Vietnam: What are the lastest regulations on the registration of marketing authorization for drugs and medicinal materials from October 20, 2022?
- What are the regulations on handling the application for registration of drugs and medicinal materials before October 20, 2022 in Vietnam?
- What are the regulations on the roadmap for changing the registration of marketing authorization for drugs and medicinal materials in Vietnam?
- In what cases will the application for registration of drugs and medicinal materials be assessed according to the simplified procedures applied from October 22, 2022 in Vietnam?
What are the regulations on handling the application for registration of drugs and medicinal materials before October 20, 2022 in Vietnam?
On September 5, 2022, Circular 08/2022/TT-BYT issued the new regulations on registration of drugs and medicinal materials.
Thus, according to the provisions of Article 45 of Circular 08/2022/TT-BYT, the handling of application for registration of drugs and medicinal materials before October 20, 2022 is conducted as follows:
- The applications submitted before the effective date of this Circular may continue to comply with regulations at the time of submission, unless the facilities voluntarily comply with regulations from the promulgating date of Circular 08/2022/TT-BYT.
- The applications submitted before the effective date of Circular 08/2022/TT-BYT, which are in the process of settlement, can apply the relevant regulations in this Circular and the regulations before the effective date of Circular 08/2022/TT-BYT in the direction of convenience for businesses, organizations and individuals.
- For drugs submitted to registration applications according to regulations before the effective date of Circular 32/2018/TT-BYT and granted certificates of marketing authorization or renewed certificates of marketing authorization, facilities may only manufacture finished products from medicinal materials exported by manufacturing facilities that meet manufacturing practices with an appropriate scope in accordance with the provisions of Article 141 of Decree 54/2017/ND-CP.
The manufacturing facilities and the registrar are required to store proving documents as prescribed in Clause 1, Article 22 of Circular 08/2022/TT-BYT and present them to relevant competent authorities upon request.
- The registration of marketing authorization of Covid-19 vaccines in case of emergency shall comply with the provisions of Circular 11/2021/TT-BYT of the Minister of Health guiding the registration of circulation of Covid-19 vaccines in case of emergency.
- In case the WHO publishes an updated Certificate of Pharmaceutical Product (CPP) form, within 12 months from the date the updated CPP form is published on the WHO website, the registrant must submit a CPP with sufficient content according to the updated CPP form in the application for registration of drugs. CPP that has not been updated (old form) shall still be accepted if the CPP is still valid at the time of receiving the application for registration of drugs.
- Contents related to the reference water management agency of the reference country specified in Clause 2, Article 2 of Circular 32/2018/TT-BYT referenced in other legal documents will continue to be implemented until the legal document is amended, supplemented, replaced or annulled.
- In case the drug has been announced by the Ministry of Health before the effective date of this Circular, the Drug Administration of Vietnam shall adjust, update, change, and supplement information on announced brand-name drugs according to the provisions of this Circular under the request of the drug registration facility.
- In case of Annexes I, III, IV issued together with Circular 08/2022/TT-BYT updated according to ASEAN general technical requirements, within 6 months from the date on which the updated documents are published on the web portal of Aseanimunities/economic-community/standard-andcomformance/key documents-publications, the Drug Administration of Vietnam organizes translation and publishes the updated content on the website of the Ministry of Health and Website of the Drug Administration of Vietnam.
Within 06 months from the date the Drug Administration of Vietnam publishes the updated content on the website of the Ministry of Health and the website of the Drug Administration of Vietnam, the registration facilities, the manufacturers must update in the application for registration of drugs.
- Drugs registered to be manufactured in Vietnam in the form of technology transfer, drugs with secondary packaging shall continue to comply with the provisions of Circular 32/2018/TT-BYT until the Circular on registration of marketing authorization for processed drugs and technology-transferred drugs in Vietnam by the Ministry of Health is promulgated and takes effect.
What are the regulations on the roadmap for changing the registration of marketing authorization for drugs and medicinal materials in Vietnam?
