Tagged with Legal

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests that clinical data be arranged in either the format of Part…

Pharma Legal Handbook What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Pharmaceutical 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…

Pharma Legal Handbook What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in Thailand. The authorization process for the marketing of traditional medicines and…

Pharma Legal Handbook What types of liability are recognized in your jurisdiction? The laws of Thailand provide for civil, criminal, and administrative liabilities. Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for a damage caused by deficient goods. This liability…

Pharma Legal Handbook What are the basic requirements to obtain patent and trademark protection? Patent The “subject matter” contained in a patent application may be patented if the following requirements are met: Novelty: Before the filing date, the subject matter must not have been publicly used anywhere in Thailand, and the details of…

Pharma Legal Handbook Are there proposals for reform or significant change to the healthcare system? Significant changes to the healthcare system include the following: The Patent Act The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The Act’s amendments…

Pharma Legal Handbook Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? Yes. Pursuant to Section 12 of the Drug Act 1967, as amended, any domestic manufacturing, importing or ordering into Thailand, including the distributing of active pharmaceutical…

Pharma Legal Handbook Chapter 9: Cannabinoid Drugs Are Cannabinoid Drugs authorized in your country? For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by other means without involving a cannabis plant. The formulations of cannabinoid drugs may…

Pharma Legal Handbook What is the definition of Rare Diseases in your country? Neither the Ministry of Public Health in Thailand (MoPH) nor the Thai Food and Drug Administration (Thai FDA) has prescribed a definition for “rare diseases.” However, the Unit of Clinical Genetics, Department of Paediatrics, Faculty of Medicine at Mahidol University,…

Pharma Legal Handbook What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the Ministry of Health (www.moh.gov.vn). The Ministry of Health (“MOH”) is organized into a number of divisions,…

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? By law, clinical research documentation for the purpose of obtaining the drug MA must conform to the guidance of the International Council for Harmonization (ICH), the MOH, the European Medicines Agency (EMA) or…

Pharma Legal Handbook What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Pharmaceutical products Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals. In general, a pharmaceutical product circulating on…