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Request Drugs FDA in Thailand

Drug-Sample
Drug-SampleFDA

Description

Services

Under FDA Drugs, we provide services for four categories which are as below
1. Generic drugs registration
2. Manufacture for generic drugs / traditional drugs
3. Import generic drugs / traditional drugs
4. Selling generic drugs / traditional drugs

Government fee
• Checklist and Self-Assessment Report 500
• Approval letter for manufacturing generic drugs 8,000
• Approval letter for manufacturing traditional drugs 1,000
• Approval letter for importing generic drugs 10,000
• Approval letter for importing traditional drugs 5,000
• Approval letter for selling generic drugs 2,000
• Approval letter for selling traditional drugs 300
• Approval letter for selling drugs for animals 1,000
• Submit request for manufacture or import sample drug 100/300
• Submit request for generic drug 500/1000/25000
• Evaluation of academic documents 1500 – 395,000
(Days of checking 80 -280)
• Approval letter of registration 500/2,000

Procedure and Timeline
1. We will discuss with the client to check the documents that you have and we will prepare the documents that you need to be filled.
2. We will apply to Thai FDA.
3. Thai FDA will inspect the documents and will request more documents from us if necessary.
4. We will get the registration certificate.
It will take 10-11 working days in order to finish the process and get approved from the officer for the paper checking.
Note: For inspection of inventory or required more documents, the time may be varied. In case of checking academic documents evaluate for generic drug registration, it will take 3 months to 9 months until the officer finish the evaluation.

Required Documents
• Completed application form (Yor.1, Phor Yor.8, Nor Yor.8)
• Copy of Manufacture license and GMP standard ( Manufacture within country)
• Copy of GMP standard (if imported)
• Copy of imported license (if imported)
• Certificate of free sale (if imported )
• Certificate of Pharmaceutical Product (if imported)
• Drug formula
• Photos only for capsules and suppository (color, size and shape should be clear)
• Labeling
• Manufacturing method
• Storage conditions
• Drug analytical control method
• Drug literature
• Raw material specifications of active(s) and inert ingredients with the corresponding control methods in details
• Finished product specification with the corresponding control methods in details
• Certificate of analysis of active ingredient(s)
• Stability studies of the finished product
• Product information (Package Insert, Summary of Product Characteristics or Product data sheet, Patient Information Leaflet)
• Applicant declaration
o Applicant declaration for generic drug registration
o Applicant declaration for conditions of generic drugs(If distribute only to hospital)
o Applicant declaration for exporting (Sor Aor.1)
o International trade partner (invoice, profoma invoice, letters of credit if export)
o Declaration letter for exporting generic drugs (Only export)
o Power of Attorney

For more information, please feel free to contact us:
Phone Nos.: +66 2933 6121, +66 2933 6122, +66 2933 5601
(for call inside Thailand use 0 instead of +66)
Fax: +66 2933 6120
Email: mgr@panwa.co.th
Please CC: to our alternate email: panwagroup@gmail.com

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Listing ID: 7075b692352a9242

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