Pursuant to the provisions of Article 46 of Circular 08/2022/TT-BYT as follows:
- From October 20, 2022, the manufacturer has more than 02 drugs with the same medicinal ingredient, dosage form, route of administration, content or or the concentration in a dosage unit that has been granted a marketing authorization, when submitting an application for extension of marketing authorization, the manufacturer shall coordinate with the drug registration facility in selecting and requesting the extension of the marketing authorization for 2 drugs as prescribed in Clause 6, Article 8 of this Circular, the remaining drugs that have already been granted marketing authorizations will be extended the validity of the certificate of sale free until the end of December 31, 2025.
- For domestically produced drugs and medicinal materials that have been granted marketing authorizations before the effective date of this Circular, and establishments that wish to import medicinal materials such as excipients or capsule shells to Vietnam: Before importing to Vietnam for the first time, the applicant must update all information on medicinal materials being excipients and capsule shells in the approved dossier to the online public service system of the Drug Administration odd Vietnam. Within 05 working days from the date the facility updates the information on the system, the Drug Administration of Vietnam must complete the announcement. The registration facility is responsible for the accuracy of the updated information compared to the information in the approved application and is not required to update the information again at the next importation.
- The application of registration numbers according to the structure specified in Appendix I issued together with this Circular upon issuance or renewal of marketing authorization shall be applied from January 1, 2003.
- For drugs that have been granted registration numbers before January 1, 2023, whose marketing authorization are renewed, they may continue to use the registration numbers granted before renewal for a maximum period of 12 months from the date granted a registration book according to the structure specified in Appendix VI issued together with Circular 08/2022/TT-BYT.
In what cases will the application for registration of drugs and medicinal materials be assessed according to the simplified procedures applied from October 22, 2022 in Vietnam?
Pursuant to the provisions of Article 33 of Circular 08/2022/TT-BYT as follows:
Cases applied the process of rapid appraisal, shortened appraisal
1. Rapid appraisal
The applications for registration of drugs shall be appraised according to the rapid appraisal process when one of the following conditions is satisfied:
a) Drugs on the List of rare drugs promulgated by the Minister of Health;
b) Medicines to meet urgent needs for national defense, security, national defense, epidemic control, and disaster recovery;
c) Domestic drugs are manufactured on new production lines meeting GMP standards or on upgraded production lines meeting GMP-EU, GMP-PIC/S standards and equivalent within 18 months from the date of issuance of the certificate. GMP certification;
d) Vaccines pre-evaluated as satisfactory by WHO, vaccines used in the national expanded immunization program;
d) Specialized drugs, drugs in special dosage forms containing no more than 02 (two) similar drugs (same active ingredients, same dosage form, same content and concentration) with a certificate of drug circulation registration. valid in Vietnam at the time of application submission, including:
- Medicines for cancer treatment;
- New generation antiretroviral drugs;
- New generation antibiotics;
- Drugs used in the treatment of dengue fever, tuberculosis, malaria;
- Immunosuppressive drugs used in organ transplantation.
e) Domestically produced drugs, including:
- Drugs manufactured, processed or transferred from Vietnam with technology for cancer treatment, vaccines, biological products, new-generation antiviral drugs, new-generation antibiotics, and inhibitors Immunotherapy for bereavement:
- Medicinal herbs with scientific and technological topics at national, ministerial or provincial level which have been accepted and accepted as satisfactory, drugs manufactured entirely from domestic herbal sources meeting GACP;
- New domestically produced drugs that have completed clinical trials in Vietnam;
g) New drugs (cancer treatment, new generation antivirals, new generation antibiotics), reference biological products;
h) The original brand-name drug is manufactured, processed or transferred in Vietnam;
i) The drug is changed in production facility leading to the issuance of a new circulation registration certificate according to the provisions of Point b, Clause 2, Article 55 of the Law on Pharmacy,
2. Shortened appraisal
- A drug registration dossier shall be appraised according to the shortened appraisal process when the following conditions are simultaneously satisfied:
a) Drugs manufactured at establishments that are periodically assessed by the Drug Administration for meeting good manufacturing practices;
b) Drugs on the List of non-prescription drugs;
c) Drugs other than modified-release dosage forms;
d) The drug is not used directly on the eyes.
Thus, the above cases are cases where the application for registration of drugs and medicinal materials is assessed according to the simplified procedures applied from October 22, 2022.
Circular 08/2022/TT-BYT takes effect from October 20, 2022.
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