Subject: RE: [EXT] RE: Emergency/special authorization foruse/Экстренное / специальное разрешение на регистрацию
From: "KURTSIKASHVILI, Giorgi" <[email-masked]>
To: "Ms T. Gabunia ([email-masked])" <[email-masked]>
Cc: "Tamar Kirvalidze ([email-masked])" <[email-masked]>, "DOMENTE, Silviu" <[email-masked]>
Date: Mon, 29 Mar 2021 11:18:09 +0000

Dear Tamar,

Thank you very much, we will follow up with this request.

Best regards,

Giorgi

From: Tamar Gabunia

Sent: Saturday, March 27, 2021 6:37 PM

To: KURTSIKASHVILI, Giorgi

Cc: Tamar Kirvalidze ([email-masked])

Subject: FW: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Giorgi

Just to keep you in the loop of this communication.

Best

Tamar

From: Tamar Kirvalidze [mailto:[email-masked]]

Sent: 26 March, 2021 17:11

To: PLUUT, Elisabeth <[email-masked]>

Cc: Tamar Gabunia <[email-masked]>; Zaal Kapanadze <[email-masked]>; Kakhaber Shalikadze <[email-masked]>;
Zaal Kapanadze <[email-masked]>; PIRGARI, Dorina <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Isis,

Please find attached signed Confidentiality Agreement for  Sinopharm / BIBP and Sinovac vaccines.

Kind regards,

Tamar

From: PLUUT, Elisabeth [mailto:[email-masked]]

Sent: Wednesday, March 3, 2021 12:36 AM

To: Tamar Kirvalidze <[email-masked]>

Cc: Zaal Kapanadze <[email-masked]>; Gocha Aladashvili <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Tamar,

Thank you for sharing the CA for Sinopharm/BIBP vaccine.

Once WHO has issued an EUL recommendation will we provide access to the dossier.

We do register all requests, however please do not hesitate to remind us when we have issued the EUL.

Kind regards,

Isis

From: Tamar Kirvalidze <[email-masked]>

Sent: Tuesday, March 2, 2021 1:46 PM

To: PLUUT, Elisabeth <[email-masked]>

Cc: Mr Z. Kapanadze ([email-masked]) <[email-masked]>; Gocha Aladashvili <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Isis,

Please find attached signed Confidentiality Agreement for  Sinopharm / BIBP vaccine.

Kind regards,

Tamar

Tamar Kirvalidze

Chief Specialist

Registration and Permits Division of the Service Department

LEPL Regulation Agency for Medical and Pharmaceutical Activities

144, Ak. Tsereteli Ave, Tbilisi, Georgia

Mobile: + 995 555 005 777

From: PLUUT, Elisabeth [mailto:[email-masked]]

Sent: Thursday, February 18, 2021 4:18 PM

To: Tamar Kirvalidze <[email-masked]>; KURTSIKASHVILI, Giorgi <[email-masked]>

Cc: PIRGARI, Dorina <[email-masked]>; DOMENTE, Silviu <[email-masked]>; ESENAMANOV, Vasily <[email-masked]>; Ms T. Gabunia ([email-masked])
<[email-masked]>; Zaal Kapanadze <[email-masked]>; Gocha Aladashvili <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Tamar,

No problem at all. We will provide access this afternoon. AZ will be manufacturing at their different sites. So as we don’t know which vaccine goes where we ask. Also in the future if you require access to any other vaccine,
we just need a new CDA.

If you have any questions, please feel free to contact us.

Kind regards,

Isis

Isis E. Pluut DrPH MPH

Scientist

Vaccines & Immunization Devices Assessment Team (VAX)

Prequalification Unit (PQT)

Regulation and Prequalification Department (RPQ)

Access to Medicines and Health Products Division (MHP)

World Health Organization

Geneva, Switzerland

Tel: + 41 22 791 1267

Mobile/WhatsApp : +41 79 353 27 32

E-mail:
[email-masked]

From: Tamar Kirvalidze <[email-masked]>

Sent: Thursday, February 18, 2021 12:21 PM

To: KURTSIKASHVILI, Giorgi <[email-masked]>; PLUUT, Elisabeth <[email-masked]>

Cc: PIRGARI, Dorina <[email-masked]>; DOMENTE, Silviu <[email-masked]>; ESENAMANOV, Vasily <[email-masked]>; Ms T. Gabunia ([email-masked])
<[email-masked]>; Mr Z. Kapanadze ([email-masked]) <[email-masked]>; Gocha Aladashvili <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Isis,

I am sorry for the mistake. I have attached the updated CA.

