You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

August 27, 2021

Regulatory Pathway for Pesticide Registration in Myanmar

Subscribe to Updates

The process of registering pesticide products in Myanmar has been slowed significantly by regulatory challenges since the enactment of the Pesticide Law in 2016. In some cases, the whole process can take almost three years. Nonetheless, this stringent and time-consuming process has been functioning smoothly, and Tilleke & Gibbins has successfully received approvals from the Pesticide Registration Board (PRB) despite the ongoing COVID-19 pandemic and state of emergency in the country.

Overview

Since its enactment, the Pesticide Law of 2016 has governed the regulation of local and imported pesticides under the oversight of the Plant Protection Division (PPD) and the joint secretary of the PRB. All foreign and domestic companies (including subsidiaries and joint ventures) looking to have their agricultural or household pest control products imported into Myanmar must first provide the products’ complete formulas and lists of active ingredients to the PPD, and apply for a pesticide registration certificate. Applications should be supported by a letter of consent from the manufacturer and various other technical documents and requirements. Experts at the PRB will review the technical dossier and inform the applicant if any re-submissions are required.

Key Considerations

One common cause of delay in the registration process is the requirement to submit both English and Myanmar translations of proposed labels to the PRB. Because the PRB takes a restrictive view of these labels and their translations, having the labels initially reviewed by a local regulatory expert familiar with the requirements will streamline the process by flagging potential issues for correction before submission to the PRB.

After document submission is complete, the next stage of the process is further lab testing according to requirements set out by the Myanmar Pesticide Law. Applicants will need to supply the formulated product in an amount sufficient for carrying out supervised trials and quality control tests. There are also detailed technical specifications regarding the necessary laboratory testing, sample analysis, and certification of the product and its active ingredients. In order to import the necessary products to conduct these laboratory tests, the applicant must obtain a recommendation letter from the Laboratory Department of the PPD and pay the required laboratory fees. Applicants should also create the label at this time. Typically, a label should include hazard pictograms (symbols) along with usage directions, the names of the manufacturer and distributor, and the expiry date—all in the Myanmar language. This label must be approved by the PPD.

Upon completion of the laboratory tests, the PPD assists with evaluation of the technical documents, corresponding test results, and reviewed labels. The results of the PPD’s evaluation will then be submitted to the PRB, which will finally decide whether to approve the application and grant the applicant experimental, provisional, or full registration. Upon payment of the registration fees, an experimental registration is valid for two years, a provisional registration is valid for five years, and a full registration is valid for ten years. Some applications are rejected after PRB meetings due to a lack of required documentation, use of a banned active ingredient (aldrin, arsenic compounds, binapacryl, etc.), or a determination that the product is hazardous for the country’s agriculture.

Outlook

Though it is time consuming and laborious, the registration process for pesticide products in Myanmar has proved to be effective and functional. Moreover, the stringent application of the requirements has shown that Myanmar takes the issue of pesticides seriously, and will take time to scrutinize the introduction of new pest control substances for agricultural and household use. The PPD recently announced an online application system that will expedite the final evaluation process by eliminating some bottlenecks caused by the current reliance on physical documents and in-person procedures. Altogether, the encouraging indications—including Tilleke & Gibbins’ repeated success in the registration process, and the authorities’ diligence in following the registration process—signal that companies looking to make their pesticide products available in Myanmar have a viable avenue for doing so safely and responsibly.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

