I. REGISTRATION OF FOOD SUPPLEMENTS
(i) General requirements
Myanmar FDA Guideline on Drug Registration Application of 2014 indicates that the registration of food supplements is equal to the one for pharmaceuticals. The applicant must be a Myanmar resident. For imported food supplements, authorization must be completed by a local entity which represents a foreign company.
The Registration must be completed through a registration form with the FDA, the form can be obtained with the FDA offices of Naypyitaw and Yangon at a cost of [1000] kyats.
A Separate registration has to be made for pharmaceutical preparations of different strength or different dosage form.
For imported food supplements, the FDA will issue an "Approval for importation of Drug Samples" after receiving the application. The drug samples as specified and required in the application may then be imported into the country.
(ii) Required documentation
The required information for food supplements (differing from the more extensive documentation required for Pharmaceuticals) can be summarized as follows:
- A letter of authorization for the legal presentation of the manufacturer in Myanmar
- Free sale certificate (original) from country of origin
- Copy of manufacturing license: legalized or endorsed
- ISO Certificate
- Documents on quality;
- Raw material specification (sources)
- Raw materials quality control
- Master formula
- Manufacturing process
- Finished product specification
- Reference text
- Certificate of Analysis (finished product)
- Stability test of finished product
- Safety and efficacy data
- Action of active ingredient (reference text)
- Safety data of finished product
- Research paper/Literature of food supplement (approved by internationally recognized research institute)
(iii) Payment
Guidance indicates a registration assessment fee of [300,000] kyats should be paid at the time of the submission of the application.
When the drug is approved for registration another [500,000] kyats should be paid. Failure to pay the fees within 90 days, will results in cancellation of the application.
(iv) Outcome
A Registration Certificate will be issued.
In case of a negative outcome, the procedure needs to start from beginning again. Submitted dossiers are not reclaimable.
(v) Modifications
Modifications of existing drug registrations are to be brought with the FDA. The holder of the Registration Certificate should apply for a Variation of Registration, stating the reasons for change, relevant data or findings from studies which justifies the modification and the significant effect of the changes to the specification of the drug.
In the case that the modifications are approved, a fee of [100,000] kyats per type of amendment will be charged. The charge may however be waived when the change is in the benefit of public safety and efficacy of drugs.
(vi) Renewal
Should be brought 90 days before the validity of the registration terminates. The documentation is the same as required for the initial application, including new information. A new registration fee of [500,000] kyats will be charged.
