Medicine (pharmaceuticals)
- Document symbol
- G/LIC/N/3/MMR/1
- Original language
- English
- Published on
- 04/10/2023
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
Regarding all pharmaceuticals, a local representative or applicant must register in the Myanmar Food and Drugs Administration through Electronic submission system in order to request the Drug Importation Approval Certificate (DIAC), which is a kind of Recommendation Letter, before importation, marketing and distribution according to the National Drugs Law. After receiving the Import Approval Certificate from FDA, the importer shall apply the import license to the Department of Trade, Ministry of Commerce. The whole application process are described in Standard Operating Procedure (SOP) and guidelines which can be seen on the website (https://fda.gov.mm).
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
Permits are required for all pharmaceuticals (drugs) and vaccine.
Q3. The system applies to goods originating in and coming from which countries?
The licensing system applies to products originating in and coming from all countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The licensing system is not intended to restrict the quantity or value of imports, except the international control substances (psychotropic and narcotics) so as to protect the quality, efficacy and safety of pharmaceuticals.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The approval system is a statutory requirement of National Drug Law (1992), its amendment Law (2014), (2023) and the sub-section 4 (c) and sub-section 13 (b) under the Export and Import Law (2012).
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
No quantitative limit on the importation of a product.
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
The pharmaceuticals cannot be imported without import recommendation letter and import license. License cannot be obtained within a shorter time-limit and it may take 30 working days of time.
Q7.b. Can a licence be granted immediately on request?
Drug Importation Approval Certificate (DIAC) can be issued within three months, but import license cannot be granted immediately upon request. Prior review of the application is required.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
Importers may apply for approval in any time of the year.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
For application of license, there will be two administrative bodies; (1) DIAC from the Food and Drug Administration (FDA) and Import License from the Department of Trade.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
In general, no application is refused so long as that application meets the ordinary criteria.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
All persons, firm or institution which fulfils the legal requirement are equally eligible to apply import license. The eligibilities for recommendation letter are proceeding in line with the National Drug Law and related notification.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
Information concerning the application for pharmaceuticals has been published on the website of Food and Drugs Administration (FDA), Myanmar Trade Portal and Ministry of Commerce. Firstly, an applicant requests the Drug Importation Approval Certificate (DIAC) to the FDA through Electronic submission system with the following documents:
- Applicant's information (For renewal application, old DIAC information);
- Certificate of Exporter or Importer Registration;
- Supervising person's information;
- Drug attached lists of registered pharmaceuticals;
- Detailed description of dimension of warehouse (length x width x high);
- Letter of Authorization (LOA) from owner;
- Myanmar Chamber of Commerce for Pharmaceutical and Medical Device Membership Certificate;
- Certificate of Incorporation issued by DICA;
- Consignment specification for importation of drugs;
- Brief description of good distribution/storage practice with relevant photos (e.g. Bin-card, Ledger, Warehouse's photos, etc.); and
- Video file for drug storage system.
After receiving the approval of import recommendation letter from FDA, the applicant shall apply the import license through trade net 2.0 online application systems of the Department of Trade.
Q11. What documents are required upon actual importation?
The following documents are required upon actual importation:
- Drug Importation Approval Certificate (DIAC) issued by FDA;
- Import License issued by DOT;
- Invoice and Packing list; and
- Bill of lading, air consignment note or truck note.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
The applicant shall pay 500,000 MMK as a DIAC fee in applying the import approval through FDA E-submission. There is no license fee for medicine.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment is required in connection with the issue of license.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The validity of Drug Importation Approval Certificate (DIAC) is three years and renewal application needs to apply during 90 days before expiration of the certificate. See reply for validity of a license and its extension in controlled chemical substances section.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
There is no penalty for non-utilization of a license.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Licenses are not transferable between importers.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
There is no other condition attached to the issue of a license.