On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07). Circular 07 will take effect on November 1, 2022, replacing Circular No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence data when registering drugs. Circular 07 includes provisions on (i) generic drugs containing active pharmaceutical ingredients (APIs) or having dosage forms that require BE reporting when registering the drugs in Vietnam and (ii) dossiers for BE reporting of generic drugs. The most outstanding point under Circular 07 is that the list of APIs requiring the submission of BE reports in their drug registration dossier includes 26 APIs instead of 12 APIs as specified in the previous circular. In addition, generic drugs having the following dosage forms must have a BE report in the drug registration dossier: Drugs in immediate-release dosage form, with systemic effects, containing APIs included in the list of 26 APIs and not falling in the cases of BE reporting exemption, Drugs in modified-release dosage form, with systemic effects, that do not fall in the cases of BE reporting exemption. Roadmap for Application From November 1, 2022, the registrants of the following drugs must submit a report on BE study data along with the drug registration dossier: Generic enteric-coated drugs, in immediate-release or modified-release form, containing single APIs or fixed-dose API combinations in which the APIs are included in the list of 26 APIs mentioned above. Other generic drugs in modified-release form, except for enteric-coated drugs with APIs excluded from the list of 26 APIs. From November 1, 2025 (36 months after the effective date of Circular 07), the registrant must submit a BE data dossier along with the drug registration dossier for all generic enteric-coated drugs in modified-release form. From November 1, 2026 (48 months

Thailand’s recent removal of cannabis from the list of narcotics represents a significant development for the country, and it has some human resources teams wondering whether they should prepare certain measures in order to prevent detrimental incidents from happening in their organizations. For example, some employees could still be under the influence of cannabis because they used it before coming to work. In the past, this was rarely a consideration as cannabis was clearly banned. Using cannabis or possessing cannabis inside the employer’s premises subjected employees to criminal liability including imprisonment and fines. However, now that the government has removed cannabis from the narcotics list under the Narcotics Act, such incidents are more likely to occur. This likelihood has led to concern among many employers about how they can prevent or handle these incidents. An employer does have the right to prohibit any employee from bringing cannabis inside its premises, as it is the property of the employer. The employer has the management right to do this, particularly as an employee’s use of cannabis may very well disturb other employees. But if the employer would like to set penalties for breaching the prohibition, the picture is more complicated. Employers’ Work Rules Under the Labour Protection Act (LPA), an employer who has at least 10 employees must have Thai-language work rules. These work rules must include the following items: Specification of working days, regular working hours, and rest periods; Holidays and rules for taking holidays; Rules concerning overtime work and work on holidays; Arrangements for payment of wages (i.e., schedule and location); Overtime pay, holiday pay, and holiday overtime pay; Leave and rules for taking leave; Discipline and disciplinary actions; Submission of grievances; and Termination of employment, severance pay and special severance pay. To issue or amend work rules (e.g., to introduce cannabis-related rules), employers must: Announce the implementation of work rules within 15 days of

タイが最近麻薬のリストから大麻を削除したことは、同国にとって重要な変化であり、人事チームの中には、会社内で有害な事件が起きないようにするために、何らかの対策をすべきではないかと考えている場合もあるだろう。 例えば、出勤前に大麻を使用したため、勤務中に大麻の影響を受けている労働者がいたらどうだろう。以前は大麻が明確に禁止されており、使用者の敷地内で大麻を使用したり所持したりすると、労働者は懲役や罰金などの刑事責任を問われたため、このような問題はほとんど考慮されていなかった。しかし、政府が麻薬法に基づいて麻薬のリストから大麻を削除した今、そのようなことがより起こりやすくなっており、多くの使用者の間で、どうすればこのようなことを防止し、対処できるかという懸念が生じている。 会社の敷地は使用者の支配下にあるから、使用者には労働者が社内に大麻を持ち込むことを禁止する権限がある。特に、労働者が大麻を使用することは他の労働者を著しく妨害する可能性があるため、雇用主はこれを管理する権限を有する。しかし、労働者が禁止に違反した場合の罰則を設けたい場合は、そこまで単純にはいかない。   就業規則  労働者保護法（Labor Protection Act）では、10人以上の労働者を雇用する場合、タイ語の就業規則を定めなければならない。就業規則には、次の項目が含まれている必要がある。 労働日、所定労働時間及び休憩時間の指定。 休日・休日の取得の規則。 時間外労働及び休日労働に関する規則。 賃金の支払いの手配（支払日と支払場所）。 時間外賃金、休日賃金及び休日時間外賃金。 休暇及び休暇の取得の規則。 懲戒処分。 苦情の申出。 雇用の終了、解雇補償金及び特別解雇補償金。   就業規則（例えば、大麻関連のルールを導入するために）を作成又は変更する場合、使用者は次のことを行う必要がある。（なお以前は、労働者保護局長又はその指名する者に就業規則又は就業規則の変更書の写しを送付することが義務付けられていたが、2017年の労働者保護法改正でこれは撤廃された。） 就業規則を作成又は変更した日から15日以内に就業規則の実施を公表すること。 就業規則及びその変更を常時社内に保管すること。及び 就業規則・その修正を職場において公開していること。使用者は、就業規則又はその修正を電子的に公開することもできる。   しかし、労働者の雇用条件に影響を与えるような就業規則の変更には、より多くの意見を聞くことが必要である。労働関係法（Labor Relations Act）の下では、使用者は雇用条件を一方的に変更することはできない。 「雇用条件」という用語は、タイ法の下での広い概念であり、賃金、福利厚生、労働日数、労働時間等など雇用の条件であることが明確なものから、労働者の苦情の提出に関する規則、雇用の終了、懲戒処分、就業規則の改正、その他契約又は慣行により義務とされる職場の条件などの事項までを広く含む概念である。例えば、変動制のボーナスの基準は雇用条件とみなされ得るため、雇用者が書面においてそれを変更する権利を明示的に留保していない場合、これらの基準を使用者が一方的に変更することができない可能性がある。同様に、労働者に支給されるシャトルサービスなどの福利厚生も、雇用条件になりうる。 労働条件に影響を与える就業規則の変更をしようとする場合には、労働関係法に従い、労働者に対し要求を記載した通知書を交付して交渉するか、労働者の同意を得なければならない。ただし、就業規則に、使用者が将来就業規則を変更する権利を留保する旨の条項がある場合は、雇用条件に影響を与えない範囲での就業規則の変更をすることができる。例えば、就業規則に部署ごとの労働者数が記載されている場合などは、雇用条件の利益に影響を与えない範囲で変更することができる。 以上から、大麻に関する規則については、前述のとおり、使用者が社内で労働者が大麻を使用することを禁止することは可能だが、大麻を社内に持ち込んだ労働者を解雇するという規則を設けたい場合又はその他の罰則を科すとしたい場合には、雇用条件に影響があると考えられるため、使用者が一方的に行うことはできない。したがって、このような就業規則の改正を考える使用者は、労働関係法の手続きに従って、労働者に要求を記載した通知書を交付するか、労働者に同意を求めることによって、手続きを進めなければならない。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。Cannabis and Human Resources Considerations in Thailand