Best regards,

Tamar

Tamar Kirvalidze

Chief Specialist

Registration and Permits Division of the Service Department

LEPL Regulation Agency for Medical and Pharmaceutical Activities

144, Ak. Tsereteli Ave, Tbilisi, Georgia

Mobile: + 995 555 005 777

From: KURTSIKASHVILI, Giorgi [mailto:[email-masked]]

Sent: Thursday, February 18, 2021 1:27 PM

To: PLUUT, Elisabeth <[email-masked]>; Tamar Kirvalidze <[email-masked]>

Cc: PIRGARI, Dorina <[email-masked]>; DOMENTE, Silviu <[email-masked]>; ESENAMANOV, Vasily <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Importance: High

Dear Isis,

Apologize for the mistake. We were instructed NRA to do so as of our understanding.

I copy Tamar from NRA for further action.

Dear Tamar – I am so sorry for incorrect guidance.

Please let me know if you need any additional help.

Best regards,

Giorgi

From: PLUUT, Elisabeth <[email-masked]>

Sent: Thursday, February 18, 2021 1:16 PM

To: KURTSIKASHVILI, Giorgi <[email-masked]>

Cc: PIRGARI, Dorina <[email-masked]>; DOMENTE, Silviu <[email-masked]>; ESENAMANOV, Vasily <[email-masked]>

Subject: RE: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear colleagues,

Thank you again for sharing the CDA for Georgia,

Could you please doublecheck with the NRA. Under “applicant” the NRA indicated their name. this should be the name of the manufacturer.

For Tozinameran and COVISHIELD this is clear as indicated in the first column. However for AZD1222 this is not clear and needs to be indicated. At this stage we only have the dossier for AZ/SK Bioscience. But as other
vaccines (AZ1222) will be manufactured in different countries, this needs to be specified.

Thank you in advance.

Regards,

Isis

Isis E. Pluut DrPH MPH

Scientist

Vaccines & Immunization Devices Assessment Team (VAX)

Prequalification Unit (PQT)

Regulation and Prequalification Department (RPQ)

Access to Medicines and Health Products Division (MHP)

World Health Organization

Geneva, Switzerland

Tel: + 41 22 791 1267

Mobile/WhatsApp : +41 79 353 27 32

E-mail:
[email-masked]

From: KURTSIKASHVILI, Giorgi <[email-masked]>

Sent: Wednesday, February 17, 2021 6:38 AM

To: GWAZA, Luther <[email-masked]>; PLUUT, Elisabeth <[email-masked]>

Cc: PIRGARI, Dorina <[email-masked]>; DOMENTE, Silviu <[email-masked]>; ESENAMANOV, Vasily <[email-masked]>

Subject: FW: [EXT] RE: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Dear Colleagues,

Please be kindly informed that NRA Georgia nominated contact point with following contact details:

Ms. Tamar Kirvalidze, Chief Specialist

Registration and Permits Division of the Service Department

LEPL Regulation Agency for Medical and Pharmaceutical Activities

144, Ak. Tsereteli Ave, Tbilisi, Georgia

Email:
[email-masked]

Mobile: + 995 555 005 777

Please find attached signed Confidentiality Agreement and list of documents required for national emergency authorization.

Would appreciate confirmation of safe receipt of this email with attachments.

Kind regards,

Giorgi

--

Giorgi Kurtsikashvili, M.D.

National Officer

WHO Country Office in Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

GPN.: 74214

Tel.: + 995 32 299 80 73

Mobile: +995 599 76 44 43
mailto:[email-masked]

From: NRA WHO Europe <[email-masked]>

Sent: Thursday, February 11, 2021 14:57

To: PIRGARI, Dorina <[email-masked]>; BENES, Oleg <[email-masked]>

Cc: EU Heads Of COs <[email-masked]>; GARNER, Sarah <[email-masked]>; DATTA, Siddhartha Sankar <[email-masked]>; POLISHCHUK, Olexandr <[email-masked]>;
LINDHARDT, Lisbeth Sjaelborg <[email-masked]>; LITTLEWOOD, Jodie Anne <[email-masked]>

Subject: Emergency/special authorization for use/Экстренное / специальное разрешение на регистрацию

Importance: High

* Русская версия этого письма приводится ниже

Emergency/special authorization for use

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The
objective is to make medicines, vaccines, and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy, and quality. The assessment weighs the threat posed by the emergency as well
as the benefit that would accrue from the use of the product against any potential risks.

Each National Regulatory Authority (NRA) shall identify the best option for authorization for use of the vaccine during the pandemic. If NRA decides to authorize the vaccines based on the WHO EUL procedure it should be
aligned with the national legal framework and follow the below-listed steps.

