of December 21, 2021 No. 179
About modification of the Decision of Board of the Eurasian economic commission of September 17, 2019 No. 159
According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014 and items 4 and 7 Protocols on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the specified Agreement), being guided 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. Bring in the 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 of medicine" changes according to appendix.
2. This Decision becomes effective after 30 calendar days from the date of its official publication.
Action of the changes provided by the paragraph third the subitem "an" of Item 1 (concerning amendment after line item 04028) and the paragraph third the subitem "an" of Item 2 (concerning line item with code 3.2.R.1) of appendix to this Decision extends to the legal relationship which arose from the effective date Decisions of Council of the Eurasian economic commission of January 30, 2020 No. 9.
Action of the changes provided by the paragraph the second the subitem "an" of Item 1 and the paragraph the second the subitem "an" of Item 2 appendices to this Decision extends to the legal relationship which arose from the effective date Decisions of Council of the Eurasian economic commission of March 5, 2021 No. 14.
Chairman of Board of the Eurasian economic commission
M. Myasnikovich
to the Decision of Board of the Eurasian economic commission of December 21, 2021 No. 179
1. In the qualifier of document types of the registration file of medicine approved by the specified Decision:
a) in the Section I:
after line item with code of document type 01016 to add with line items of the following content:
|
" |
|
01017 |
the summary for the registration application with provision of bibliographic sources and data |
|
|
|
|
01018 |
the summary for the registration application of generic, hybrid or biosimilar (biosimilar) medicines |
|
|
|
|
01019 |
the summary for the registration application in the presence of patents in state member of the Eurasian Economic Union concerning the registered medicine |
|
|
|
|
01020 |
the summary for the registration application in particular cases |
|
|
|
|
01021 |
the summary for the registration application with establishment of post-registration measures (registration on conditions) |
"; |
after line item with code of document type 04028 to add with line item of the following content:
|
" |
|
04029 |
records (reports) on the made product series |
"; |
b) in the Section II 5 in column 3 to state line item in the following edition: "EC 058 – 2021 (edition 2)".
2. In the reference book of structural elements of the registration file of medicine approved by the specified Decision:
a) in the Section I:
to replace line item with code 1.8.2 with line items of the following content:
|
" |
1.8.2 |
documents on clinical trials and the summary for reasons for the registration application |
1.8 |
0 |
|
|
|
|
1.8.2.1 |
permission of authorized body to performing clinical trial |
1.8.2 |
1 |
04017 |
|
|
|
1.8.2.2 |
the list of the carried-out inspections on compliance to proper clinical practice |
1.8.2 |
1 |
04018 |
|
|
|
1.8.2.3 |
copies of reports on conducting inspections |
1.8.2 |
1 |
04019 |
|
|
|
04020 |
| ||||
|
|
04021 |
| ||||
|
|
04022 |
| ||||
|
|
04023 |
| ||||
|
|
1.8.2.4 |
copies of agreements |
1.8.2 |
1 |
04024 |
|
|
|
1.8.2.5 |
the summary for the registration application with provision of bibliographic sources and data |
1.8.2 |
1 |
01017 |
|
|
|
1.8.2.6 |
the summary for the registration application of generic, hybrid or biosimilar (biosimilar) medicines |
1.8.2 |
1 |
01018 |
|
|
|
1.8.2.7 |
the summary for the registration application in the presence of patents in state member of the Eurasian Economic Union concerning the registered medicine |
1.8.2 |
1 |
01019 |
|
|
|
1.8.2.8 |
the summary for the registration application in particular cases |
1.8.2 |
1 |
01020 |
|
|
|
1.8.2.9 |
the summary for the registration application with establishment of post-registration measures (registration on conditions) |
1.8.2 |
1 |
01021 |
"; |
to state line item with code 3.2.R.1 in the following edition:
|
" |
3.2.R.1 |
records (reports) on the made product series |
3.2.R |
1 |
04029 |
"; |
b) in the Section II 5 in column 3 to state line item in the following edition: "EU 030 – 2021 (edition 2)".
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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