Chapter III
APPLICATIONS FOR VACCINE MARKETING AUTHORIZATION ISSUANCE, RENEWAL AND AMENDMENT
Article 15. Regulations on documents in applications for vaccine marketing authorization issuance, renewal and amendment
1. Documents in applications for vaccine marketing authorization issuance, renewal and amendment are provided for in Clauses 1, 2, 3, 7, 8, 9, 10, 11 and 15 Article 23 of Circular No. 32/2018/TT-BYT and Points a and l Clause 5 Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 by the Ministry of Health on amendments to and abrogation of some legislative documents promulgated or jointly promulgated by the Minister of Health (hereinafter referred to as “Circular No. 29/2020/TT-BYT”).
2. Regulations on CPP:
a) CPP must have a signature, name of the signer, issuance date and seal of the issuer;
b) CPP must be issued by a pharmaceutical authority.
If CPP is not issued by a pharmaceutical authority, the applicant shall provide documentary proof that the issuer has competence for such issuance and the pharmaceutical authority of that country does not issue CPP as per the law of that country;
c) CPP must include all information mentioned in Appendix 02 enclosed therewith. Appendixes to CPP (if any) shall be verified by the issuer;
d) If an imported vaccine does not have CPP, this certificate may be replaced by a legal document issued by the competent authority of the export country proving that the vaccine has been granted marketing authorization and containing the following basic information: vaccine name, active ingredients, active ingredient concentration or content, dosage form, name and address of manufacturing facility and confirmation that the vaccine is authorized in that country.
CPPs of vaccines manufactured by multiple manufacturing facilities or substitute legal documents must specify the name, address and role of each facility.
3. Applications shall be formulated using the forms in Appendix 03 enclosed therewith. Other relevant administrative documents must be signed and stamped by the legal representative or authorized person of the legal representative of the applicant instead of using a signature stamp.
4. Letters of authorization shall be made using the forms in Appendix 04 enclosed therewith. An application shall include one authentic copy or copy with confirmation seal of the applicant or representative office (for foreign applicants) of the letter of authorization in the following cases:
a) Applicant authorization using the form in Appendix 04A enclosed therewith;
b) Authorization of application signing using the form in Appendix 04B enclosed therewith; if the person authorized to sign the application is not the head of the representative office, the letter of authorization must bear the seal and countersignature of the head of the representative office in Vietnam (for foreign applicants).
5. Submit authentic copies with the signature and confirmation seal of the manufacturing facility of quality standards, analyzing methods, certificates of analysis and stability analysis documents (included in documents on active ingredients and finished products); or copies with confirmation seal of the applicant (seal of the representative office is acceptable for foreign vaccines) of these documents.
If the manufacturing facility does not use a seal as per regulations of its home country, the confirmation seal is not required. In this case, the applicant shall provide a confirmation seal, guarantee that the manufacturing country does not use the required seal and take responsibility for the honesty of the abovementioned documents.
A certificate of analysis must include the following information: administrative information (name and address of manufacturing facility, name and signature of person in charge and date of certificate signing) and information on samples of the vaccine and vaccine ingredients (product name, batch number, expiry date, applied quality standards, quality criteria, quality requirements, analysis results and conclusion about batch quality).
Article 16. Documents on quality in applications for vaccine marketing authorization issuance and amendment
Documents on quality shall adhere to regulations in Clause 7 Article 25 of Circular No. 32/2018/TT-BYT, guidelines in Part II of ASEAN Common Technical Document (ACTD) or Module 3-ICH-CTD and the following regulations:
1. Batch release certificate shall be issued by an analyzing unit appointed by the competent authority of the manufacturing country.
2. In case the applicant cannot provide the document mentioned in Clause 1 of this Article, the applicant shall provide certificates of analysis, quality standards and analyzing methods confirmed by analyzing units appointed by the competent authority of the manufacturing country according to regulations in Clause 5 Article 1 of Circular No. 03/2020/TT-BYT dated January 22, 2020 by the Minister of Health on amendments to some Articles of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on quality of pharmaceutical products and pharmaceutical starting materials.
3. Documents on manufacturing process assessment and stability analysis must include data on 03 commercial-sized batches.
