Marketing, Manufacturing, Packaging & Labeling, Advertising
The key facts about marketing, manufacturing, packaging & labeling, advertising in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products are the same.
Companies and individuals that wish to place a drug on the market must:
- Obtain a license from the Thai FDA to manufacture, sell or import drugs. Both the drug manufacturing license and the drug import license are valid from January 1 to December 31, and must be renewed on a yearly basis.
- After obtaining a license, the manufacturer or importer must submit an application for manufacturing or importing drug samples. For imported drug products, an importer will also be required to submit an application for GMP clearance of the overseas manufacturer in order to ensure that the overseas manufacturing site meets PIC/S GMP requirements. The GMP Clearance approval granted by the Thai FDA will have the same validity as the GMP certificate issued by the regulatory authority in the country of manufacturing.
- Submit a full marketing approval application, including samples, to the Thai FDA for review and registration. The registration scheme and technical documentation vary depending on the classification of the drug product. Currently, the drug registration dossier can be arranged in either the ASEAN Common Technical Dossier (ACTD) or the ICH-eCTD format. The timeframe for registration approval for a new drug is approximately 220 business days. For a generic drug, the timeframe for registration approval is approximately 155 business days.
Companies and individuals that wish to place a medical device on the market must:
- Obtain a license from the Thai FDA to manufacture or import medical devices. The medical device manufacturing license and the medical device importing license are both valid for a period of five years. Each type of license must be renewed before December 31 of the fifth year.
- Submit a full marketing approval application to the Thai FDA for review and registration. The registration dossier template for Licensed Medical Devices and Detailed Notification Medical Devices must comply with the format of the Common Submission Dossier Template (CSDT), as outlined in AMDD. The timeframe for registration approval of Licensed Medical Device and Detailed Notification Medical Device is around 9 to 12 months. Documentation requirements for Notified (General) Medical Devices are not as stringent compared to the other medical device classes. Only the product description/information, product catalog, and the Certificate of Free Sale (CFS) are required. If the product is a sterile product or implanted product, a quality system certificate (i.e. GMP certificate, ISO 13485 certificate) will also be required. The timeframe for registration approval of a Notified (General) Medical Device is around 7-15 business days.
2. What is the authorization process for the marketing of generic versions of these products?
The authorization process for the marketing of generic products is the same as the process for new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products. For more information please see question 3.1 (above).
The Drug Act, as amended, is the main act regulating marketing authorization for modern drugs, including biologics and other medicinal products.
Registration of new modern drugs requires the applicant to submit a complete ASEAN Common Technical Dossier (ACTD) or ICH Common Technical Dossier (ICH CTD)—which includes a quality study, non-clinical study, and clinical study—together with product samples, to the Thai FDA. If the application passes the review stage, the new modern drug will undergo a two-year safety monitoring period.
The requirements for registering generics are similar to those for registration of new modern drugs; however, the documents required in the ACTD slightly differ. For generic products, the Thai FDA only requires that a quality study and bioequivalent study accompany the ACTD.
3. What are the typical fees for marketing approval?
Please see question 4 in Regulatory, Pricing and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
Please see question 5 in Regulatory, Pricing and Reimbursement Overview.
5. What are the requirements, if any, for post-approval pharmacovigilance?
All new drugs registered and approved for marketing in Thailand must undergo a mandatory SMP for at least two years. During the SMP, new drugs can only be dispensed in hospitals. The company must provide periodic safety updates and report any adverse reactions to the Thai FDA during this time period.
Even though SMPs are not an obligation for generic products or medical devices, the Thai FDA still requires manufacturer of these products to submit adverse effect reports. This report must include the total number of products dispensed, the total number of patients exposed, and the number and details of adverse drug reactions (ADR).
The Thailand Health Product Vigilance Center (HPVC), under the supervision of the Thai FDA, is the main organization responsible for collecting and monitoring information about adverse events and corrective action of health products (including drugs and medical devices). There are several channels for submitting a report including by mail, in person, online, via email (email@example.com), or via facsimile (66+ 2591 8457).
6. Are foreign marketing authorizations recognized?
Applicants do not receive a relaxed or expedited review process because of any foreign marketing authorizations. However, the application form requires applicants to inform the Thai FDA of any approved or pending market authorizations granted in other countries. If foreign market authorizations have been obtained in a country where the regulatory practice is credible and globally accepted, such authorization could be used as evidence to support the application.
