基因轉殖植物輸出入許可辦法

The regulations are established pursuant to the first paragraph of Article 52, Plant Variety and Plant Seed Act (refereed as “the Act” hereafter.)

1Transgenic plants referred to the Art are categorized into two parts based on their intended use:

21.For propagation or culture use.

32.For testing or research and development use in laboratories.

1To import the transgenic plant for propagation or culture use based on Clause 1 Article 2 of the Regulations, the importer shall submit application with following information and documents specified below to the central competent authority. The importer can start the import process only after the import approval is granted.

2Required information:

31.Name, phone and address of the importer;

42.The production country, export country and departure port;

53.Name and quantity of the transgenic plant to be imported; and

64.Purpose and use of the imported transgenic plant.

7Required accompanying documents:

81.The approval documents are pursuant to the second paragraph of Article 52,the Act;

92.Origin of the host plant and information of the host transgenic plant’s botanical characteristics, propagation and pollination etc.;

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1To import the transgenic plants for testing or research and development use in laboratories according to Clause 2, Article 2 of the Regulations, the importer should submit application with following information and documents specified below to the central competent authority. The importer can start the import process only after the import approval is granted

2Required information:

31.Name, phone and address of the importer;

42.The production country, export country and departure port;

53.Name and quantity of the transgenic plant to be imported; and

64.Purpose and use of the imported transgenic plant.

7Required accompanying documents:

81.Origin of the host plant and information of the host transgenic plant’s botanical characteristics, propagation and pollination etc.;

92.Origin of the donor of transgene(s) and information on characteristics and function of the transgene(s);

1To export the transgenic plants, the exporter shall submit application with following information and documents specified below to the central competent authority. The exporter can start the export process only after the export approval is granted.

2Required information:

31.Name, address and phone number of the exporter;

42.Name and quantity of the transgenic plant to be exported; and

53.Purpose and use of the exported transgenic plant.

6Required accompanying documents:

71.Origin of the host plant and information on the host plant’s botanical characteristics, propagation and pollination etc.;

82.Origin of the donor of the transgene(s) and information on characteristics and function of the transgene(s);

93.Packaging method and labeling;

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In order to verify the nature of imported transgenic plants, the central competent authority shall take samples free of charge from the imported consignments during entrance. The importer of the transgenic plants shall not deny such request.

The central competent authority shall grant confidentiality to exporters or importers of transgenic plants who request to the central competent authority for protection of the confidential information about their business as described important parts in the production method of the transgenic plant.

1For the approval or rejection of export or import application of transgenic plants, the central competent authority shall make a decision by the following deadlines.

21.For the application case that only implement documents review, the central competent authority shall conclude the application case within 60 days starting from the effective application date. If the central competent authority cannot conclude the application case, the approval or rejection deadline shall be allowed to extend for once and only one time.

32.For an application case that has to sample for verification in addition to documents review, the central competent authority shall conclude the application case within 270 days starting from the effective application date.

The central competent authority will announce and publish the format of application forms and other relevant accompanying documents.

This Regulations will take into effect from the date it is promulgated.