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規制法対応

規制法対応

Key Contacts

カンボジア

インドネシア

ラオス

ミャンマー

タイ

ベトナム

David Mol

     +855 23 964 210

     [email protected]

Jay Cohen

     +855 23 964 210

     [email protected]

Wongrat Ratanaprayul

     +6221 2971 8099

     [email protected]

Irene Djalim

     +6221 2971 8001

     [email protected]

Alan Adcock

     +66 2056 5871

     [email protected]

Yuwadee Thean-ngarm

     +95 9 772 440 002

     [email protected]

Alan Adcock

     +66 2056 5871

     [email protected]

Atthachai Homhuan

     +66 2056 5610

     [email protected]

Hien Thi Thu Vu

     +84 24 3772 5606

     [email protected]

OVERVIEW

業界を知悉した弁護士・専門家がサポートいたします。

当事務所の規制関連業務チームは、この地域での数十年にわたる業務経験を基礎に、今日の技術革新に対応した効率的なサポートを提供します。 当事務所の規制関連業務チームは、経験豊富な弁護士・専門家に加えて、クライアントの業界に応じて、薬剤師、農業コンサルタント、その他の業界の規制専門家が参画します。当地域の重層的な公式・非公式の規則、方針、手続きをクリアし、更にはクライアントが規制当局と建設的な関係を築けるようにサポートしてまいります。

当事務所は、医薬品、バイオテクノロジー製品、食品・サプリメント、鎮静剤・向精神剤、医療機器、化粧品などにつき、各国の食品・医薬品規制官庁や農業製品規制機関への登録を支援しています。

当社の規制関連サービスは以下の事項に関連して提供されています。

  • 臨床試験
  • 公衆衛生当局への登録
  • 食品・医薬品規制官庁からのからの輸入、輸出、製造に関わるライセンス取得
  • 農業規制当局への登録
  • 畜産物・水産物・危険物の登録
  • 輸出入および製造ライセンス
  • ライセンスの継続
  • 規制遵守
  • ラベリングおよび広告関連の許可申請・取得
  • 知的財産
Case Studies
Regional | Life Sciences | Regulatory Affairs

Market Entry for Plant-Based Meat Substitutes Foodtech Company

Assisted a world-leading foodtech innovator known for developing plant-based meat substitutes in establishing a presence and a market for their products in Indonesia and Thailand, including extensive advice on food product registration with local FDAs.

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Experience

  • Acted as counsel to a major pharmaceutical company, which representation included liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.
  • Represented a world-leading pharmaceutical company on regulatory due diligence in their spin-off of high revenue product lines (i.e., over-the-counter antihistamines, cough relief syrups, tablets and elixirs) to another major pharmaceutical company.
  • Retained to advise an American biotechnology manufacturing company on Southeast Asian drug approval for several of their bespoke personal care and pharmaceutical products.
  • Acted for a Canadian standards and regulatory consultancy firm in conducting a regulatory landscape project on anti-microbial processing aids for the food industry in four jurisdictions in Southeast Asia. Our Regulatory Affairs teams across our offices advised the client on applicable government agencies, regulations, regulatory submissions, and other requirements for their product. The invaluable information we provided prompted the client to retain our teams for a subsequent regulatory landscape project on nutraceuticals.
  • Assisted a European medical device and pharmaceutical company active in over 50 countries to successfully obtain VIPRI (Vietnam Intellectual Property Research Institute) opinions that two foreign-produced products imported into Vietnam were infringing.
  • Assisted a global pharmaceutical company, with registration of and regulatory approval for its drugs with the Myanmar Food and Drug Administration (FDA), while simultaneously working to stem the flow of counterfeit drugs that were being sold in the Myanmar market.
  • Acted as lead Thai counsel to a major pharmaceutical company on various regulatory affair matters including, liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.
  • Seconded a lawyer to the Vietnam subsidiary of a U.S.-based global medical devices and consumer products company to fill their in-house counsel position. Our secondee was in charge of legal matters for all of the client’s subsidiaries and representative offices in Vietnam in relation to their pharmaceuticals, consumer goods, and medical devices operations
  • Helped a multinational food company comply with Thai FDA requirements. Advised the client on advertising and promotional materials in Thailand, with particular emphasis on the requirements of the FDA and the consequences of improper ad content.
  • Acted on behalf of a major U.S.-based agrichemical manufacturer. The case involved termination of the client’s distributor for breach of contract and IP (patent and trademark) infringement. In addition, we represented the client in re-registration of its full range of products with the Thai Ministry of Agriculture.
  • Negotiated with the Thai FDA to reclassify a client’s drug product from a new chemical entity (NCE) to new combination (NCO) and secured the successful registration of this product.
  • Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
  • Secured an export license for the client in an efficient manner, as required by the head of the product group.
  • Coordinated the actions of multiple parties (the reviewers in Thailand, the foreign regulatory affairs authority, and the firm) to timely secure a pharmaceutical product license for the client.
  • Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
  • Handled a portfolio of products of a pharmaceutical client.  Our representation included assisting in the registration of the products, reviewing and advising on product labels, and assisting in transferring the products to a third company.
  • Secured medical device registration for a top shoe manufacturer and trader in Thailand by giving beneficial advice to the client and working closely with the client to resolve issues with its application.
  • Registered, in a seamless and efficient manner, a cosmetic product for a large importer in a limited period of time, which enabled the client to timely launch the product.
  • Advised a global pharmaceutical company on all aspects of doing business in Vietnam, including the formation and operation of a representative office, registration as a foreign pharmaceutical company, property transactions, and employment termination and labor disciplinary procedures.
  • Assisted a multinational confectionery company with registration of various chocolate and mint products in Thailand and Vietnam, and provided advice on food labeling requirements, classification of food products, food additive regulations, and parallel import of foods.

