Subject: FW: Re:Re: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
From: Maia Nikoleishvili <[email-masked]>
To: Gocha Aladashvili <[email-masked]>, "[email-masked]" <[email-masked]>, "[email-masked]" <[email-masked]>
Cc: tgabunia <[email-masked]>
Date: Thu, 25 Mar 2021 10:52:00 +0000

მოგესალმებით,

სინოვაკის წარმომადგენლისგან მიღებული დამატებითი ინფორმაციის თანახმად, გაცნობებთ, რომ თანდართული ანალიზის სერთიფიკატი მოწოდებულია ნიმუშის სახით.

ტვირთის გამოგზავნის დროს მოგვაწვდიან კონკრეტული სერიული ნომრების შესაბამის ანალიზის სერთიფიკატს.

აქვე დამატებით გიგზავნით ვაქცინის ვადის დამადასტურებელ დოკუმენტს.

პატივისცემით,

მაია ნიკოლეიშვილი

ადმინისტრაციის საერთაშორისო ურთიერთობებისა და პროტოკოლის სამმართველოს უფროსი

საქართველოს ოკუპირებული ტერიტორიებიდან დევნილთა, შრომის, ჯანმრთელობისა და სოციალური დაცვის სამინისტრო

მის: წერეთლის გამზ. 144 თბილისი 0159 საქართველო

ტელ.: +995 32 2510034 (0802)

მობ.: +995 577 272713

ელ. ფოსტა:
[email-masked]

From:
侯凯迪 [mailto:[email-masked]]

Sent: Thursday, March 25, 2021 2:29 PM

To: Maia Nikoleishvili ; 张启超

Cc: 王天萍 ;
孟伟宁 ; chinaembassyingeorgia
; tgabunia ; a.khvtisiashvili ; nikoleishvilim ;
杨光 ;
林潇 ;
张启超 ; Archil Kalandia

Subject: Re:Re: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 Maia,

Please find the enclosed file for the vaccine validity document.

Best regards,

Catie

侯凯迪

Catie HOU

国际注册专员

Specilist of International Regulatory Affairs

010-8279
9648

+86 13756906318

[email-masked]

www.sinovac.com

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: "侯凯迪
<[email-masked]>"

To: "Maia Nikoleishvili <[email-masked]>","张启超
<[email-masked]>"

CC: "王天萍
<[email-masked]>","孟伟宁
<[email-masked]>","chinaembassyingeorgia <[email-masked]>","tgabunia <[email-masked]>","a.khvtisiashvili
<[email-masked]>","nikoleishvilim <[email-masked]>","杨光
<[email-masked]>","林潇
<[email-masked]>","张启超 <[email-masked]>","Archil
Kalandia <[email-masked]>"

Sent: 2021-03-22 16:30

Subject: Re: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 Maia,

Glad to know that! Thank you for sharing the information!

We look forward to the EUA and Letter of Commitment from your government.

Best regards,

Catie

侯凯迪

Catie HOU

国际注册专员

Specilist of International Regulatory Affairs

010-8279
9648

+86 13756906318

[email-masked]

www.sinovac.com

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.

----- Original Message -----

From:Maia Nikoleishvili <[email-masked]>

To: 侯凯迪 <[email-masked]> 张启超 <[email-masked]>

CC: 王天萍 <[email-masked]> 孟伟宁 <[email-masked]> chinaembassyingeorgia
<[email-masked]> tgabunia <[email-masked]> a.khvtisiashvili <[email-masked]> nikoleishvilim
<[email-masked]> 杨光 <[email-masked]> 林潇
<[email-masked]> 张启超 <[email-masked]> Archil Kalandia <[email-masked]>

Sent: 2021-03-22 16:00

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 kevin and Catie,

Please accept my apologies for the delayed response. We much appreciate the Chinese government’s and your respective organization’s support
at this very special and challenging time of the global pandemic.

On behalf of the Ministry, I would like to kindly confirm that the Certificate of EUA  as well as the signed Letter of Commitment for Receipt of the Covid-19
Vaccine Donation will be submitted before the end of this week, as soon as we receive the government approval.

