Interest in organic farming, soil health, and regenerative agriculture has increased rapidly in recent years, and the demand for biological and organic fertilizers has accordingly undergone dramatic growth. Biological fertilizers contain specific levels of microorganisms (such as nitrogen-fixing bacteria); organic fertilizers similarly contain microorganisms and typically come from animals and plants, such as livestock manure and crop residues. Although responsible fertilizer use is still necessary to prevent unintended effects, these “living fertilizers” can boost yields and promote plant productivity without many of the adverse environmental effects and safety concerns of chemical fertilizers. This makes them highly sought after for organic farming, and prized by agricultural operators looking to promote soil health as a bedrock of sustainable agricultural practices. As the global trade for organic and biological fertilizers has scaled up, producers and agribusiness companies have expanded organic and biological fertilizer offerings to new markets. Not only do different countries have their own regulations for fertilizers in general, but they also often have specific requirements and rules for biological and organic fertilizers. This guide provides fertilizer producers and traders with an overview of the legal landscape for these fertilizers in three major Southeast Asian markets so that businesses can make their fertilizers available and foster sustainable agricultural practices in the region. The full Biological and Organic Fertilizers in Indonesia, Thailand, and Vietnam guide can be downloaded through the button below.

On July 13, 2022, the Vietnamese government issued Decree No. 46/2022/ND-CP amending and supplementing some articles of Decree No. 13/2020/ND-CP providing detailed guidance on the Law on Animal Husbandry (“Decree 46”). The new decree took effect on the issuance date. Among the changes introduced by Decree 46 are a number related to animal feed. Recognition of Testing Methods of Exporting Countries Decree 46 clarifies the steps to recognize animal feed testing methods of laboratories in exporting countries. Under the amended regulations, the Department of Livestock Production (DLP) will organize an assessment team to appraise each dossier for recognition of animal feed testing methods within 30 days of receipt of a complete dossier. If the dossier lacks required information or authenticity, the DLP will organize a practical assessment team at the exporting country’s testing laboratory. If the dossier passes the assessment, within five working days from the completion of the assessment, the DLP will issue a decision on recognition of the testing method. The validity of this decision has been lengthened from three years to five years. State Inspection of Animal Feed Quality Process of State Inspection Decree 46 specifies the process to conduct state inspection of the quality of imported animal feed by unifying the regulations stipulated in the related legal documents listed in Decree 13. The process includes the submission of a state inspection dossier, timelines to receive feedback from the inspection authority, and further steps that can be taken upon receiving acceptance or refusal decisions from the authority. For traditional animal feed and complete compound animal feed, imported shipments are customs-cleared as soon as the importer completes the customs procedures. Within 15 days from the customs clearance date, the importer must submit the conformity assessment results. The importer has complete responsibility for the conformity assessment results, and

In late 2021, the government of Vietnam issued Decree 98 on the management of medical devices (Decree No. 98/2021/ND-CP dated November 8, 2021), which came into force on January 1, 2022. This is the primary legislation on medical devices in Vietnam. To provide necessary guidance and elaboration on the implementation of Decree 98, the Ministry of Health recently issued Circular No. 05/2022/TT/BYT dated August 1, 2022 (“Circular 05”), which took effect on the same day. The most notable aspect of Circular 05 is that it unifies, in a single legislative document, previous regulations on medical devices that were scattered in multiple circulars issued by the Ministry of Health (Circular No. 39/2016/TT-BYT dated October 28, 2106; Circular No. 46/2017/TT-BYT dated December 15, 2017, as amended by Circular No. 23/2021/TT-BYT dated December 9, 2021; and Circular No. 33/2020/TT-BYT dated December 31, 2020). The effectiveness of these circulars was terminated when Circular 05 took effect. Circular 05 sets out regulations and principles for the classification of medical devices, and adds or supplements the following lists: List of in vitro diagnostic medical devices (IVD) not subject to quality assessment by Vietnamese competent authorities when registering under the quick registration procedure. List of class B, C and D medical devices allowed to be traded as normal goods. List of medical devices required to be accredited for safety and technical functions before use. List of medical devices requiring import permit licenses. While Circular 05 does not introduce major changes to the previous regulations, the consolidation and up-to-date guidance on Decree 98 will simplify the task of registration and circulation for medical device companies doing business in Vietnam.

Patent is an essential piece of the amended Law on Intellectual Property (“Amended IP Law”), which was passed by the National Assembly of Vietnam on June 16, 2022, and will take effect on January 1, 2023 (except for the regulation on protection of experimental data for agrochemical products, which will take delayed effect on January 14, 2024). Among the amended and supplemented contents of the Amended IP Law, there are notable patent-related amendments to Article 60 on assessing the novelty of inventions and Article 96 on grounds for invalidating patent protection titles. We discuss these changes below. Secret Prior Art Under Article 60.1 A significant amendment to Clause 1, Article 60 of the Amended IP Law on the novelty of inventions is to broaden the scope under which an invention can be considered to have lost its novelty. For the first time in Vietnam, “secret prior art” –a patent application with an earlier filing date or priority date but published on or after the filing date or priority date of an examined patent application – is introduced as a prior art document. In the diagram above, at the time of filing of the A2 application, secret prior art A1 has been filed but not yet published, making it inaccessible to the public. At this point, only the A1 applicant and the IP Office are aware of the A1 application. Under the current provisions of the 2005 IP Law, as amended in 2009 and 2019, the A1 patent application is not eligible to be a prior art document when assessing the novelty of A2. However, based on the “first-to-file principle” and the principle of priority, the IP Office has still had other approaches to bar the patentability of an A2 patent application if there is such an A1 application. By