Subject: RE: [EXTERNAL] RE: E-mail from SSA Georgia: Somatropin
From: Besik Datukishvili <[email-masked]>
To: "Allafi, Ramiz" <[email-masked]>
Cc: "Sultanova, Yuliya" <[email-masked]>, "Pronin, Anton" <[email-masked]>, "Kozenkov, Dmitry" <[email-masked]>, "Kulbekova, Dina" <[email-masked]>, Giorgi Tsotskolauri <[email-masked]>, [email-masked], [email-masked], [email-masked], [email-masked], [email-masked], [email-masked]
Date: Tue, 26 Nov 2019 13:00:21 +0000

Добрый день, Рамиз!

Сообщаю, что Законодательство Грузии действительно предусматривает одноразовый импорт лекарственного средства, если это обусловлено общественными и государственными интересами Страны (наш случай является именно таковым).

Соответственно, после предоставления Вами цены на Генотропин, данный вопрос будет рассмотрен тендерной комиссией и я думаю, что в тендерных условиях будет сделано допущение об однаразовой поставке незарегистрированного фармацевтического продукта.

С наилучшими пожеланиями,

Бесо

From: Allafi, Ramiz [mailto:[email-masked]]
Sent: Tuesday, November 26, 2019 14:58
To: Besik Datukishvili <[email-masked]>
Cc: Sultanova, Yuliya <[email-masked]>; Pronin, Anton <[email-masked]>; Kozenkov, Dmitry <[email-masked]>; Kulbekova, Dina <[email-masked]>
Subject: RE: [EXTERNAL] RE: E-mail from SSA Georgia: Somatropin
Importance: High

Бесик, добрый день!

Получил дополнительную информацию от отдела регистрации.

На сегодняшний день препарат Генотропин не зарегистрирован в Грузии.

Единственная возможность его ввезти это разовый ввоз который оформляется под конкретного пациента или группу пациентов.

Можно ли выделить пациентов, нуждающиеся в данном препарате, в отдельную группу для получения одобрения на ввоз данного препарата?

Или уточните пожалуйста, какие есть другие способы ввоза,  незарегистрированного препарата, разрешенные законодательством.

Спасибо!

С уважением,

Рамиз

From: Allafi, Ramiz
Sent: Thursday, November 21, 2019 5:39 PM
To: Besik Datukishvili <[email-masked]>
Cc: Sultanova, Yuliya <[email-masked]>; Pronin, Anton <[email-masked]>; Kozenkov, Dmitry <[email-masked]>
Subject: RE: [EXTERNAL] RE: E-mail from SSA Georgia: Somatropin
Importance: High

Бесик, добрый день!

Мне сообщили что мы можем вести коммуникацию на русском языке. Если это будет удобно для Ваших коллег то можем продолжить на русском языке.

Наш препарат Генотропин (соматропин) – запрос на актуальность регистрации отправлю отдельно.

Цену уточняю, глобальная команда как раз запрашивала информацию которую Вы описали в пунктах 3-4.

Как получу цену вернусь к Вам с информацией.

Спасибо!

С уважением,

Рамиз

From: Besik Datukishvili <[email-masked]>
Sent: Tuesday, November 19, 2019 11:15 AM
To: Allafi, Ramiz <[email-masked]>
Cc: Sultanova, Yuliya <[email-masked]>; Pronin, Anton <[email-masked]>; 'Giorgi Tsotskolauri' <[email-masked]>; [email-masked]; 'lela mamulashvili' <[email-masked]>; [email-masked]; [email-masked]; [email-masked]; [email-masked]
Subject: [EXTERNAL] RE: E-mail from SSA Georgia: Somatropin

Good morning, dear Ramiz!

It is very nice to meet you and I hope that our cooperation will be fruitful.

Sorry, I could not answer your questions yesterday, but today I will answer with pleasure:

1. The delivered pharmaceutical product must satisfy the following conditions - On the Georgian pharmaceutical market, authorized products must be presented, acceptable packaging/labeling. Unfortunately, I don’t know which of your products are registered in Georgia. If you send me the exact list of medicines, then I’ll ask our colleagues from the adjacent Agency.

2. The shelf life (validity) of the delivered medicinal products, at the time of delivery, must be at least 12 months.

3. In 2019, the following medicine was purchased: Sizen 8 mg, Click. Easy (SOMATOTROPIN), Merck Serono S.p.A, Italy. Beginning in 2015, company «Gepha» provided the lowest price to us and, based on this price, there were practically no competitors. I certainly don’t know what the situation will be with regard to procurement for 2020, but I think that competition will increase.

4. According to the Law of Georgia on Public Procurement, all purchases of pharmaceutical products are carried out through an open tender. However, if a very low price is acceptable, which is acceptable to the state, it will be possible to consider the issue of direct procurement. Other issues, including aspects of confidentiality, can be discussed at the conclusion of the contract.