If data on 03 commercial-sized batches cannot be provided, provide data on at least 01 commercial-sized batch and 02 pilot-sized batches (at least 1/10 of the commercial size) and comparison table for manufacturing processes and stability analyses of commercial-sized batch(s) and pilot-sized batches, vaccine batches used in the clinical trial and certificate of analysis of each batch.
4. Regarding documents on quality of vaccines with transferred technology that have unexpired Vietnamese marketing authorizations when they are pre-technology transfer vaccines
Documents on quality of vaccines with transferred technology shall comply with the guidelines in Clauses 1, 2 and 3 of this Article and include the following documents:
a) Comparison table for differences (if any) between the pre-technology transfer vaccine and vaccine with transferred technology and documentary proof according to regulations in Appendix II to Circular No. 32/2018/TT-BYT and Clause 2 Article 18 of this Circular;
b) Documents on active ingredients of the vaccine with transferred technology provided by the receiving facility upon change of an active ingredient manufacturing facility of the pre-technology transfer vaccine;
c) Documents of the finished product of the vaccine with transferred technology shall be formulated by the receiving facility and include the following documents:
- Report on manufacturing process assessment (for manufacturing stages done at the receiving facility);
- Report on assessment of suitability of analyzing procedure (may be replaced by documents on analyzing procedure transfer formulated by the transferring facility and receiving facility);
- Data on batch analysis and certificate of analysis of the finished product.
5. If the pre-technology transfer vaccine has not been granted Vietnamese marketing authorization or its Vietnamese marketing authorization has expired, documents on quality of the vaccine with transferred technology shall adhere to the guidelines in Clause 4 of this Article and documents on quality of the pre-technology transfer vaccine shall comply with the guidelines in Part II-ACTD or Module 3-ICH-CTD.
6. For vaccines undergoing secondary packaging in Vietnam
All documents on vaccine quality prior to secondary packaging in Vietnam shall conform to Part II-ACTD or Module 3-ICH-CTD and Clauses 1, 2 and 3 of this Article if the vaccine has not been granted Vietnamese marketing authorization or its Vietnamese marketing authorization expires prior to secondary packaging in Vietnam.
Article 17. Preclinical and clinical documents in applications for vaccine marketing authorization issuance and amendment
1. Preclinical documents shall follow the guidelines in Part III-ACTD or Module 4-ICH-CTD.
2. Clinical documents shall follow the guidelines in Part IV-ACTD or Module 5-ICH-CTD.
Article 18. Applications for vaccine marketing authorization issuance, renewal and amendment
1. Applications for vaccine marketing authorization issuance, renewal and amendment are provided for in Clauses 1, 3 and 4 Article 28 of Circular No. 32/2018/TT-BYT and Articles 15 and 16 of this Circular and shall include the following documents:
a) For multiple vaccines registered using one application according to regulations in Clause 2 Article 5 herein, documents on quality must be prepared for each single-dose and multi-dose packaging specification and for each involved manufacturing facility as per regulations of this Circular;
b) For vaccines with change of manufacturing site or manufacturing facility according to regulations in Clause 2 Article 11 herein:
- Letter of authorization of the clinical data owner, which allows the manufacturing facility or applicant to use the clinical data, in case the applicant or manufacturing facility does not own the clinical data or is not affiliated to the same corporation as the clinical data owner;
- Documentary proof that change of manufacturing site or manufacturing facility does not affect vaccine quality.
2. In case of applying for amendment to a matter not provided for in Appendix II to Circular No. 32/2018/TT-BYT (including update of virus mutation), the applicant shall classify and submit technical documents following guidelines of USFDA, EMA, MHRA or WHO.
Article 19. Applications for vaccine marketing authorization issuance, renewal and amendment for vaccines with transferred technology and vaccines undergoing secondary packaging
1. Vaccines with transferred technology must meet all of the following requirements:
a) Vaccine manufacturing technology transfer involves transfer of technology for one or more than one part of or the whole vaccine manufacturing process to the receiving facility. Transfer of secondary packaging technology shall not be considered as vaccine manufacturing technology transfer.
b) The vaccine with transferred technology and pre-technology transfer vaccine must meet all of the following criteria:
- The two vaccines have the same formula;
- The two vaccines have the same manufacturing facility, quality standards and analyzing procedures for active ingredients;
- Excipients of the two vaccines have the same quality standards and analyzing procedures;
- Excipients of the two vaccines have the same quality standards and analyzing procedures;
c) In case there is a difference between the vaccine with transferred technology and pre-technology transfer vaccine according to regulations in Point a of this Clause, implement the guidelines in Appendix II to Circular No. 32/2018/TT-BYT and regulations in Clause 2 Article 18 of this Circular.
