Ministry of Health of Vietnam promulgated Circular 25/2021/TT-BYT stipulating statistical reports in the field of pharmacy and cosmetics, where manufacturers and traders of drugs, medicinal ingredients and cosmetics shall submit reports on these fields.
Article table of contents
Notice: Manufacturers and traders of cosmetics shall submit report from 01/02/2022 in Vietnam
Specifically, Article 2 of Circular 25/2021 applies to regulatory authorities and units in Vietnam performing statistical reports in the field of pharmacy - cosmetics; authorities, organizations and individuals in Vietnam involved in performance of statistical tasks in the field of pharmacy - cosmetics, including:
(1) Units of and affiliated to the Ministry of Health.
(2) Departments of Health of provinces and central-affiliated cities (hereinafter referred to as “Provincial Departments of Health”).
(3) Health agencies of ministries and regulatory authorities.
(4) Manufacturers and traders of drugs, medicinal ingredients and cosmetics (hereinafter referred to as “manufacturers/traders”) and other authorities, organizations and individuals involved in performance of statistical tasks in the field of pharmacy - cosmetics.
Clause 3, Article 3 of Circular 25/2021 also stipulates:
Reporting units include units of and affiliated to the Ministry of Health, Provincial Departments of Health, ministerial health agencies and manufacturers/traders whose names shall be specified in the upper right-hand corner of each statistical report form.
According to the Circular, guidelines for statistical reports in the field of pharmacy and cosmetics are as follows:
Report forms
Reporting units use report forms following the regulations, including:
- Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for Provincial Departments of Health provided in Appendix I enclosed Circular 25/2021;
- Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for manufacturers and traders provided in Appendix II issued together with Circular 25/2021;
- Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for ministerial health agencies provided in Appendix III issued together with Circular 25/2021;
- Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for units of and affiliated to the Ministry of Health provided in Appendix IV issued together with Circular 25/2021.
Reporting period
Statistical reporting period is a specific span of time for which a reporting entity is required to express their business performance in figures according to statistical items included in statistical report forms.
Statistical reporting periods shall be determined according to solar calendar, including:
- First half-year statistical report begins on January 01 and ends on June 30 of that statistical reporting period;
- Annual statistical report begins on January 01 and ends on December 31 of that statistical reporting period;
- Ad hoc statistical report: If ad hoc statistical reports are reported to serve the performance of state management tasks by a regulatory authority or requesting authority, a written request, in which the reporting period, deadline for report submission and specific statistical reporting criteria must be specified, is required.
Method for submitting reports: Physical reports are required until the Ministry of Health accepts statistical reports submitted online.
Report recipient is the authority whose name is written in the upper right-hand corner of each report form and under the name of the reporting unit
Submission deadline: The date of receipt of a report shall be written in the upper left-hand corner of each report form.
Circular 25/2021/TT-BYT takes effect from 01/02/2022.
