Act on Agro-pesticides Management Article 10
When the agro-pesticide manufacturers and dealers apply for approval of registration for formulated agro-pesticides under specified in the preceding Article, the applicants shall fill in the application form, attach the certification documents that the agro-pesticides passed the tests of standard specifications prescribed, and submit the data of physicochemical and toxicological tests, field trials, 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, all or a portion of the test data mentioned in Paragraph 1 may be exempted from submission.1. After the expiration of the period stipulated 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 trials 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 trials and toxicological test may be exempted from submission.3. When applying for registration approval for technical grade agro-pesticides, the data of the field trials may be exempted from submission.4. The field trials may be exempted if a registered formulated agro-pesticide 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 agro-pesticide 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 trials under Paragraph 1 shall be prescribed by the central competent authority.
中文原文 農藥管理法第10條
農藥生產業或販賣業者依前條申請核准登記時，應填具申請書，並檢附農藥標準規格檢驗合格證明文件、理化性與毒理試驗、田間試驗資料及其他相關資料。
前項資料於下列期間內，非經資料權利人同意，其他申請人不得引據該資料提出申請：
一、農藥新有效成分經核准登記者，自核准登記之日起算十年。
二、成品農藥新增、變更劑型或含量經核准登記者，自核准登記之日起算七年。
三、成品農藥新增使用範圍經核准登記者，自核准登記之日起算四年。
有下列情形之一者，農藥生產業或販賣業者申請核准登記時，得免依第一項規定檢附部分或全部試驗資料：
一、於前項期間屆滿後，而以與該核准登記農藥之相同有效成分、劑型、含量或使用範圍申請核准登記者，得免檢附部分或全部毒理試驗及田間試驗資料。
二、於前項期間內經資料權利人同意引據其資料，而以與該核准登記農藥之相同有效成分、劑型、含量或使用範圍申請核准登記者，得免檢附毒理試驗及田間試驗資料。
三、以農藥原體申請核准登記者，得免檢附田間試驗資料。
四、成品農藥申請變更為較安全劑型並經中央主管機關同意者，得免檢附田間試驗資料。
五、申請核准登記之農藥屬安全性高或使用風險低，並經中央主管機關同意者，得免檢附部分或全部毒理試驗資料。
第一項所定農藥標準規格、理化性與毒理試驗及田間試驗之準則，由中央主管機關定之。
前項資料於下列期間內，非經資料權利人同意，其他申請人不得引據該資料提出申請：
一、農藥新有效成分經核准登記者，自核准登記之日起算十年。
二、成品農藥新增、變更劑型或含量經核准登記者，自核准登記之日起算七年。
三、成品農藥新增使用範圍經核准登記者，自核准登記之日起算四年。
有下列情形之一者，農藥生產業或販賣業者申請核准登記時，得免依第一項規定檢附部分或全部試驗資料：
一、於前項期間屆滿後，而以與該核准登記農藥之相同有效成分、劑型、含量或使用範圍申請核准登記者，得免檢附部分或全部毒理試驗及田間試驗資料。
二、於前項期間內經資料權利人同意引據其資料，而以與該核准登記農藥之相同有效成分、劑型、含量或使用範圍申請核准登記者，得免檢附毒理試驗及田間試驗資料。
三、以農藥原體申請核准登記者，得免檢附田間試驗資料。
四、成品農藥申請變更為較安全劑型並經中央主管機關同意者，得免檢附田間試驗資料。
五、申請核准登記之農藥屬安全性高或使用風險低，並經中央主管機關同意者，得免檢附部分或全部毒理試驗資料。
第一項所定農藥標準規格、理化性與毒理試驗及田間試驗之準則，由中央主管機關定之。