Ingredient, if any:
- Safety data of finished product
- Research Paper/ Literature of Food Supplement (endorsed by a DFDA-Recognized Research Institute)
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.
Procedure for registration of OTC & Food Supplements
- The applicant shall submit the finished product specification along with the LOA.
- 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.
- 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.
- The applicant needs to submit the dossier along with a soft copy to the Myanmar FDA.
- Once the FDA receives the dossier and the application, the applicant shall remit the assessment and laboratory fee.
- After payment of the fee, the applicant needs to wait for the reply from the FDA. The FDA may ask for any additional requirements.
- If there are no requirements for the FDA, FDA goes for final evaluation.
- The FDA issues product approval and notifies the applicant.
- 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.
Fee for registration of OTC & Food Supplements
|Assessment fees||MMK 300,000|
|Laboratory fees||MMK 130.000 – MMK 650,000 (Depending on the product)|
|Registration fees||MMK 500,000|
The approval process takes about 18-24 months with a validity of 5 years.
Registration Dietary Supplement, Functional Food Supplement and Health Supplement Registration
Requirements for registration Dietary Supplement, Functional Food Supplement, and Health Supplement Registration
- Letter of Authorization
- Finished Product Specification
- List of Ingredients / Q and Q Formula
- Free Sale Certificate/ GMP Certificate/ Manufacturing License/ Other Certificates
- Health Certificate or Certificate of Analysis (COA)
- Product Label Artwork
Fee for registration
The registration fee for Dietary Supplements, Functional Food Supplements, and Health supplements is MMK 500,000.
After approval, the FDA issues import recommendation letters for Dietary supplements, Functional Food supplements, and Health supplements.
The approval process takes about 3 months with a validity of 2 years.
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