Document from CIS Legislation database © 2003-2022 SojuzPravoInform LLC

DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of March 10, 2022 No. 39

About approval of Rules of realization of general process "Exchange of data on results of inspection of systems of quality management of producers of medical products"

According to Item 30 of the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the Agreement on the Eurasian Economic Union of May 29, 2014) and being guided by the Decision of Board of the Eurasian economic commission of December 19, 2016 No. 169, the Board of the Eurasian economic commission solved:

1. Approve the enclosed Rules of realization of general process "Exchange of data on results of inspection of systems of quality management of producers of medical products".

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

Chairman of Board of the Eurasian economic commission

M. Myasnikovich

Approved by the Decision of Board of the Eurasian economic commission of March 10, 2022 No. 39

Rules of realization of general process "Exchange of data on results of inspection of systems of quality management of producers of medical products"

I. General provisions

1. These rules determine requirements to realization of general process "Exchange of data on results of inspection of systems of quality management of producers of medical products" (further - general process), the functions performed by the public authorities of state members of the Eurasian Economic Union authorized on implementation and (or) coordination of activities in the field of the address of medical products (further respectively - state members, the Union, authorized bodies), and the Eurasian economic commission (further - the Commission), procedure for exchange of information between them and the scope of information, transferred and published on information portal of the Union in case of realization of general process.

2. These rules are developed according to provisions of the Agreement on the Eurasian Economic Union of May 29, 2014 (further - the Agreement), Agreements on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 (further - the Agreement) and Decisions of Council of the Eurasian economic commission of November 10, 2017 No. 106 "About Requirements to implementation, maintenance and assessment of quality management system of medical products depending on potential risk of their use" (further - Requirements to quality management system).

3. For the purposes of these rules concepts which mean the following are used:

"interested persons" - the physical persons or legal entities interested in receipt of data from the list of the inspecting organizations which request also receive data on information portal of the Union;

"the report on inspection" - the report on results of inspection of systems of quality management of producers of medical products prepared by the organization authorized on conducting inspection of production;

"the list of the inspecting organizations" - general information resource which is created by the Commission, containing data on the inspecting organizations.

Other concepts used in these rules are applied in the values defined by the Agreement, the Agreement, Requirements to quality management system and other acts of bodies of the Union in the field of the address of medical products and also in the field of creation and development of the integrated information system of the Union (further - the integrated system).

II. Purposes and tasks of realization of general process

4. The purpose of realization of general process is prevention of release into the stream of commerce of the medical products which are not corresponding by results of inspection of systems of quality management of producers of medical products to General requirements of safety and efficiency of medical products, requirements to their marking and the operational documentation on them approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 27.

5. Within realization of general process it is necessary to solve the following problems:

a) provide authorized bodies with urgent data on results of inspection of systems of quality management of producers of medical products, and also on requests of producers of medical products for conducting such inspection;

b) provide the operational mutual notification of authorized bodies on results of elimination of the systems of quality management of producers of medical products of discrepancies (violations) revealed during inspection for the purpose of timely restriction (or renewals) release of medical product in the address on customs area of the Union;

c) provide updating of registration files of the medical products which are in circulation regarding data on compliance of systems of quality management of producers of medical products to Requirements to quality management system;

d) provide possibility of the automated control of effective periods of reports on inspection for the registered and registered medical products;

e) provide continuous access for all participants of process of registration and control of the addressing of medical products urgent data on the organizations authorized on conducting inspection of production (further - the inspecting organizations), and also about schedules of conducting inspection of production (further - the schedule of inspection);

e) provide easy access for interested persons to the data published on information portal of the Union from the list of the inspecting organizations, including in machine-readable type.

III. Participants of general process

6. Participants of general process are:

a) authorized bodies;

b) Commission;

c) interested persons.

7. Within realization of general process the authorized body performs the following functions:

a) submission to the Commission of data on the applications for conducting inspection of production received from producers of medical products, and also about the status of such requests for inclusion in the technological database containing index data on requests and results of inspection of systems of quality management of producers of medical products (further - the technological database);

b) submission to the Commission of data on results of inspection of systems of quality management of producers of medical products (reports on inspection) for forming of the technological database (it is represented authorized body of the reference state);

Warning!!!

This is not a full text of document! Document shown in Demo mode!

If you have active License, please Login, or get License for Full Access.

With Full access you can get: full text of document, original text of document in Russian, attachments (if exist) and see History and Statistics of your work.

Get License for Full Access Now

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.