Pharmaceuticals Supplements Medical Devices
About Us Careers FAQ All Insights
Privacy Policy Terms of Service
Thai FDA Drug Registration Local Authorized Representative (LAR) & Importer of Record (IOR) Dossier Preparation, ACTD Submissions & Thai Labeling GMP Compliance Consulting Post-Approval Lifecycle Management Pharmacovigilance Government Fee Schedule Pharmaceutical Insights
Thai FDA Supplement Registration Local Importer & Orr.7 Import License GMP Requirements for Supplement Manufacturers Labeling & Health Claims Ingredient Approval & Novel Food Advertising Approval & the Kho Or Permit Supplement Insights
Thai FDA Medical Device Registration Device Classification: AMDD Classes 1-4 Local License Holder & Establishment Licensing Technical File & CSDT Preparation Labeling Requirements: B.E. 2568 (2025) Medical Device Insights
Email WhatsApp (+66) 082.208.2460
Email WhatsApp (+66) 082.208.2460

Your Factory Must
Meet the Standard

Thailand supplement GMP requirements govern every foreign factory seeking Thai FDA approval. Thai FDA will not approve an imported supplement unless the manufacturing site shows a food production system equivalent to or not inferior to Thailand's own GMP standards. Codex GMP, HACCP, and ISO certifications are accepted, but the certificate must be current and submitted in the form Thai FDA now requires. The rules on that submission changed in late 2024.

GMP Requirements for Thailand Supplement Registration

Thai FDA's food importation framework requires evidence that the foreign factory operates a food manufacturing system equivalent to or not inferior to GMP 386 or GMP 420, the standards set by MOPH Notification No. 386 B.E. 2560 (2017) and No. 420 B.E. 2563 (2020). GMP 420 applies broadly across food products. The requirement is not that the factory hold a Thai certificate, but that it demonstrate an equivalent system.

Accepted equivalents include GMP under Thai law, Codex GMP, HACCP, and ISO 9000 or ISO 22000. A manufacturer already certified to a recognized international food-safety standard is usually most of the way there, but the evidence must be current at submission and must remain valid through the review. An expired certificate can stall a file that is otherwise complete.

What changed in November 2024

Thai FDA revised how foreign manufacturing certificates are submitted, removing a notarization step for certificates that can be checked online. The change reduces cost and delay for many manufacturers, but only where the certificate is genuinely verifiable.

GMP is necessary, not sufficient

A strong GMP position clears one requirement. It does not by itself register a product. The manufacturing evidence sits alongside classification, the importer and import license, the Thai-language label, and the claim and ingredient review. A manufacturer with excellent GMP and a misclassified product, or a claim it cannot make, is not closer to approval. GMP is a gate to pass, not the whole pathway.

The Vero Approach

We assess a manufacturer's existing GMP and food-safety certifications against what Thai FDA will accept, and we tell the client plainly whether the current evidence is sufficient or whether a gap needs to be closed before submission.

We prepare the certificate documentation in the form Thai FDA now requires, including the post-November 2024 rules on verifiable certificates, so the manufacturing evidence does not become the reason a file is delayed.

When a certificate is approaching expiry during a review window, we flag it early. The avoidable failure is an expired certificate halting a dossier that was otherwise on track.