of August 21, 2018 № 135
About the qualifier of the document types which are drawn up by consideration of the registration file of medical product
In co compliance article 31 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 specified Agreement) 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 commission decided:
1. Approve the enclosed qualifier of the document types which are drawn up by consideration of the registration file of medical product (further – the qualifier).
2. Include klassifikatorv structure of resources of single system of normative reference information of the Eurasian Economic Union.
3. Determine that:
the qualifier is used from the date of the introduction of this Decision in force;
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 the address of medical products.
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 August 21, 2018 №135
Document group code |
Document type code |
Name of the document |
01 |
The documents processed in case of representation by the applicant additional and clarifications in the course of registration and examination of medical product | |
0101 |
the inquiry sent to the applicant with indication of nature of notes | |
0102 |
the answer of the applicant with indication of nature of notes | |
0103 |
the notification on need of submission of copies of the documents confirming payment of fees in the state of recognition | |
0104 |
the notification on reconciliation procedure payment directed by the applicant to authorized body (the expert organization) of the reference state | |
0105 |
the notification on reconciliation procedure payment directed by the applicant to authorized bodies (the expert organizations) of the state (states) of recognition | |
0106 |
the documents submitted by the applicant and containing transfer of the operational document or application instruction of medical product, management on field service and the text of marking on state language (state languages) of the state (states) of recognition | |
0107 |
the notification on need of elimination of the revealed violations and (or) submission of missing documents sent to the applicant | |
0108 |
return note to the applicant of statements for registration and examination and documents | |
0109 |
the return note to the applicant of the additional materials and data provided in response to request | |
0110 |
return note of the statement for modification of the registration file and documents | |
0111 |
the return note of the statement for modification of the registration file in notifying procedure and documents | |
0112 |
return note of the statement for approval of the expert opinion and documents | |
0113 |
return note of the statement for action cancellation (cancellation) of the registration certificate and documents | |
0199 |
Another | |
02 |
The documents processed by authorized body of state member of the Eurasian Economic Union by results of examination of the registration file of medical product | |
0201 |
the notification on refusal in registration of medical product sent to the applicant | |
0202 |
the notification on refusal in modification of the registration file of medical product sent to the applicant | |
0203 |
registration certificate of medical product | |
0204 |
the notice of registration of medical product sent to the applicant | |
0205 |
the notification on modification of the registration file sent to the applicant | |
0206 |
the notification on refusal in modification of the registration file sent to the applicant | |
0207 |
the notification on refusal in modification of the registration file in notifying procedure sent to the applicant | |
0208 |
the notification on modification of the registration file in notifying procedure sent to the applicant |
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