მოგესალმებით ძვირფასო მეგობრებო,

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?