ქალბატონო თამარ, კოლეგებო,
ჩინეთის საელჩოდან მიღებული ინფორმაციის თანახმად გაცნობებთ, რომ ჩინეთის საელჩო და სინოვაკი თანახმა არიან ჩვენს მიერ შეთავაზებულ პირობაზე ვაქცინოს
შემოტანასთან დაკავშირებით - შემოვიტანოთ და გამოვიყენოთ მას შემდეგ რაც მიიღებს ჯანმოს ან მკაცრი მარეგულირებელების სიაში შემავალი ქვეყნის ავტორიზაციას.
ქალბატონი თამარის მითითებით, ალბათ დონაციის წერილში უნდა ავსახოთ ეს დათქმა.
თუ მისაღებია ეს ფორმულირება, დამიდასტურეთ ან მომწერეთ ჩასწორებული ვერსია და ჩინეთის მხარეს გავუგზავნი დასადასტურებლად.
The Donor Parties and the Donee agree to use donated materials after granting Emergency Use Authorization by WHO and/or by the Stringent Regulatory
Authorities (SRAs) (https://www.who.int/medicines/regulation/sras/en/)
in order to indemnify the Donor Parties against potential liabilities that might arise out of the use of the Donated Materials.
პატივისცემით,
მაიკო
From: Natela Khmaladze
Sent: Friday, March 19, 2021 12:10 PM
To: Maia Nikoleishvili
Cc: tgabunia
Subject: Re: Sinovac Vaccine
გავივლით მაიკო და მოგაწოდებთ ჩვენს პოზიციას მალევე.
სს
ნათია
From: Maia Nikoleishvili
Sent: Friday, March 19, 2021 11:59
To: Natela Khmaladze; Shorena Okropiridze
Cc: tgabunia
Subject: FW: Sinovac Vaccine
ნათია,
ქალბატონი თამარის დავალებით გიგზავნი სინოვაკთან გასაფორმებელი დონაციის წერილის პროექტს.
სინოვაკი საქართველოს უსასყიდლოდ გადმოსცემს 100 000 დოზა ვაქცინას.
ვაქცინას ამ ეტაპზე არ აქვს ჯანმოს ან რომელიმე მკაცრი მარეგულირებლის ავტორიზაცია, მხოლოდ ჩინეთის მარეგულირებლის ეფრუვალი აქვს.
გთხოვთ, გვაცნობთ თქვენი პოზიცია დონაციის წერილთან (Letter of Commitment for Receipt of the Covid-19 Vaccine Donation) დაკავშირებით.
პატივისცემით,
მაიკო
From: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Sent: Thursday, March 18, 2021 4:40 PM
To: tgabunia
Subject: Sinovac Vaccine
ქალბატონო თამარ,
როგორც მოგეხსენებათ, კომპანია სინოვაკი საქართველოს უსასყიდლოდ გადმოსცემს 100 000 დოზა ვაქცინას.
კომპანია ამ ეტაპზე ჩვენგან ელოდება რეაგირებას, კერძოდ გადაუდებელი გამოყენების ავტორიზაციის (EUA) წერილს და თანდართული დონაციის წერილის (Letter of Commitment for Receipt of the Covid-19
Vaccine Donation) ხელმოწერას.
დანართის სახით ვაგზავნი სინოვაკის ვაქცინასთან დაკავშირებულ ყველა დოკუმენტაციას ერთად.
პატივისცემით,
მაიკო
From: Maia Nikoleishvili
Sent: Wednesday, March 17, 2021 10:37 PM
To: '侯凯迪'
<houkd2963@sinovac.com>
Cc: 王天萍 <wangtp@sinovac.com>;
孟伟宁
<mengwn@sinovac.com>;
chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>;
tgabunia <tgabunia@moh.gov.ge>;
a.khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>;
nikoleishvilim <nikoleishvilim@gmail.com>;
杨光 <yangg@sinovac.com>;
林潇
<linxiao@sinovac.com>;
张启超 <zhangqc@sinovac.com>;
Archil Kalandia <akalandia@mfa.gov.ge>
Subject: RE: Re:RE: Re:格鲁吉亚新冠产品注册
Fw:Registration and Supply of COVID-19 vaccine toGeorgia fromSinovac China
Dear Catie,
Thank you for your e-mail. National Regulation Agency is reviewing the provided documents and I will get back to you soon with further updates.
We much appreciate all your efforts and continued support.
