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Irene Djalim

Manager, Regulatory Affairs

Biography

Irene Djalim is the manager of the regulatory affairs department in Tilleke & Gibbins’ Jakarta office. With a strong technical background and detailed knowledge of Indonesian intellectual property law, Irene handles prosecution of patent applications in mechanical, chemical, and pharmaceutical fields, in which she helps inventors protect their innovations. She prepares and files applications for patents, petty patents, and industrial design patents, prosecutes the patents until they are granted, and maintains the patents after they are granted. Irene also regularly performs patent searches as well as freedom-to-operate analyses and infringement assessments.

In addition to her intellectual property practice, Irene leads regulatory affairs matters for clients in the life sciences sector. She advises on regulatory requirements and market entry strategies for pharmaceuticals, medical devices, cosmetics, food products, and other regulated products in Indonesia. Working closely with manufacturers, distributors, and marketing authorization holders, she assists with product registrations, licensing matters, regulatory compliance, interactions with government authorities, and postmarket regulatory issues, helping clients navigate Indonesia’s regulatory framework and bring products to market efficiently.

Irene graduated with a degree in chemical engineering from the Georgia Institute of Technology and obtained a Magister Akuntansi from Institut Bisnis dan Informatika Indonesia. Prior to specializing in patent work, she had experience working in a United States government agency and an automotive manufacturing facility in Indonesia. Irene is a registered IP consultant in Indonesia. Irene is a member of the Intellectual Property Consultant Association and the Asia Patent Attorneys Association.

Experience

  • Formulated strategic advice for clients on patent filing and prosecution in Indonesia, as well as PCT filing to maximize protection.
  • Provided regulatory advice and assistance with regard to product registration of hazardous substances in Indonesia, and collaborated with the Ministry of Agriculture.
  • Prepared and filed patent, utility model, and industrial design applications.
  • Represented clients in maintaining their patent portfolios through payment of annuity fees and other actions.
  • Provided regulatory advice on product registration of traditional medicine in Indonesia with the Indonesian FDA (BPOM).
ABOUT Irene

