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

“Narcotics” means any form of chemicals or substances which, upon being consumed whether by taking orally, inhaling, smoking, injecting or by whatever means, causes physical or mental effect in a significant manner such as need of continual increase of dosage, having withdrawal symptoms when deprived of the narcotics, strong physical and mental need of dosage and the health in general being deteriorated, and also includes plant or parts of plants which are or give product as narcotics or may be used to produce narcotics and chemicals used for the production of such narcotics as notified by the Minister in the Government Gazette, but excludes certain formula of household medicine under the law on drugs which contain narcotic ingredients.

Products required having license

  • Narcotic drug schedule 2
  • Narcotic drug schedule 3
  • Psychotropic substance schedule 3 and 4

For Example: Import Narcotics category 3 to Thailand

Provision Cost

Government Fee (new drug)                       9,000

Note: Additional cost may occur depending on the active ingredient or academic analysis.

I.Request Import License of Narcotic drug schedule 3

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

No Required Documents Original Copies Remarks

 

1 Copy of ID card/passport 1
2 Copy of house registration 1
3 Copy of manufacturing, import and export license, or purchase order of generic drug to Thailand 1
4 Application form of manufacturing, import, export or selling of narcotics drug schedule 3 (Yor Sor. 3-1) 1
5 Photo 3×4 cm 3
6 Health certificate 1
7 Certified pharmacy practitioner certificate 1 In case of changing the name, must bring payment slip for evidence.
8 Free sale certificate of narcotic drug schedule 3 and pharmacists 1
9 Company affidavit 1 Not more than 6 months
10 Appointment letter (duty stamp 30)

-Attached together with copy of house registration and ID card of both parties)

1 Only juristic person
11 Power of Attorney 1
12 Diagram of place which shows every corner of the place 1

Step 2: Submit to Thai FDA

The officer will check the accurate of evidence and supporting documents by taking 8 working days, if there is no additional requirement, they will contact back within 2 working 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.Narcotic drug schedule 3 registration

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

No Required Document

 

Original Copies Remarks
1 Copy of license to manufacture or import the narcotics of category 3 1
2 Certificate of Pharmaceutical Product or Certificate of Free Sale is required for the import product 1
3 Good manufacturing Practices (GMP) certificate 1 2
4 Photograph of the pharmaceutical products
5 Drafts of the labels and patient information leaflets 1 2
6 The formulation of one unit 1
7 The complete batch manufacturing master formula. 1 2
8 Method of manufacture 2
9 In-process specification and the control method 1 2
10 Raw material specification and the control method 1 2
11 Certificate of analysis of the raw material of the active ingredient 1 2
12 Analytical data and the chromatogram or spectrum of the raw material of the active ingredient 1 2
13 Finished product specification and the control method 1 2
14 Certificate of analysis of the finished product 1 2
15 Analytical data and the chromatogram or spectrum of the finished product 1 2
16 Packaging, labeling and storage 1
17 Method validation, in the case that the analysis methods used does not conform to the one in the official pharmacopeias 1 2
18 Data from the stability study 1 2
19 A letter of authorization 1

Step 2: Submit to Thai FDA

The officer will check the accurate of evidence and supporting documents by taking 157 working days to inform the results if there is no additional documents are required.

Step 3: Receive the approval import license.

The license will be valid for 5 years.

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.

Remark: Must have export and import license or shipping provider in order to import to Thailand.

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