Dear Giorgi

Just to keep you in the loop of this communication.

Best

Tamar

Dear Isis,

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

Kind regards,

Tamar

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

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

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: pluute@who.int

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

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

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: pluute@who.int

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: tkirvalidze@moh.gov.ge

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:kurtsikashvilig@who.int

* 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:

a.       the contact details of the focal point

b.       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 - gwazal@who.int;

Elisabeth PLUUT pluute@who.int;

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;

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 - gwazal@who.int;

Elisabeth PLUUT pluute@who.int;

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: whoeul@who.int

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)

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

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

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

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

o   Regulatory approval of COVID-19 Vaccine AstraZeneca

• Government of Canada/Health Canada

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

o   The general site re to COVID-19 vaccines

• United States Food and Drugs Administration (US FDA)

o   News release of 11 December 2020 provides links to:

o   Pfizer-BioNTech COVID-19 vaccine EUA letter of authorization

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

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

o   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