In cases where the approval loses its effect or is rescinded, the designation shall lose its effect. It shall also lose its effect in cases where a person who has had obtained the designation does not make the request under the provisions of paragraph (1) of Article 33 within six months from the day following the date of the public notice under the provisions of paragraph (1) of Article 11 applied mutatis mutandis pursuant to the provisions of paragraph (2) of Article 16.〔【出典】日本法令外国語訳データベースシステム 〕
承認された
【形】
approved〔【略】APPD〕
confirmed
OK'd
okayed
承認されたマスターラベルは、発行ラベルとの比較のために保存・管理すること。
Master (approved) labels should be maintained for comparison to issued labels.〔【出典】ICHガイドライン 〕
承認された代表者
acknowledged representative
承認された国家
a recognized country(国際的に)
承認された変更
approved change
承認された方法で保護される
be protected in an approved manner
be safeguarded in an approved manner
承認された方法で終了する
be terminated in an approved manner
承認された方法で設置される
be installed in an approved manner
承認された書式
approved form
承認された署名
authorized signatures
承認された製造者
approved maker
承認された議題
approved agenda
承認されていない
【形】
non-approved
unapproved
unrecognized
unsanctioned(行為などが / 行為などが正式に)
承認されない
【形】unapproved
承認される
get a [the] green light(着手・実施などについて公式な)
get the nod〈話〉
【自動】go(事が)
承認してもらうため
for approval
承認します。
I support the proposal.〔会議〕
承認し難いこと
inadmissibility
承認するのをためらう
hesitate to give the OK
承認する人
approver
承認できない
【形】unallowable
承認できる
【形】
approvable
recognizable
承認なしで
without endorsement
承認なし変更を防ぐ
prevent unauthorized alteration
承認に向けて進んでいる
be on track for approval
承認に必要な_票に_票不足する
fall __ votes short of the __ votes needed for approval
Firm evidence in support of claims requires that the results of the confirmatory trials demonstrate that the investigational product under test has clinical benefits.〔【出典】ICHガイドライン 〕
A person who intends to apply for Approval may submit, prior to such application, to the Minister of Justice, documents same in substance with a written application for Approval and its accompanying documents and may request a preliminary examination.〔【出典】日本法令外国語訳データベースシステム 〕
In cases where a person who has obtained the approval does not make the request under the provisions of paragraph (1) of Article 25 within six months from the day following the date of the public notice under the provisions of paragraph (1) of the preceding Article, or within six months from the day following the date of rescission of the registration upon his/her request under the provisions of Article 29, the approval shall cease to be effective.〔【出典】日本法令外国語訳データベースシステム 〕
In applying for Approval, a person who intends to obtain Approval shall read aloud in front of the officer designated by the Minister of Justice the documents provided for in Items vi to viii inclusive of Paragraph 1 of Article 4, and shall confirm the contents of his/her pledge.〔【出典】日本法令外国語訳データベースシステム 〕