弁護士・専門家

RELATED INSIGHTS

AWARDS & RANKINGS
3月 12, 2024
Tilleke & Gibbins has been nominated for three esteemed awards at the upcoming Chambers Asia-Pacific and Greater China Region Awards 2024: Thailand Firm of the Year Vietnam Firm of the Year Outstanding Firm for Diversity & Inclusion The nomination for Thailand Firm of the Year marks Tilleke’s fourth consecutive nomination and 10th overall since 2010, with the firm previously clinching the award in 2014. The firm is also a repeat nominee for the Outstanding Firm for Diversity & Inclusion award, while this is the first time Chambers has shortlisted Tilleke for the Vietnam Firm of the Year category in these awards. The winners of the Chambers Asia-Pacific and Greater China Region Awards 2024 will be announced at an exclusive in-person event scheduled to take place in Hong Kong on May 29, 2024. To learn more about the Chambers Asia-Pacific and Greater China Region Awards 2024 and browse the full list of nominations, please visit the Chambers and Partners website.
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1月 30, 2024
The International Financial Law Review (IFLR) recently unveiled the shortlists for the IFLR Asia-Pacific Awards 2024, and Tilleke & Gibbins has been nominated for Thailand Firm of the Year at this competition recognizing outstanding legal firms and professionals across the Asia-Pacific region. The IFLR Asia-Pacific Awards are based on research by the IFLR team and careful selection by an internal panel of judges. The firm’s nomination conveys the firm’s continued commitment to excellence and its leading position in Thailand’s legal landscape. Winners of the IFLR Asia-Pacific Awards 2024 will be revealed at a gala dinner to be held in Hong Kong on March 20, 2024, at an event that will bring together industry leaders and legal professionals to celebrate excellence in the legal field. IFLR is a longstanding legal publication focusing on financial, transactional, and related matters in business law. To browse a full list of nominees for the IFLR Asia-Pacific Awards 2024, please see the shortlist on the IFLR website.
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12月 14, 2023
The recently released 2024 edition of Chambers Asia-Pacific gives Tilleke & Gibbins high marks across all of the firm’s jurisdictions in Southeast Asia. In addition to the practice-area rankings, individual practitioners from the firm’s offices across the region received a record total of 35 individual rankings.
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9月 27, 2023
At the Asialaw Awards 2023 ceremony held on September 26, Tilleke & Gibbins was the recipient of five awards—three firmwide and two individual. The excellence of the firm’s insurance practice was recognized across the region with the Regional Insurance Firm of the Year award. The accolade, which is based on in-house research and input from clients and industry commentators, recognizes Tilleke & Gibbins’ ability to provide top-tier legal services in the insurance sector across the region. Tilleke & Gibbins also won four Client Choice Awards, which celebrate exceptional client service and satisfaction. The awards, which span both firmwide and individual categories, include the following: Client Choice Award – Myanmar Firm of the Year Client Choice Award – Vietnam Firm of the Year Client Choice Award – Myanmar Lawyer of the Year: Yuwadee Thean-ngarm Client Choice Awards – Vietnam Lawyer of The Year (Honorable Mention): Thomas J. Treutler For more information on the Asialaw Awards 2023 and to browse a full list of the winners, please visit the Asialaw website.
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across Southeast Asia.

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© 2020 Tilleke & Gibbins International Ltd. All rights reserved.

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