On 5 May 2025, the Livestock Breeding and Veterinary Department (the “Department”) under the Ministry of Agriculture, Livestock and Irrigation (“MOALI”) issued the Order on the Registration of Veterinary Medicinal Products (the “Order”), pursuant to Sections 11(o) and 55(c) of the Animal Health and Livestock Development Law (the Law)  amended on 15 January 2025. The Order will take effect on 5 November 2025 and applies to both domestic production and importation of veterinary medicinal products. Under Section 11(o), the Department is authorized to regulate the registration and prescribe conditions for animal feed and veterinary medicinal products that are produced, processed, distributed, exported, or imported.

The Order sets out procedural requirements and includes standardized forms such as Form (1) for Veterinary Medicinal Products Registration, Form (2) for One-Time Import Approval for Veterinary Medicinal Products, Form (3) for the Veterinary Medicinal Products Sample List, and Form (4) for the Veterinary Medicinal Product Registration Certificate.

Applicants must submit Form (1) along with relevant supporting documents, including two copies of the product summary, the manufacturer’s address, and website, to the Department. For imported products, additional documentation is required, including original approval from the exporting country’s regulatory authority and a Certificate of Analysis (COA). Foreign companies must appoint a technical expert residing in Myanmar as their authorized representative.

Upon approval, applicants are required to pay a registration fee within the stipulated timeframe to the Department’s designated account. Failure to make payment within the stipulated timeframe will result in the application being void. All review fees, laboratory testing fees, and submitted product samples are non-refundable. The Veterinary Medicinal Product Registration Certificate (Form 4) must be collected in person by the applicant or their authorized representative at the Department’s Head Office within six months of payment.

Applicants must be residents of Myanmar and must only correspond with countries capable of providing documentation in English. For locally produced products, the manufacturer must submit the application directly to the Department. For imported products, the application must be submitted by the appointed authorized representative residing in Myanmar.

In conclusion, the Order establishes a formalized and comprehensive regulatory framework to ensure the safety, quality, and compliance of all veterinary medicinal products manufactured or imported in Myanmar.

The information provided here is for information purposes only and is not intended to constitute legal advice. Legal advice should be obtained from qualified legal counsel for all specific situations.