In some cases, the drug registration could be carried out via the Abridged Evaluation Pathway. To fall within the scope of the Abridged Evaluation Pathway, the applicant should ensure that the following criteria are met:
- The MA drug registration dossier is submitted to the Thai FDA within two years from the date of approval of the drug by the benchmark agency (e.g., EMA, US FDA, TGA, Health Canada, MHRA, PMDA). If there is a need to submit the application after such date, the applicant must consult with the Thai FDA on a case-by-case basis. In any case, the maximum period for submission is three years from the date the benchmark agency approved the drug.
- The MA license approved by the benchmark agency as well as the indications, dosage strength, treatment regimen, and patient population must not be revoked, rejected, or withdrawn, nor can the evaluation or approval be suspended during an appeal of the benchmark agency’s decision.
Furthermore, the applicant can request a Priority Review, if a drug product is intended for preventing and/or treating:
- Diseases considered as immediate health problems in Thailand with urgent need (e.g., infectious diseases);
- Serious life-threatening conditions (e.g., AIDS treatment drugs, anti-cancer drugs, etc.); or
- Other drugs deemed appropriate by the Thai FDA.
There is no difference in registration requirements under the Abridged Evaluation Pathway and priority review; however, the timeframe for evaluation of a drug registration dossier will be reduced from the normal registration process. For example, the timeframe for the normal registration pathway of a new drug (i.e., a new chemical entity) is 220 business days. With the Abridged Evaluation Pathway, the timeframe will be reduced to 180 business days. In cases where the priority review is applicable, the timeframe will be further reduced to 150 business days.
7. Are parallel imports of medicines or devices allowed?
Parallel imports are not permitted in Thailand because the exhaustion of rights principle is recognized by most intellectual property laws in Thailand. Additionally, it is mandatory for a company to obtain a drug import license and marketing authorization for each of the pharmaceutical products before importing such products into Thailand.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Pharmaceutical companies must ensure that their marketing activities are in accordance with Drug Act and the Code of Conduct of Pharmaceutical Industry.
In general, a state official can only receive property or any other benefit from any person (other than a relative) if the value of the benefit received from each person, and on each occasion, is less than THB 3,000.
In order to prevent corruption, government purchases of pharmaceuticals must generally be conducted with a high degree of transparency, and all quantities and pricings of purchased products must be disclosed.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturing of pharmaceutical products and medical devices is regulated by the following agencies:
- The Drug Division is responsible for the approval of manufacturing licenses for medicines.
- The Medical Devices Control Division is responsible for the approval of manufacturing licenses for medical devices.
After obtaining a manufacturing license, the license owner’s buildings and facilities will be inspected by a regulator in order to (1) determine the sufficiency of facilities and personnel to manufacture the medicine or medical device; and (2) assess compliance with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) Good Manufacturing Practices (GMPs), or Thai GMP/ ISO13485 for medical devices.
In the event that the regulator finds that a licensee has violated any provision under the Drug Act or Medical Device Act, the regulator can suspend or revoke the manufacturing license.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
Yes, the Thai FDA has implemented PIC/S GMPs as a requirement for local drug manufacturers, and this requirement is compatible with definitions laid out by the U.S. FDA and the EMA. In general, both local and foreign manufacturers must comply with GMPs.
11. What is the inspection regime for manufacturing facilities?
Manufacturers must ensure that all activities in their facility comply with the requirements of PIC/S GMPs. In addition, the manufacturer must prepare a site master file, and Standard Operation Procedure (SOP). The frequency of the inspection will be 1 year, 2 years, or 3 years, depending on the results of the risk assessment. The Thai FDA inspector will assess two main aspects; namely the General aspect, and Production and Quality control aspect. After the audit is complete, the Thai FDA inspector will send an audit report to the drug manufacturer within 15 days.
If the inspector found critical or major defects, the GMP certificate will not be granted for the manufacturer. The manufacturer must then send a Corrective Action and Preventive Action (CAPA) report to the Thai FDA inspector within 15 days for reconsideration. The FDA inspector will follow up on any improvements made and may perform an additional inspection.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, manufacturing facilities are open for inspection by foreign or third-party inspectors.
