Cosmetic Regulation in Myanmar Decoded
Discover the cosmetic regulation scenario in Myanmar with insights on the implementation of the notification system, required documents, challenges, and collaboration efforts to ensure compliance with ACD requirements. Stay informed and compliant in the cosmetic industry in Myanmar.
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OVERVIEW OF COSMETIC REGULATION IN MYANMAR Dr Nwe Oo FDA
1. Implementation of the cosmetic Product notification system for placement of Cosmetic Products In Myanmar the new cosmetic regulation aligned with the ACD - promulgated on 15thOctober 2010. the cosmetic notification system - 1st January 2011.
the notification process -- hard copies with ASEAN notification template. The current notification certificate valid for two years FDA trying to upgrade the manual system to electronic online system (supported by ASEAN Regional Integration Supported by the European Union - ARISE).
II. The required documents submitted for notification The letter of authorization from owner or manufacturer Business License of local company full ingredient list with the percentage of restricted substances.
The copy of free sale certificate from the country of origin or copy of acknowledgement of cosmetic notification from any other ASEAN country. (to prevent counterfeit & clearly differentiate from pharmaceuticals if there is query on the products)
The acknowledgement of cosmetic notifications can delay due to incomplete information (ingredient list provided in the notification form including the concentration of the restricted ingredients) If no query for ingredient list - FDA can issue the certificate of acknowledgement of notification within 7-8 working days.
The number of acknowledgement of notification is still too low compared to the cosmetic products placed in the market FDA collaborate with the Ministry of Trade , Customs and other relevant authorities to ensure all cosmetic products in Myanmar market are notified & comply with the ACD requirements
The mutual collaboration established between these Ministries at the entry points - monitor the status of the imported products & the parallel importers particularly on unauthorized importations. Consequently, the notified cosmetic products would gain free movement at across the borders.
III. Post Market Surveillance Difficulties in PMS activities - lack of manpower - up to date schedule Due to limited facilities ,testing only for the presence of hydroquinone ,retinoic acid and steroids
PMS activities have shown that some acknowledged products still do not comply with the ASEAN labeling requirements especially in languages
FDA inform the local importer company for writing to amend the labeling in English language. Nowadays, there is no PIF audit because of poor experience in auditing for regulators and lack of human resources.
