• Medicine (pharmaceuticals)

Non-automatic

• Protect human, animal or plant life and health; protect environment

Same as the "Administrative bodies"

• http://www.fdamyanmar.gov.mm/wp-content/uploads/2018/01/Drug-Regulation.pdf
• http://www.mtg.com.mm/fda/wp-content/uploads/2018/03/Amendment-of-National-Drug-Law.pdf

• G/LIC/N/2/MMR/1
• G/LIC/N/2/MMR/12

• G/LIC/N/2/MMR/1

  
  

  The National Drug Law 1992

  
  

  The National Drug Law Amendment 2014
  
  According to the National Drug Law, the DFDA only issues the Drug Importation Approval Certificate after checking the Goods Storage Practice and Goods Distribution Practice.

  
  

• G/LIC/N/2/MMR/12
  
  According to National Drug Law, Notification No. 3/1993 is concerned with registration of pharmaceuticals in Myanmar describing the requirements for drug registration.

  
  

• G/LIC/N/2/MMR/13

  
  

  Notification No.161/2023: Amendment of the Drug Registration Notification

  
  

  Modification: Administrative purpose, Duration of licensing, Documentation requirements (including application form), Processing time for issuing licence, Licence fee/administrative charge

  
  

  Article 1

  
  

  1.(a) According to the section 7 of the National Drug Law, a person who wants to register a drug must apply to the Department of Food & Drug Administration.

  
  

  (b) An application under sub-article (a) may be registered using e-submission system.

  
  

  (c) When applying according to sub-article (b), the information in this system must be completed and applied correctly.

  
  

  (d) Submission of drug sample and specific documents must be complied with Drug Registration Guideline by the Department of Food and Drug Administration.

  
  

  2. After the description of Article 6 of the Drug Registration Notification, E-submission application to the Department of Food and Drug Administration must be made via online payment system.

  
  

  3. Article10

  
  

  (a) For imported registered drugs, the prescribed annual fees must be paid regularly via online payment system during validity period of Drug Registration Certificate. If annual fees are dismissed for two consecutive years, the renewal registration will not be allowed.

  
  

  (b) Imported registered drugs must be submitted to the Department of Food and Drug Administration for laboratory testing, once every five years of registration, and the Laboratory analysis fee must be paid via online payment system.

  
  

  (c) For local registered drugs, an annual GMP inspection of plant by the Department of Food and Drug Administration and random sampling and testing of high-risk drugs must be complied.

  
  

  4. Article 11

  
  

  A person who wishes to apply for renewal Registration certificate must apply in accordance with the specific requirements on 6 months before the expiry of the drug registration certificate.

  
  

  5. The term "Myanmar Food and Drug Authority" stated in Articles 7, 8, 9, 10 and 13 of the Drug Registration Notification shall be replaced by "Department of Food and Drug Administration assigned by the Myanmar Food and Drug Authority".