Thailand’s Office of the Personal Data Protection Committee (PDPC) has opened a public hearing period on its draft notification regarding cross-border transfer of personal data. The public hearing is open through October 24. The notification, once issued, will supplement the principle of cross-border transfer of personal data outside of Thailand set out in the Personal Data Protection Act (PDPA). The notification sets out the following key matters: Definitions “Transfer of personal data” means any sending or transferring of personal data by a transferor of personal data, either by way of a physical transfer or a remote transfer through a computer system or an internet network to the recipient of the personal data. It does not include sending personal data through an intermediary by transiting between computer systems or internet networks, or any storing or retaining of personal data, either permanently or temporarily, by a cloud computing service provider, whereby the personal data transferor and the personal data recipient (1) are not making the order, (2) are not involved with any data selection or the content of the personal data sent and received through the computer systems or internet networks, or (3) have the purpose of entering into an agreement or any juristic act. “Binding corporate rules” means the agreed terms or policy on personal data protection made between the personal data transferor and the personal data recipient to establish appropriate measures for safeguarding personal data within a group of corporations or companies. “Standard contractual clauses” means the contractual terms made between the personal data transferor and the personal data recipient to establish appropriate measures for safeguarding personal data. “Code of conduct” means a code that sets out the obligations of a personal data transferor and a personal data recipient outside of Thailand. “Certification” means an undertaking in relation to safeguarding personal data, in order to establish

On October 3, 2022, Thailand’s Ministry of Labour issued an announcement canceling the prohibition on lockouts and strikes, which had been in place since the onset of the COVID-19 pandemic. While this cancellation does not apply to ongoing labor disputes already being considered under the interim arrangements, it will apply to all other labor disputes from October 5, 2022, when it was published in the Government Gazette. Lockouts and strikes are basic rights of employers and employees under the Labour Relations Act B.E. 2518 (1975). However, these rights can be suspended—as they have been since May 8, 2020, when the Ministry of Labour announced that all labor disputes that could not be resolved through negotiation must be presented to the Labour Relations Committee in lieu of organizing strikes or lockouts. The announcement referred to the necessity of such special administration during the COVID-19 situation in order to prevent possible negative impacts on both employers and employees. On September 30, 2022, Thailand ended its COVID-19 emergency decree and dissolved the country’s Centre for COVID-19 Situation Administration. In light of this, the Ministry of Labour decided to end the requirement that unresolved labor disputes be sent to the Labour Relations Committee. The ministry’s cancellation of the prohibition will once again allow employers and employees to organize lockouts and strikes under the Labour Relations Act, starting October 5, 2022. For more details on this development, or for assistance with employment-related questions or disputes in Thailand, please contact Tilleke & Gibbins at [email protected] or +66 2056 5555.

