Myanmar Cosmetic Regulations

April 3, 2013 | Contact Author | By: To Yo Be, Contributing Author and Consultant
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Keywords: Myanmar | ASEAN | MFDA | cosmetic regulation | application | registration | documents | labeling

Abstract: Myanmar is a member state of the ASEAN community and must abide by ASEAN Cosmetic Directive; however, like other member states, it has local regulatory bodies such as the Ministry of Health that supervise goods sold in the country.

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TY Be, Myanmar cosmetic regulations, Cosm & Toil 128(2) 72 (Feb 2013)

Myanmar is a member state of the ASEAN community and must abide by ASEAN Cosmetic Directive; however, like other member states, it has local regulatory bodies such as the Ministry of Health that supervise goods sold in the country. Specifically, cosmetic products are governed by the Ministry of Health’s Public Health Law of 1972 (the PH Law).

Cosmetic products must occasionally conform with general standards enacted by the government with reference to guidelines enforced by the U.S. Food and Drug Administration (FDA) and the ASEAN Cosmetic Directive. In addition, the PH Law allows Myanmar to create a regulatory authority that has the power to seize harmful personal goods, household goods and cosmetics from the market and destroy them. However, neither formal versions of standards nor a regulatory authority have been formally established, making cosmetic regulation in Myanmar a future task.

The Food and Drug Administration (MFDA) in Myanmar is concerned mainly with drug registrations and is not involved with the other items such as personal goods, household goods and cosmetics. Nonetheless, medicated shampoos and medicated soaps can be registered with the FDA, which is expected to commence registration of cosmetics in near future. Classification of cosmetics that are medicinal, have drug-related claims and functional properties are supposed to mirror the ASEAN Cosmetics Directive, with influence from the FDA. It is important to note that this classification is subject to local regulatory bodies, which can adopt the ASEAN Cosmetic Directive but act according to FDA guidelines. Therefore, it is important for manufacturers, importers, exporters and distributors of cosmetic ingredients and products to be aware of the MFDA’s relevant regulation. To meet the required registration with the MFDA, raw materials or drugs must meet the following criteria.

• An applicant must be a resident of Myanmar. If the producer is a foreign company, the applicant must be a resident representative of the foreign company.

• An authorization letter must be given by the foreign manufacturer to the local party. If such a letter is granted to a local company, rather than an individual, an employee of the company who is authorized to serve as a contact person must also be designated in the letter of appointment.

• 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.