How Pharmacy Regulation Works in Cambodia: An Overview

Students, pharmacists and patients all benefit from knowing who sets the rules for medicines in Cambodia. This overview explains the main pieces of the framework in plain English. It is deliberately cautious: we describe only points we could confirm in documents we opened, and we say so when a detail could not be confirmed.

The short version

The core statute is the Law on the Management of Pharmaceuticals (1996, amended 2007).
The Ministry of Health (MoH) supervises pharmaceutical activity; its Department of Drugs and Food (DDF) handles product registration.
Pharmacies, manufacturing, import-export and advertising need MoH authorisation, and a pharmacy needs a pharmacist present.
Counterfeit and substandard medicines are a recognised concern, and the law penalises dealing in them.

The legal foundation

The English text of the 1996 law, published on WIPO Lex, is short: 15 articles. The National Assembly adopted it on 9 May 1996 and it was promulgated on 17 June 1996. It defines pharmaceuticals broadly, and sera, vaccines, blood products and traditional medicines are brought within its scope.

The law leaves much of the detail to lower instruments. MoH prakas (ministerial regulations) are to set out, for example, the formalities for opening, closing or moving a pharmacy, how medicines are stored, and advertising rules (Article 7). If these terms are new to you, read our guide to the hierarchy of Cambodian legal documents.

A law amending the 1996 text followed in 2007. The Cambodia National Trade Repository lists it with the date 28 December 2007. We did not read the amended text, so we do not describe what it changed.

Who regulates medicines: the Ministry of Health and the DDF

Article 9 of the 1996 law gives MoH responsibility for supervising pharmaceutical activity, while veterinary medicines fall to the agriculture ministry. The DDF describes its mandate as making sure that drugs manufactured, imported, exported, distributed or sold in Cambodia are of acceptable quality, safety and efficacy. Documents use slightly different English names for this department, so check the exact name on current MoH notices.

DDF guidance dated 2019 explains that applications for product registration and marketing authorisation moved online on 1 August 2019 through the Cambodia Pharmaceutical Online Registration System (CamPORS), and that paper applications stopped after 31 March 2020. WHO says it supported this system from 2017. The guidance adds that applicants must be locally incorporated entities with a pharmaceutical business scope, and that an authorisation can be suspended for reasons such as strong safety concerns. Procedures change, so confirm them on the current DDF site.

Licensing: what “authorised” means in practice

Under Article 8, MoH authorisation is required to open, close or relocate a pharmacy or a manufacturing establishment, to run an import-export business, to import and store pharmaceuticals or raw materials, and to advertise medicines. A US government country guide similarly notes that only MoH-licensed companies may import drugs.

The National Trade Repository describes the manufacturing licence as issued by MoH through its one-window service, supported by documents such as a pharmacist certificate recognised by MoH, a health certificate and a criminal-record letter. We deliberately do not list licence categories, fees or processing times, because we could not confirm a current official schedule.

Pharmacists and professional registration

Article 8 also requires a pharmacist to be present in every pharmacy, or a replacement who meets MoH standards. Pharmacists register with the Pharmacy Council of Cambodia; press coverage reports that online registration launched in March 2023, with applicants needing a recognised degree, demonstrated competence and fitness, and a clean criminal-record check. A 2016 research assessment noted gaps at that time, such as no mandate for licence renewal, so treat it as dated background.

Prescriptions and dispensing: the principles

As far as we could see, the 1996 law does not spell out prescription rules. Those principles appear in policy documents:

The Medicines Policy of Cambodia (2010) says only authorised personnel should dispense, prescribers should work within the medicines list set for their level, and pharmacies should dispense on prescription except for specified over-the-counter products. It also provides for inspection, a national quality-control laboratory and adverse-reaction reporting.
The National Policy to Combat Antimicrobial Resistance (2014) aims for antimicrobials to be dispensed only with a valid prescription, backed by stricter monitoring of pharmacies.

Policies show direction; they are not binding rules. For current prescription-only lists, consult the latest MoH prakas.

Counterfeit and substandard medicines

WHO uses two key terms. Substandard medicines fail to meet quality standards or specifications, often because of poor manufacturing or quality control. Falsified medicines deliberately misrepresent their identity, composition or source. WHO estimates that at least 1 in 10 medicines in low- and middle-income countries is substandard or falsified.

For Cambodia, a US government guide mentions a grey market of smuggled pharmaceuticals that are often counterfeit. The 1996 law provides its heaviest penalties, fines or imprisonment or both, for deliberately dealing in counterfeit, damaged-quality or expired drugs that endanger consumers (Article 12). We do not quote amounts, because they come from the original text and may have changed in 2007. As general advice, not official guidance: buy from licensed pharmacies and report suspicious products to a pharmacist or the health authorities.

Where to find official texts

WIPO Lex hosts an English text of the 1996 law.
The DDF website publishes registration guidance and CamPORS information.
The Cambodia National Trade Repository lists the 2007 amendment and related instruments, such as a 2013 prakas on registering overseas manufacturers.

English versions are often unofficial translations; where exact wording matters, check the Khmer original or ask a qualified lawyer.

Frequently asked questions

Can a pharmacy operate without a pharmacist? The 1996 law requires a pharmacist, or a qualified replacement under MoH standards, to be present. Check current prakas for the details.

How do I check whether a product is registered? We could not verify a public look-up tool. The DDF is the body to ask.

Key takeaways

The 1996 law, amended in 2007, is the foundation, with prakas filling in detail.
MoH supervises, the DDF registers products, and the Pharmacy Council registers pharmacists.
Licence categories, fees and penalty amounts are not covered here; check current MoH and DDF notices.

Sources

Eksastra is an independent project and is not a government body. This guide is general information, not legal or medical advice. Always follow the rules and instructions of the Ministry of Health and your own institution. See our Disclaimer.