With best regards,
Maia
From:
侯凯迪 [mailto:houkd2963@sinovac.com]
Sent: Tuesday, March 16, 2021 10:53 AM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc: 王天萍 <wangtp@sinovac.com>;
孟伟宁 <mengwn@sinovac.com>;
chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>;
tgabunia <tgabunia@moh.gov.ge>;
a.khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>;
nikoleishvilim <nikoleishvilim@gmail.com>;
杨光 <yangg@sinovac.com>;
林潇 <linxiao@sinovac.com>;
张启超 <zhangqc@sinovac.com>;
Archil Kalandia <akalandia@mfa.gov.ge>
Subject: Re:RE: Re:格鲁吉亚新冠产品注册
Fw:Registration and Supply of COVID-19 vaccine toGeorgia fromSinovac China
Dear Maia,
Thank you for the quick response.
Regarding the previous email you request the batch release certificate, we have not available to provide the batch release certificate. However, we could provide the certificate from NIFDC,China
which is also the public authority of China. Please find the enclosed file as an example and shall not have any meaning for commercial or registration. Please review and check the format is acceptable for CoronaVac registration in Georgia. Besides, if you
request the document which is correspondent to the commercial batches delivered to your country, please be kindly informed that we could know the commercial batches for shipment only after we get EUA approval certificate from the country. So we will send you
the certificate document from NIFDC and also the CoA for the product delivered to Georgia after the EUA approved.
If you have any requests,please don't hesitate to contact us.
Best regards,
Catie
侯凯迪
Catie HOU
国际注册专员
Specilist of International Regulatory Affairs
010-8279
9648
+86 13756906318
400
898 2688
北京市海淀区上地西路39号北大生物城(100085)
No.39, SHANGDI West Road, Haidian District, Beijing, P.R.C.
北京市昌平区中关村科技园区昌平园智通路15号(102200)
No.15, ZHITONG Road, Changping Science Park, Changping
District, Beijing, P.R.C.
From: "Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>"
To: "侯凯迪
<houkd2963@sinovac.com>"
CC: "王天萍
<wangtp@sinovac.com>","孟伟宁
<mengwn@sinovac.com>","chinaembassyingeorgia
<chinaembassyingeorgia@gmail.com>","tgabunia
<tgabunia@moh.gov.ge>","a.khvtisiashvili
<a.khvtisiashvili@mfa.gov.ge>","nikoleishvilim
<nikoleishvilim@gmail.com>","杨光
<yangg@sinovac.com>","林潇
<linxiao@sinovac.com>","张启超
<zhangqc@sinovac.com>","Archil
Kalandia <akalandia@mfa.gov.ge>"
Sent: 2021-03-13 01:20
Subject: RE: Re:格鲁吉亚新冠产品注册
Fw:Registration and Supply of COVID-19 vaccine toGeorgia fromSinovac China
Dear Catie,
Many thanks for your response and provided documents.
With this e-mail, I would like to kindly share the details related to your questions:
1.
Drug license approved by the Chinese authority is acceptable for the NRA of Georgia. Hereby, if any of the Stringed Regulatory Authorities of the countries listed here
https://www.who.int/medicines/regulation/sras/en/
have granted emergency use authorization to the Sinovac vaccine, please inform us, if not, we will take into consideration the Drug license granted by the NMPA of China.
2.
Yes, under the certificate of quality of medicines is meant batch release certificate. The Batch numbers (same as to be delivered to Georgia) should be listed either in the batch release certificate
separately or in the Certificate of Analysis.
3.
Information pack of the product provided under the Annex 2 is acceptable.
4.
It will be good to receive packing list, invoice, CoA and air-way bill before departure.
Thank you again for your support and fruitful collaboration.
With best regards,
Maia
From:
侯凯迪 [mailto:houkd2963@sinovac.com]
Sent: Friday, March 12, 2021 9:50 AM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc:
王天萍 <wangtp@sinovac.com>;
孟伟宁 <mengwn@sinovac.com>;
chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>;
tgabunia <tgabunia@moh.gov.ge>;
a.khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>;
nikoleishvilim <nikoleishvilim@gmail.com>;
杨光 <yangg@sinovac.com>;
林潇 <linxiao@sinovac.com>;
张启超 <zhangqc@sinovac.com>
Subject: Re:格鲁吉亚新冠产品注册
Fw:Registration and Supply of COVID-19 vaccine toGeorgia fromSinovac China
Annex.1_Drug License_CoV_China 20210209-20220204.pdf (339.58KB)查看/下载(Preview/Download)
Annex 2_Packaging.zip (3.72MB)查看/下载(Preview/Download)
温馨提示：此附件保存期为15天，请您尽快下载。
Suggestion: The storage period of this attachment is 15days. Please download it as soon as possible.
--------------------------------------------------------------------------------------------------
Dear Maia,
This is Catie from the internation regulatory affairs team of Sinovac.
For the documents you requested previously ,please find the answer in blue:
A preliminary confirmation assessment document of medicines
issued by World Health Organization and/or a document confirming the registration of medicines issued by the country or interstate pharmaceutical product state regulatory authority, which are recognized by the Georgian Government and/or a document confirming
the registration of medicines in the country of manufacture;
Please find the enclosed file for drug liscence approved by Chinese authority as Annex 1. May I ask which countries of approval could recognized
by the Geogian Government?