Thank you again for your efforts and continued support.

With best regards,

Maia

From:
侯凯迪 [mailto:[email-masked]]

Sent: Tuesday, March 16, 2021 10:53 AM

To: Maia Nikoleishvili <[email-masked]>

Cc:
王天萍 <[email-masked]>;
孟伟宁 <[email-masked]>;
chinaembassyingeorgia <[email-masked]>; tgabunia <[email-masked]>; a.khvtisiashvili <[email-masked]>;
nikoleishvilim <[email-masked]>;
杨光 <[email-masked]>;
林潇 <[email-masked]>;
张启超 <[email-masked]>; Archil Kalandia <[email-masked]>

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

[email-masked]

www.sinovac.com

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 <[email-masked]>"

To: "侯凯迪
<[email-masked]>"

CC: "王天萍
<[email-masked]>","孟伟宁
<[email-masked]>","chinaembassyingeorgia <[email-masked]>","tgabunia <[email-masked]>","a.khvtisiashvili
<[email-masked]>","nikoleishvilim <[email-masked]>","杨光
<[email-masked]>","林潇
<[email-masked]>","张启超 <[email-masked]>","Archil
Kalandia <[email-masked]>"

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:[email-masked]]

Sent: Friday, March 12, 2021 9:50 AM

To: Maia Nikoleishvili <[email-masked]>

Cc:
王天萍 <[email-masked]>;
孟伟宁 <[email-masked]>;
chinaembassyingeorgia <[email-masked]>; tgabunia <[email-masked]>; a.khvtisiashvili <[email-masked]>;
nikoleishvilim <[email-masked]>;
杨光 <[email-masked]>;
林潇 <[email-masked]>;
张启超 <[email-masked]>

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

[email-masked]

www.sinovac.com

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
<[email-masked]>"

To: "Maia Nikoleishvili <[email-masked]>","侯凯迪
<[email-masked]>"

CC: "chinaembassyingeorgia <[email-masked]>","Tamar
Gabunia <[email-masked]>","Khvtisiashvili <[email-masked]>","nikoleishvilim <[email-masked]>","yangg
<[email-masked]>","mengwn <[email-masked]>","王天萍
<[email-masked]>"

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
[email-masked] 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

www.sinovac.com

[email-masked]

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 <[email-masked]>"

To: "张启超
<[email-masked]>"

CC: "chinaembassyingeorgia <[email-masked]>","Tamar
Gabunia <[email-masked]>","Khvtisiashvili <[email-masked]>","nikoleishvilim <[email-masked]>","yangg
<[email-masked]>","mengwn <[email-masked]>","王天萍
<[email-masked]>"

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:[email-masked]]

Sent: Monday, March 8, 2021 1:35 PM

To: Maia Nikoleishvili <[email-masked]>

Cc: chinaembassyingeorgia <[email-masked]>; Tamar Gabunia <[email-masked]>;
Khvtisiashvili <[email-masked]>; nikoleishvilim <[email-masked]>; yangg <[email-masked]>; mengwn
<[email-masked]>; 王天萍 <[email-masked]>

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

www.sinovac.com

[email-masked]

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 <[email-masked]>"

To: "张启超
<[email-masked]>"

CC: "chinaembassyingeorgia <[email-masked]>","Tamar
Gabunia <[email-masked]>","Khvtisiashvili <[email-masked]>","nikoleishvilim <[email-masked]>"

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:
[email-masked]

From:
张启超 [mailto:[email-masked]]

Sent: Monday, March 8, 2021 11:13 AM

To: Maia Nikoleishvili <[email-masked]>; nikoleishvilim <[email-masked]>

Cc: chinaembassyingeorgia <[email-masked]>

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
<[email-masked]>"

To: "mnikoleishvil <[email-masked]>","nikoleishvilim
<[email-masked]>"

CC: "yangg <[email-masked]>","mengwn
<[email-masked]>","王天萍 <[email-masked]>"

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

www.sinovac.com

[email-masked]

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.