Implementation Regulations Governing Materials for Communicable Disease Control and Establishment of Resources

Link to law: http://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?PCode=L0050010

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Chapter 1 General Principles

Article 1

This set of Regulations is formulated in accordance with regulations of Paragraph 2 of Article 20, and Article 26 of the Communicable Disease Control Act (hereafter referred to as the Act).

Article 2

The materials for communicable disease control mentioned in this set of Regulations refer to pharmaceuticals, devices and protective equipment mentioned in Article 20 of the Act.
Competent authorities at various levels, to confront with epidemic situations and the needs for the control of communicable diseases, shall establish a safety stockpile control mechanism of materials for communicable disease control. The items are as per Appendix.
To promote the flow of stocks, competent authorities at various levels, may, by not jeopardizing the objectives of the stockpiles mentioned in the preceding Paragraph, in accordance with provisions of this set of Regulations, allocate the materials for communicable disease control.

Appendix:Items of Safety Stockpile for Materials for Communicable Disease Control.doc

Article 3

The communicable disease control resource systems mentioned in Article 26 of the Act refer to relevant databases on communicable disease control manpower, materials and facilities established by the central competent authority; their classifications are as follows:
1. communicable disease control manpower database;
2. communicable disease control materials database;
3. communicable disease control facilities database.

Article 4

For databases of the preceding Article, the central competent authority may conduct surveys and renew them by needs of communicable disease control.
For surveys of the preceding Paragraph, related organizations and medical care institutions shall coordinate.

Chapter 2 Reserves and Allocation

Article 5

The central competent authority shall establish a safety stockpile model of materials for communicable disease control to meet national demands for disease control and allocation of materials for communicable disease control. The model shall be reviewed periodically.
Local competent authorities shall establish safety stockpile models of materials for communicable disease control to meet needs for public health and disease control in their jurisdictions, and report to the central competent authority for approval.

Article 6

To meet the needs for isolating patients during large-scale epidemics of communicable diseases, medical care institutions shall determine by themselves the safety stockpile size and types of stockpile for 30-day period, and report the basis of calculation and parameters to the local competent authorities for approval.

Article 7

To meet needs for the control of epidemics, the central competent authority may requisition the materials for communicable disease control stockpiled by local competent authorities; in principle, the total amount requisitioned shall not exceed one half of the stockpiles of the local competent authorities; local competent authorities may not refuse.
The materials for communicable disease control so requisitioned in the preceding Paragraph shall be returned in new articles within six months.

Article 8

The central competent authority, in response to the needs of the epidemic situations, may appropriate without remuneration materials for communicable disease control to governmental organizations, schools, institutions, enterprises or organizations under the following circumstances:
1. for executing communicable disease control work in coordination with the central competent authority;
2. for executing work designated by the commanding officer of the central epidemic command center.
During the non-epidemic period, the central competent authority may appropriate without remuneration materials for communicable disease control that have exceeded two-thirds of the labeled validity date or been stocked for more than three years to institutions (organizations) mentioned in Subparagraph 1 of the preceding Paragraph for use in communicable disease control. Their transportation costs may be reduced or waived.
The preceding Paragraph also applies to the materials for communicable disease control stocked by the local competent authorities.

Article 9

Governmental organizations, schools, institutions, groups or enterprises may request local competent authorities in their districts for requisition of materials for communicable disease control; local competent authorities shall assess the needs of requisition for communicable disease control and the needs for safety stockpile of the institutions to consider the quantity of requisition to be accepted.
When local competent authorities are unable to supply the request of the preceding Paragraph, they shall refer the request documents to the central competent authority for handling.
For the materials for communicable disease control requisitioned, new articles or articles of similar quality shall be returned in six months; transportation costs required for the requisition of materials for communicable disease control, except under some special circumstances, shall be borne by the requesting institutions.

Article 10

(deleted)

Article 11

Materials for communicable disease control that shall be returned in accordance with regulations of Article 7 and Article 9, when the materials cannot be returned in time under certain circumstances, application in writing for delayed return shall be made to the organization handling the requisition request for approval of the delayed return.
If application for delayed return is not made in accordance with regulations of the preceding Paragraph, or if materials are not returned in due time, the organizations handling the requisition shall ask for compensation for the costs needed for the re-procurement of the materials originally requisitioned; however, during the epidemic period and with the approval of the competent authorities, this regulation does not apply.

Chapter 3 Reporting and Inspection

Article 12

Competent authorities, hospitals qualified by hospital accreditation and other organizations keeping stockpiles of materials for communicable disease control shall assign full-time personnel to be responsible for the management of the materials for communicable disease control; and by regulations of the central competent authority, report changes of their stockpiles and related information.

Article 13

Local competent authorities shall periodically inspect the use of the pharmaceuticals for communicable disease control; for use that does not meet requirements, the users shall be ordered to return the pharmaceuticals for communicable disease control of the same amount and same validity.

Article 14

Competent authorities shall conduct inspections annually of the materials for communicable disease control of units at various levels. If defects are detected, supervision for improvement shall be made.
Relevant organizations (institutions), groups, medical care institutions shall coordinate with the inspections; they shall not refuse, falsely report or conceal facts.
Competent authorities at various levels, when conducting inspections, shall notify in advance the units to be inspected; when conducting inspections, the persons in charge shall automatically present documents sufficient for identification, and notify the units in writing the subject matters and kinds of inspection.

Chapter 4 Management of Validity

Article 15

The materials for communicable disease control in stock by competent authorities and medical care institutions at various levels shall be maintained regularly and necessary sample-testing conducted. Materials that are overdue the labeled validity date shall not be included in the stockpile for management.
Materials for communicable disease control that are overdue the labeled validity date shall be processed, unless otherwise regulated by law, by the competent authorities at various levels in the following ways:
1. save for use in training and education and research;
2. donate to organizations (institutions), schools and public enterprises for non-disease control use;
3. replace with new products or sold by the remaining value of the materials for communicable disease control;
4. destroy;
5. other ways designated by the central competent authority.

Article 16

Disinfectants or pesticides stockpiled by competent authorities at various levels shall be, within three months prior to the validity, appropriated to local relevant organizations for effective use.

Article 17

(deleted)

Chapter 5 Supplementary Provisions

Article 18

This set of Regulations shall be implemented on the day of promulgation.