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DECISION OF BOARD OF THE EUROASIAN 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 Euroasian economic commission of November 17, 2015 No. 155, Board of the Euroasian 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 Euroasian economic commission

T. Sargsyan

Approved by the Decision of Board of the Euroasian 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

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