Proposal Dossier for Issuing Marketing Authorization for Technologically Transferred Vaccines Without Existing Marketing Authorization in Vietnam

Pursuant to Clause 3, Article 19 of Circular 11/2021/TT-BYT prescribing the dossier for the application of a circulation registration certificate for technology-transferred vaccines in cases where the vaccine before technology transfer has not yet obtained a circulation registration certificate in Vietnam or its circulation registration certificate in Vietnam has expired as follows:

Administrative dossier:

- To be implemented according to the provisions at Point a, Point b, Clause 1, Article 18 of this Circular and the following documents:

+ Administrative documents prescribed at Point b, Clause 5, Article 28 of Circular No. 32/2018/TT-BYT except for the Application Form which is implemented according to Appendix 03 and the Power of Attorney (if any) implemented according to Appendix 04 promulgated together with this Circular;

+ Legal document substituting for the pharmaceutical product certificate prescribed at Point d, Clause 2, Article 15 of this Circular for technology-transferred vaccines which are foreign vaccines (if any);

+ Good Manufacturing Practice (GMP) certificate of the facility receiving the technology transfer for vaccine production with a scope of production suitable for the technology-transferred vaccine;

- Technology transfer registration certificate for cases of technology transfer prescribed in Clause 1, Article 31 of the Law on Technology Transfer.

+ Quality dossier: to be implemented according to the provisions of Clause 5, Article 16 of this Circular;

+ Preclinical and clinical dossier: to be implemented according to the provisions of Article 17 of this Circular;

+ Dossier for the vaccine before technology transfer includes documents of the vaccine before technology transfer according to the provisions for the dossier for the issuance of a circulation registration certificate prescribed in Clause 1, Article 18 of this Circular.

In case the circulation registration certificate for the vaccine before technology transfer is not applied for, the expected label for circulation in Vietnam is not required.

Sincerely!