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Myanmar Cosmetic Product Registration

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Myanmar Cosmetic Product Registration

COSMETIC REGISTRATION IN MYANMAR

Regulatory Authority

Department of Food, Health and Drug Administration

Link for Regulatory Authority

https://www.fda.gov.mm/

Local Regulation

Health Products Act and its Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations 2007 (the Regulations)

Who can Register?

An applicant must be a Myanmar resident. The applicant must be a resident representative of the foreign company if the producer is a foreign corporation.

 

Data to be Communicated

  • A company profile.
  • The product certificate in the World Health Organization (WHO) format for its certification scheme on the quality of products moving in international commerce. 
  • Good Manufacturing Practice (GMP) certificate
  • Photocopy of the production licence that has been adequately endorsed.
  • A pro forma statement (assessment of company financials)
  • A summary of the product information sheet.

For Importers and Distributors

  • A copy of the authorisation letter from the product owner or manufacturer.
  • A copy of business licence of the local company or certificate of incorporation.
  • Acknowledgement of cosmetic notification from the country of origin.
  • Complete ingredient listing and the percentage of restricted ingredients.
  • Complete original label one set (outer and immediate packaging)

For Manufacturers

  • A copy of the business licence of the manufacturer.
  • A copy of the private industrial registration certificate.
  • A photocopy of the cosmetic manufacturing licence.
  • Full ingredient listing and the percentage of restricted ingredients.
  • Complete original label one set (outer and immediate packaging)

Process to Register Cosmetic Product

A list of products for importation/manufacture must be entered in a registry book at the MFDA to begin registration. The foreign manufacturer must provide the local party with an authorization letter. Suppose the appointment letter is given to a local corporation rather than an individual. In that case, the letter of appointment must additionally name a company employee who is allowed to serve as a contact person.

Timeframe and Fees

According to the product category, the applicant must submit a letter of intent to pay assessment fees (US $100) and laboratory analysis fees (5,000 MMK). The applicant must pay the assessment fees to a Myanmar Foreign Trade Bank account. Registration expires and expires 21 days before the expiration date.

Additional Information

The name of the product, batch number, date of manufacturing, expiration date, quantity or volume, usage restrictions, and the manufacturer’s name and address must all be included on the label. In addition to the information listed above, the label must have a translation into the local language (Burmese), the Myanmar product notification number, and storage instructions. 

Cosmetic labels shall comply with the Directive 2019 and any other requirements instructed by the Food and Drug Administration.

Product Information File (PIF): The entity responsible for introducing the cosmetic product to the market must maintain the following information accessible to the FDA:

  • Copy of the Notification form and the original acknowledgment receipt from FDA.
  • Authorization letter from the product owner or related agreement letter.
  • License to operate and certificate of incorporation of the local company.
  • Quantitative composition of the product; for perfume compositions, the name and code of identity of the supplier.
  • Statement detailing the quality and functions of each raw material/ingredient.
  • Specifications of raw materials, including water, and finished product.
  • Manufacturing methods employed to verify the ingredients of cosmetic products, corresponding with the Certificate of Analysis.
  • Criteria for microbiological control of cosmetic products and chemical purity of ingredients, along with methods for verifying compliance with these criteria.
  • Quality control procedures for product, label, and packaging.
  • Stability testing data and report or stability assessment supporting the expiry date.
  • Manufacturing method compliant with ASEAN Guidelines for Cosmetic Good Manufacturing Practice (GMP), along with GMP Certificate from the country of origin.
  • Safety assessment for human health of the finished product, ingredients, chemical structure, and level of exposure (including a signed statement of opinion with the name and qualifications of the safety assessor).
  • Existing data on adverse effects on human health resulting from the use of the cosmetic product.
  • Supporting data for claimed benefits of cosmetic products based on composition or tests performed.
  • The product information file must be available in English and/or the national language.

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