of April 24, 2018 №64
About approval of the qualifier of document types of registration case of medicine
In co compliance article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and 7 Protocols on information and communication technologies and information exchange within the Eurasian Economic Union (appendix №3 to the Agreement on the Eurasian Economic Union of May 29, 2014) and 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 Euroasian economic commission of November 17, 2015 №155, Board of the Euroasian economic komissiireshit:
1. Approve the enclosed qualifier of document types of registration case of medicine (further – the qualifier).
2. Turn on the qualifier in structure of resources of single system of normative reference information of the Eurasian Economic Union.
3. Determine that:
the passport of the qualifier is applied from the effective date this Decision;
use of specification symbols of the qualifier 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 Euroasian economic commission of April 24, 2018 №64
|
Document group code |
Document type code |
Name |
|
01 |
The documents processed by provision by the applicant additional and clarifications | |
|
0101 |
Request about provision of the missing additional information, necessary explanations or amendments of the documents and data provided in the registration file of medicine | |
|
0102 |
Request of the state of recognition concerning documents of the registration file of medicine | |
|
0103 |
Notes to the registration file of medicine from the state of recognition | |
|
0104 |
Reply to the request about provision of the missing additional information, necessary explanations or amendments of the documents and data provided in the registration file of medicine | |
|
0105 |
Request about provision of the copy of the master file of system of PRAC | |
|
0106 |
Response of the applicant to request of the state of recognition | |
|
0107 |
The answer of the applicant to notes from the state of recognition | |
|
0199 |
Another | |
|
02 |
The documents processed as a result of examination of the registration file of medicine | |
|
0201 |
Expert report on assessment of results of preclinical (not clinical) researches | |
|
0202 |
Report of the expert in assessment of clinical trials | |
|
0203 |
Expert report on critical evaluation of aspects of quality of medicine | |
|
0205 |
Expert report on assignment of the status of new active pharmaceutical substance | |
|
0206 |
Test report | |
|
0207 |
Expert valuation report of safety, efficiency and quality | |
|
0299 |
Another | |
|
03 |
The documents processed when conducting inspection of production in the course of medicine registration | |
|
0301 |
The instruction about conducting inspection of production | |
|
0302 |
The report on inspection of production on compliance to requirements of Rules of proper production practice of the Eurasian Economic Union | |
|
0399 |
Another | |
|
04 |
The documents processed in the course of interaction of authorized bodies of state members of the Eurasian Economic Union by consideration of the registration file of medicine | |
|
0401 |
Expert valuation report of safety, efficiency and quality | |
|
0402 |
Expert opinion on possibility (impossibility) of modification of the registration file of medicine | |
|
0403 |
The inquiry of authorized body (the expert organization) of the state of recognition sent | |
|
0404 |
The reply of authorized body (the expert organization) of the reference state sent to authorized body of the state of recognition | |
|
0405 |
Notes of the state of recognition concerning the final expert report on quality | |
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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