Location

Languages

    English

    Bahasa Indonesia

Education

    BSChE, Georgia Institute of Technology

    M.Ak, Institut Bisnis dan Informatika Indonesia

Insights

September 9, 2026
On June 30, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 11 of 2026 on Food Packaging, which expands the list of approved food-contact substances and recognizes a broader range of permissible functions for those substances. The new regulation, which revokes BPOM Regulation No. 20 of 2019, reflects developments in packaging technology and materials science. Although the new regulation provides more advantages to business actors by adding more food contact substances to the approved list for use in food packaging, there are more stringent rules and restrictions for testing. One of the most significant changes is a comprehensive migration-testing framework that sets out requirements for packaging materials, testing conditions, food simulants, and specific migration limits. Overall and Specific Migration Under BPOM Regulation No. 20 of 2019, migration requirements were primarily set out within the lists of approved food-contact substances and packaging materials. BPOM Regulation No. 11 of 2026 instead expressly requires packaging materials that come into direct contact with food to meet both overall and specific migration limits. These are defined as follows: Overall migration: The total quantity of all substances that migrate from the packaging, regardless of whether the substances are hazardous or nonhazardous to health. Specific migration: The quantity of a particular identified substance known to be hazardous to health that migrates from the packaging. Stricter Limits on Heavy Metals The overall migration limit for plastic packaging remains unchanged under both regulations at 60 mg/kg or 10 mg/dm². However, the new regulation introduces significant changes to the regulation of heavy metals. Under the 2019 regulation, four heavy metals—lead, cadmium, chromium VI, and mercury—were subject to a single combined limit of 1 mg/kg. The 2026 regulation, however, requires each heavy metal to meet its own individual specific migration limit, adds arsenic as
August 10, 2026
On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a
July 13, 2026
Indonesia’s Halal Product Assurance Agency (BPJPH) has issued new regulations establishing clearer procedures for imposing administrative sanctions on businesses that violate halal product assurance requirements. BPJPH Regulation No. 2 of 2026 on the Imposition of Administrative Sanctions for Violations of Halal Product Assurance Implementation, issued on June 5, 2026, strengthens Indonesia’s halal compliance framework, as mandated under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 42 of 2024 on the Implementation of Halal Product Assurance. BPJPH Regulation No. 2/2026 also supports the upcoming mandatory halal compliance deadline of October 17, 2026, which will apply to a broad range of products and services, including imported food and beverages, slaughtering products and services, natural and quasi-drugs, health supplements, cosmetics, chemical and genetically engineered products, clothing and accessories, household goods, prayer equipment, stationery, and class A medical devices. Scope BPJPH is authorized to impose administrative sanctions for violations of halal product assurance requirements committed by businesses, halal inspection agencies (LPH), halal auditors, halal product process companion institutions (lembaga pendamping PPH), and halal product process companions (pendamping PPH). The head of BPJPH has authority to determine, cancel, or amend the imposition of administrative sanctions, including upon receipt of objections. This authority covers revocation of Halal Certificates (including foreign halal certificate registration numbers), withdrawal of goods from circulation, freezing of LPH operations, freezing of halal product process companion institutions, revocation of PPH companion institution registration numbers, revocation of halal auditor registration numbers, and revocation of LPH accreditation status. Administrative Sanctions Businesses may be subject to any of the following administrative sanctions: Written warning; Administrative fine; Revocation of the halal certificate, including revocation of foreign halal certificate registration numbers; and Withdrawal of goods from circulation. The regulation sets out the types of violations that may trigger these sanctions, with each
June 4, 2026
Indonesia’s Minister of Health has issued Decree No. HK.01.07/MENKES/301/2026 on the Affixation of Nutritional Labels and Health Information to Ready-to-Eat Processed Food Products. The decree came into force on April 14, 2026, and was issued to implement the Health Law and Minister of Health Regulation No. 3 of 2026 on Disease Control. The decree requires the inclusion of Nutri-Level labeling on the front-of-pack nutrition labeling (FOPNL) to indicate the product’s nutritional level based on the content of sugar, salt, and fat (“gula, garam dan lemak (GGL)”). Changes from 2024 Draft Regulation The Nutri-Level labeling was previously proposed in 2024 by the Indonesian FDA (BPOM) through a draft regulation concerning nutrition information. While the categories of Nutri-Level labeling remain the same in the issued decree, the content requirements of sugar, salt and fat in the decree are different from the earlier proposal introduced in the 2024 draft BPOM regulation. In addition, the decree has further specified that the content of fat in the Nutri-Level labeling is the content of saturated fat, not total fat as previously proposed in the 2024 draft. The decree requires Nutri-Level labeling to be implemented in beverage products, which is the same as previously proposed in the 2024 draft BPOM regulation. Other food products may gradually become subject to mandatory Nutri-Level labeling under future implementing regulations. Nutri-Level Labeling Food levels as shown by the Nutri-Level labeling are classified into four color-coded categories from A to D: Level A (lowest amount) in dark green Level B in light green Level C in yellow Level D (highest amount) in red The Nutri-Level labeling is represented by the following image. The requirements for each level for sugar, salt, and fat content, based on amounts per 100 milliliters of product in beverage form, are as follows. Nutri-Level information must be

