UNION OF MYANMAR

Ministry of Health

Department of Health

Food and Drug Administration
Office No(47),Nay Pyi Taw, Myanmar

 

Registration Procedure

1. To apply name registration for assessment fees ( It will take 10 days or 14 days )
2. After getting assessment fees documents from FDA, to remit assessment fees on Monday and Wednesday only at FDA.
   - Monday ( variation fees, assessment fees, registration fees )
   - Wednesday ( assessment fees, registration fees )
3. After remitting the assessment fees, to apply FDA permit ( It will take 10 days )
4. After getting FDA permit, to apply FOC Trade permit at Airport Trade Office. ( It will take 2-3 days only )
   - Need to apply Trade permit if the weight of samples is too much. (or) if the products too much for samples dispatching.
5. After getting FDA permit and Trade permit, to inform to dispatch the samples and to submit at FDA.
6. After submitting the samples, to submit the dossiers.
   - For dossier submission,
   - Need to take number upto 9:30 am on Tuesday for renwal and on Thursday for new product.
   - Firstly FDA accept the dossiers without checking details and unlimited dossier qty.
   - Up to 3 pm only. ( renewal on Tuesday/new on Thursday )
   - Then, after two weeks, FDA issue the preview for the complete dossier, and return back the incomplete dossier to whom concern. Time is from 3 pm to 4:30 pm.
   
7. Next, two weeks, can pay lab test fees.
8. After paid lab test fees, our product is under registration process and have to follow up and have to wait for approval.
9. After getting approval, to pay registration fees.
10. After two months, we will get DRC.
    - After getting DRC, to apply attachment for DIAC. ( It will take 3 weeks. )

Initial application for Registration

1. An application for registration of drug must be submitted to the Department of Health, Food and Drug Administration in the original prescribed form (Form 1 Registration). Form (1) is available at one hundred kyats each at office of the Food and Drug Administration.
   
2. Separate registration has to be applied for pharmaceutical preparations of different strength or different dosage form.
   
3. Form 1 must be filled out in type print. Enclosures submitted together with application form shall be mar ked with proper reference. A form which is filled incompletely or improperly will not be accepted.
   
4. Form (1) must also be accompanied with two sets of documents on complete information of drugs. (See Annex-I for type of documentation required). Documents have to be submitted in file in an order as listed in “Documents Required for Registration of Drugs”. A list of documents submitted should be shown on the first sheet of the file.
   
5. An application with incomplete documentation will not be accepted.
   
6. (a) an application must be submitted in person by an authorized representative of owner of drug. * Any application made by mail or facsimile or means other than in person, will not be accepted. An authorized representative has to be a resident in Myanmar.
   (b) Should an authorization for representation be granted to the local company, the representative shall be a company employee authorized to serve as a contact person.
   
7. Registration assessment fees must have been remitted to Myanmar Foreign Trade Bank (MFTB) in favor of Drug Advisory Committee Account No.(IDA-06-91892) when submission of the application form is made. *Product licence holder at country of origin
   
8. (a) If it is an application for registration of drugs manufactured outside Myanmar. The Food and Drug Administration will issue “Approval for importation of Drug Samples” (Annex II) after receiving application. The drug samples as specified in the approval shall then be imported into the country. The holder of the approval shall comply not only with the conditions stipulated in the approval shall comply not only with the conditions stipulated in the approval but also with the regulations of commerce and Customers Department.
   (b) As per Ministry of Health Notification 3/93dated 5-8-93 paragraph 5, prior approval shall be obtained from Food and Drug Administration for importation of sample drug. For the importation of sample drug without prior approval of the FDA, the FDA will not issue approval certificate.
9. (a) The following kind of drug samples are normally required. - Drug samples the quantity of which is sufficient for clinical trial on sixty patients. For certain rare diseases fewer numbers of samples may be acceptable. - Samples for laboratory analysis. - Samples for retention. (b) For the total numbers of sample drugs to be submitted, please refer to FDA circular 1/97(a) “Required quantities of sample drugs for registration” (Annex III) (c) All drug samples must be accompanied with their respective analytical report (the certificate of analysis). The name and designation of an official who signs the report must be stated. The photocopy of report is not acceptable.
10. The evaluation process for registration will be started only when all the requirements for registration application have been met; viz: (a) remittance of Registration Assessment Fees, (b) complete set of documents, (c) sufficient quantity of drug samples.
11. (a) When the drug is approved for registration, the applicant will be notified to remit 200 United States Dollar as Registration Fees. The notification will be made only on the notice board of FDA. (b) Failure to remit registration fees within 90 days from the date of intimation will constitute forgoing of an application by an applicant. If so happens, neither the Registration Assessment fees remitted nor registration documents and drug samples will be returned.
12. Failure to make a follow-up of an application by an applicant for more than six months from the date of remittance of assessment fees, will be taken as forgoing of an application.
13. The Registration Certificate (Form II) will be issued only when the acknowledgement of receipt of payments is submitted, issued by MFTB submitted.
14. The submitted dossiers are not reclaimable in case of rejection of application.

