+66 2 933 9000 bkk@panwa.co.th

Services

Under FDA Drugs, we provide services for four categories which are as below

  1. Generic drug registration
  2. Manufacturing license for generic drug / traditional drug
  3. Import license of generic drug / traditional drug
  4. Sale license of generic drug / traditional drug

 

Import Modern Drugs to Kingdom of Thailand

Provision Cost

  • Government Fee                                                                                                   15,030
  • Evaluation of academical document by professional (if any)                               182,500            

Procedure and Timeline

I.Request the import license of drug

Step 1:  Prepare the required documents and fill the application form

Ordinary Person

  • Copy of ID card/ passport and work permit (1 set)
  • Copy of house registration ( 1 set)
  • Copy of declaring property (1 set)
    • Copy of book bank with deposit of at least 10,000 Baht and bring book bank to show the officer
    • Copy of title deed

Juristic Person

  • Copy of ID card/passport and work permit of director (1 set)
  • Power of attorney (1 set)
  • Copy of consent letter to use the place or approval letter from house owner (if any) (1 set)
  • Copy of letter the person appointed by the juristic person to conduct business ( 1 set)
  • Copy of company affidavit which is not over 6 months (1 set)

Required documents

  • Application form (Nor. Yor. 1 & 7 )
  • 3×4 cm photo of applicant (3 pieces)
  • The related documents showing the ownership over the location
    1. Copy of house registration which mention host name or applicant name
    2. Consent letter by showing the relative relationship evidence between applicant and consent party which should have same surname
    3. Proof of the ownership letter that the consent party agreed for sale
    4. Copy of house registration and ID card of consent party
    5. Copy of the resident contract
  • Copy of contract between the applicant and operator (3 set)
  • Copy of Pharmacy Practitioner Certificate ( 1 set)
  • Original health certificate of applicant and operator which not more than 3 months (1 set)
  • Color photo and blueprint of the requested location in various corner (1 set)
  • Copy of certificate of free sale from abroad (1 set)

Step 2: Submit to Thai FDA.

The officer will check the accurate of evidence and supporting documents by taking 38 days, if there is no additional requirement, they will contact back within 7 days after they approved.

Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.

Step 3: Receive the approval import license.

The license will be valid till 31st December of issuing year.

 

II.Drug registration (except biopharmaceutical)

Step 1:  Prepare the required documents and fill the application form

Part I : Administrative and data product information

  • Photos only for capsules and suppository
    • Color, size and shape should be clear
  • Copy and original of certificate of pharmaceutical product (1 set)
  • Copy and original of import license of modern drug (1 set)
  • Copy and original of certificate of GMP standard from manufacturer (1 set)
  • Copy and original of certificate of free sale (1 set)
  • Labeling
  • Copy and original of product information (Package insert, product data sheet, patient information leaflet)

Part II : Quality (Original paper)

  • General information
    • General information ( Nomenclature, structure, general properties)
  • Manufacturers
  • Characterization (impurities, elucidation of structure and characteristic)
  • Control of drug substance
    • Specification, certificate of analysis, analytical procedures and validation of analytical
  • Reference standards of materials
  • Stability
  • Drug product
    • Description and composition, pharmaceutical development, component of drug products, finished product, container closure system, microbiological attributes, compatibility
  • Manufacture
    • Batch formula,
    • Manufacturing process and control, process control
    • Control of critical steps and intermediates
    • Process evaluation
  • Control of excipients
    • Specifications, analytical procedure, excipients of Human or Animal Origin
  •  Control of finished product
    • Specification, certificate of analysis, analytical procedures, validation of analytical procedures, batch analyses, characterization of impurities, justification of specification,
  • Stability
  • Container closure system
  • Product Interchangeability equivalence evidence (for only some medicine)

Part III: Safety : Nonclinical document (Original)

Part IV : Efficacy : Clinical document (Original)

Step 2:  Submit to Thai FDA.

After completion of preparing documents, we will submit to FDA. The consideration process will take place 2 times with the first time by 95 days and second time with 60 days. After that, the authority will make decision for approval the drugs by taking 65 days. The officer will contact back within 7 days after they approved.

Remark: If there are no additional documents required and no accurate of evidence document occurred, the time will not be varied. Please note that we will start counting the day after we prepare all the required documents and signed by the applicant.

Step 3: Receive the approval product license.

Remark: It is required to have the sale license in order to sell in locally.

 

III.Request the license per invoice (LPI)

Step 1: Prepare the document                  

Authorized juristic person

  • Copy of certified company affidavit not more than 6 months (1 set)
  • Power of attorney with copy of ID card (1 set)

Delegated juristic person

  • Power of attorney not more than 1 year with 30 Baht stamps together with a set of copy
  • Copy of certified company affidavit not more than 6 months (1 set)
  • Copy of ID card of authorized person (1 set)
  • Cop y of ID card/passport and work permit of delegated person (1 set)

Required document

  • The approval of product license
  • The detail information that was filled in application form
  • Invoice packing list
  • Certificate of place of manufacture

Step 2:  Apply for the LPI

Submit the documents through E-Form or at FDA and this can be done within 1 day.

Step 3: Receive the license

It requires renewing every time of importing.

 

 

 

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