A copy of the certificate of quality of medicines and/or
a document certifying the medicines were manufactured in accordance with international standards, issued by the competent authority (relevant governmental body, recognized international organizations, special regulatory bodies);
Does this mean the batch release certificate? or the CoA from NIFDC, China?
Information pack of the product (describing indications,
potential side events other important details for end users);
Please find the enclosed file for the packaging information as Annex 2.
Certificate of Analysis should be submitted along with shipment documents Air Waybill, Invoice, Packing list.
I will contact Kevin to obtain the air waybill, invoice and packing list. And he will provide the CoA together.
侯凯迪
Catie HOU
国际注册专员
Specilist of International Regulatory Affairs
010-8279
9648
+86 13756906318
400
898 2688
北京市海淀区上地西路39号北大生物城(100085)
No.39, SHANGDI West Road, Haidian District, Beijing, P.R.C.
北京市昌平区中关村科技园区昌平园智通路15号(102200)
No.15, ZHITONG Road, Changping Science Park, Changping
District, Beijing, P.R.C.
From: "张启超
<zhangqc@sinovac.com>"
To: "Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>","侯凯迪
<houkd2963@sinovac.com>"
CC: "chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>","Tamar
Gabunia <tgabunia@moh.gov.ge>","Khvtisiashvili
<a.khvtisiashvili@mfa.gov.ge>","nikoleishvilim
<nikoleishvilim@gmail.com>","yangg
<yangg@sinovac.com>","mengwn
<mengwn@sinovac.com>","王天萍
<wangtp@sinovac.com>"
Sent: 2021-03-10 12:12
Subject: Re:RE: Re:RE: Fw:Fw:Registration and Supply of COVID-19 vaccine toGeorgia fromSinovac
China
Dear Maia,
The CDA and registration document list are well received with many thanks for your cooperation!
May I take this opportunity to introduce my colleague Ms. Catie
houkd2963@sinovac.com who is
from our Int'l Regulatory Affairs team. Catie will take care of the registration issues for COVID-19 vaccine in Georgia, believe she will get back to you very soon with all the required documents.
Hope the product registration will be approved very soon, so that we can supply COVID-19 vaccine to Georgia at earlist.
BTW, I will send you the fully executed CDA once it's signed and stamped by our side within this week.
Sincerely Yours
Kevin Zhang 张启超
International Business Development Manager- EUR & AP Region
Product Manager- Influenza Vaccine
International Business Department
+86-18610838454
北京市海淀區上地西路39號北大生物城(100085)
No.39, SHANGDI West Road, Haidian District, Beijing, P.R.C.
中國香港德輔道西103號樂基商業中心19樓1906室
Room 1906, 19th Floor, Lucky Commercial Building, 103 Des Voeux Road West,
Hong Kong, P.R.C.
From: "Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>"
To: "张启超
<zhangqc@sinovac.com>"
CC: "chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>","Tamar
Gabunia <tgabunia@moh.gov.ge>","Khvtisiashvili
<a.khvtisiashvili@mfa.gov.ge>","nikoleishvilim
<nikoleishvilim@gmail.com>","yangg
<yangg@sinovac.com>","mengwn
<mengwn@sinovac.com>","王天萍
<wangtp@sinovac.com>"
Sent: 2021-03-09 23:00
Subject: RE: Re:RE: Fw:Fw:Registration and Supply of COVID-19 vaccine toGeorgia fromSinovac
China
Dear kevin,
Thank you for your e-mail. The provided CDA is acceptable for the Ministry. We included MFA of Georgia as a signatory party since they are also engaged in the negotiations.
With this e-mail I am sending the signed/stamped CDA and looking forward to receiving the countersigned one in order to proceed with the next steps.
Hereby, I am sending the list of documents to be submitted to NRA for issuing the import permit:
·
A preliminary confirmation assessment document of medicines issued by World Health Organization and/or a document confirming the registration of medicines issued by the country or interstate pharmaceutical product state regulatory
authority, which are recognized by the Georgian Government and/or a document confirming the registration of medicines in the country of manufacture;
·
A copy of the certificate of quality of medicines and/or a document certifying the medicines were manufactured in accordance with international standards, issued by the competent authority (relevant governmental body, recognized
international organizations, special regulatory bodies);
·
Information pack of the product (describing indications, potential side events other important details for end users);
·
Certificate of Analysis should be submitted along with shipment documents Air Waybill, Invoice, Packing list.
We remain at your disposal to discuss further details.
Thank you once again for your support.
