【縛雞之見】英文拷到 G / D 找中文翻譯
The administration is good at making
simple things a mess.
Foxconn and TSMC have donated the vaccines to the administration. However, the administration still asks them
to apply the expansion of the vaccination from the adults whose age is above 18
years to the teens ranging from 12 to 18.
The point is the donors that have completed the donation are not qualified to
apply anything that does not belong to them.
And it is Tzu Chi, which claimed to donate BNT for teens, not Foxconn
and TSMC.
So why the administration so asked by using the essential lawyer skill that
dogfights the opposite indefinitely.
已經完成捐贈，所有權即屬於政府。為何擴大施打範圍，還需要捐贈者申請：捐贈者已無資格申請非屬於自己的東西。不是嗎？而且，向下開放到12-18歲的，不就是政府的職權？再不繼，也不會是鴻海與台積電，而是慈濟，不是嗎？
這就是刁難—將事件帶往重疊的灰色地帶，進行永無止盡的纏鬥，一個基本的律師技巧。
BNT該補件？台積電、永齡這麼說 NOWNews 20210720
台積電與鴻海永齡日前分別購得1000萬劑的BNT疫苗，並全數捐贈給官方防疫之用，但現在傳出食藥署至今（20）日仍未通知兩家廠商要申請緊急使用授權變更適用適應症，而我國目前僅通過18歲以上成人接種，若未補件，恐怕不能予以12歲至18歲青少年施打，稍早兩間公司也分別做出簡單回應。
台積電表示，BNT疫苗已完成捐贈程序，後續全權交由官方政府部門處理，並不會提出申請；鴻海永齡也持相同說法，表示不影響採購，認為後續交由疾管署處理。
食藥署則表示，BNT疫苗緊急授權僅限18歲以上成人接種，若要開放到12歲以上的青少年也能接種，需要再申請、進行補件，來修正先前的EUA，目前尚缺乏製造廠相關資料，相關企業、廠商也陸續補件中，只要在疫苗快到之前申請都可以。
至於疾管署部分，署長周志浩表示，永齡和台積電的BNT疫苗，會由指揮中心來做專案申請，專案申請會將12至18歲的緊急使用納入申請內容，請民眾放心。
I'm afraid you are having a very poor understanding of quality systems.
回覆刪除An approver being an appliant at the same time is not acceptable under any circumstances.
Under this concept, CECC/CDC instead of TFDA being the applicant of EUA renewal is the only acceptable method.
同意 CH 您的看法。就報導內容最後一段，就是如此。這也是政府部門分工職責所在。
刪除食藥署提出現行法律規範(物品的使用)；捐贈者(原擁有者暨原申請者)強調捐贈物就由政府單位全權處理；疾管署說，對啊，是我(新擁有者與新申請者)。
食藥署沒通知兩家公司(原捐贈者)，很正確的做法啊~~~因為不是由他們提出呀。
記者以為挖到一條大新聞，跑去問台積電與鴻海永齡.....
兩家公司的回應也很正常：東西我已經捐出去了，後續就是政府部門去處理。
食藥署：blah~blah~需要再申請、進行補件，來修正先前的EUA，(制式回應，又沒指明是捐贈者來再申請)
疾管署：就是我來申請啦！
就記者自己腦補了一段可怕的劇情：現在傳出食藥署至今（20）日仍未通知兩家廠商要申請緊急使用授權變更適用適應症，而我國目前僅通過18歲以上成人接種，若未補件，恐怕不能予以12歲至18歲青少年施打......
(我也來腦補一段。記者訪問台積電或是鴻海永齡時的開場白：聽說依食藥署的規定 blah blah~~
訪問食藥署時說：台積電跟鴻海永齡表示他們不會提出再申請....
疾管署署長在旁邊聽到了，翻白眼：啃，又想挖甚麼坑？立即接話說，會由指揮中心來做專案申請)
(台下：刁難~~刁難~~刁難)
The issue is not about CO or CoC.
回覆刪除The point is "who" is eligible to apply: the donors or the responsible authority.
I am sorry that you did not stick to the facts and understanding the focus of the comment.
The media reports that the FDA asked TSMC and Foxconn, which have ended up their donation, to apply FDA their vaccinations to extend from the adults to the age of 12-18.
Having been completed the donation, Foxconn and TSMC can do nothing but follow the quality, the quantity, and the delivery. They have not eligible or have no right to involve in the rules and the practices of the vaccination. That is beyond the contract.
I wonder why the administration requires such.
The news updated - the CDC, as an applicant, will apply to the FDA for the extension. That is the right way.
.
It is important to know media only presents one side of face - and most likely its preferred side.
回覆刪除Being true that the donation is completed, and the vaccines are "possessed" by the government now, the government is not one of the concerned parties in the business contract. As a result, the manufacturer or agent have no contractual obligation to provide the required data to the government for EUA. It is reasonable this request will need TSMC and Foxconn's "help" to be submitted.
CH seems to mix up concepts.
回覆刪除The media might report what it prefers; however, the fact is the fact.
It is nothing to do with what a media agency stands for.
6/1: the ministry of Health and Welfare deleted EUA for BNT because its negotiation failed. And the news report said that the related technical data is for import.
https://health.udn.com/health/story/121833/5501203
6/10: FDA confirmed that it is about to issue the EUA for J&J and BNT.
https://www.taiwannews.com.tw/ch/news/4220166
So people can see that these are before the meet Gou, Liu, and Tsai in the Presidential Palace on 6/18. It means that EUA is about 40 days before the business contract, donation contract, not to mention import.
The EUA we are talking about is the extension from the adult to the teens. Foxconn and TSMC did not talk about it ever. It is Tzu Chi that mentions it. If anyone should apply the extension to TFDA, it should be Tzu Chi or TCDC.
Very good mentions. I have not been following these pieces of news closely, but I now do find the explanation from the minister acceptable.
回覆刪除陳時中解釋，今年初COVAX平台的確有確認要提供台灣9.5萬劑BNT疫苗，而疫苗進入要施打階段一定會有緊急使用授權EUA，因此3月的疫苗接種意願書才會將BNT疫苗列入緊急使用授權。沒想到，對方卻在5月3日通知無法供應，才會有更新版本的意願書出現。
陳時中說明，前一波和BNT的合約有一點觸礁延遲，但我方仍沒有放棄希望，在1月底COVAX要配發BNT疫苗時，我方也表達願意接受，並在2月4日被告知可取得9.5萬劑BNT疫苗，會列入配送名單，進來後仍要通過審查程序，卻在5月3日被通知無法供應，非常遺憾。
https://newtalk.tw/news/view/2021-05-30/581533
Back to the beginning, CDC already stated that they will apply for the inclusion. So you already answered your own question, right?
That is right if the CDC applies.
回覆刪除The news agency reported the other way in the first place: TSMC and Yong-lin should apply.
However, they revised the report later.
Don't know what is going wrong? (But the thing is going right.)
Thank you for the sharing. It explains more in detail.
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