Your Guide to Myanmar
Here below we help you dive deep into the regulatory requirements of Myanmar and answer some of the basic questions.
Still confused with the complete process? - Genedrift assists you with all regulatory requirements as mentioned.
Guide to Drugs
The registration - from start to end !
The registration process is mostly paper driven, however, at certain steps e Submissions are permitted.
The process requires for first submission of a Brand Name Clearance / Assessment Approval, which is followed by payment of fees.
The Brand Name Clearance is valid for 2 months from the date of approval and can be applied only through a local agent.
No Dossiers or Samples are required until Samples permit has been obtained form the FDA.
The complete process usually takes between 20 to 26 months
Site Audits are not required. Only WHO GMP / GMP / cGMP Stating compliance with WHO TRS Certificate and COPP is sufficient to proceed for registration.
Document - Checklist
The FDA follows a slightly modified form of ACTD Guidelines, with various changes in Module 1 and minor changes in other sections. A checklist for the Dossier is enclosed. The checklist is same for Drugs / Biological / Biosimilars. While the checklist is same even for OTCs, the content required in each section varies with the category. FDA accepts only stability studies conducted under Zone IV B stability conditions. Three batches with 6 months accelerated and minimum 12 months real-time stability data along with commitment letter is required.
Need our assistance ! We, at Genedrift can handle this for you.
Click here to download the checklist.
Guide to Food, Medical Devices, Cosmetics
The process for Food, Medical Devices and Cosmetics is different from Drugs. In the latter, we are issued a Registration Certificate (DRC), whereas for others, we are issued an Import Recommendation (IR). Depending on the class, type and other other factors, the IR is valid for 1 to 3 years.
The process is with some parts online, while rest all offline and paper based.
The complete process takes less than 3 months.
The FDA requires only a limited set of documents to review and permit IR for Food and Cosmetics.
A Checklist for Food is here.
However, the FDA is very careful in reviewing the Certificate of Analysis of Finished Food Products and limits of heavy metes.
For a detailed guide on the application with FDA, get in touch with us.
Click here to download the checklist
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