MEDGATE – SERVICE PROVIDER
FOR PHARMACEUTICAL REGISTRATION IN VIETNAM

What is the concept of drugs? 

(According to Article 2, Chapter I, Law on Pharmacy No. 105/2016/QH13)

Drugs are products containing active ingredients or medicinal materials intended for the prevention, diagnosis, treatment, alleviation, regulation of physiological functions of the human body, including pharmaceuticals, medicinal materials, traditional medicines, vaccines, and biological products.

Entities or businesses wishing to bring drugs to the market must register and declare with the The Drug Administration of Viet Nam- the Ministry of Health.

Legal basis for drug registration

– Circular 08/2022/TT-BYT issued on September 5, 2022: Marketing authorization of drugs and medicinal materials
– Circular 07/2017/TT-BYT issued on May 5, 2017: Promulgation of List of OTC Drugs.
– Circular 06/2017/TT-BYT issued on May 3, 2017: Promulgating list of toxic drugs and toxic medicinal ingredients
– Circular 42/2017/TT-BYT issued on November 13, 2017: Promulgating a list of toxic medicinal materials for drug production.
– Circular 21/2018/TT-BYT issued on September 12, 2018: Marketing authorization of traditional drugs and herbal materials
– Circular 20/2017/TT-BYT issued on May 10, 2017: Elaborating some articles on controlled drugs and medicinal ingredients of the law on pharmacy and the government’s decree no. 54/2017/ND-CP
– Circular 01/2018/TT-BYT issued on January 18, 2018: On labeling and package inserts of drugs and medicinal ingredients

Introduction to drug registration services

Drug registration services involve the process that businesses must undergo to circulate and sell pharmaceutical products in the market. The registration process is time-consuming and requires Regulatory Affairs Specialists with in-depth knowledge, a solid understanding of the procedures, and experience in preparing documentation. It also necessitates continuous monitoring and updating of new regulations and requirements from regulatory authorities, ensuring the application of the latest information for effective and compliant operations.

Subject and requirements for drug registration

Facilities/businesses wishing to register drugs must meet the following conditions:

a) Facilities/businesses engaged in manufacturing, wholesale, export, import of drugs and drug ingredients in Vietnam.
b) Facilities/businesses dealing in foreign drugs and drug ingredients must have a representative office in Vietnam.

Requirements for obtaining drug registration in Vietnam:

a) Ensure safety and effectiveness.
b) Produced at facilities meeting required conditions.
c) Manufactured according to the drug production process and meets quality standards.

** For drugs without a registration certificate, the facility must submit an application for evaluation of manufacturing facilities’ compliance with good manufacturing practices in the following cases:

a) Foreign manufacturing facilities registering drugs for the first time in Vietnam.
b) Drugs produced on a production line not yet evaluated by the Ministry of Health.
c) Drug ingredients are registered for the first time in Vietnam.
d) Foreign manufacturing facilities registering medicinal materials for the first time in Vietnam.

** For drugs with a registration certificate but the manufacturing facility and drug ingredients have not been evaluated by the Ministry of Health, the facility must submit an application for evaluation of manufacturing facilities’ compliance with good manufacturing practices in the following cases:

a) When applying for a dossier of an extension of the drug registration certificate.
b) When applying for a new drug registration certificate due to a change in the manufacturing facility’s location, as specified in points b or c, clause 2, Article 55 of the Law on Pharmacy.

** In cases where drugs are produced through multiple production stages at different facilities, the registering facility must submit an evaluation request for all facilities participating in drug production.