2. An application for issuance of marketing authorization to a vaccine with transferred technology when the pre-technology transfer vaccine has an unexpired Vietnamese marketing authorization shall include:
a) Administrative documents:
Administrative documents shall adhere to the regulations in Points a and b Clause 1 Article 18 of this Circular and include the following documents:
- Administrative documents mentioned in Point a Clause 5 Article 28 of Circular No. 32/2018/TT-BYT, excluding the application and letter of authorization (if any), which shall be made using the forms in Appendix 03 and Appendix 04 enclosed therewith respectively;
- Good manufacturing practice certificate of the receiving facility whose scope is suitable for the manufacturing of the vaccine with transferred technology;
- Certificate of technology transfer registration for technology transfer cases mentioned in Clause 1 Article 31 of the Law on Technology Transfer.
b) Documents on quality, which shall be formulated according to the regulations in Clause 4 Article 16 of this Circular;
c) Preclinical and clinical documents, which shall be formulated according to the regulations in Article 17 of this Circular.
3. An application for issuance of marketing authorization to a vaccine with transferred technology when the pre-technology transfer vaccine does not have a Vietnamese marketing authorization or its Vietnamese marketing authorization has expired shall include:
a) Administrative documents:
Administrative documents shall adhere to the regulations in Points a and b Clause 1 Article 18 of this Circular and include the following documents:
- Administrative documents mentioned in Point b Clause 5 Article 28 of Circular No. 32/2018/TT-BYT, excluding the application and letter of authorization (if any), which shall be made using the forms in Appendix 03 and Appendix 04 enclosed therewith respectively;
- Legal documents substituting CPP mentioned in Point d Clause 2 Article 15 of this Circular if the pre-technology transfer vaccine is a foreign vaccine (if applicable);
- Good manufacturing practice certificate of the receiving facility whose scope is suitable for the manufacturing of the vaccine with transferred technology;
- Certificate of technology transfer registration for technology transfer cases mentioned in Clause 1 Article 31 of the Law on Technology Transfer.
b) Documents on quality, which shall be formulated according to the regulations in Clause 5 Article 16 of this Circular;
c) Preclinical and clinical documents, which shall be formulated according to the regulations in Article 17 of this Circular;
d) Documents on the pre-technology transfer vaccine, including documents of the pre-technology transfer vaccine mentioned in Clause 1 Article 18 of this Circular.
If the pre-technology transfer vaccine is not applying for marketing authorization, the label expected to be used in Vietnam is not required.
4. Applications for marketing authorization of vaccines undergoing secondary packaging in Vietnam shall be formulated according to regulations applicable to change of secondary packaging facility in Appendix II to Circular No. 32/2018/TT-BYT if these vaccines have unexpired Vietnamese marketing authorizations prior to secondary packaging.
5. An application for issuance of marketing authorization to a vaccine undergoing secondary packaging in Vietnam if this vaccine does not have a Vietnamese marketing authorization or its Vietnamese marketing authorization has expired prior to secondary packaging shall adhere to the regulations in Points a and b Clause 1 Article 18 of this Circular and include the following documents:
a) Administrative documents mentioned in Point b Clause 6 Article 28 of Circular No. 32/2018/TT-BYT, excluding the letter of authorization (if any), which shall be made using the form in Appendix 04 enclosed therewith;
b) Documents on quality, which shall be formulated according to the regulations in Clause 6 Article 16 of this Circular.
6. Regarding applications for marketing authorization renewal or amendment for vaccines with transferred technology or undergoing secondary packaging in Vietnam:
Applications for vaccine marketing authorization renewal or amendment of vaccines with transferred technology or undergoing secondary packaging shall be formulated according to regulations in Clauses 3 and 4 Article 28 of Circular No. 32/2018/TT-BYT and Article 15 of this Circular. For application for amendment to contents not included or provided in Appendix II to Circular No. 32/2018/TT-BYT (including updates on virus mutations), the applicant shall submit technical documents in compliance with guidelines of USFDA, EMA, MHRA or WHO.
Tìm kiếm
Thông tư 11/2021/TT-BYT (Bản Word)