The Thai FDA can outsource some work, such as onsite inspections and evaluations of technical documents, to external experts of local or overseas agencies, who have been approved by, and are listed with the Thai FDA.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
The Drug Act and the Medical Device Act are the main acts regulating the requirements for storage, packaging, and handing of medicinal products and medical devices, respectively.
Specifically for drug facilities, a first-class pharmacist must always be present during business hours, as they will be responsible for monitoring, recording, and maintain proper storage of drugs.
All medicinal product and medical device storage facilities must display a signboard that reads “Place for Storage of Drugs/Medical Devices.” The storage room must enclosed by walls and must have a door. Any doors or walls that are made of transparent glass should be covered with a dense film the inside of the storage room cannot be seen from the outside. The storage room floor must be made of a material that will not collect dust. Finally, the storage room must have shelves in order to designate a separate place for each type of product.
For product packaging, labeling is mandatory. The labeling information that is to be used for the products must be submitted to the Thai FDA during the product registration process. Under the Drug Act, this labeling information can be submitted in the form of a package insert, a summary of the product’s characteristics, or a patient information leaflet.
Furthermore, the Thai FDA periodically issues notifications providing specific required information that must be included on the label of specified drugs such as antibiotics, antihistamines, sedatives, etc.
14. What information must be included in medicine and device labeling?
Product label information and the size of the whole package are mandatory documents that must be submitted to the FDA to obtain marketing approval. Under the Drug Act, labeling information can be submitted in the form of a package insert, a summary of the product’s characteristics, or a patient information leaflet.
The required information for package inserts is listed below:
- Product name
- Name and strength of active ingredients
- Product description
- Recommended dose
- Instructions for use (including modes of administration, contra-indications, general warnings and precautions, interactions with other medical products, warnings and precautions for pregnant and lactating women, undesirable effects, and possible overdose and treatment)
- Dosage forms and packaging available
- Name and address of manufacturing/marketing authorization holder
- Date of revision of package insert
Package labeling must contain:
- Product name
- Dosage form
- Registration certificate number
- Composition or active ingredient with the quantity, unit, or strength.
- Pack sizes
- Lot/batch number
- Manufacturer’s name and country of origin
- Date of manufacture
- If applicable, and on a red label, a statement that the drug is classified as a specially controlled drug, dangerous drug, or common household drug in Thailand
- Expiration date and the word “expiry” in Thai
Medical Device-product Labeling
On Nov 5, 2020, the Ministry of Public Health published the Notification Re: Rules, Procedures and Conditions for Labels and Package Inserts of Medical Devices, which will be be fully implemented 360 days from the date of publication date (i.e., October 31, 2021). According to this Notification, the medical device companies must prepare medical device package inserts that include the following information from October 31, 2021, onwards.
- Product name
- Product description (i.e., type, category, components, principles, etc.)
- Indications/intended Use
- Weight/amount (packing size)
- Manufacturer’s name and address or importer’s name and address (in case of imported product, the label must also indicate the name and address of the overseas manufacturer)
- Instructions for use
- Storage conditions
- Warnings, precautions, and contradictions
- Revision date
- Other statements or specific warnings, as required for certain medical devices (i.e., “Single-use only”, “Sterile product”, “Store away from sunlight”, “This is not for self-testing”, etc.)
In addition, labels for medical devices must include the following;
- Product Name
- Product description (i.e. type, category, components, principles, etc.)
- Indications/intended Use
- Weight/amount (packing size)
- Manufacturer’s name and address or Importer’s name and address (in case of imported product, the label must also indicate the name and address of the overseas manufacturer)
- Contact address for more information or complaints
- Instructions for use
- Storage conditions
- Warnings, precautions, contradictions
- Registration number
- Batch number or serial number
- Manufacturing date or expiry date showing the year as 4 digits
Other statements or specific warnings, as required for certain medical devices (i.e., “Single-use only”, “Sterile product”, “Store away from sunlight”, “This is not for self-testing”, etc.)
15. What additional information may be included in labeling and packaging?
Any information that does not infringe other legal requirements such as advertising regulations or unauthorized use of a trademark.
16. What items may not be included in labeling and packaging?
Any information that infringes upon other legal requirements, such as comparative advertising, exaggerating statements, or unauthorized use of a trademark.
