In Decision No. 376/QD-TTg dated March 17, 2021, the Prime Minister sets the goal that by 2030, at least 100 patented drugs, vaccines, medical biological products, and drugs that Vietnam has not been able to produce, must be technologically transferred.
In order to achieve the goal set out in Decision No. 376/QD-TTg, on August 15, 2023, the Ministry of Health issued Circular No. 16/2023/TT-BYT ("Circular 16") which regulates the registration for circulation of contract-manufactured drugs and technologically transferred drugs in Vietnam, replacing Circular No. 23/2013/TT-BYT on guidelines for pharmaceutical contract manufacturing. The additional provisions related to technologically transferred drugs are expected to attract investment and promote the activity of technology transfer in drug manufacturing in Vietnam.
In this legal update, ATA will focus on updating some prominent contents in Circular 16 related to technology transfer issues in drug manufacturing and the registration of technologically transferred drugs in the market.
1. Entities named in the registration of technologically transferred drugs
a) Conditions for entities named in the registration of technologically transferred drugs
- For technology transfer facilities for drug manufacturing
In the case of Vietnamese technology transfer facilities for drug manufacturing: Must have a valid pharmaceutical business certificate with one of the following business forms: production, wholesale, export, import of drugs, drug materials;
In the case of foreign technology transfer facilities for drug manufacturing: Must have (i) legal documents issued by foreign competent authorities permitting at least one of the following business forms: production, wholesale, export, import of drugs, drug materials, and (ii) a license to establish a representative office in Vietnam.
- For technology recipient facilities for drug manufacturing
Technology recipient facilities for drug manufacturing are automatically named in the registration of technologically transferred drugs or can authorize other facilities meeting the legal requirements for registration as specified, except for cases where there is a different agreement.
b) Responsibilities of entities named in the registration
- Take responsibility for the legality of the registration dossier, issues related to intellectual property rights for the drug;
- Notify the Drug Administration within 30 days from the date of the decision to withdraw the drug circulation registration in any country worldwide before transferring technology.
2. Clarification of mandatory contents in the technology transfer contract for technologically transferred drugs
Previously, technology transfer contracts in the medical field were only based on the general technology transfer contract provisions under the 2017 Technology Transfer Law. Circular 16 clarifies certain mandatory provisions to be included in the technology transfer contract for technologically transferred drugs, including:
- Agreement on providing technical documents of the technology transfer facility for drug manufacturing to the technology recipient facility;
- Responsibilities of the parties in the contract regarding intellectual property issues related to technologically transferred drugs;
- Technology transfer roadmap for manufacturing stages of the drug production process in Vietnam and the responsibilities of relevant parties in reporting progress to the Drug Administration;
(Note: The reporting shall be conducted annually from the date of issuance of the circulation registration certificate for technologically transferred drugs with the same content as the drug before the technology transfer, including formula, process, quality standards, and trade name).
- Cases of agreement cancellation and responsibilities due to violations of the agreement.
3. Procedure for registering the circulation of technologically transferred drugs (hereinafter referred to as "Drug Circulation Registration")
a) Competent authority: Drug Administration - Ministry of Health
b) Application dossier for issuing circulation registration certificate includes:
(i) Administrative dossier: Request form, legal documents, technology transfer contract;
(ii) Quality dossier of various types of drugs;
(iii) Pre-clinical and clinical documents for vaccines, and biological products;
(iv) Follow-up, safety, and efficacy evaluation reports, and drug use status reports before technology transfer.
c) Time limit for issuing circulation registration certificates for drugs
(i) In the case of drugs before technology transfer that already has a valid circulation registration certificate in Vietnam at the time of dossier submission: within 03 months from the date of receipt of a complete and valid application dossier.
(ii) For drugs before technology transfer that have not been granted a circulation registration certificate in Vietnam or whose circulation registration certificate has expired at the time of dossier submission: within a maximum of 09 months from the date of receipt of a valid application dossier.
4. Announcement of the list of technologically transferred drugs registered for circulation
- The Drug Administration publishes the list of technologically transferred drugs (including contract-manufactured drugs with technologically transferred drug manufacturing) granted/renewed circulation registration certificates on the website https://dav.gov.vn/, Bao Suc Khoe Va Doi Song newspaper.
- Suspension or revocation of drug announcements in case of:
(i) Failure to comply with the technology transfer roadmap for manufacturing stages of the drug production process in Vietnam submitted in the application for circulation registration of drugs;
(ii) Cases where the drug no longer meets the requirements for circulation registration in Vietnam.
Circular 16 is effective from October 1, 2023. For dossiers submitted before this date, they shall continue to be processed according to the previous regulations, except for cases where the registered facility submits a written explanation, supplementation, or voluntary implementation according to this Circular.
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