HEALTH SUPPLEMENT LICENSING

The procedure for obtaining a license to manufacture health supplements (GMP certification) is carried out based on full compliance with food safety conditions and Good Manufacturing Practice standards.

Licensing conditions require the manufacturing facility to ensure:

• Implementation and maintenance of a quality management system controlling the entire production and distribution process;
• Availability of qualified personnel trained in GMP and food safety; the person in charge must hold a university degree or higher and have at least 3 years of relevant experience;
• Facilities and equipment designed in a one-way workflow, ensuring hygiene and preventing cross-contamination;
• A documentation system enabling product traceability;
• Fully established procedures for production, quality control, testing, and monitoring;
• An independent quality control unit;
• Procedures for handling complaints, product recalls, and internal inspections;
• Mandatory application of GMP standards as regulated by the Ministry of Health.

Application dossier includes:

• Application form for GMP Certificate;
• Layout of production areas and production lines;
• List of main equipment used at the facility.

Procedure:

• Submit the dossier online, by post, or directly to the Ministry of Health;
• Within 15 working days, the competent authority establishes an inspection team to conduct an on-site assessment;
• If compliant, the GMP Certificate is issued within 30 working days from receipt of a valid dossier;
• If non-compliant, the facility must rectify and report for reconsideration.

The GMP Certificate is valid for 03 years and must be renewed prior to its expiration.