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REGISTRATION FOR DRUG CIRCULATION IN VIETNAM

The pharmaceutical business contributes significantly to the country's human resource development. We all know that if pharmacists are properly trained in schools and centers, pharmacists with advanced professional knowledge and abilities would make a significant contribution to medical examination and treatment, thereby boosting the country's human resource quality. High-quality workers will be in good health, will work hard, and will produce in order to optimize their creativity at work, which will serve as a springboard for them to assert their abilities and contribute to society. Accompanying the development of the pharmaceutical business, the registration of drug circulation plays an important role in the development of the health sector of Vietnam in general as well as preserving and ensuring the health of the Vietnamese people in particular. So, what is the registration process for drugs in Vietnam? Let’s unravel the legal procedures for drug registration with Doanh Tri Law through the following article!

Legal basis

  • Circular 32/2018/TT-BYT for Marketing Authorization of Drugs and Medicine Ingredients 
  • Vietnam 2016 Law on Pharmacy

I. Registration procedures for domestically produced new drugs
- Application for Registration

  • Cover
  • Profile Table of Contents
  • Registration form
  • Summary of drug properties
  • Production process
  • Quality standards and testing methods (complete and detailed);
  • Drug testing report of one of the following establishments: Testing institute, testing sub-institute. Having a production facility that meets GMP standards, a testing laboratory that meets GLP
  • Research paper on stability
  • Drug label
  • Sample material: 1 packing unit for 1 regulation for circulation registration
  • Look up trademarks or trademark protection certificates for drugs bearing trade names.

- Registration procedure

  • The registration dossier is sent to the Drug Administration of Vietnam (Department of Drug Administration).
  • The Drug Administration of Vietnam receives and appraises dossiers and organizes a drug review council and issues a list of drugs with registration numbers. Within 12 months from the date of receipt of a complete application for a drug registration certificate (except for the case specified in Article 41 of Circular 32), the Drug Administration of Vietnam shall grant a drug registration certificate. medicine practice.
  • Return to the notice unit, the decision to issue the registration number at the receiving place
  • The registration is done by post or submitted in advance at the Drug Administration of Vietnam.

II. Procedures for registration of foreign modern drugs circulating in Vietnam
- Application for Registration

  • Cover
  • Profile Table of Contents
  • Application for registration
  • Certificate of eligibility for pharmacy business or license for foreign company registration for the company in whose name is registered.
  • Summary of drug properties
  • The drug marketing license in the country of manufacture is issued by a competent authority (FSC or CPP).
  • GMP certificate.
  • Production process (Please state in full and in detail);
  • Quality standards and testing methods.
  • Drug testing sheet of the manufacturer.
  • Research paper on drug stability.
  • Drug labels; (designed or attached).
  • Drug sample.
  • Look up trademarks or certificates of trademark protection for drugs bearing trade names.

- Registration procedure

  • The registration dossier is sent to the Drug Administration of Vietnam (Department of Drug Administration).
  • The Drug Administration of Vietnam receives and appraises dossiers and organizes a drug review council and issues a list of drugs with registration numbers;
  • Return to the notice unit, the decision to issue the registration number at the receiving place

The above article provides information regarding the issue of drug registration in Vietnam. For more detailed information, please contact Doanh Tri Law Firm through the following means of communication: 
Hotline: (+84) 911.233.955 or Email: luatdoanhtri@gmail.com
Doanh Tri is always pleased to cooperate with our customers!

 

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