On September 5, 2022, Vietnam’s Ministry of Health (MOH) issued Circular No. 08/2022/TT-BYT on the registration of drugs and drug materials (Circular 08). Circular 08 will come into effect on October 20, 2022, and replace Circular No. 32/2018/TT-BYT and its amendments, which are the current regulations on drug registration. Below are some noteworthy contents of Circular 08: The requirements on providing a Certificate of Pharmaceutical Product (CPP) are less stringent under the new regulations. For example, a CPP is now only required to include content as stipulated in the WHO’s CPP template. No additional contents—such as specification of finished products, APIs, herbal ingredients, and names and addresses of the API/herbal ingredient’s manufactures as under the current regulations—are required. Another new point is that, for the registration dossiers of new chemical drugs, vaccines, and imported biologicals (except probiotics), applicants are required to submit only one CPP issued by the manufacturing country if the CPP issuing authority is the EMA or any SRA (Stringent Regulatory Authority); no additional CPP/legal document is required as currently. There will be a new option for providing legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements. In particular, in addition to a GMP certificate, manufacturing license stating the manufacturer meets GMP, CPP for API with content satisfying GMP, Certification of Suitability (CEP), or self-evaluation form, it is acceptable if the company submits a Good Agricultural and Collection Practices/GACP certificate (for herbal ingredients) or other legal documents granted by the authorities containing at least the following contents: name and address of the manufacturer, certification that the manufacturer meets GMP requirements, and name of the drug substance/excipient/capsule/semi-finished medicinal material/medicinal ingredient. For vaccines, serums containing antibodies, and derivatives of human blood and plasma, Circular 08 introduces a more lenient

On August 31, 2022, the Government of Vietnam issued Decree No. 58/2022/ND-CP guiding the registration and management of operations of foreign non-governmental organizations (NGOs) in Vietnam (“Decree 58”). This decree will come into effect on November 1, 2022, replacing Decree No. 12/2012/ND-CP of the Government dated March 1, 2012, on the same matter (“Decree 12”). In general, the provisions under Decree 58 appear more detailed and stricter than those under Decree 12. In particular, there are two notable changes in Decree 58 in comparison with its predecessor: the definition of foreign NGO and the suspension and termination of a foreign NGO’s operation. New Definition of Foreign NGOs Under Decree 58, “foreign non-governmental organization” means a non-profit organization, social fund or private fund established under foreign laws; having legitimate capital sources from foreign countries; conducting development assistance and humanitarian aid activities not for profit or other purposes in Vietnam; and not receiving financial donations, calling for sponsorship, or raising funds from Vietnamese organizations and individuals. This definition has been narrowed in comparison to Decree 12, which, in addition to non-profit organizations, social funds, and private funds, also included “other social or non-profit organizations” as a category. Decree 58 further affirms that foreign NGOs must have capital sources from overseas and cannot receive funding from local sources. The last requirement had been a matter of concern in the past when foreign NGOs wanted to receive donations from Vietnamese entities. In practice, the prohibition of local funding had been known as an unwritten policy of the government; it is now officially recognized in Decree 58, and will prevent foreign NGOs from approaching local funding sources. More Specific Suspension and Termination Regulations Under Decree 12, there was no separation between the circumstances in which a foreign NGO’s operation would be suspended and those in which it would be terminated.

2022年6月16日、ベトナム知的財産法の改正法が国会議員の95.58%の同意を得て最終的に成立した。本改正法は、知的財産の所有権と執行の両方について改正が行われたため、知的財産権者だけでなく法執行機関からも大きな注目を集めている。 特に、改正知的財産法の下で、ベトナムは、EVFTA（European Union – Vietnam Free Trade Agreement）やCPTPP（Comprehensive and Progressive Agreement for Trans-Pacific Partnership）のような自国が締結している国際条約や協定を遵守するために音響商標を認める。音響商標を保護するには課題があるが、音響商標の採用によって、技術の発展期において知的財産権所有者に対して知的財産を保護するための1つの有用なタイプの保護を提供できることが期待されている。 著作権については、共同著作者の基準が明確化され、著作者数（2人以上）、著作者の貢献度、著作者の意図などの詳細が示されている。これらの基準は、英国や米国などの他国の法制度と類似している。共同著作者の定義は著作物の所有権を決める上で重要な役割を果たすため、この改正は共同著作物の所有権に関する争いが少なくなるというより良いシナリオを約束する。 国会は知的財産権侵害対策の一つとして行政罰を維持する。この点は、知的財産権を保護する方法として行政罰が記載されていなかった改正法の草案とは対照的である。行政罰が知的財産法から削除される点は多くの学者や弁護士から強い否定的な反論を受けていた。彼らは、実務的な観点から、民事訴訟の手続が行政罰の適用よりも時間と費用がかかることが多く、知的財産権所有者の権利保護を妨げると主張していた。さらに、知的財産権の侵害は、知的財産権所有者の法的利益に影響を及ぼすだけでなく、社会の発展や消費者の安全にも悪影響を及ぼす可能性がある。国会で修正されたことで、知的財産権所有者は、利用可能なすべての有効な保護手段を有しているという安心感を得ることができる。 改正知的財産権法は、ベトナムの知的財産における新時代を約束し、 2023年1月14日に施行される音響商標に関する規定並びに2024年1月14日に施行される農薬の試験データ保護に関する規定を除き、 2023年1月1日に施行される。