Laws Information

法規資訊
Title: Agro-pesticides Management Act
Am Date: 2018-05-23
Legislative History: Amendment to Articles 10 and 59 promulgated on May 23, 2018.

Transaction

Amended

Article 10
When the agro-pesticide manufacturers and dealers apply for approval of registration for formulated agro-pesticides under the preceding Article, they shall fill in the application form, attach the certification documents that the agro-pesticides passed the tests of standard specifications prescribed, submit the data of physicochemical and toxicological test and field test and other relevant documents.
In the following period, the data in the preceding paragraph shall not be cited by other applicants without receiving the approval of the data holder for use of the test data.
1. For a product that has a new active ingredient which has previously obtained approval for registration, a period of ten years starting from the date of approval for registration.
2. For a product that has a new or changed content or formulation that has previously obtained approval for registration, a period of seven years starting from the date of approval for registration.
3. For a product that has new scope of application that has previously obtained approval for registration, a period of four years starting from the date of approval for registration.
When the agro-pesticide manufacturers and dealers apply for approval of registration for formulated agro-pesticides, if one of the following conditions applies, then all or a portion of the test data in paragraph one may be exempted from submission.
1. After the expiration of the period in the preceding paragraph, when applying for approval of registration with the same active ingredient, formulation, content or the scope of application of the registered agro-pesticide, all or a portion of the data of the field test and toxicological test may be exempted from submission.
2. Under the permission of data holder for the use of test data during the period in the preceding paragraph, when applying for approval of registration with the same active ingredient, formulation, content, or the scope of application of the registered agro-pesticide, all data of the field test and toxicological test may be exempted from submission.
3. When applying for approval of registration for technical grade agro-pesticides, the data of the field test may be exempted from submission.
4. The field test may be exempted if a registered formulated product had previously applied for the permit of a comparatively safer new formulation and was approved by the central competent authority.
5. All or a portion of the data of the toxicological test may be exempted when applying for approval of registration for formulated product considered to be safe or has a low risk of    application and was approved by the central competent authority.
The directions for the standard specifications, physicochemical property test, toxicological test and field test under paragraph one shall be prescribed by the central competent authority.

Article 59    
This Act shall become effective as of the date of its promulgation.
However, the date of entering into force of the articles amended on May 8, 2018 shall be decided by the Executive Yuan.