With best regards,
Maia
From:
张启超 [mailto:zhangqc@sinovac.com]
Sent: Monday, March 8, 2021 1:35 PM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>
Cc: chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>;
Tamar Gabunia <tgabunia@moh.gov.ge>;
Khvtisiashvili <a.khvtisiashvili@mfa.gov.ge>;
nikoleishvilim <nikoleishvilim@gmail.com>;
yangg <yangg@sinovac.com>; mengwn
<mengwn@sinovac.com>;
王天萍 <wangtp@sinovac.com>
Subject: Re:RE: Fw:Fw:Registration and Supply of COVID-19 vaccine to Georgia fromSinovac China
Dear Maia,
Thank you for your prompt response, thank the Chinese embassy for the coordination as well BTW!
We will look forward to your feedback to the CDA and also the document list for emergency authorization, to proceed with EUA approval and supply of COVID-19 vaccine to Georgia very
soon.
Thank you in advance for your cooperation!
Sincerely Yours
Kevin Zhang 张启超
International Business Development Manager- EUR & AP Region
Product Manager- Influenza Vaccine
International Business Department
+86-18610838454
北京市海淀區上地西路39號北大生物城(100085)
No.39, SHANGDI West Road, Haidian District, Beijing, P.R.C.
中國香港德輔道西103號樂基商業中心19樓1906室
Room 1906, 19th Floor, Lucky Commercial Building, 103 Des Voeux Road West,
Hong Kong, P.R.C.
From: "Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>"
To: "张启超
<zhangqc@sinovac.com>"
CC: "chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>","Tamar
Gabunia <tgabunia@moh.gov.ge>","Khvtisiashvili
<a.khvtisiashvili@mfa.gov.ge>","nikoleishvilim
<nikoleishvilim@gmail.com>"
Sent: 2021-03-08 16:23
Subject: RE: Fw:Fw:Registration and Supply of COVID-19 vaccine to Georgia fromSinovac
China
Dear Mr. Kevin Zhang,
Many thanks for your e-mail.
On behalf of the Ministry I would like to extend my sincere gratitude to you and your respective organization for your commitment to support our country at this very special and challenging time
of the global pandemic.
We will proceed with the CDA and send you the list of required documentation for emergency authorization from the national regulatory agency no later than 9th of March.
Thank you again for your support and cooperation.
With best regards,
Maia
Maia Nikoleishvili MPA
Head of International Relations and Protocol Division of Administration
Ministry of IDPs from the Occupied Territories, Labour, Health and Social Affairs of Georgia
Address: 144 Tsereteli ave., 0159 Tbilisi, Georgia
Tel.: +995 32 2510034 (0803)
Cell phone: +995 577272713
E-mail: mnikoleishvili@moh.gov.ge
From:
张启超 [mailto:zhangqc@sinovac.com]
Sent: Monday, March 8, 2021 11:13 AM
To: Maia Nikoleishvili <mnikoleishvili@moh.gov.ge>;
nikoleishvilim <nikoleishvilim@gmail.com>
Cc: chinaembassyingeorgia <chinaembassyingeorgia@gmail.com>
Subject: Fw:Fw:Registration and Supply of COVID-19 vaccine to Georgia from Sinovac China
Dear Ms. Maia Nikoleishvili,
Greeting from Sinovac. I resend my previous email, look forward to your prompt reply, thank you!
BTW, I copy this email to the Chinese embassy in Georgia as well.
Sincerely Yours
Kevin Zhang 张启超
From: "张启超
<zhangqc@sinovac.com>"
To: "mnikoleishvil <mnikoleishvil@moh.gov.ge>","nikoleishvilim
<nikoleishvilim@gmail.com>"
CC: "yangg <yangg@sinovac.com>","mengwn
<mengwn@sinovac.com>","王天萍
<wangtp@sinovac.com>"
Sent: 2021-03-05 10:23
Subject: Registration and Supply of COVID-19 vaccine to Georgia from Sinovac China
Dear Ms. Maia Nikoleishvili,
Greeting from Sinovac! I get your contact information from the Chinese embassy in Georgia, It's nice to know you.
As you may see that Chinese gov is going to provide Georgia gov with a certain quantity of COVID-19 vaccines produced by Sinovac. Before delivery of the aforementioned vaccines,
product registration need to be approved by the local authority, so may we request you please send us the document list for product registration, so that we can prepare for and provide all the required documents to start up registration application ASAP.
Meanwhile, could you review attached CDA which need to be signed by both parties, to proceed with the registration work.
Thank you in advance for your cooperation!
Sincerely Yours
Kevin Zhang 张启超
International Business Development Manager- EUR & AP Region
Product Manager- Influenza Vaccine
International Business Department
+86-18610838454
北京市海淀區上地西路39號北大生物城(100085)
No.39, SHANGDI West Road, Haidian District, Beijing, P.R.C.
中國香港德輔道西103號樂基商業中心19樓1906室
Room 1906, 19th Floor, Lucky Commercial Building, 103 Des Voeux Road West,
Hong Kong, P.R.C.