I hope I answered your questions in full, but if additional and/or new questions arise, I’ll answer with pleasure.

I would like to thank you in advance, and hope for future cooperation.

Best regards,

Besik Datukishvili

From: Allafi, Ramiz [mailto:[email-masked]]
Sent: Monday, November 18, 2019 13:00
To: Besik Datukishvili <[email-masked]>
Cc: Sultanova, Yuliya <[email-masked]>; Pronin, Anton <[email-masked]>
Subject: RE: E-mail from SSA Georgia: Somatropin

Dear Besik,

Could you please throw the light on some points.

What is competitors landscape? Especially which brand was purchased for 2019 (39,600 milligrams Somatropin) ?

Am I right, that the purchase will be organized directly from manufacture on the base of Non-disclosure agreement. So it means the price will be confidential.

Thank you in advance!

Kind Regards,

Ramiz Allafi

Rare Diseases Country Brand Lead

Caucasus and Central Asia

Mob: +7701 768 22 03

From: Allafi, Ramiz
Sent: Monday, November 18, 2019 12:53 PM
To: Besik Datukishvili <[email-masked]>
Cc: Sultanova, Yuliya <[email-masked]>; Pronin, Anton <[email-masked]>
Subject: RE: E-mail from SSA Georgia: Somatropin

Dear Besik,

My name Ramiz and I’m in charge of Rare Disease portfolio in Pfizer. Nice to meet you!

The request is clear for us. I’ve already send the message to Pricing team to clarify possible price for Georgia.

Also I have a question regarding regulatory requirements.

Which packs we could ship to Georgia? What is the permissible exp.?

As soon as I'll get information on prices I'll reach out to you.

Thank you!

Kind Regards,

Ramiz

From: Sultanova, Yuliya <[email-masked]>
Sent: Monday, November 11, 2019 3:03 PM
To: Besik Datukishvili <[email-masked]>
Subject: E-mail from SSA Georgia: Somatropin

Dear Mr. Datukishvili,

Thank you for reaching Pfizer on the matter,

Your e-mail is well received and was retransmitted to the responsible regional colleagues,

Once the feedback is received, it will be delivered  for your consideration,

Kind regards,

Yuliya Sultanova

+77787474742
BDM IM CauCAR / Caucasus & Central Asia

PFIZER Biopharmaceuticals Group
www.pfizer.com

PFIZER Export B.V. branch office in Kazakhstan, 100/4 Nazarbayev Ave., 050000, Almaty, Kazakhstan

From: Besik Datukishvili <[email-masked]>
Sent: Monday, November 11, 2019 11:32 AM
To: Sultanova, Yuliya <[email-masked]>
Subject: [EXTERNAL] RE: Test mail from Pfizer

Dear Julia,

I am sending you from the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia, Legal Entity of Public Law, Social Service Agency, Head of State Procurements’ Division - Besik Datukishvili.

We would like to inform you that in Georgia the Social Service Agency is the largest state purchaser in the field of pharmaceutical products and medical devices and cooperates with local and foreign contrahens.

Agency implements procurement of specific medical products, Somatropin (Human somatotropic hormone derived from recombinant DNA technology). Release form: Ready-made injection solution either in powder or solvent form (in ampoule/cartridge for pen) and/or in any other form. Volume of goods - 46 680 milligrams.

We are aware that Pfizer, Inc. represents one of the leaders among the manufacturers of the pharmaceuticals and produces Somatropin under the brand name «Genotropin».

Taking into consideration our state and social interests, the LEPL – Social Service Agency of Georgia is interested to execute procurement of the corresponding medical product directly from the manufacturer, company - Pfizer, Inc., or through Georgian distributors.

In this respect, in case you are interested in the bargain, we are kindly asking you to provide information about the price (in USD and/or in EUR) and delivery conditions to Georgia.

At the same time, we inform that in 2019, the Agency purchased 39,600 milligrams Somatropin, with a total value of 128 898 euros (the cost of one milligram is 3.2550 euros).

If you have additional questions, write to me - I will answer with pleasure.

I would like to thank you in advance, and hope for future cooperation.

Best regards,

Besik Datukishvili

From: Sultanova, Yuliya [mailto:[email-masked]]
Sent: Monday, November 11, 2019 09:36
To: Besik Datukishvili <[email-masked]>
Subject: Test mail from Pfizer

Dear Mr. Datukishbvili,

This is a test mail  for you to submit the request on medications direct purchase discussed earlier,

Kind regards

Yuliya Sultanova

+77787474742
BDM IM CauCAR / Caucasus & Central Asia

PFIZER Biopharmaceuticals Group
www.pfizer.com

PFIZER Export B.V. branch office in Kazakhstan, 100/4 Nazarbayev Ave., 050000, Almaty, Kazakhstan