主题:【转帖】物质的制造和进口

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Article 21
Manufacturing and import of substances
1. A registrant may start or continue the manufacture or import of a substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date, without prejudice to Article 27(8).
In the case of registrations of phase-in substances, such a registrant may continue the
manufacture or import of the substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8).
In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).
2. If the Agency has informed the registrant that he is to submit further information in
accordance with the third subparagraph of Article 20(2), the registrant may start the
manufacture or import of a substance or production or import of an article if there is no indication to the contrary from the Agency within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to Article 27(8).
3. If a lead registrant submits parts of the registration on behalf of one or more other
registrants, as provided for in Articles 11 or 19, any of the other registrants may
manufacture or import the substance or produce or import the articles only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and provided that there is no indication to the contrary from the Agency in respect of the registration of the lead registrant acting on behalf of the others and his own registration.
第21条 物质的制造和进口
    1.在不损害第27条第8款规定的情况下厂,在呈文日期后3周内,如化学品管理局无异议,注册人可根据第20条第2款的规定,开始或继续该物质或物品的制造或进口。
    对于分阶段物质的注册,在不损害第27条第8款规定的情况下,在呈文日期后3周内,或在第23条规定的截止期前两个月内提交注册申请,如化学品管理局无异议,注册人可根据第20条第2款的规定,在该截止期前的3个月内继续该物质或物品的制造或进口。
    在不损害第27条第8款规定的情况下,对于根据第22条的规定进行的注册更新,在更新数据后3周内,如化学品管理局无异议,注册人可根据第20条第2款继续该物质的制造
或进口,或物品的生产或进口
2.在不损害第27条第8款规定的情况下,如果化学品管理局已根据第20条第2款第3段的规定通知注册人提交进一步信息,在化学品管理局收到完成注册所需的进一步信息后3周内无异议,注册人可开始该物质或产品的制造或进口。
3.如果一个主导注册人按照第11条或第19条的规定以一个或多个其他注册人的名义提交部分注册,任何其他制造商或进口商只有在本条第1款或第2款所规定的期限到期后,方可制造或进口该物质,或生产或进口该物品,只要化学品管理局对主导注册人以他人或自己名义进行注册无异议。
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