Thông tư 25/2021/TT-BYT

CIRCULAR

PRESCRIBING STATISTICAL REPORTS IN THE FIELD OF PHARMACY AND COSMETICS 

Pursuant to the Law on Statistics dated November 23, 2015;

Pursuant to the Government’s Decree No. 94/2016/ND-CP dated July 01, 2016 providing guidelines for implementation of the Law on Statistics;

Pursuant to the Government’s Decree No. 85/2017/ND-CP dated July 19, 2017 defining organizational structure, tasks and powers of the centralized statistical organization system and statistical systems of ministries and ministerial agencies;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Drug Administration of Vietnam;

The Minister of Health promulgates a Circular prescribing statistical reports in the field of pharmacy - cosmetics.

Article 1. Scope

This Circular provides regulations on statistical reports, which are used to serve the collection of statistical information in the health-sector statistical indicator system, on drugs (including modern drugs, herbal drugs, vaccines and biological products other than in-vitro diagnostic reagents), medicinal materials (including semi-finished herbal ingredients, except herbal ingredients) and cosmetics.

Article 2. Regulated entities

This Circular applies to regulatory authorities and units performing statistical reports in the field of pharmacy - cosmetics; authorities, organizations and individuals 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 (hereinafter referred to as “ministerial health agencies”).

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.

Article 3. Statistical reports in the field of pharmacy and cosmetics 

1. Report forms, including:

a) Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for Provincial Departments of Health provided in Appendix I enclosed herewith;

b) Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for manufacturers and traders provided in Appendix II enclosed herewith;

c) Forms and instructions on preparation of statistical reports in the field of pharmacy - cosmetics for ministerial health agencies provided in Appendix III enclosed herewith;

d) 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 enclosed herewith.

2. 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:

a) First half-year statistical report begins on January 01 and ends on June 30 of that statistical reporting period;

b) Annual statistical report begins on January 01 and ends on December 31 of that statistical reporting period;

c) 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.

3. Reporting units

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.

4.  Report recipient and submission deadline:

a) 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;

b) Submission deadline: The date of receipt of a report shall be written in the upper left-hand corner of each report form.

5. Method for submitting reports:

Physical reports are required until the Ministry of Health accepts statistical reports submitted online.

Article 4. Implementation organization

1. Reporting units shall:

a) Fully, strictly and accurately comply with regulations on required information and submission deadlines laid down herein and assume legal responsibility for their submitted reports;

b) Review and provide reports and information contained therein at the request of recipients.

2. The Drug Administration of Vietnam shall:

a) Take charge and cooperate with relevant agencies/units to organize the implementation of this Circular;

b) Take charge and cooperate with relevant agencies/units to review regulations on statistical reports in the field of pharmacy - cosmetics in accordance with regulations of this Circular and propose amendments necessary to solve any difficulties arising during the implementation of this Circular or ensure the conformity of this Circular with reality;

c) Act as a contract point in receiving, consolidating and analyzing statistical figures in the field of pharmacy - cosmetics, and submitting them to the Department of Planning and Finance for consolidation and disclosure as prescribed;

d) Monitor, instruct, inspect and submit reports on the implementation of this Circular.

3. Department of Planning - Finance shall:

a) Act as the contact in disseminating statistical information on pharmacy - cosmetics in a timely, adequate, comprehensive, public and transparent manner on the basis of data and figures provided by the Drug Administration of Vietnam;

b) Cooperate with the Drug Administration of Vietnam in instructing and inspecting the implementation of regulations on statistical reports in the field of pharmacy - cosmetics.

4. Provincial Departments of Health and ministerial health agencies shall organize the collection and consolidation of figures and reports as prescribed in Article 3 of this Circular.

5. Department of Information Technology shall take charge and cooperate with the Drug Administration of Vietnam and relevant units in applying information technology and statistical reporting system in the field of pharmacy - cosmetics.

Article 5. Effect

This Circular comes into force from February 01, 2022.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the Drug Administration of Vietnam) for consideration./.