NRAs shall provide:

the contact details of the focal point

the required list of documents from the “regulatory tools available” for the national emergency authorization and sign the ‘Confidentiality Agreement’ (attached); kindly
note the agreement is in English and is not subject to translation.

For any questions on the confidentiality agreement please feel free to contact:

Luther GWAZA - [email-masked];

Elisabeth PLUUT [email-masked];

WHO will facilitate the provision of documentation from the checklist (including dossier, reports, risk-management plans (RMP); etc. In case of additional information or/and
documentation is required, WHO will facilitate;

All the information will be shared with the NRAs using a secure platform to avoid hacking of the e-mails; to ease the sharing (large) of documents; etc. for any
question – [email-masked]

Экстренное / специальное разрешение на регистрацию

Процедура включения в реестр средств для использования в чрезвычайных ситуациях (EUL) позволяет оценить приемлемость новой продукции медицинского назначения во время чрезвычайных ситуаций в области общественного здравоохранения.
Ее цель состоит в том, чтобы сделать эти лекарственные препараты, вакцины и средства диагностики доступными в кратчайшие сроки в целях преодоления чрезвычайной ситуации, обеспечивая при этом соблюдение строгих критериев безопасности, эффективности и качества.
В ходе оценки сопоставляется угроза, создаваемая чрезвычайной ситуацией, а также преимущества, которые может принести использование данного продукта, с любыми потенциальными рисками.

Каждый национальный регулирующий орган (НРО) должен определить лучший вариант для получения разрешения на использование вакцины во время пандемии. Если НРО примет решение на основании процедуры ВОЗ
EUL, то процедура должна быть приведена в соответствие с национальной правовой базой и следовать перечисленным ниже шагам.

НРО должны предоставлять:

а. контактные данные координатора

б. требуемый список документов из «имеющихся инструментов регулирования» для национального разрешения на чрезвычайную ситуацию и подписание «Соглашения о конфиденциальности» (прилагается); Обращаем
ваше внимание, что соглашение составлено на английском языке и не подлежит переводу.

По вопросам соглашения о конфиденциальности обращайтесь:

Luther GWAZA - [email-masked];

Elisabeth PLUUT [email-masked];

ВОЗ будет способствовать предоставлению документации из контрольного списка (включая досье, отчеты, планы управления рисками (ПУР) и при необходимости, другой дополнительной информации.

Вся информация будет передана НРО с использованием безопасной платформы во избежание взлома электронной почты и упрощения обмена (больших) файлов; и т.п. По вопросам безопасной платформы обращайтесь:
[email-masked]

For more information /Дополнительная информация:

WHO

Emergency use listing procedure

RECOMMENDATION FOR AN EMERGENCY USE LISTING OF COVID-19
mRNA VACCINE (NUCLEOSIDE MODIFIED) SUBMITTED BY Pfizer Europe MA EEIG

Coronavirus disease (COVID-19):
Use of Emergency Use Listing procedure for vaccines against COVID-19

COVID-19 Vaccines

Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process

European Medicines Agency (EMA):

Comirnaty – conditional marketing authorization;

First COVID-19 vaccine safety update published

COVID-19 Vaccine Moderna

Update
on assessment of marketing authorization application for Moderna’s mRNA-1273 COVID-19 vaccine

COVID-19 Vaccine AstraZeneca

CHMP summary of positive opinion for COVID-19 Vaccine AstraZeneca

COVID-19 Vaccine AstraZeneca - Product information

Risk management plan summary for COVID-19 Vaccine AstraZeneca

United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA)

Information
for health-care professionals on the Pfizer/BioNTech COVID-19 vaccine

Information for United
Kingdom recipients of the Pfizer/BioNTech COVID-19 vaccine

Conditions
of authorization for the Pfizer/BioNTech COVID-19 vaccine

Decision (Regulatory approval of Pfizer/BioNTech vaccine for COVID-19, of 2 December 2020)
with links:

Regulatory approval of COVID-19 Vaccine AstraZeneca

Government of Canada/Health Canada

Decision
(of 9 December 2020) with links to an extended list of resources:

The general site re to COVID-19 vaccines

United States Food and Drugs Administration (US FDA)

News
release of 11 December 2020 provides links to:

Pfizer-BioNTech COVID-19 vaccine EUA letter of authorization

Pfizer-BioNTech COVID-19 vaccine EUA fact sheet for health-care providers

Pfizer-BioNTech COVID-19 vaccine EUA fact sheet for patients

In addition, on 10 December 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), US FDA, released the briefing document “Pfizer-BioNTech COVID-19
Vaccine” with detailed product characterization.

Thank you very much

EURO NRA support team and VPI