Updating Changes to Registered Drugs

1. Updating changes to registered drugs shall be made only with the approval of Food and Drug Administration.
2. For this purpose, the holder of registration certificate shall apply for variation of Registration; to FDA starting
   (a) reason for change.
   (b) Relevant data or findings from studies on which is based the justification of change.
   (c) Significant effect of changes to the specifications of drug.
3. The following shall be submitted together with the application:
   (a) The attestation by country’s drug regulatory authority to approval of such changes. If the regulatory authority’s attestation cannot be provided, explain the reason for it.
   (b) A photo copy of Registration Certificate of drug.
4. (a) When it is decided to approve of changes, US $ 100 fees will be levied on an applicant. The Drug Advisory Committee may waive this requirement if it believes that change is of benefit to public as regards quality, safety and efficacy of drugs. (b) An original Registration Certificate must then be submitted to make approved amendments on the certificate.

Renewal of Registration

1. Application for renewal of registration shall be submitted 90 days before the validity of the registration terminates. Failure to adhere to the 90 days requirement may result in disruption of continued validity of registration.
2. Application shall be submitted in the same manner as prescribed for application for registration of drug.
3. The drug samples for clinical trial are normally not required. However if the situation warrants the repeatclinical trial, the samples will be asked. The samples for laboratory analysis and for retention are still required. Please refer to FDA circular 1/97 b” Required quantities of sample drug for analysis and retention”. (Annex IV)
4. The documentary requirement is the same as that of an initial application (See Type of documents required for registration Annex I). Information provided, however, has to be updated. New findings which had not been submitted in an initial application have to be submitted too.
5. Registration Assessment fees must have been remitted to the Drug Advisory Committee Account No. 91892 at the time of application of renewal of registration. When the renewal of registration is approved of, two hundred United States Dollar must be remitted as Registration Fees.
6. Upon approval of renewing, new Registration Number will be designated, which shall make the old Registration Number void.
7. Failure to apply for renewal of registration shall result in invalidation of registration with effect from the date of expiry of the certificate.

Fees Levied

1. Registration Assessment Fees     100 US$ + Fees (in Kyats) for
2. Registration Fees                       300 US$ laboratory analysis
3. Variation of Registration 100 US$
   Note: (1) & (2) are levied either for fresh registration or renewal of registration.

Registration of Active Pharmaceutical Raw Materials

1. Documentary requirements

1. Administrative Documents
   1. A certificate of product issued by the regulatory authority of its own country that the product is authorized to be sold in country of origin.
   2. (a) Properly endorsed photocopy of valid manufacturing license. (b) GMP certificate of manufacturing plant.
   3. A letter of authorization for legal representation of manufacturer (owner of product) in Myanmar.
   4. A business registration certificate of local representatives.
2. Pharmaceutical Documents
   1. Generic name
   2. Chemical name
   3. Empirical & Structural Chemical formula
   4. Pharmacopoeia to which the product conforms.
   5. Pharmaceutical specifications (including physical characteristics, solubility, identification, loss on drying, sulphated, ash, heavy metal, purity, assay, etc.)
   6. Method of analysis
   7. Manufacturing process
   8. Quality Assurance System ( including control of starting material, in-process control, finished raw material control packaging control, etc.).
   9. Certificate of analysis.
   10. Stability test report of at least three different batches.
   11. Recommended Shelf-life.
   12. Recommended Storage conditions.
   13. Packaging specifications.

2.   Fees Amounts

(a) Assessment fees          US$ 100 + Fees in Kyats for laboratory analysis 
(b) Registration fees           US$ 300 (c) Variation fees US$ 100

 3. Application shall be made in the same manner as prescribed for registration application of finished product.

 4. A sample (20 gm) has to be submitted together with the dossier. The sample must be packed & labeled properly. An approval of FDA for importation of sample raw material is also required.

Variation of Registered Drugs

1. For Pack Size Addition

1. Documentary Requirements
   1. Covering Letter
   2. A Specification of packaging
   3. Sample of Medicine
   4. Certificate of Analysis ( COA )
   5. Stability Data ( *Remark - If the presentation of medicine is same, no need stability. )
   6. Copy of Drug Registration Certificate
   
2. Sample amount of Medicine Required
   Request to FDA

2. Change in Company Name

1. Documentary Requirements
   1. Manufacturing License
   2. Good Manufacturing Practice Certificate
   3. Certificate of Pharmaceutical Product
   4. Sample of Medicine
   5. Covering Letter
   6. Copy of Drug Registration Certificate
   7. Letter of reason for changing of Company Name
   
2. Sample amount of Medicine Required
   Request to FDA

3. Change in Brand Name

1. Documentary Requirements
   1. Covering Letter from Manufacturer or Owner
   2. Certificate of Pharmaceutical Product
   3. Medicine Sample or Art Work Design for packaging (3) sets.
   4. Manufacturing Approved attached list.
   
2. Sample amount of Medicine Required
   Request to FDA

Required quantities of Sample drugs for Renewal.. Click Here
Required quantities of Sample drugs for initial registration.. Click Here

Read more Click Here.

Click to download Detail Asean Guide Line.
Click to download Product Information check list.

Click to downloadDummy Dossier (1).pdf.
Click to downloadDummy Dossier (2).pdf.
Click to downloadDummy Dossier (3).pdf.
Click to downloadDummy Dossier (4).pdf.
Click to downloadDummy Dossier (5).pdf.
Click to downloadDummy Dossier (6).pdf.