Awards & Rankings

September 29, 2026
Tilleke & Gibbins has been named a finalist in four categories at the ALB Indonesia Law Awards 2026, highlighting the strength of the firm’s Indonesia practice across intellectual property, life sciences, and technology. The firm has been shortlisted in three firm categories: Intellectual Property Firm of the Year Medical and Healthcare Firm of the Year TMT Firm of the Year In addition, Wongrat Ratanaprayul, partner and director of Tilleke & Gibbins’ Indonesia operations, has been shortlisted for Woman Lawyer of the Year (Law Firms). The ALB Indonesia Law Awards recognize outstanding law firms, in-house teams, legal professionals, and transactions in Indonesia. The winners will be announced at an awards ceremony on October 22, 2026, at the Grand Hyatt Jakarta. For more information, please see the full shortlist for the ALB Indonesia Law Awards 2026.
September 23, 2026
Tilleke & Gibbins has received eight nominations for the Managing IP Asia-Pacific Awards 2026, recognizing the strength of the firm’s intellectual property practice across Southeast Asia. The firm has been shortlisted in the following categories: Asia-Pacific Firm of the Year (Domestic) Cambodia Firm of the Year Indonesia Firm of the Year Thailand Patent Firm of the Year Thailand Trademark Firm of the Year Vietnam Patent Firm of the Year Vietnam Trademark Firm of the Year In addition, Darani Vachanavuttivong, managing partner and managing director of the firm’s intellectual property practice, has been shortlisted for Asia-Pacific Practitioner of the Year (General Law Firms). The eight nominations reflect the continued recognition of Tilleke & Gibbins’ regional capabilities in intellectual property protection, commercialization, and enforcement. The winners will be announced at a ceremony in Kuala Lumpur on November 5, 2026. For more information, please see the full Managing IP Asia-Pacific Awards 2026 shortlist.
June 4, 2026
Tilleke & Gibbins has reinforced its position as one of Southeast Asia’s leading patent practices in the newly released IAM Patent 1000 2026, earning top-tier firm rankings in Indonesia, Thailand, and Vietnam, alongside 23 individual recognitions across the region. The firm achieved Gold rankings in Thailand and Vietnam and a Highly Recommended ranking in Indonesia—the highest tier available in the jurisdiction—highlighting the strength and consistency of its regional patent practice. This marks the firm’s 14th consecutive year in the top tier for Thailand, seventh consecutive year for Vietnam, and third straight year ranked among Indonesia’s leading firms. The firm’s strong regional performance is further reflected in the individual rankings, with the following Tilleke & Gibbins practitioners recognized for their expertise in patent law: Indonesia Irene Djalim Melinda Ambrizal Wongrat Ratanaprayul Thailand Alan Adcock Atthachai Homhuan Darani Vachanavuttivong Jakkrit Kuanpoth Napagate Triratana Nattriya Supmoon Nuttaphol Arammuang Peeyakorn Suparugbundit San Chaithiraphant Somboon Earterasarun Suebsiri Taweepon Sukontip Jitmongkolthong Wong Vorravitwattana Vietnam Dat Thanh Nguyen Giang Hoang Bach Hien Thi Thu Vu Hung Tuan Nguyen Linh Duy Mai Loc Xuan Le Thanh Phuong Vu The IAM Patent 1000 identifies the world’s leading patent firms and practitioners through extensive qualitative research based on feedback from clients, peers, and industry stakeholders. For more details, please see the IAM Patent 1000 rankings for Indonesia, Thailand, and Vietnam.
May 14, 2026
Asian Legal Business (ALB) has published the ALB Asia IP Rankings 2026, the latest edition of its annual guide recognizing leading intellectual property firms across the region. Continuing the approach introduced last year, the rankings present a unified table in each jurisdiction, combining patent and trademark/copyright work to provide a more holistic view of the IP market. Tilleke & Gibbins has retained strong rankings in all three jurisdictions covered by the survey: Thailand: Tier 1 Vietnam: Tier 1 Indonesia: Tier 2 The rankings are based on work conducted between February 2025 and February 2026, covering both ongoing and completed contentious and noncontentious matters. ALB’s research draws on firm submissions, client feedback, editorial resources, and market input to identify the region’s leading IP practices. Tilleke & Gibbins’ IP team has maintained a strong track record across all ranked jurisdictions since the inception of the ALB IP Rankings in 2018. To view the full rankings, please see the May 2026 issue of ALB.

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