Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:
1. Applications and procedures for vaccine marketing authorization issuance, renewal and amendment.
2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.
3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.
Article 2. Interpretation of terms
In this Circular, the terms below are construed as follows:
1. “facility transferring vaccine manufacturing technology" refers to the party that owns or has the right to use a vaccine manufacturing technology as per the law and transfers ownership of the technology or right to use the technology to a facility receiving vaccine manufacturing technology to apply it to one or more than one part of or the whole manufacturing process (hereinafter referred to as “transferring facility”).
2. “facility receiving vaccine manufacturing technology" refers to the party that receives ownership of a vaccine manufacturing technology or right to use the technology from a transferring facility under an agreement between two parties to apply it to one or more than one part of or the whole manufacturing process (hereinafter referred to as “receiving facility”).
3. “vaccine with transferred technology" refers to a vaccine manufactured by the receiving facility with one or more than one part of or the whole manufacturing process using the manufacturing technology transferred by the transferring facility under an agreement between two parties.
4. “pre-technology transfer vaccine" means a vaccine which is granted marketing authorization in Vietnam or not yet granted marketing authorization in Vietnam, which is researched and developed in compliance with quality, safety and effectiveness requirements, and the ownership or right to use the manufacturing technology of which is transferred by the transferring facility to the receiving facility to apply it to one or more than one part of or the whole manufacturing process.
Article 3. Rights and responsibilities of vaccine registration applicants, manufacturing facilities, transferring facilities and receiving facilities
1. Vaccine registration applicants (hereinafter referred to as “applicants”) shall have the rights and responsibilities mentioned in Article 57 of the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016 (hereinafter referred to as “Law on Pharmacy”) and Article 3 of Circular No. 32/2018/TT-BYT dated November 12, 2018 by the Ministry of Health on marketing authorization of drugs and medicinal ingredients (hereinafter referred to as “Circular No. 32/2018/TT-BYT").
2. Vaccine manufacturing facilities (hereinafter referred to as “manufacturing facilities”) shall have the rights and responsibilities mentioned in Article 43 of the Law on Pharmacy and Article 4 of Circular No. 32/2018/TT-BYT.
3. Transferring facilities and receiving facilities shall have the rights and responsibilities mentioned in the Law on Technology Transfer No. 07/2017/QH14 dated June 19, 2017 and relevant guidelines.
4. Applicants shall cooperate with manufacturing facilities in the following tasks:
a) Implement regulations in Clauses 2 and 3 Article 11 and Clause 1 Article 13 of this Circular for vaccines without sufficient clinical data;
b) Develop comprehensive pharmacovigilance systems for their products as per regulations and fully report on adverse events following immunization to General Department of Preventive Medicine;
c) Ensure compliance with risk management plans of their vaccines throughout the product life cycle.
Article 4. Regulations on reporting on monitoring and assessment of safety and effectiveness
1. Pharmacy businesses, healthcare establishments, vaccination facilities and provincial Centers for Disease Control and Prevention (CDCs) must monitor, supervise, collect and consolidate data on, assess and report adverse events following immunization and other relevant information to competent authorities according to regulations in Articles 77 and 78 of the Law on Pharmacy, national guidelines on pharmacovigilance and relevant provisions.
2. Applicants must submit reports on vaccine safety and effectiveness assessment using the form in Appendix 01 enclosed therewith as follows:
a) Submit a report on safety and effectiveness assessment every 02 months during the effective period of the marketing authorization to National DI & ADR Center and General Department of Preventive Medicine;
b) Submit a report when applying to Drug Administration of Vietnam for marketing authorization renewal.
Article 5. Application language, format and quantity
1. Language, format and quantity of vaccine registration applications are provided in Clauses 1, 2, 4 and 5 Article 6 of Circular No. 32/2018/TT-BYT.
2. Multiple vaccines may be registered using one application if they share the following elements: vaccine name, dosage form, administration route, vaccine quality standards and formula, including similar active ingredient concentration or content.
3. Regulations on use of online applications:
a) Application quantity and components: 01 electronic application containing the components required by this Circular shall be submitted online and 01 physical copy of each administrative document (excluding vaccine labels and package insert) shall be submitted to Drug Administration of Vietnam;
b) Applicants and manufacturing facilities may use digital signatures on relevant documents. Digital signatures shall be registered and used according to regulations in the Government’s Decree No. 130/2018/ND-CP dated September 27, 2018 on guidelines for of the Law on E-Transactions of digital signatures and digital signature authentication;
c) Roadmap for application of online documents shall be announced by the Minister of Health.
Article 6. Vaccine registration fees
Applicants shall incur fees related to vaccine registration as per law provisions on fees and charges.
Article 7. Effective period and symbols of vaccine marketing authorization, deadlines for renewal application and for label and package insert registration
1. Effective period and symbols of vaccine marketing authorization and deadline for renewal application are provided in Article 8 of Circular No. 32/2018/TT-BYT.
2. Approved Vietnamese labels and package inserts may exclude commercial packaging of vaccines published on the website of Drug Administration of Vietnam and shall be provided for each vaccination facility to ensure that health officials, healthcare workers and vaccine recipients have full access to approved information.
Article 8. Regulations on verification of information on legal documents
1. Drug Administration of Vietnam shall cooperate with relevant Vietnamese and foreign bodies and diplomatic missions or browse websites in official English database systems provided by competent foreign authorities to verify the following legal documents in vaccine registration applications:
a) Certificates of Pharmaceutical Product (hereinafter referred to as “CPP") or substitute legal documents mentioned in Point d Clause 2 Article 15 of this Circular in applications for vaccine marketing authorization issuance, renewal and amendment;
b) Legal documents issued by competent foreign authorities of foreign applicants applying for drug registration for the first time in Vietnam.
2. Vaccine registration applications shall be verified and assessed at the same time and results of legal document verification according to Clause 1 of this Article must be available before the marketing authorization is issued, renewed or amended.
Article 9. Organization and operation of marketing authorization advisory board
Organization and operation of marketing authorization advisory board (hereinafter referred to as “advisory board”) are provided in Article 44 of Circular No. 32/2018/TT-BYT.
Article 10. Organization and operation of vaccine registration application assessors
Organization and operation of vaccine registration application assessors are provided in Article 45 of Circular No. 32/2018/TT-BYT.
Tìm kiếm
Thông tư 11/2021/TT-BYT (Bản Word)