Table Of Contents (TOC) for GEORGIA

GEORGIA

Authority

MOH of Georgia pharmacological committee

website

www.molsha.ge/eng/govdivisions.php

if any

REQUIREMENT FOR PRODUCT REGISTRATION

S.No

Registration Documents for Georgia

Administrative Part

1

Application of a competitor with a list of attached documents (with the indication of pages)

Application shall meet provisions under article 78 of the General Administrative Code.

2

Application for registration of a medicinal product in Georgia (Application Form - original)

3

Original power of attorney granted by the competitor for registration to the individual or legal entity on giving authorization to represent.

4

Certificate of a pharmaceutical product in a form recommended by the World Health Organization (original), or if not any – document certifying compliance of manufacturing  of the medicinal product with GMP standard or a manufacturing license of the medicinal product issued by the authorized agency of a manufacturing country.

5

Standard packing of the medicinal product to be registered (including those of BAAs) with the standard marking (or in form of electronic version).

6

Instruction for use of a medicinal product (including those of BAAs correcting pathological status) (in case of BAAs for the preservation of  physiological status – recommendation for use) in a Georgian language.

Technical part of registration documents

1

Chemical composition of a medicinal product with the indication of all ingredients and their quantity per dosage unit

2

Relevant document authorizing remanufacture of a medicinal product under the license.

3

Monographs or indication of monographs included in international collections of standards on active substance (s) (specification and methods of analysis)

4

Name  and address of a manufacturer (s) of active substance (s)

5

Monographs or indication of monographs included in international collections of standards on inactive substance (s) (specification and methods of analysis)

6

Monographs on the methods of analysis of a medicinal product including specification

7

Scheme of technological process of manufacture of a medicinal product

8

Drug sample – 2 standard packs plus the quantity necessary for two analyses attached with a relevant quality certificate;

9

Reference-standard (s) in a quantity sufficient for 2 analyses attached with a relevant quality certificate

10

Stability data of a medicinal product;

11

Bioequivalency or therapeutic equivalency data with the consideration of form and way of administration of a medicinal product (in compliance with recommendation of the World Health Organization)

12

Publications and bibliography;