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 USD 99.
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 process for the marketing of new drugs, biologics, medical devices, 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. (Note: An import license is valid from January 1 to December 31 and must be renewed on a yearly basis.)
- After obtaining a license, obtain authorization to manufacture or import drug samples.
- Submit a full marketing approval application, including samples, to the Thai FDA for review and registration. Registration requirements differ for general drugs (which include generics, new medicines, and new generics) and traditional drugs. Drug product licenses also need to be renewed.
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 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)—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).
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.
7. Are parallel imports of medicines or devices allowed?
Parallel imports are not permitted in 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 Bureau of Drug and Narcotic 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 ISO13485 for medical devices.
In the event that the regulator finds that a licensee has violated any provision under the Drug Act of 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 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 company must prepare a site master file, and Standard Operation Procedure (SOP).
After a site inspection, the manufacturer must submit an inspection report and Corrective Action and Preventive Action (CAPA) report to the Thai FDA.
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 be 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 so that 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?
Pharmaceutical Product 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
Package labeling must contain:
- Shelf life
- Prohibited uses or cautions
- Manual guide
- Name and address of manufacturer or importer
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 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 the Consumer Protection Act, B.E. 2522 (1979), the PReMA Code, and Section 88 of the Drug Act.
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 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 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 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. However, all advertisements for medical devices must obtain approval from the Thai FDA before being disseminated.
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.