Myanmar Cosmetic Regulations

By: To Yo Be, Contributing Author and Consultant

Posted: January 7, 2013

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• Registration must be initiated by entering a list of products for importation/manufacture in a registry book at the MFDA. The applicant must submit a letter of intent for payment of assessment fees (US $100) including those for laboratory analysis (5,000 MMK) according to the category of the product. Thereafter, the applicant must pay such assessment fees to a designated account at Myanmar Foreign Trade Bank

• Administrative documents required include: the letter of authorization mentioned above, a company profile, the product certificate in a format adopted by the World Health Organization (WHO) for its certification scheme on the quality of the product moving in international commerce, a Good Manufacturing Practice (GMP) certificate, properly endorsed photo-copy of the manufacturing license, a pro forma statement (assessment of company financials) and a summary of the product information sheet. These documents are to state: the name of product including the brand, the formula and composition with justification for its registration to local authorities, data on physical and chemical properties, analytical methods for active substances (if any), information/documents relating to quality control of raw materials, manufacturing process, standard procedure for in-process quality control, finished product specifications and packaging specifications.

• Labeling must include: the name of the product, batch number, date of manufacture, expiration date, quantity or volume, usage conditions and name and address of manufacturer. In addition to the above mentioned particulars, a translation into local language (Burmese), Myanmar product notification number and storage conditions must be shown on the label.