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
Advertising Requirements for Pharmaceutical Products
Sections 88–90 of the Drug Act, B.E. 2510 (1967), as amended, and the Regulations of the Thai FDA’s Rules on Advertisements of Drugs for Sale B.E. 2545 (2002) (Advertisement Rule) are the main pieces of legislation governing the advertisement of pharmaceuticals in Thailand. Advertisements targeted at the general public and/or at health care professionals are subject to Thai FDA review and approval before dissemination. The advertising license is valid for a period of five years and is non-renewable.
Advertising Restrictions for Pharmaceutical Products
Advertisements for prescription or pharmacy-dispensed medicines can only be targeted at medical professionals. Pharmaceutical products in the household remedy category, which is called over-the-counter (OTC) in other jurisdictions, can be advertised directly to consumers and the general public; however, that advertising is subject to Thai FDA review and must be in accordance with Sections 88-90 of the Drug Act, the Consumer Protection Act, B.E. 2522 (1979), Thai FDA Regulation: Advertisement Rule, and the PReMA Code.
Advertisements must not:
- Boast that a medicine can miraculously or absolutely treat, cure, or prevent a disease or illness;
- Exaggerate or falsely declare properties of the medicine;
- Give the impression that the drug has a substance as its chief or component ingredient that it does not have, or has in a lower quantity than is believed to be present;
- Give the impression that it is an abortifacient or a strong emmenagogue;
- Give the impression that it is an aphrodisiac or a birth control drug;
- Advertise specially controlled drugs or dangerous drugs;
- Contain certification or endorsement of the drug’s therapeutic properties by any other person;
- Show its therapeutic properties as being capable of curing, mitigating, treating, or preventing diseases (or symptoms) as notified by the MOPH under Section 77 of the Drug Act (e.g., diabetes, cancer, paralysis, tuberculosis, leprosy and disease, or health conditions regarding brain, heart, lung, liver, spleen and kidney); or
- Advertise impolitely, by means of singing and dancing, or by showing the distress or suffering of a patient.
Advertising Requirements of Medical Devices
Sections 56-60 of the Medical Device Act, B.E. 2551 (2008), as amended, and the Notification of the FDA Re: Prescription of Rules, Procedures and Conditions for Advertising Medical Devices B.E. 2553 (2010), are the main pieces of legislation governing the advertisement of medical devices. Advertisements targeted at the general public are subject to Thai FDA review and approval before dissemination. The advertising license is valid for a period of three years and is non-renewable.
According to the Notification of the Ministry of Public Health: Rules, Procedures and Conditions for Medical Device Advertisements Directed towards Medical Professionals and Public Health Officials, which are Exempt from Approval, dated November 5, 2002, medical device advertisements directed at medical professionals and public health officials can be exempt from approval if the medical devices meet the following criteria:
- Medical devices that receive market authorization approval for manufacturing, importation, or sale; or
- Medical devices that receive an exemption for manufacturing, importation, or sale in accordance with Section 27(1), 27(2), 27(3), 27(4), 27(5), 27(6) and 27(8) of the Medical Device Act B.E. 2551 (2008), as amended.
Nonetheless, the advertisers must first notify the Thai FDA by submitting:
- The advertisement notification (Jor Kor form); and
- The advertising material via the Thai FDA’s electronic portal. In addition, the advertiser must secure access to only medical professionals and public health professionals.
Additionally, the Ministry of Public Health also published the Notification: Characteristics of Medical Device Advertisements that do not Require Approval, dated November 5, 2020, which exempts from the approval process medical device advertisements which display only a tradename or trademark logo.
Advertising Restrictions for Medical Devices
A company or individual who wishes to advertise a medical device product must first obtain a medical device advertising license from the Medical Device Control Division and must comply with the requirements prescribed by the FDA.
The following types of advertisements of medical devices are prohibited:
- Advertisement of a medical device that is subject to a ban on manufacture, import, or sale
- Advertisement of a counterfeit, substandard, poor quality, or unsafe medical device
- Any advertisement which is false or uses exaggerated statements (e.g., using boastful or deceptive wording)
- Any advertisement that shows more details than specified in the product label or medical device documentation, unless supported by evidence or a reliable academic publication; such advertisement must not relate to details on the indication or purpose of medical device use.
