of September 7, 2018 №149
About the list of stages (stages) of production of medicines
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 commission decided:
1. Approve the enclosed list of stages (stages) of production of medicines (further – the list).
2. Include the list in structure of resources of single system of normative reference information of the Eurasian Economic Union.
3. Determine that:
a) the passport of the list is applied from the date of the introduction of this Decision in force;
b) use of specification symbols of the list 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 Eurasian economic commission of September 7, 2018 №149
|
Code of stage (stage) |
Name of stage (stage) |
|
05 |
The issuing quality control |
|
10 |
Medicine quality control |
|
15 |
Quality control bulk (balk) product |
|
20 |
The producer (all stages, including the issuing quality control) |
|
25 |
Producer (ready dosage form) |
|
30 |
Producer (intermediate production stages) |
|
35 |
Producer of solvent |
|
40 |
Producer of pharmaceutical substance |
|
60 |
Packer (secondary package) |
|
75 |
Packer (primary package) |
|
99 |
Another |
|
№ of payment order |
Designation of element |
Description |
|
1 |
2 |
3 |
|
1 |
Code |
018 |
|
2 |
Type |
1 reference book |
|
3 |
Name |
list of stages (stages) of production medicines |
|
4 |
Abbreviation |
PESPLS |
|
5 |
Designation |
EU 018-2018 (edition 1) |
|
6 |
Details of the act of adoption (approval) of the reference book (qualifier) |
The decision of Board of the Eurasian economic commission of September 7, 2018 No. 149 |
|
7 |
Date of Introduction in action (the beginning of use) of the reference book (qualifier) |
from the effective date Decisions of Board of the Euroasian economic commission |
|
8 |
Details of the act of phase-out of the reference book (qualifier) |
– |
|
9 |
End date of use of the reference book (qualifier) |
– |
|
10 |
Operator (operators) |
RU, Ministry of Health of the Russian Federation. Authorized organization: Federal State Budgetary Institution Scientific Center of Examination of Means of Medical Application |
|
11 |
Appointment |
the list is intended for systematization of data on extent of participation in production of medicines of different production sites, and also about the phases (stages) of production of medicines completed by them |
|
12 |
Summary |
it is used when forming of the state members of the Eurasian Economic Union of documents represented by subjects of drug circulation to state bodies, including in electronic form, and also for ensuring information exchange in case of realization of general processes within the Eurasian Economic Union |
|
13 |
Keywords |
production of medicines, stage, stage, production site |
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