February 14, 2024
Thailand is preparing to implement new rules on drug importation for clinical studies. The Medicines Regulation Department of Thailand’s Food and Drug Administration (Thai FDA) first issued the Notification Re. Detailed Requirements for Drug Importation into Thailand for Clinical Studies almost a year ago, and the notification is expected to come into effect on March 1, 2024. Key Provisions The notification aims at enhancing the efficiency of conducting clinical studies while ensuring the protection of human subjects participating in such studies within Thailand. Some of its key provisions include: Definition of Clinical Study. The notification defines a “clinical study” as a study of a medicine involving human subjects, conducted to provide supporting evidence for the registration of a medicinal product in Thailand or other countries, including for additional indications or variations of a registration dossier. Compliance with ICH GCP. Clinical studies conducted in Thailand must adhere to the current edition of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. Clinical Trial Application. Sponsors are required to submit a clinical trial application along with supporting documents to the Thai FDA for approval before commencing a clinical study. The permit remains valid for five years and is renewable. Supply of Investigational Drugs. Sponsors must obtain investigational drugs from manufacturers compliant with Good Manufacturing Practice (GMP) standards as recognized by the Thai FDA. Postapproval Obligations. The secretary-general of the Thai FDA may impose postapproval conditions or order investigators to conduct or suspend certain activities to ensure human subject protection and regulatory compliance. Regulatory Oversight. The Thai FDA is responsible for inspecting and overseeing the regulatory compliance of clinical studies, including during prestudy, ongoing, and poststudy phases. The Thai FDA may also conduct inspections of clinical studies conducted overseas. The Thai FDA
Read More
December 15, 2023
As part of its membership in Lex Mundi, Tilleke & Gibbins has published an updated edition of its Guide to Doing Business in Thailand for 2023. This guide outlines the key factors for starting and operating a business in the Thai market. Issues covered include: Investment incentives Financial facilities Exchange controls Import and export regulations Structures for doing business Requirements for the Establishment of a Business Operation of the Business Cessation or Termination of the Business Labor legislation, relations, and supply Tax Immigration requirements This publication is part of Lex Mundi’s Country Guides series prepared by member firms in more than 100 jurisdictions worldwide. The guides serve as a useful resource for planning international business strategy and researching new markets. The full Guide to Doing Business in Thailand is available through the button below.
Read More
December 6, 2023
New regulatory requirements for medical device registration and notification in Laos are set to enter into force in the coming weeks under the plan found in Notification No. 9606 to implement Decision No. 1470/MOH on Registration and Notification of Medical Devices (Decision 1470). The notification, issued on October 25, 2023, by the Food and Drug Department (FDD) under the Ministry of Health (MOH), outlines the FDD’s strategic plan for phased-in registration and notification requirements for medical devices. In the first phase, starting January 1, 2024, the FDD will initiate the registration process for class C (moderate-high risk) and D (high risk) medical devices. Meanwhile, operators dealing with class A (low risk) and B (low-moderate risk) devices can continue applying for import permits without having to register the devices or notify the FDD. In the subsequent phase, starting January 1, 2025, operators will have to notify the FDD about class A devices and complete the registration process for class B devices. To prepare for these requirements, import-export companies in the pharmaceutical and medical products sector must submit a list of medical devices, including their classification based on the country of manufacture, to the FDD by December 15, 2023. This measure is aimed at enabling the FDD to streamline the collection, guidance, and preparation processes to ensure efficient registration within the set time frame. While import-export companies can still submit their lists after either December 15, 2023, or January 1, 2024 (the registration commencement date), registration may be delayed since the FDD will prioritize those who submit their lists by the December 15 deadline. The list of medical devices should encompass medical devices imported in the past as well as those intended for future import permission applications. During the initial registration stage (i.e., from January 1, 2024), import-export companies that are
Read More
October 25, 2023
Cambodia’s Ministry of Health (MOH) continues to increase awareness among the public and private sector of the need for strict healthcare regulations and strict enforcement to advance the quality of the country’s healthcare sector. In April 2023, the MOH issued a notification letter reminding advertisers of health products that they need to obtain a permit before advertising their products in Cambodia. On October 12, 2023, the MOH issued two press releases on continued noncompliance in the healthcare sector. The two press releases address the illegal advertising of both healthcare products and private healthcare services. The releases also address unlicensed healthcare professionals and general noncompliance by private healthcare services. These releases indicate that the MOH, in cooperation with local authorities, will substantially increase its enforcement efforts across Cambodia. Since October 12, several private healthcare clinics have had their operations closed and licenses suspended or revoked, signaling the ministry’s intent to enforce the legal framework. Noncompliant Advertising of Health Products The first press release focuses on the continued illegal advertising of health products and the advertising of unregistered health products. Health products include modern medicines, traditional medicines, health supplements, medical devices, cosmetics, and other products that prevent or treat diseases. The release highlights that the MOH has noticed ongoing unauthorized and illegal advertising, commenting that these are often found online and on social media. The noncompliant advertising referenced in the release includes advertising of health products without the required advertising permit, advertising products that are not properly registered with the MOH, and advertising by unlicensed companies and individuals. The MOH also states in the release that some advertisements are using inappropriate and noncompliant content that is not based on medical science and exaggerates the qualities of the health products—specifically mentioning skin-whitening cosmetics. The ministry’s press release also informs the public of
Read More