Megate JSC. provides pharmaceutical registration service in Vietnam

Procedure for Drug Registration

Application for Drug Registration (for new pharmaceuticals, vaccines, biological products)

*Administrative documents

a) Registration form
b) Letter of Authorization for the registering entity (if any)
c)  Letter of Authorization  for signing on the registration dossier (if any)
d) Drug Label Sample and anticipated drug usage instructions for circulation Registration.
e) Certificate of eligibility for pharmaceutical business in Vietnam for the registering entity
f) Legal documents, license for establishing a representative office in Vietnam for foreign registering entities
g) Summary of product characteristics for new pharmaceuticals, vaccines, biological products according to Form 6/TT issued with this Circular
h) Legal documents of the drug substance manufacturing facility, excipients, capsule shell, finished pharmaceutical products, and medicinal materials
i) Certificate from the testing facility in cases stipulated in Section 16, Article 22 of this Circular
j) Risk management plan (for vaccines) according to Form 7/TT issued with this Circular
k) Drug label Sample and actual drug usage instructions for circulation in the country of production or the country granting CPP for foreign drug registration dossiers
l) CPP certificate for foreign drug registration dossiers
m) GMP compliance assessment documents for cases specified in Article 95 of Decree No. 54/2017/NĐ-CP for foreign pharmaceutical manufacturing facilities when registering for circulation in Vietnam (except for cases where the facility has published information on GMP compliance on the Drug Administration Department’s website or the facility has submitted a dossier for the Drug Administration to assess GMP compliance).

*Quality, preclinical, and clinical documentation according to ACTD guidelines

Application for Circulation Registration for Medicinal Materials

*Administrative documents

a) Registration form
b) Letter of Authorization for the registering entity (if any)
c) Letter of Authorization for signing on the registration dossier (if any)
d) Drug label Sample and anticipated drug usage instructions for circulation Registration.
e) Certificate of eligibility for pharmaceutical business in Vietnam for the registering entity
f) Legal documents, license for establishing a representative office in Vietnam for foreign registering entities
g) Legal documents of the drug substance manufacturing facility, excipients, capsule shell, finished pharmaceutical products, and medicinal materials
h) Certificate from the testing facility in cases stipulated in Section 16, Article 22 of this Circular
i) Drug label Sample and actual drug usage instructions for circulation in the country of production or the country granting CPP for foreign drug registration dossiers
j) CPP certificate for foreign drug registration dossiers
k) GMP compliance assessment documents for cases specified in Article 95 of Decree No. 54/2017/NĐ-CP for foreign pharmaceutical manufacturing facilities when registering for circulation in Vietnam (except for cases where the facility has published information on GMP compliance on the Drug Administration Department’s website or the facility has submitted a dossier for the Drug Administration Department to assess GMP compliance).
l) CPP certificate for raw materials allowed for production or circulation in the country of production for foreign applications for raw material registration.

*Quality, preclinical, and clinical documentation according to ACTD guidelines

Validity Period of Drug Registration

(According to Article 8, Circular 08/2022/TT-BYT: Marketing authorization of drugs and medicinal materials)

1. The validity period of the drug registration certificate is 5 (five) years from the date of issuance or renewal.

2. The validity period of the drug registration certificate is 3 (three) years from the date of issuance for the following drugs:

a) New drugs, vaccines granted initial drug registration certificates, reference biological products, similar biological products granted initial drug registration certificates in Vietnam.
b) Drugs with the same active ingredient, concentration, dosage form as new drugs, but not yet granted a 5-year registration certificate.
c) Cases continued to be monitored for safety and effectiveness based on the advice of the Council.
d) Drugs falling under the provisions of points a, b, and c of this section but, at the time of submitting an application for renewal of the drug registration certificate, do not have safety and effectiveness reports due to reasons such as not yet being circulated, or having safety and effectiveness reports but limited usage in terms of quantity, number of patients, and time of use according to the opinion of the Council or recommendation from the healthcare facility for the need to continue monitoring safety and effectiveness.

3. Deadline for submitting renewal applications: Within 12 months before the expiry of the drug registration certificate, the registering entity must submit a renewal application to avoid interruptions in the distribution of drugs in the market.

For consultation on MEDGATE’s registration and import-export services, please contact us at the hotline 098.546.1894 or send a message via our fan page for immediate assistance.

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