Thailand's Ministerial Regulation No. 5 (2025) Digitizes Hazardous Substance Applications

On June 19, 2025, the Royal Gazette published Ministerial Regulation No. 5 (B.E. 2568), issued under the Hazardous Substance Act B.E. 2535, in Volume 142, Part 41 ก. It is the most recent regulation issued under the Act, and it is not a change to what counts as a hazardous substance or how those substances get classified. It is a procedural regulation, and its single practical function is moving the application process for hazardous substance manufacturing, import, export, and possession onto Thailand's electronic government service system. For companies that have dealt with Thai FDA's hazardous substance process before, this is the change that explains why the application experience looks different today than it did even two years ago, and why the processing timelines DeeMED now quotes to clients are shorter and more predictable than the figures that circulated before 2025.

What Ministerial Regulation No. 5 actually changed

Before this regulation, an applicant seeking a hazardous substance manufacturing license, an import or export registration, or a possession permit worked through a paper-based submission process, with physical documents delivered to and reviewed by the relevant competent authority, most commonly the Department of Industrial Works or the Thai FDA depending on the substance category and activity. Ministerial Regulation No. 5 replaces that paper channel with a digitized procedure built on Thailand's e-government service infrastructure, centered on the info.go.th platform. Applications for manufacturing, import, export, and possession activities under the Hazardous Substance Act now move through this electronic system from submission through review, rather than through a physical filing counter.

This is worth stating plainly because it is easy to conflate a digitization regulation with a substantive one. The regulation does not touch Section 38's grounds for refusing a registration, it does not change what qualifies as Type 1 through Type 4 hazardous substance activity, and it does not alter labeling, safety data sheet, or efficacy testing requirements. What it changes is the channel a company uses to submit an application and the way that application moves through government review once submitted.

Why an e-government filing channel matters more than it sounds

A paper-based government process has a structural weakness that has nothing to do with how competent or fast any individual official is: a physical file sitting in a queue is opaque to the applicant. There is no reliable way to confirm where a submission actually sits in the review process, whether it has been assigned to a reviewer, or whether a request for additional information has already been issued and is sitting unread in an inbox somewhere. A digitized process built on a national e-government platform closes that visibility gap. An application submitted through info.go.th generates a trackable record that both the applicant and the reviewing authority can reference, which removes a meaningful source of the uncertainty that has historically made hazardous substance timelines hard to predict.

The digitization also standardizes the intake step itself. A paper application depends on a reviewing official manually checking that every required attachment is present and properly formatted before substantive review can begin; a digital submission portal can enforce required fields and attachment types before an application is even accepted into the queue. That does not eliminate documentation problems, an incomplete Safety Data Sheet or a mismatched efficacy report still causes a delay under the digitized system exactly as it did under the paper one, but it does remove an entire category of administrative back-and-forth that used to happen before substantive review even started.

The processing timelines this regulation enabled

The government processing windows DeeMED currently quotes for Type 3 hazardous substance activity reflect the post-digitization environment this regulation created, not the pre-2025 paper-based baseline. A new manufacturing production site or line currently runs a 30-day government processing window. A new import storage registration runs 19 days. A new export storage registration runs 14 days. A general-case possession permit runs 15 days. These figures come from Thailand's electronic government service procedures now governing the process, and they represent the time a competent official spends actively reviewing a complete, correctly submitted file once it has entered the digitized system.

It is worth being precise about what these numbers do and do not measure, since this is a distinction we cover in more depth in our companion piece on why hazardous substance registrations get rejected or delayed. The government processing window measures active review time inside the system. It does not include the weeks or months a company spends beforehand preparing a GHS-compliant Safety Data Sheet, sourcing a Certificate of Free Sale, running efficacy tests against the specific claim on its label, or finalizing its Thai entity structure so the application is even eligible to be filed. A digitized, trackable review process is a genuine improvement over the pre-2025 paper system, but it does not shorten the preparation work a company has to complete before that clock starts running.

What a digitized process means for tracking and planning

The most immediate operational benefit of Ministerial Regulation No. 5 is that a company, or its regulatory consultant, can now check the actual status of a pending application through the electronic system rather than relying on informal follow-up calls or waiting for a paper notice to arrive by mail. That matters for project planning in a very concrete way: a company that knows on day 12 of a 19-day import registration window that its file has cleared initial review and moved to final sign-off can make confident commitments to its own customers and logistics partners, where a company working through the old paper system had no equivalent way to confirm progress until a decision letter physically arrived.

It also changes how a company should respond to an application that appears to be running past its expected window. Under the digitized system, that is a signal worth investigating immediately, since the electronic record should show where the file actually sits and whether a request for additional information is outstanding. Under the old paper system, the same delay carried much more ambiguity, since there was no reliable middle-ground signal between "still under review" and "something has gone wrong," and a company often had no good option beyond waiting longer or calling to ask.

What has not changed

Ministerial Regulation No. 5 is a procedural regulation, and the substantive law it operates under is unchanged. The Hazardous Substances Act's classification structure across Types 1 through 4 still governs which activities require a license versus a simpler registration or notification. Section 38's grounds for refusing a registration on quality, safety, naming, or authenticity grounds are unchanged. The documentation package a Type 3 applicant has to assemble, the application form, product label and formula, manufacturing and labeling process description, GHS-compliant Safety Data Sheet, efficacy test results where relevant, active-ingredient concentration confirmation, Certificate of Free Sale for imported products, and juristic-person registration, is unchanged. What the regulation changes is entirely about how that documentation moves through government review once it is ready, not about what documentation is required or what standard it has to meet.

Why this matters for companies planning a Thailand entry

For a foreign company weighing how long a hazardous substance registration will realistically take before it can bring a product to the Thai market, the practical takeaway from Ministerial Regulation No. 5 is that the government's own review time is now faster and more transparent than it used to be, but the total project timeline is still driven primarily by how quickly a company can assemble a complete, correctly documented application. A digitized system rewards a well-prepared file with a fast and trackable review; it does not rescue a poorly prepared one from the same documentation gaps that caused delays under the old paper process. Planning a Thailand hazardous substance filing around the digitized government window while still budgeting realistic time for document preparation, laboratory testing, and Thai entity setup remains the difference between a project that lands on schedule and one that does not.

DeeMED tracks government processing timelines through Thailand's electronic government service system as part of our Hazardous Substance registration and licensing work, so clients know where their filing actually stands rather than guessing based on how long a paper process used to take.