Frequently Asked Questions

1) Issues relating to drug importation for personal use

Q1: What should I do if I need to bring drugs from abroad for personal use when traveling to Thailand?

A1: The type of health product being imported determines which law is applicable to its importation:

1. Where the product is a psychotropic substance and/or a narcotic, you should obtain an approval before bringing the product into the country. Lists of substances which fall into these types of products can be found at: http://permitfortraveler.fda.moph.go.th/ or you may contact: narcotic@fda.moph.go.th.
2. Where the product is an herbal product for human use, please contact the relevant division at herbaldivision@fda.moph.go.th
3. Where the product is a modern drug that is a finished pharmaceutical product, the following steps shall be taken:

Under section 12 of the Drugs Act, B.E. 2510 (1967), no person shall manufacture, sell, import or order into the kingdom any modern drug unless such person receives a license from the licensing authority. Thus, bringing drugs or ordering drugs to be shipped into Thailand by post is not allowed. If it is necessary for you to use any drug:

1) In the case of a traveler traveling into Thailand, you may bring with you any modern drug for personal use for no longer than 30 days according to section 13 (4) of the Drugs Act, B.E. 2510 (1967) and its amendments. The drug should be kept in its original container and should be accompanied by its prescription from the doctor.

2) In the cases other than a traveler traveling into Thailand:

2.1) You may buy drugs which are available for sale in Thailand. You may check whether the drug of your desired trade name is available for sale in Thailand by checking the drug trade name on the website of the Food and Drug Administration under the topic “Health Products Search”.

2.2) Where the drug under that trade name is not available for sale in Thailand, you may visit a hospital to consult a doctor for an alternative drug. Where no alternative drug is available, it is recommended that you consult expert doctors in a university’s faculty of medicine hospital to find other suitable treatments. Where it is of the utmost necessity, hospitals under ministries, sub-ministries and departments with the duty of preventing or treating diseases may be able to import drugs for use in their specific patients in accordance with section 13 (5) of the Drugs Act, B.E. 2510 (1967) as amended by the Drugs Act (No.3), B.E. 2522 (1979).

2) Issues relating to drug registration

Q2: What is the format of the Certificate of Pharmaceutical Product that needs to be submitted together with the application for vaccine and biological product registration?

A2: For the format of the Certificate of Pharmaceutical Product, please refer to the CPP examples in the Manual/Rules for the Registration of Biological Products for Human Use in Accordance with ASEAN Harmonization, issued under the Notification of the Food and Drug Administration Re: Drug Registration under the Agreement on the ASEAN Harmonization Product on Pharmaceutical Registration (B.E. 2551 (2008)), and the Notification of the Food and Drug Administration Re: Implementation of the ASEAN Harmonized Product on Pharmaceutical Registration (No.2), B.E. 2564 (2021). 

Q3: Is there a special channel for the registration of COVID-19-related drugs and what are the procedures?

A3: You may learn about the procedures for COVID-19-related drug registration from the Notifications of the Food and Drug Administration Re: Conditional Approval of Modern Pharmaceutical Products for Human Use in Pandemic Emergency Situations, details as follows;

Condition for emergency use No.1

Condition for emergency use No.2

Condition for emergency use No.3

3) Issues relating to registration of modern veterinary drug 

Q4: What are the categories of veterinary drug registration?

A4: Registration of veterinary drugs can be divided into 2 main categories: registration of modern drugs and registration of traditional drugs.

Registration of modern veterinary drugs is divided into chemical drugs and biological products or vaccines. Registration of traditional veterinary drugs is divided into traditional drugs and developed herbal drugs. 

You can learn details about the procedures for the registration of each category of veterinary drugs from manuals/rules and accompanying documents for the application for registration on the “Public Manual Information Center” website at: https//www.info.go.th. Type in the names of the public manuals to learn the details, as follows:

Q5: Where can I download the application forms for veterinary drug registration?

A5: The documents and forms for the application for veterinary drug registration can be found on the “Public Manual Information Center” website at: https//www.info.go.th. Type in the name of the public manual you are looking for, or search using keywords such as “veterinary drugs”, “drug registration” or “veterinary drug registration.” Select the relevant public manual, and then select “8. Forms, Examples and Manuals for Filling in the Forms”. You will find the form for the application for drug registration, as well as relevant approval/certification documents.

Q6: How long does the process for veterinary drug registration take?

A6: The time required for a veterinary drug registration will depend on the category of the drug. The public manual for each category of veterinary drug registration will specify the procedures and time required for such procedures under the topic “4. Procedures, Time and Responsible Division”. For example, registration of a modern chemical drug which is a generic drug will take 120 business days, while registration of a modern chemical drug which is a new drug will take 220 business days, given that in both cases accompanying documents required for the registration are correct and complete in accordance with the technical requirements and no additional explanation or document is required to be submitted. Where additional explanation or document is required for the consideration of the authority, this may take longer. 

Q7: How much are the fees for veterinary drug registration?

A7: Registration fees will be collected in accordance with the Notification of the Ministry of Public Health Re: Fees Collectable from Applicants in the Drug Approval Process. The fees may vary depending on the category of the drug formula. Registration fees comprise the application/dossier screening validation fee and technical document evaluation fee. The certificate of registration fee also applies once the registration is approved, for examples:

In the public manual for each category of veterinary drug registration, fees will be specified under the topic “6. Fees”.

Q8: What are the procedures for veterinary drug registration?

A8: Procedures for the registration of modern veterinary drugs consist of both pre-registration procedures and registration procedures, having these essential steps as follows: 

1. In the case of domestic manufacturing, the manufacturer must be a licensed manufacturer of the modern drugs:

Step 1: Application for a license to manufacture drug sample for the purpose of drug registration by submitting the application form for a license to manufacture drug sample for the purpose of drug registration (Form Por.Yor.8).

Step 2: Application for drug registration by submitting the application form for drug registration (Form Yor.1), drug sample, technical documents regarding drug quality, efficacy and safety, as well as other evidence as specified by the Medicines Regulation Division;

2. In the case of importation or ordering of modern drugs into the country, the importer or the person ordering must be a licensed importer of the modern drugs:

Step 1: Consideration for the granting of GMP Clearance of Overseas Pharmaceutical Manufacturers;

Step 2: Application for a license to import or order drug sample into the Kingdom for the purpose of drug registration (Form Nor.Yor.8);

Step 3: Application for drug registration and approval by submitting the application form for drug registration (Form Yor.1), drug sample, technical documents regarding drug quality, efficacy and safety, as well as other evidence as specified by the Medicines Regulation Division. 

For more information and details regarding each step of the procedures, please refer to the public manual under the specific topic.