Annulment of 4 legislative documents of the Ministry of Health of Vietnam (effective from December 15, 2024)

Annulment of 4 legislative documents of the Ministry of Health of Vietnam (effective from December 15, 2024)

Article 1 of Circular 25/2024/TT-BYT stipulates the complete annulment of four legal documents issued by the Minister of Health and jointly issued, including:

- Circular 13/2011/TT-BYT providing guidance on the division of tasks, inspection criteria, and inspection procedures serving state management on quality and food safety hygiene in the health sector, issued by the Ministry of Health

- Circular 02/2016/TT-BYT supplementing Article 9 of Circular 14/2012/TT-BYT on the principles and standards of "Good Manufacturing Practice for Pharmaceutical Packaging" (GMP) and guidelines for implementation, issued by the Minister of Health

- Circular 06/2022/TT-BYT prescribing the list and registration numbers for medical equipment used in the prevention and control of COVID-19 in urgent situations, issued by the Minister of Health

- Joint Circular 10/2005/TTLT-BYT-BTC guiding Decision 265/2003/QD-TTg on policies for individuals exposed to HIV or infected with HIV/AIDS due to occupational accidents and risks, issued by the Ministry of Health and the Ministry of Finance

Annulment of 4 legislative documents of the Ministry of Health of Vietnam (effective from December 15, 2024)​ (Image from the Internet)

What does the Dossier for appraisal of a draft Circular in Vietnam include?

According to Article 102 of the Law on the Promulgation of Legal Documents 2015 (amended by Clause 28 of Article 1 Law on Amendments to the Law on the Promulgation of Legal Documents 2020) on the appraisal of draft Circulars:

Article 102. Appraisal of Draft Circulars

1. The legal department of a ministry or equivalent governmental body is responsible for appraising the draft circular before submitting it to the Minister or Head of the equivalent governmental body.

For circulars having provisions that directly affect the rights, obligations, interests of individuals, enterprises, or related to multiple sectors or drafted by the legal department, the Minister or Head of the equivalent governmental body shall establish an advisory council including representatives from related agencies, organizations, units, experts, and scientists to conduct the appraisal.

2. The appraisal dossier includes:

a) Proposal for the draft circular;

b) Draft circular;

c) Compilation and explanation of the responses to opinions from agencies, organizations, individuals, and stakeholders directly affected by the draft; copies of feedback;

[...]

Thus, the dossier for appraising a draft Circular includes the following documents:

[1] Proposal for the draft circular

[2] Draft circular

[3] Compilation and explanation of the responses to opinions from agencies, organizations, individuals, and stakeholders directly affected by the draft; copies of feedback

[4] Policy impact assessment report in the draft circular (if any); administrative procedure evaluation in cases mandated by laws or resolutions by the National Assembly; report on gender equality integration (if any)

[5] Other documents (if any)

Note: Documents [1] [2] are submitted in paper form, while the remaining documents are submitted electronically.

What documents are included in the draft Dossier of Circular submitted to the Minister, Head of an Equivalent Governmental Body in Vietnam?

According to Article 103 of the Law on the Promulgation of Legal Documents 2015 (amended by Clause 29 of Article 1 Law on Amendments to the Law on the Promulgation of Legal Documents 2020) on the dossier for submission of a draft circular to the Minister or Head of an equivalent governmental body:

Article 103. Dossier for Submission of a Draft Circular to the Minister or Head of an Equivalent Governmental Body

1. Proposal to the Minister or Head of an equivalent governmental body for the draft circular.

2. Draft circular.

3. Appraisal report; explanation and response to appraisal opinions.

4. Compilation and explanation of the responses to opinions from agencies, organizations, individuals, and stakeholders directly affected by the draft.

[...]

Thus, the dossier for submission of a draft circular to the Minister or Head of an equivalent governmental body includes:

[1] Proposal to the Minister or Head of an equivalent governmental body for the draft circular.

[2] Draft circular.

[3] Appraisal report; explanation and response to appraisal opinions.

[4] Compilation and explanation of the responses to opinions from agencies, organizations, individuals, and stakeholders directly affected by the draft.

[5] Policy impact assessment report in the draft circular (if any); administrative procedure evaluation in cases mandated by laws or resolutions by the National Assembly; report on gender equality integration (if any).

[6] Other documents (if any).

Note: Documents [1] [2] [3] are submitted in paper form, while the remaining documents are submitted electronically.