- Any advertisement which shows endorsement or praise of medical device benefits by a person, whether directly or indirectly
- Any advertisement which offers a chance to receive a prize by any means
- Any advertisement that shows the ability to prevent, cure, relieve, or treat a disease (or symptoms of a disease) which is banned by a Notification from the Minister
- Advertisement of a medical device name which is boastful, false, deceptive, misleading, or contrary to good morals and Thai tradition
- Any advertisement that is impolite or may cause disharmony or disunity among the people
- Any advertisement which discredits or provides a comparison to a medical device of another operator, except for comparisons to one’s own products or academic comparisons; in any event the name of a medical device or product technology of other persons must not be mentioned.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
The channel of distribution of drugs are differ depending on their classification:
- Household remedies (or OTC products) can be sold anywhere, because a sales license is not required.
- Pre-packed drugs that are not dangerous or are not specially controlled drugs can be sold in drugstores and dispensed by medical professionals.
- Dangerous drugs can be sold without a prescription but must be dispensed by a licensed pharmacist.
- Specially controlled drugs which may possess a potentially harmful effect on health, if misused, are dispensed by prescription only. Some specially controlled drugs are only available in a hospital.
Medicinal products and medical devices can be delivered via post, but the online sell of medicines, except household remedies, is not yet allowed in Thailand.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
For any non-household remedy drugs, all direct-to-consumer marketing activities are prohibited under the Drug Act. Therefore, only household remedy drugs can be advertised directly to consumers and the general public.
While the law does not expressly limit the types of advertising activities for household remedy drugs, the Thai FDA must provide permission for the picture, sound, or text, use in the advertisement before they are featured on radio, television, motion pictures, printed materials, or internet media. Advertisements for household remedy drugs must in comply with the advertising conditions set by the Thai FDA (see question 3.17, above).
The PReMA Code provides a guideline that patient education material should be distributed for educational purposes and should encourage patients to seek further information or explanation from an appropriate healthcare professional. Therefore, hotlines, websites, or other similar information services can be set up to provide general information that useful to the public. Such services must strictly be general and cannot include any promotional information or personal medical advice.
20. May medicines and devices be advertised or sold directly to consumers?
Only household remedy drugs can be sold and advertised directly to consumers or the general public. However, such advertising is subject to Thai FDA review and approval before dissemination (see question 3.19 above for more information).
Drugs classified as dangerous or specially controlled drugs cannot be advertised directly to consumers or the general public; however, they can be advertised to medical practitioners.
Medical devices can be advertised directly to consumers, medical practitioners, or both, depending on the license applied for and the license granted by the Thai FDA. As of today, advertisements targeted at the general public must obtain approval from the Thai FDA before being disseminated. However, advertisements directed at medical professionals and public health officials can be exempt from approval. In such cases, the advertiser must first notify the Thai FDA by submitting an advertisement notification together with the proposed advertisement material.
21. How is compliance monitored?
The agencies responsible for monitoring marketing activities are:
- The Thai FDA under the supervision of the MOPH, and
- The Office of the Consumer Protection Board of Thailand under supervision of Prime Minister’s Office.
The FDA will conduct site visits and online investigations when they come across any advertising violations or complaints. In the event of a site visit or online investigation, a notice will be sent to the advertiser requesting an explanation or defense of their case.
22. What are the potential penalties for noncompliance?
The Secretary-General of the Thai FDA can issue a written order to cease any advertisement deemed to be contrary to the Drug Act. If is determined that the advertisement misled the public, the Thai FDA can order the violator to issue a corrective advertisement.
Any violation of the Drug Act’s marketing provisions is subject to a fine of up to THB 100,000. The calculation of the fine will depend on the amount of time it takes the advertiser to act after receiving a warning or notice of violation, and the number of occurrences of other wrongdoings. For example, if a promotional booth uses three posters and two gimmick gifts that were never been submitted for FDA approval, they could be fined for a combination of the five offences.
For PReMA members, if a complaint regarding a breach of the PReMA Code is filed by another PReMA member, the complaint will be administered by the PReMA Chief Executive Officer and the Code of Conduct Committee, which has the power to sanction its members.
Any person who advertises a medical device without approval, will be liable to imprisonment for a term not exceeding six months, a fine not exceeding THB 50,000, or both, per Section 116 of the Medical Device Act, as amended.