Dear Ms. Laimute, Dear Agne,

Ms. Keti Shermadini responded to your questions. Please find them below

1. Are both Regulatory Agency and NCDC under the MoH?

The National Center for Disease Control and the LEPL Regulatory Agency of Medicinal and Pharmaceutical Activities are under the MoH. 

2. If licensing of BE is moved to Regulatory Agency, what will be the future for Transfusiology subgroup in MoH?  Who would be responsible for policy of transfusiology in MoH?

 

Considering that the final decision regarding the Competent Authority has not been made, at this stage, as you already know, the draft law proposes two options: a) the Agency for Regulation of Pharmaceutical Activities shall be determined as a Competent Authority; B) there is a general record of the competent authority (the competent authority is responsible for the protection of the quality and safety of blood and its components within the scope of its competence in compliance with the requirements established by this Law and the relevant subordinate normative acts). 

Article 9. Competent authority

1.                   The competent authority in the field of the quality and safety of blood and blood components shall, within its purview, be responsible for compliance with the requirements established by this Law and appropriate subordinate normative acts.

(1.    The Regulation Agency for Medical and Pharmaceutical Activities, a legal entity under public law, as a competent authority in the field of the quality and safety of blood and blood components, shall be responsible within the limits of its authority for compliance with the requirements established by this Law and appropriate subordinate normative acts)

2.                   The competent authority is a license issuer for the activities described in Article 13 of this Law.

3.                   The competent authority shall have powers to inspect and to carry out appropriate monitoring measures at the blood establishments.

4.                   Besides the functions listed in Clauses 1-3 of this Article, the competent authority shall:

a)      Ensure the operation of the systems of haemovigilance and traceability of blood and blood components in the country;

(a)   In coordination with the L. Saqvarelidze National Center for Disease Control and Public Health, a legal entity under public law, ensure within its limits of authority the operation of the systems of haemovigilance and traceability of blood and blood components in the country)

b)      Coordinate activities of the blood establishments;

c)       Implement other measures assigned as falling within its limits of authority by this Law and subordinate normative acts issued pursuant to this Law.

Article 18. (1). The competent authority shall ensure the establishment of an integrated system of notification of the serious adverse events and serious adverse reactions.

 

According the draft law, the main responsibilities of the Competent Authority will include:

·         licensing, Authorization, Accreditation 

·         Inspections and appropriate control measures of Blood Establishments (and hospital blood banks?)

·         Vigilance system (haemovigilance) in coordination with the National Center for Disease Control including notification of SARE and traceability. 

·         Coordinate activities of the blood establishments

·         Implementation and enforcement of policy/ legislation on blood transfusion

·         International cooperation

 

3. If licenses for BE are issued by the MoH, and licenses of other health care institutions are issued by Regulatory Agency, are they somehow different? Do licensing requirements differ as well?

 

4. Does MoH of Georgia issue licenses only for BE or are there other health care services licensed by MoH?

Currently, the LEPL Regulatory Agency of Medicinal and Pharmaceutical Activities at the MoH is responsible for licensing of the health care institutions, pharmaceutical organizations as well as for blood and tissue establishments. In case if the Regulatory Agency will be delegated responsibilities of the Competent Authority, it is expected that the licensing of health care institutions and blood establishments will be within it‘s competency, however this question remains open.

 Best,

Keti

RTA Assistant

Twinning project “Strengthening Blood Safety System in Georgia”

mob: +995 599 155002

---------- Forwarded message ----------
From: ketevan shermadini <shermadinik@yahoo.com>
Date: Tuesday, July 14, 2020
Subject: Activity 2.1.1 - follow-up
To: turkia babilina <bturkia@yahoo.com>, Anzor tchavtchavadze <atchavtchavadze@moh.gov.ge>, "kgagnidze@moh.gov.ge" <kgagnidze@moh.gov.ge>, Ekaterine Adamia <eadamia@moh.gov.ge>, Keti Khizanishvili <keti.khizanishvili@gmail.com>
Cc: Vladimer Getia <khgetia@gmail.com>

მოგესალმებით ძვირფასო მეგობრებო,

გავეცი მოკლე პასუხები ქეთის მიერ გადმოგზავნილ ზოგიერთ შეკითხვას, გთხოვთ გადახედოთ.

