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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/11/22 05:36
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Chapter Law Content

Title: Drug Injury Relief Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter II Drug Injury Relief Fund
Article 5
In order to provide the drug injury relief services, the competent authority shall establish the Drug Injury Relief Fund, which comes from the resource as follow:
1. Imposition from drug manufacturers and importers.
2. Late payment penalties.
3. Income from subrogation claims.
4. Donations.
5. Interest generated by the Fund.
6. Other relevant income.
Article 6
The competent authority may commission to other authority (institution) or organization to take charge of the following matters; if necessary, a corporate foundation can be established for :
1. Payment of relief application.
2. Collection and management of imposition.
3. Other matters related to drug injury relief.
Based on the commission set forth in the preceding Paragraph, the competent authority may request the commissioned authority (institution) or organization to submit service and financial reports, and may assign officials to inspect the service conditions and to review documents, including accounting books, etc.
Article 7
Drug manufacturers and importers shall, according to the deadline specified by the competent authority, pay the imposition, in a ratio of its drug sales numbers of the previous year, to the Drug Injury Relief Fund.
The ratio of the imposition set forth in preceding Paragraph is One Tenth Percent (0.1%) of the sales number when the amount of the Fund has not reached TWD Three Hundred Million (300,000,000); When the amount of the Fund is more than TWD Three Hundred Million (300,000,000), the competent authority may, after considering the actual circumstances and financial situation of the Fund, adjust the ratio between Two Hundredths Percent (0.02%) and Two Tenths Percent (0.2%) of the sales numbers.
If drug manufacturers or importers cannot provide the information regarding sales numbers of the previous year, the imposition shall be collected by an estimation of the sales numbers of the current year. If the estimation differs from the actual numbers, the difference shall be refunded or collected in the next year.
For those drug manufactures or importers paying the imposition in accordance with this Act and their drugs causing drug injury, the competent authority may increase the ratio to One Tenth Percent (0.1%), and the ratio set forth in the second Paragraph will not be applied.
Article 8
If drug manufacturers and importers fail to pay the imposition within the deadline and still not pay the money after receiving of a written notice, they shall be subject to a late payment penalty of one hundredth (1%) of the imposition for every two days. The amount of the late payment shall not exceed twice to the original imposition amount.
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