Document from CIS Legislation database © 2003-2020 SojuzPravoInform LLC

DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 17, 2019 No. 159

About the qualifier of document types of the registration file of medicine and the reference book of structural elements of the registration file medicinal drug

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, and 7 Protocols on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the specified Agreement) and being guided items 4 by the Regulations on single system of normative reference information of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of November 17, 2015 No. 155, Board of the Eurasian economic commission solved:

1. Approve enclosed:

the qualifier of document types of the registration file of medicine (further - the qualifier);

the reference book of structural elements of the registration file of medicine (further - the reference book).

2. Turn on the qualifier and the reference book in structure of resources of single system of normative reference information of the Eurasian Economic Union.

3. Determine that:

the qualifier and the reference book are used from the date of the introduction of this Decision in force;

use of specification symbols of the qualifier and the reference book is obligatory in case of realization of general processes within the Eurasian Economic Union in the field of drug circulation.

4. This Decision becomes effective after 30 calendar days from the date of its official publication.

Chairman of Board of the Eurasian economic commission

T. Sargsyan

Approved by the Decision of Board of the Eurasian economic commission of September 17, 2019, No. 159

Qualifier of document types of the registration file of medicine

I. The disaggregated data from the qualifier of document types of the registration file of medicine

Section code

Document type code

Name

01

the documents necessary for performing procedures, connected with medicine registration

01001

the cover letter to the statement on medicine registration performing procedures

01002

the statement for registration of medicine for medical application (reduction of the registration file of medicine in compliance with requirements of the Eurasian Economic Union)

01003

statement for modification of the registration file of medicine

01004

statement for medicine re-registration

01005

the document confirming payment of expert works and (or) the registration fee (duty) according to the legislation of state member of the Eurasian Economic Union

01006

the certificate on the medicine (certified in accordance with the established procedure) according to the format recommended to WHO

01007

the document confirming registration in the manufacturing country and (or) in the country - the holder of the registration certificate on the medicine (certified in accordance with the established procedure)

01008

the explanatory note with reasons for lack of data on medicine registration

01009

the expert report issued in case of registration of medicine in the manufacturing country or the country - the holder of the registration certificate

01010

transfer into Russian of the expert report issued in case of registration of medicine in the manufacturing country or the country - the holder of the registration certificate

01011

the conclusion of Expert committee on medicines under the Eurasian economic commission following the results of initial scientific consulting of rather this medicine

01012

the recommendation of Expert committee on medicines under the Eurasian economic commission following the results of initial scientific consulting of rather this medicine

01013

the list of the countries in which medicine is given on registration is registered, was refused in registration or its market circulation was suspended

01014

the letter of the holder of the registration certificate on compliance of clinical trials of the medicine declared on registration to requirements of the Rules of proper clinical practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 79 (further - Rules of proper clinical practice of the Eurasian Economic Union)

01015

letter of the holder of the registration certificate on the additional trade name of medicine

01016

the conclusion (recommendation) of authorized body (authorized organization) of state member of the Eurasian Economic Union following the results of initial scientific consulting of rather this medicine

02

the documents describing general characteristic of medicine, the instruction on its medical application, marking

02001

the project of general characteristic of medicine in Russian

02002

draft of the instruction on medical application of medicine (leaf insert)

02003

project of marking of medicine

02004

prototype of secondary (consumer) package of medicine

02005

prototype of primary (internal) package of medicine

02006

prototype of intermediate packaging of medicine

02007

prototype of the label of medicine

02008

medicine sticker prototype

02009

description of results of the user testing of the text of the instruction on medical application

02010

the general characteristic of medicine approved by authorized body of the manufacturing country or country - the holder of the registration certificate

02011

the instruction on medical application of medicine approved by authorized body of the manufacturing country

03

the documents confirming quality of medicine and its components

03001

certificate of conformity to Article of the Pharmacopoeia of the Eurasian Economic Union

03002

the certificate of conformity to Article of the European pharmacopeia on spongy encephalopathy

03003

the document issued by authorized bodies of veterinary supervision of country of source of raw materials

03004

the letter of the holder of the master file of active pharmaceutical substance with the obligation according to the preliminary notification about changes in the master file of active pharmaceutical substance

03005

the letter confirming the consent of the holder of the master file of pharmaceutical substance to submission of documents of the closed part of the master file to pharmaceutical substance at the request of authorized body

03006

certificate of conformity of pharmaceutical substance to requirements of the European pharmacopeia

03007

the certificate on the master file of plasma issued by authorized body of the manufacturing country

03008

the certificate on the master file of vaccinal antigen issued by authorized body of the manufacturing country

04

the documents on production and preclinical and clinical development of medicine including confirming compliance to requirements proper pharmaceutical the practician

04001

the document confirming compliance of the producer (production site) to requirements of Rules of proper production practice of the Eurasian Economic Union, issued by authorized body of state member of the Eurasian Economic Union

04002

the document confirming compliance of the producer (production site) to requirements of proper production practice, issued by authorized bodies of the country of arrangement of the production site and (or) other authorized body

04003

permission to the production of medicines issued by authorized body of the country of arrangement of the production site

04004

the license for production of medicines granted by authorized body of the country of arrangement of the production site

04005

the report on inspection of the production site on compliance to requirements of rules of the proper production practice which is carried out by authorized body of the manufacturing country or other authorized body

04006

the plan of carrying out the adjusting and warning actions (CAPA) after inspection of the production site on compliance of GMP which is carried out by authorized body of the manufacturing country or other authorized body

04007

the report on carrying out the adjusting and warning actions (CAPA) after inspection of the production site (production sites at different production phases) on compliance of GMP which is carried out by authorized body of the manufacturing country or other authorized body

04008

the contract (contract) between the holder of the registration certificate of medicine and producer of medicine concerning observance of requirements of GMP

04009

the contract (contract) between the contractual production site and producer concerning observance of requirements of GMP

04010

data on the regulatory measures taken by authorized body by results of inspections concerning the production site

04011

the letter of the authorized person on quality about compliance of conditions of production of the medicine declared on registration to requirements of Rules of proper production practice of the Eurasian Economic Union

04012

data on claims concerning quality of medicine

04013

confirmation of lack of claims concerning quality of medicines

04014

consent to conducting pharmaceutical inspection to compliance to requirements of the international treaties and acts constituting the right of the Eurasian Economic Union

04015

main file (master file) of the production platform / site (production sites)

04016

scheme of production phases of medicine

04017

permission of authorized body to conduct of clinical trial

04018

the list of the carried-out inspections on compliance of proper clinical practice (GCP)

04019

the report on conducting inspection of the research center which was taking part in clinical trials of medicine

04020

report on conducting inspection of the sponsor

04021

report on conducting inspection of the contractual research organization for clinical trials of medicine

04022

the report on conducting inspection of other organizations concerning medicine research

04023

the report on conducting other inspections for the purpose of determination of compliance of proper clinical practice (GCP)

04024

contract between the sponsor of clinical trial and research center

04025

the table with the list of clinical trials

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