პატივისცემით,

ქეთი

 

1. Are both Regulatory Agency and NCDC under the MoH?

The National Center for Disease Control and the LEPL Regulatory Agency of Medicinal and Pharmaceutical Activities are under the MoH.

2. If licensing of BE is moved to Regulatory Agency, what will be the future for Transfusiology subgroup in MoH?  Who would be responsible for policy of transfusiology in MoH?

 

Considering that the final decision regarding the Competent Authority has not been made, at this stage, as you already know, the draft law proposes two options: a) the Agency for Regulation of Pharmaceutical Activities shall be determined as a Competent Authority; B) there is a general record of the competent authority (the competent authority is responsible for the protection of the quality and safety of blood and its components within the scope of its competence in compliance with the requirements established by this Law and the relevant subordinate normative acts).

Article 9. Competent authority

1.                   The competent authority in the field of the quality and safety of blood and blood components shall, within its purview, be responsible for compliance with the requirements established by this Law and appropriate subordinate normative acts.

(1.    The Regulation Agency for Medical and Pharmaceutical Activities, a legal entity under public law, as a competent authority in the field of the quality and safety of blood and blood components, shall be responsible within the limits of its authority for compliance with the requirements established by this Law and appropriate subordinate normative acts)

2.                   The competent authority is a license issuer for the activities described in Article 13 of this Law.

3.                   The competent authority shall have powers to inspect and to carry out appropriate monitoring measures at the blood establishments.

4.                   Besides the functions listed in Clauses 1-3 of this Article, the competent authority shall:

a)      Ensure the operation of the systems of haemovigilance and traceability of blood and blood components in the country;

(a)   In coordination with the L. Saqvarelidze National Center for Disease Control and Public Health, a legal entity under public law, ensure within its limits of authority the operation of the systems of haemovigilance and traceability of blood and blood components in the country)

b)      Coordinate activities of the blood establishments;

c)       Implement other measures assigned as falling within its limits of authority by this Law and subordinate normative acts issued pursuant to this Law.

Article 18. (1). The competent authority shall ensure the establishment of an integrated system of notification of the serious adverse events and serious adverse reactions.

 

According the draft law, the main responsibilities of the Competent Authority will include:

·         licensing, Authorization, Accreditation

·         Inspections and appropriate control measures of Blood Establishments (and hospital blood banks?)

·         Vigilance system (haemovigilance) in coordination with the National Center for Disease Control including notification of SARE and traceability.

·         Coordinate activities of the blood establishments

·         Implementation and enforcement of policy/ legislation on blood transfusion

·         International cooperation

 

3. If licenses for BE are issued by the MoH, and licenses of other health care institutions are issued by Regulatory Agency, are they somehow different? Do licensing requirements differ as well?

 

4. Does MoH of Georgia issue licenses only for BE or are there other health care services licensed by MoH?

Currently, the LEPL Regulatory Agency of Medicinal and Pharmaceutical Activities at the MoH is responsible for licensing of the health care institutions, pharmaceutical organizations as well as for blood and tissue establishments. In case if the Regulatory Agency will be delegated responsibilities of the Competent Authority, it is expected that the licensing of health care institutions and blood establishments will be within it‘s competency, however this question remains open.

 

 

Ketevan Shermadini, MD

Physician-Epidemiologist

Infectious Diseases, AIDS and

Clinical Immunology Research Center.

 

16, Al Kazbegi Ave,

Tbilisi, 0160, Georgia

 

Tel: (995 32) 2398018

Fax: (995 32) 2399144

Mob: (995 599) 274878

 

On Tuesday, July 14, 2020, 12:42:01 PM GMT+4, Keti Khizanishvili <keti.khizanishvili@gmail.com> wrote:

ძვირფასო კოლეგებო,

ლიეტუველმა ექსპერტებმა გვთხოვეს, ვუპასუხოთ მათ რამოდენიმე კითხვას, რომლებიც ქვემოთ არის მოცემული. 

Dear Keti, would you be so kind to answer a few questions for me and Laimutė:

1. Are both Regulatory Agency and NCDC under the MoH?
2. If licensing of BE is moved to Regulatory Agency, what will be the future for Transfusiology subgroup in MoH? Who would be responsible for policy of transfusiology in MoH?
3. If licenses for BE are issued by the MoH, and licenses of other health care institutions are issued by Regulatory Agency, are they somehow different? Do licensing requirements differ as well?
4. Does MoH of Georgia issue licenses only for BE or are there other health care services licensed by MoH?

