Requirements and Procedures for GMP Certification for Health Supplement Manufacturing Facilities under Decree 46/2026/ND-CP
Detailed guide on quality management system requirements, personnel, and GMP certification procedures for health supplement manufacturers under the new Decree.
Decree 46/2026/ND-CP, issued on January 26, 2026, establishes a detailed legal framework for the implementation of the Food Safety Law. This document clearly defines the mandatory standards that enterprises must meet to obtain a Certificate of Food Safety Eligibility according to Good Manufacturing Practice (GMP) principles for health supplements.
To obtain certification, manufacturing facilities must adhere to strict requirements: establishing a quality management system based on GMP principles to control the entire process from production to distribution. Personnel must hold relevant qualifications in medicine, pharmacy, nutrition, or food technology, with at least 3 years of specialized experience. Notably, the heads of production and quality control must be official, full-time employees, operating independently of each other.
Factory layouts and equipment must be designed according to a one-way flow principle to prevent cross-contamination and the accumulation of pollutants. Enterprises are required to maintain comprehensive records of production, quality control, and product stability monitoring. Facilities engaged in contract manufacturing or testing must also satisfy rigorous requirements regarding equipment and human resources.
The certification process involves submitting applications online, via post, or directly to the Ministry of Health. Upon receiving a valid application, the authorities will form an appraisal team of 5 to 6 experts to conduct on-site evaluations. The certificate is valid for 03 years. Facilities are required to submit periodic reports every 12 months on their operational status to the Vietnam Food Administration.