Pursuant to our previous articles about medical devices and their development in Thailand following the Medical Device Act B.E. 2551 and its amendments, which were adjusted according to the ASEAN Medical Device Directive, there have been more updates on the medical device regulations under the Thai Food and Drug Administration (FDA).
In this article, we will discuss the second fundamental element under the NACC’s guidelines, which is “the risk assessment to effectively identify and evaluate exposure to bribery.
In our previous article (link), we discussed the benefits for a company that has appropriate internal control measures. For the second article of the series, we will discuss the first fundamental element under the NACC’s guidelines, which is “the companies’ internal control measures should be strong, visible policies and supported by top-level management to prevent bribery.”
By way of background, kratom (Mitragyna speciosa (Korth.) Havil.) is a tropical tree with opioid properties and some stimulant-like effects, and was previously controlled under the Narcotics Act due to these properties and effects.
Under the Organic Act on Counter-Corruption, B.E. 2561 (2018), companies operating in Thailand must put in place “appropriate internal control measures” that comply with the National Anti-Corruption Commission’s (NACC) guidelines. Failure to do so carries a penalty of a fine from one to two times the value of the damage caused, or benefits gained, as a result of the violation.
On 17 May 2021, the Ministry of Public Health (MOPH) issued several notifications to prescribe the criteria and requirements in relation to the use of cannabis and hemp in cosmetics, including the permitted parts of the cannabis and hemp plant and extracts, the permitted level of THC and the permitted CBD, and applicable labelling and warning requirements. These notifications became effective on 18 May 2021.
Even though the term “cosmeceutical” is not new from the global market perspective, such products are considered relatively new from the Thai legal perspective. The Thai Food and Drug Administration (FDA) has been working on finding a new product category for herbal-based/herbal-related products with health claims for quite some time and has recently introduced the Herbal Product Act B.E. 2562 (HPA). The HPA will, generally speaking, regulate and manage the herbal drugs and herbal products which cosmeceutical is part of.