Indonesia’s National Agency of Drug and Food Control (BPOM) has issued a regulation to amend the country’s food labeling regulations by instituting various additional restrictions and providing additional clarity on food labeling requirements—not only for final food products but also for food additives and food products for further processing. The additions are contained in Regulation No. 20 of 2021 (an amendment to Regulation No. 31 of 2018), which took effect on August 2, 2021. The deadline to comply with the new labeling requirements for final food products is December 31, 2021, and the deadline for requirements related to food additives and food products for further processing is August 2, 2022. The new requirements introduced by the latest regulation are outlined below. Final Food Products Non-halal foods. The new regulation clarifies that food products containing non-halal ingredients are exempt from halal certification requirements. This provision is important as it explicitly confirms that non-halal food products can still be sold and distributed in Indonesia. Ingredient percentages. Percentages of ingredient content must be included in the list of ingredients on a food label, and on any ingredients that are emphasized on the label in words or pictures, or stated as part of the food name. Polyol warning. Labels for food products containing polyol must now include a warning to this effect. Allergen information. The new regulation provides an alternative for indicating allergen information on the food label. Under the 2018 regulation, allergens had to be indicated in the ingredients list in bold type, and the label had to have the disclaimer “contains allergens, see list of ingredients printed in bold.” The new regulation, however, allows allergen information to be declared on the label with the phrase “contains allergens:” followed by the allergen name(s) printed in bold. With this new alternative, it is no longer required to print allergen ingredients

On February 9, 2021, Vietnam’s Ministry of Public Security (MPS) released the full text of the Draft Decree on Personal Data Protection (“Draft PDPD”) for public consultation, after having released an outline in December 2019, with an ambitious goal for the Draft PDPD to be promulgated and take effect on December 1, 2021. This date has now passed and the Draft PDPD remains unissued, with no concrete details on when the situation will change. Many new contents have been introduced in the Draft PDPD (please see our previous articles here and here). In this article, we take a deeper look at the issues that have attracted the most attention from national and international stakeholders as they wait for the draft to be finalized and promulgated. Please click below to read the full article.  

On November 17, 2021, Vietnam deposited its instrument of accession to the World Intellectual Property Organization Copyright Treaty (WCT), becoming the 111th member of the WCT. The provisions of the WCT will officially take effect in Vietnam three months after the date the document is handed over to the Director General of WIPO, i.e., by February 17, 2022. The WCT is a special agreement under the Berne Convention that was first adopted in 1996 to deal with the protection of works and their copyright in the digital environment. The WCT additionally deals with two important objects that should be protected by copyright: (i) computer programs created in any form of expression, and (ii) databases of any kind, as long as the selection or arrangement of database content is intellectually creative. With respect to rights granted to authors, in addition to those recognized by the Berne Convention, the WCT also grants (i) distribution rights, (ii) rental rights, and (iii) broader rights of communication to the public. With respect to limitations and exceptions, Article 10 of the WCT extends to all rights the application of the “three-step” test originally set forth in Article 9(2) of the Berne Convention for the right to reproduction. That is, member states may legislate limitations and exceptions in national law, provided they are in certain special cases (i.e., they are not overly broad), do not conflict with the exploitation of the work, and do not prejudice the legitimate interests of the author. Member states may introduce new exceptions and limitations appropriate to the digital environment, as long as the conditions of the “three-step” test are met. Vietnam’s accession to the WCT not only helps the country meet its commitments in new-generation free-trade agreements such as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and the EU-Vietnam Free Trade Agreement

As international integration has been one of Vietnam’s principal economic goals, the country’s demand for a highly educated labor force equipped with international-standard education has become higher and higher. As studying abroad may be financially burdensome, international-standard education offered by local entities has become a reasonable choice for many Vietnamese students. As a result, the sector has attracted more and more investors, both local and foreign. Some popular options for global brands to enter the promising education market of Vietnam are discussed below. 1. Establishing a Foreign-Invested Educational Institution Foreign-invested educational institutions (FIEI) include (i) short-term training institutions such as foreign language centers; (ii) kindergartens; (iii) compulsory educational institutions (primary, intermediate, or high schools or combined schools); (iv) universities; or (v) branches of foreign universities). To establish a FIEI in Vietnam, a foreign investor needs to either establish a wholly foreign-owned enterprise (WFOE) or form a joint venture company with a local partner. The established company must have in its license a business line of providing educational services (e.g., primary education services or university education services) because Vietnam practices the doctrine of corporate ultra vires, meaning that all enterprises, including WFOEs and joint ventures, may only engage in activities (business lines) which are approved by the licensing authorities. Moreover, under Vietnamese laws, educational services are a conditional business line; thus, the established company must obtain required sublicenses for providing these services in Vietnam. Typically, some or all of the following steps will need to be carried out for a FIEI to be established and start operating in Vietnam: Obtaining an Investment Registration Certificate (IRC). The IRC will recognize the contents relating to the investment project, such as the investor(s), project location, objectives and scale of the project, investment capital, investment incentives and restrictions, etc. Obtaining an Enterprise Registration Certificate (ERC). The ERC will provide for the

On November 25, 2021, the Myanmar Investment Commission (MIC) issued a list of investment sectors that will receive priority attention in order to encourage national development and state building. The investment activities that MIC will prioritize are the following: Fertilizer manufacturing Cement manufacturing Iron and steel manufacturing Agriculture and livestock farming and related industries Value-added manufacturing of foodstuffs Electric vehicle manufacturing Pharmaceutical and medical device manufacturing Public transportation services Both foreign investors and local investors may invest in these sectors, and the MIC, ministries, and relevant state and regional governments will provide necessary assistance to the investors under the Myanmar Investment Law 2016. For more details on the new requirements, please contact Tilleke & Gibbins at [email protected] or +95 9 772 440 001.

