[Translation from Japanese to English ] Regarding ..., an application for revision of MF was already applied and ther...

This requests contains 240 characters . It has been translated 2 times by the following translators : ( sujiko , steveforest ) and was completed in 0 hours 18 minutes .

Requested by jini68jp at 08 Jan 2020 at 11:32 1673 views
Time left: Finished

については、既にMF変更の申請手続きをしており、PMDAから2回目の問い合わせが来ております。貴社が日本市場への見直しを検討している中で、大変恐縮ですが、PMDAへの回答が必要ですので、下記の三つの項目について、ご回答を頂けないでしょうか。2と3については、弊社で行いますが、ルール上、貴社の同意が必要ですので、回答いただけると助かります。第一回の照会事項で回答されましたが1についてNIRからTLCの変更した適切性の説明がなかったので今回第二回の照会事項で再度説明の依頼があった

Regarding ..., an application for revision of MF was already applied and there is an second enquiry from PMDA. Whilst your firm is reconsidering for the market in Japan, would you answer for following three sections because we need to answer to PMDA?
Issues on 2 and 3 will be for our firm but for the rules we require your consent therefore we would be delighted you to explain them, please.
Though there is an answer for the first matter of enquiries, as we have no suitable explanation for the recent change from NIR to TLC for 1, there is a request for asking for the explanation at the second matter of enquiries at this time.

Client

Try “Standard Translation” for specialized translation such as business purpose.

  • We can receive files such as Word, Excel, and PowerPoint.
  • There is no maximum word limit, and we deliver translations fast.
  • Higher-skilled translators will work on your request.

Feel free to contact
anytime