LICENSE FOR YOUR BUSINESS
FDA License
The Food and Drug Administration (FDA) was established in 1995 as one of the divisions under the Department of Health. The FDA division was upgraded to a separate department in April, 2013. The aim of the department is to ensure the safety and quality of Food,
Drugs,
Medical Devices and
Cosmetics in the country.
Page 7 of 21 FDA Headquarter is located in Nay Pyi Taw, the capital city of Myanmar, with five major divisions:
- Administrative division,
- Drug Control division,
- Food Control division,
- Cosmetic and Medical Device Control division
- Laboratory division
Administrative Committee: MFDBA (Myanmar Food & Drug Board of Authority) &
CFDSC (Central Food and Drug Supervisory Committee)
Technical Committee: DAC (Drug Advisory Committee)
MFDBA, chaired by Minister for Health. The authority is vested power by the law to lay down policy, guidance on production, distribution, importation, exportation, quality assurance, standard setting, classifying controlled food, food additives and substandard foods, labelling and advertisement.
FDSC (Food and Drug Supervisory Committees): The Food and Drug Supervisory Committees are formed as Central, State and Division, District and Township Food and Drug Supervisory Committees respectively.
Central FDSC (CFDSC), chaired by the Director General of Department of Health, licenses local drug manufacturers and gives drug importation approval certificates to the importers.
The State/Division FDSC, licenses drug wholesalers and retailers.
At township level the FDSCs are managed by the Township Medical Officers. The committees consist of the Township Medical Officer, the Commander of the Police, and the representatives of the City Development Committee and the General Administration Committee.
Applicant:
- Authorized representative of product license holder at country of Origin
- Resident in Myanmar
- Local Company Representative- Company Employee technical competent person authorized to serve as a contact person
Export- Import License
On 23 May 2023, the Trade Department of the Ministry of Commerce (“MOC”) issued a new importer and exporter registration (“IMPEX”) order via Notification 35/2023, replacing the Registration (Imports and Exports) Order 42/1954 issued under the Control of Imports and Exports (Temporary) Act 1947 and the Export and Import Bulletin No. 6/2018 issued by the Department of Trade on 9 August 2018.
Under this new order, the MOC has introduced a new mechanism for those wishing to engage in importing and exporting by dividing the registration requirements into two different categories — (i) for trading purposes, which requires an IMPEX Certificate (old name) or now also referred as EIR as general term; and (ii) for non-trading purposes which requires an import and export registration (“EIR”) certificate.
Below is a summary of the major changes in the registration procedures:
Who must have an IMPEX Certificate (or EIR as new name)?
Companies and cooperatives wishing to engage in the export and import of goods must apply to the Department of Trade for an IMPEX Certificate (or EIR) (the “Certificate”). Regardless of the number of branches a Myanmar entity has, it must apply for a Certificate only for its head office. Likewise, foreign companies/overseas corporations established in Myanmar under the Myanmar Companies Law must apply for a Certificate for no more than one branch.
Who must have an EIR Certificate?
Previously, government entities were exempt from the requirement to apply for the certificate to export and import goods. Now, the following entities and individuals wishing to engage in the export and import of goods for non-trading purposes must apply to the Department of Trade for an EIR Certificate:
- Government departments and organizations
- State-owned entities
- Associations registered with the relevant departments
- Individuals from religious organizations and diplomats
How to apply for the Certificate
The order introduces a new application procedure. The application will be done online through the MOC’s Myanmar Tradenet 2.0 system. The prescribed application fees are paid through the online system as well. Upon receipt of the application, the MOC official will arrange for an on-site inspection and if all is found satisfactory, approval will be granted within 15 working days after the application review and inspection.
Renewal of the Certificate
Entities must now renew their Certificate six months before its expiration. Previously, three months was sufficient.
Cancelation of the Certificate
If no application is made for renewal within one year after the Certificate has expired, the Certificate will be canceled.
Penalty
If the director of one company (Company A) is also a director of another company (Company B) whose Certificate has been suspended or cancelled, then Company A is not eligible to apply for, renew, or amend the certificate during the penalty period.
Appeal
If the application for the Certificate has been rejected or if the Certificate has been suspended or cancelled, then the entity may file an appeal with the MOC within 30 days from the date of the MOC’s decision.