On September 30, 2021, Thailand’s Revenue Department released a notification prescribing country-by-country (CBC) transfer pricing reporting requirements for multinational enterprise (MNE) groups that do business in Thailand. The Notification of the Director-General of the Revenue Department Re: Income Tax (No. 408) applies to accounting periods beginning on or after January 1, 2021, with the CBC report submitted at the same time as the annual corporate income tax (P.N.D. 50) filing (i.e., within 150 days of the end of the accounting period). For example, if the accounting period ends on December 31, 2021, the CBC report must be filed by May 30, 2022. Background The CBC report functions as part of a three-tier structure, together with a global master file and a local file, as recommended by the OECD’s Base Erosion and Profit Sharing (BEPS) Action 13 report (Transfer Pricing Documentation and Country-by-Country Reporting). The CBC reporting requirement targets large MNEs, with the aim of encouraging international tax transparency, improving tax authorities’ access to information on MNEs’ global allocation of income and taxes paid, and helping governments to assess high-level transfer pricing risks and conduct economic and statistical analysis. The CBC reporting requirement will allow Thailand to exchange tax and financial information on an automatic basis with other signatories of the Multilateral Convention on Mutual Administrative Assistance on Tax Matters. This goes in tandem with the recently passed Act Amending the Revenue Code (No. 54) B.E. 2564 (2021), which empowers the director-general of the Revenue Department to exchange information with competent authorities in other jurisdictions. Entities Required to Submit CBC Reports The CBC report notification applies to MNE groups that do business in Thailand and at least one other jurisdiction and that have consolidated group revenue of at least THB 28 billion (approx. USD 847.6 million) in a 12-month accounting period (prorated for shorter periods). Generally, ultimate

On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The new decree will take effect from January 1, 2022, replacing Decree No. 36/2016/ND-CP and its amendments on the same subject (“Decree 36”). Below are the main highlights of Decree 98: 1. Classification of Medical Devices Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the medical device. Under Decree 36, this responsibility was reserved for Vietnamese organizations qualified for medical device classification. 2. Clinical Trials of Medical Devices Decree 98 provides stricter and more detailed requirements on clinical trials. Particularly, medical device trials will include three phases, in which phases 1 and 2 need to be finished before the product registration, while phase 3 will be conducted after the medical devices are approved for circulation, following the specific requirement from the authorities. This requirement aims to continue evaluating the safety and efficacy of medical devices after they are widely used in the community in line with their usage conditions. 3. Medical Device Registration Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i.e., must obtain registration numbers) before being imported/manufactured for circulation in the Vietnam market. However, Decree 98 further stipulates new requirements as below. Validity of registration numbers Under Decree 98, the registration numbers for all classes of medical devices, not only Class A medical devices as in the current regulations, are valid indefinitely, except for registration numbers granted under the emergency registration procedure. Registration procedure for Class A/B medical devices Instead of having to register with the central level authority with a complex registration dossier as currently required, Decree 98 allows Class B medical devices to be subject to a simpler registration procedure, namely, “Declaration of applied standard” with

Attorneys from Tilleke & Gibbins have provided the latest update to the Thailand contribution to Doing Business in…, a Q&A-style guide published by Thomson Reuters Practical Law that presents an overview of the legal framework for doing business in 63 jurisdictions worldwide. The Thailand chapter of the guide outlines Thailand’s legal system and key laws applicable to foreign companies doing business in the country. The chapter specifically covers the following main topics: Legal system: Thailand’s court system and codified legal system. Foreign investment: Lists of reserved business activities, restrictions on doing business with certain jurisdictions, exchange controls and currency regulations, and grants and incentives available to investors. Business vehicles: Ordinary partnerships, registered ordinary partnerships, limited partnerships, private limited companies, and public companies. Environment: Main laws and regulations, factory operation. Employment: Laws, employment contract requirements, work permits, and termination and redundancy. Tax: Taxes on employment, tax and nontax resident employees and businesses, corporate income tax, value added tax, special business tax, municipal tax, stamp duty, dividends, interest, intellectual property royalties. Competition: Important aspects of Thailand’s regulatory regime surrounding competition, centered around the updated Trade Competition Act. Antibribery and corruption: Laws, compliance requirements, regulatory authority. Intellectual property: Patents, trademarks, registered and unregistered designs, and copyright. Marketing agreements and advertising: Regulation of marketing agreements, Thailand’s Consumer Protection Act, direct marketing, role of the Consumer Protection Board and Food and Drug Administration. E-commerce: E-commerce laws and regulations, marketing and sales via online platforms. Data protection: An outline of Thailand’s Personal Data Protection Act. Product liability: Procedures and regulations for product liability and product safety, including the Unsafe Goods Liability Act and the Consumer Case Procedure Act. Product liability: Key regulatory authorities for trade competition, environmental issues, and financial services. To browse, download, or print the Thailand chapter, please visit the Practical Law website.