As you will no doubt know, on February 1, 2021, the Myanmar military declared a state of emergency in Myanmar for a period of one year. State Counsellor Daw Aung Sang Su Kyi was detained, as were the president and various significant political and civil leaders. Min Aung Hlaing, commander-in-chief of the Tatmadaw (Myanmar armed forces) has installed himself as chairman of the State Administration Council, the current administration. New sanctions The reaction of the Biden administration has been swift. On February 10, 2021, President Biden issued Executive Order 14014, which provides bases to impose sanctions on individuals and companies deemed by the US to, among other things: operate in the defense sector of Myanmar; be responsible for policies that undermine democratic processes in Myanmar; have taken actions to undermine democratic processes or institutions, or prohibit, limit, or penalize the exercise of free speech, in Myanmar; or be a spouse or child of the foregoing. On the next day, February 11, the US Office of Foreign Assets Control (OFAC), imposed sanctions under the new executive order on ten individuals—including General Min Aung Hlaing—and three companies, including Cancri Gems & Jewelry Co, Myanmar Imperial Jade Co, and Myanmar Ruby Enterprise.  All such individuals and companies have now been designated on the US list of specially designated nationals (SDNs). Effect of sanctions As a result of such sanctions, the property of these individuals or companies that is located in the US or is under the possession or control of US companies and citizens is frozen, and US companies and citizens are generally prohibited from dealing deal with any such property.  Reportedly, roughly USD 1 billion of funds belonging to the individuals and companies blocked on February 11 are located in the US and thus now frozen. The SDN list As many

The latest edition of Practical Law’s Life Sciences Global Guide features contributions from Tilleke & Gibbins attorneys in the firm’s Yangon office. One of the sections they have provided for the Myanmar chapter of this Q&A-style guide to life sciences regulatory frameworks worldwide is “Medicinal Product Regulation and Product Liability in Myanmar.” The section includes discussion of a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following topics: Regulatory overview: Authorities, scope, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT Pricing, government funding, and reimbursement: National health care system, price regulation, and reimbursement Clinical trials Manufacturing and distribution Marketing: Authorization for marketing medicinal products, parallel imports and cross-border trade in medicines Restrictions on dealings with health care professionals Selling restrictions Advertising and promotion Data privacy Packaging, labeling, and tracking Product safety, quality, and liability Local establishment, representation, and residency requirements Reform The full “Medicinal Product Regulation and Product Liability in Myanmar” section can be accessed on the Practical Law website. Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. Tilleke & Gibbins also supplied “Pharmaceutical IP and Competition Law in Myanmar,” which was published in the Life Sciences Global Guide  at the same time.

Attorneys from Tilleke & Gibbins in Myanmar have contributed to the latest edition of Practical Law’s online Life Sciences Global Guide. The guide is a Q&A-style overview of the regulatory frameworks for the life sciences industry across multiple jurisdictions worldwide, and this year the Myanmar chapter includes two sections, one of which is “Pharmaceutical IP and Competition Law in Myanmar.” This section runs through the country’s legal and regulatory environment for patents and trademarks—particularly as they relate to pharmaceutical business in the jurisdiction. The section then turns to IP and competition law issues, with questions and answers focusing on how the country’s competition laws and regulations affect the pharmaceutical sector. Readers are also given information on how to properly comply with Myanmar law on competition, including when it comes to licensing of medicines and pharmaceutical technology. The full Pharmaceutical Intellectual Property and Competition Law in Myanmar guide can be accessed on the Practical Law website. Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. Tilleke & Gibbins also supplied the “Medicinal Product Regulation and Product Liability in Myanmar,” which Practical Law published in its Life Sciences Global Guide  at the same time.

Following the recent delisting of almost all parts of the hemp plant from Thailand’s list of prohibited narcotics (see here for further details), the Ministry of Public Health has issued a notification allowing hemp to be used in cosmetics. Prior to this development, this use of hemp (whether from natural or synthetic sources) was not allowed, as it fell under the definition of narcotics under the Notification Re: Ingredients Not Allowed for Use in Cosmetics B.E. 2559 (2016). Under the Ministerial Notification Re: Use of Hemp in Cosmetics B.E. 2564 (2021), which was published in the Government Gazette on January 11, 2021, domestic manufacturers are now allowed to produce cosmetics containing hemp seed oil or hemp seed extract, provided the cosmetics do not have a THC level exceeding 0.2% by weight. To register such products with the Thai FDA, applicants must submit a certificate of analysis, safety data sheet, and label for the agency’s evaluation. The timeline for approval of the registration (notification) of a cosmetic containing hemp seed oil or hemp seed extract is three business days. The applicant (i.e., manufacturer or toll manufacturer) must declare the amount of hemp seed extract or hemp seed oil used in the cosmetic in their notification application. Cosmetics must not use a name for the product that evokes an association with hemp flowers or narcotics, and the name of the product must be within the scope of cosmetics. For example, names containing “inflorescence,” “flower,” “CBD,” “THC” or similar will not be allowed. It should also be noted that Thailand does not yet allow the importation of cosmetics containing hemp seeds or hemp seed extract, and this regulation only applies to domestically produced hemp products—a business currently restricted to individuals or companies with Thai nationality. For more details on this development, or