On March 1, 2021, the government of Vietnam promulgated Decree No. 14/2021/ND-CP on Penalties for Administrative Violations Involving Animal Husbandry (Decree 14). The new decree took effect on April 20 and, among other contents, repeals the regulations on animal feed found in Decree No. 64/2018/ND-CP dated May 7, 2018. In the field of animal feed, notable penalties of Decree 14 include the following: Penalty forms and levels For each administrative violation, the violator will be imposed a monetary penalty, which is the main penalty form. For the same violation, the monetary penalty level applied to an organization is double the amount applied to an individual. In addition, based on the nature and extent of the violation, additional penalties may be imposed on the violators, including confiscation of violating items, and confiscating Certificates of Eligibility to manufacture animal feeds. Violations of regulations on declaring product information A fine of up to VND 3 million (USD 130) will be imposed for the act of changing information on product labels that has been published on the Portal of the Ministry of Agriculture and Rural Development (MARD) without conducting the notification procedure to inform the MARD of such change. A fine of up to VND 7 million (USD 300) will be imposed for the act of deliberately falsifying or erasing contents of documents or making false declarations in the applications for animal feed products on the Portal of the MARD. Violation of regulations on quality in importing animal feed A fine of up to VND 25 million (USD 1,080) will be imposed for the act of importing each animal feed having (i) a quantitative content of each quality criterion lower than the minimum level or higher than the maximum level compared with the standards announced or written on the goods label; or (ii)

The latest updates to Practical Law’s Life Sciences Global Guide feature contributions from Tilleke & Gibbins attorneys in the firm’s Phnom Penh office, who wrote “Medicinal Product Regulation and Product Liability in Cambodia.” This overview form Practical Law covers a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following: Regulatory overview, including relevant authorities, scope, definitions, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT Pricing, government funding, and reimbursement: Structure of the Cambodian health care system, price regulation, and reimbursement Clinical trials Manufacturing and distribution Marketing: Authorization for marketing medicinal products, parallel imports and cross-border trade in medicines Restrictions on dealings with health care professionals Selling restrictions Advertising and promotion Data privacy Packaging, labeling, and tracking Product safety, quality, and liability Local establishment, representation, and residency requirements Reform The full Medicinal Product Regulation and Product Liability in Cambodia chapter can be accessed on the Practical Law website. Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas.

In an effort to unify and streamline regulations on the management of medical devices in Vietnam, the Ministry of Health (MOH) recently developed the draft of a new decree intended to replace the existing legislation.

As a result of the decree, provisions relating to personal data protection, data subject rights, complaints, civil liabilities, penalties, and grandfather provisions, will now take effect on June 1, 2022.