You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

January 24, 2018

New Decree on Chemical Management and System for Chemical Declaration in Vietnam Benefits Chemical Trading Entities

Subscribe to Updates

On January 11, 2018, the National Single Window system for declaration of chemicals to be imported into Vietnam was officially launched. In its first week, this system was used and accessed by several major chemical companies who observed that the system was of very high quality, helping to complete the chemical declaration within a very short time. This extreme improvement comes on the heels of a new decree on chemical management in Vietnam.

Specifically, on October 9, 2017, the Government of Vietnam issued Decree No. 113/2017/ND-CP guiding the implementation of certain articles of the Law on Chemicals of 2007 (“Decree 113”). The new decree came into force on November 25, 2017, replacing Decree No. 108/2008 /ND-CP and Decree No. 26/2011/ND-CP, and addresses some limitations presented during the implementation of the previous decrees. Some of the key changes are detailed below.

National Single Window System

Certain chemicals imported into Vietnam must be declared with the Ministry of Industry and Trade (MOIT) before customs clearance. The previous chemical declaration process was done by filing paper forms (70% of all cases) or online (30%). Though paper filing was a time-consuming process and could affect the importing timeline, the online system suffered from difficulties in integrating digital signatures of the chemical trading entities, and the reports and information recorded in the online database were limited.

Decree 113 provides regulations regarding the aforementioned National Single Window system (Article 12.8), an online customs portal where traders can submit all documents and access all relevant information related to trade via a single electronic gateway, connecting customs with government agencies that deal with tax, immigration, quarantine, health, transport, agriculture, fisheries, foreign affairs, etc. The auto-reply from the MOIT is considered a declaration result which is shared with the importer and with customs before customs clearance (Article 27.4). As shown by the early results, this change should have a positive impact on the import activities of manufacturers, by providing a quick and simple procedure for the declaration of chemical importation.

Lists of Declared Chemicals

Decree 113 also provides the list of chemicals that must be declared before customs clearance. These chemicals are defined by their Vietnamese and English names, CAS (Chemical Abstracts Service) codes, HS (Harmonized System) codes, and chemical formulas. These details help chemical importers and customs agencies quickly input/verify the chemical information in the declaration form/customs form.

Chemical Extraction and Packaging

The government considers using, extracting, and packaging chemicals to be potentially high-risk activities. Articles 5.3 and 7 of Decree 113 provide regulations for extraction and packaging so that the adverse impacts on human health and the environment will be minimized. For example, chemical containers and packages are required to be tight, firm, and resistant to the chemicals themselves, weather, and normal handling impacts. The labels on the containers and packages must comply with regulations on chemical labeling. Used packages must be cleaned and stored separately.

National Chemical Inventory

Decree 113 emphasizes the importance of developing Vietnam’s National Chemical Inventory (a list of chemicals used in Vietnam under government regulations) and National Chemical Database for managing chemical safety, providing information for response systems, and providing information on hazardous chemicals in emergency situations. However, no detailed plan or timeline is provided.

 

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

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
Read More
July 1, 2026
Obtaining marketing authorization is a fundamental requirement for bringing pharmaceutical products to the Thai market. Companies must navigate the Thai Food and Drug Administration’s registration procedures while also complying with post-approval pharmacovigilance obligations, licensing requirements for manufacturing and importation, data protection rules, and other regulatory requirements. This guide provides an overview of Thailand’s regulatory framework for pharmaceutical marketing authorization, including available registration pathways, review timelines, application fees, postmarketing surveillance obligations, licensing requirements, exemptions, data exclusivity, freedom of information, and parallel import considerations. It is intended as a practical reference for pharmaceutical companies, regulatory affairs professionals, and others involved in bringing medicinal products to the Thai market. Download the guide below for a concise overview of the current requirements and procedures governing pharmaceutical marketing authorization in Thailand.
Read More
June 24, 2026
Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological
Read More
June 19, 2026
For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements
Read More