უმორჩილესად გთხოვთ, პასუხები შეძლებისდაგვარად მოკლე დროში გამოგვიგზავნოთ.  

მადლობას გიხდით წინასწარ დახმარებისთვის,

პატივისცემით,

ქეთი

---------- Forwarded message ---------
From: <agne.kaminskiene@kraujodonoryste.lt>
Date: Tue, Jul 14, 2020 at 11:35 AM
Subject: RE: Activity 2.1.1 - follow-up
To: Keti Khizanishvili <keti.khizanishvili@gmail.com>, Smid, Martin <M.Smid@sanquin.nl>, Ardenne-Stachiw, Olenka van <O.vanArdenne@sanquin.nl>, Laimutė Stonienė <l.stoniene@kraujodonoryste.lt>, Wim de Kort <wimdekort1952@gmail.com>
Cc: Amiran Gamkrelidze <a.gamkrelidze@ncdc.ge>, turkia babilina <bturkia@yahoo.com>, Vladimer Getia <khgetia@gmail.com>, Algirdas Gri <algirdasgris@gmail.com>, Kakhaber Dvalidze <kakha99@gmail.com>

Dear Keti and other colleagues,

 

We also appreciate the opportunity to participate in round table discussions. We understand that Georgian colleagues need a few days to discuss and decide on the organizational structure of future institution. Under those circumstances we agree moving our discussions to Friday.

 

Dear Keti, would you be so kind to answer a few questions for me and Laimutė:

1. Are both Regulatory Agency and NCDC under the MoH?
2. If licensing of BE is moved to Regulatory Agency, what will be the future for Transfusiology subgroup in MoH? Who would be responsible for policy of transfusiology in MoH?
3. If licenses for BE are issued by the MoH, and licenses of other health care institutions are issued by Regulatory Agency, are they somehow different? Do licensing requirements differ as well?
4. Does MoH of Georgia issue licenses only for BE or are there other health care services licensed by MoH?

Thank you very much in advance.

 

 

 

Best regards,

Agnė Kaminskienė

Lawyer

 

VšĮ Nacionalinis kraujo centras Žolyno g. 34, LT-10210, Vilnius Tel. +37068312545 agne.kaminskiene@kraujodonoryste.lt http://www.kraujodonoryste.lt

 

 

From: Keti Khizanishvili <keti.khizanishvili@gmail.com>
Sent: Monday, July 13, 2020 3:01 PM
To: Smid, Martin <M.Smid@sanquin.nl>; agne.kaminskiene@kraujodonoryste.lt; Ardenne-Stachiw, Olenka van <O.vanArdenne@sanquin.nl>; Laimutė Stonienė <l.stoniene@kraujodonoryste.lt>; Wim de Kort <wimdekort1952@gmail.com>
Cc: Amiran Gamkrelidze <a.gamkrelidze@ncdc.ge>; turkia babilina <bturkia@yahoo.com>; Vladimer Getia <khgetia@gmail.com>; Algirdas Gri <algirdasgris@gmail.com>; Kakhaber Dvalidze <kakha99@gmail.com>
Subject: Activity 2.1.1 - follow-up

 

Dear experts,

 

First of all, I would like to thank you all for participating in today's teleconference.

 

We would like to offer you to organize the second day of activity 2.1.1 at the end of this week, on July 17th. During the next three days the Georgian working group members will have internal discussions regarding the draft legislation on blood safety, as well as the organizational structure of future institution.

 

Would you kindly suggest, as Dr. Gamkrelidze asked you all, tentative functionalities of the future blood safety system monitoring organization or unit, given that the three major players will be: a. Ministry of Health, b. Regulatory Agency, c. NCDC.

 

What are potential challenges if the future NCA operates under each of these three bodies?

 

What should we pay special attention to?

 

We do not want to overstretch ourselves  but the more detailed your suggestions are, the more immensely grateful we will be. We understand that the burden of making decisions is entirely upon the Georgian side, but your expert advices will be invaluable in helping us make that decision.

 

If necessary, we can provide you with very thorough information and relevant current functions about all three institutions.

 

Thank you in advance,

 

With Regards,

Keti

 

Ketevan Khizanishvili

RTA Assistant

Twinning Project Strengthening Blood Safety System in Georgia

Mob: (+995) 599 155 00