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

Print Time:2024/12/05 03:39
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Chapter Law Content

Chapter 4 Management of Registration Approval
Article 21
A registrant shall provide information specified pursuant to subparagraph 2 to 4 of the previous article, if his supply chain companies require the proof of registration approval document.
Article 22
The valid periods of the registration approval documents issued by the central competent authority are as follows:
1. Standard registration: 5 years;
2. Simplified registration: 2 years;
3. Small quantity registration: 2 years. However, valid period of Polymers of Low concern granted under small quantity registration is 5 years.
An application of registration approval document extension for simplified registration and small quantity registration pursuant to the previous paragraph may be made by registrants three months before the expiration of the registration approval document. New registration approval document shall be issued after review.
Article 23
For a new chemical substance, which registration approval document is within valid period, a registrant shall apply for modification of registration document by attaching related documents within 30 working days after any changes to basic information related to a registrant.
If the registration type of a new chemical substance is different from the original registration approval document, the registrant shall make a new registration application and submit assessment reports in compliance with Article 6 and Article 7.
Article 24
For a new chemical substance granted under registration approval having any of the following circumstances, the registrant shall provide supplementary information initiatively or as prescribed by the central competent authority.
1. New scientific evidence or information on chemical substances is discovered.
2. New use is discovered.
3. Other matters designated by the central competent authority through public announcement.
Article 25
If a registrant who obtained a new chemical substance registration approval document is found to have any of the following circumstances, the central competent authority may void or revoke their registration approval:
1. A registrant is confirmed by an inspection that no appropriate measures are employed to manage the new chemical substance, and has been notified to make improvements within a limited time period, but fails to do so.
2. A registrant submits assessment reports containing false information or fails to perform handling in accordance with approved items under registration.
3. A registrant no longer operates business, or his documents certifying industrial/commercial registration or the academic institutes have been voided or revoked by authorities in charge of subject industry.
4. A registrant fails to make registration document modification pursuant to the previous two articles or has been notified by the central competent authority to provide supplementary information within a limited time period, but fails to do so.
Once the registration approval has been voided or revoked, a registrant is not allowed to make another new application of new chemical substances registration approval within two years.
Article 26
To avoid severe endangerment of workers health by a new chemical substance, if necessary, the central competent authority may revoke registration approval document, shorten valid period of registration, or according to its risk of hazards, restrict handling methods or use through public announcement.
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