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APPROVED
Board decision
Eurasian Economic Commission
от от 25 октября 20 2016
G.№ № 122
REGULATIONS
information exchange
between the authorized bodies of the member states of the Eurasian
Economic Union and the Eurasian Economic Commission in the
implementation by means of an integrated information system of foreign
and mutual trade of the general process "Formation, maintenance and
use of a single register of registered medicines of the Eurasian Economic
Union"
I. _ General provisions
1. This Regulation has been developed in accordance with the

following acts included in the law of the Eurasian Economic Union
(hereinafter referred to as the Union) :
Treaty on the Eurasian Economic Union of May 29, 2014 ;
Agreement on uniform principles and rules for the circulation of
medicines within the framework of the Eurasian Economic Union
of December 23, 2014 ;
Decision of the Supreme Eurasian Economic Council
dated December 23, 2014 No. 108 "On the implementation of the Agreement
on uniform principles and rules for the circulation of medicines within the
Eurasian Economic Union" ;
Decision of the Board of the Eurasian Economic Commission
dated November 6, 2014 No. 200 “On technological documents regulating
information interaction when implementing common processes by means of
2
an integrated information system for foreign
and mutual trade” ;
dated January 27, 2015 No. 5 "On approval of the Rules for electronic data
interchange in the integrated information system of foreign
and mutual trade" ;
dated April 14, 2015 No. 29 “On the list of general processes within the
framework of the Eurasian Economic Union and amendments to the Decision
of the Board of the Eurasian Economic Commission dated August 19, 2014
No. 132” ;
dated June 9, 2015 No. 63 “On the Methodology for Analysis, Optimization,
Harmonization and Description of General Processes within the Eurasian
Economic Union” ;
dated September 28, 2015 No. 125 “On approval of the Regulations on the
exchange of electronic documents in the course of cross-border interaction
between public authorities of states - members of the Eurasian Economic
Union among themselves and with the Eurasian Economic Commission” ;
dated December 22, 2015 No. 172 "Nomenclature of dosage forms" .
II . Application area
2 . This Regulation has been developed in order to ensure the uniform

application by the participants of the general process of the procedure and
conditions for performing transactions of the general process " Formation,
3
maintenance and use of a single register of registered medicines of the
Eurasian Economic Union " (hereinafter referred to as the general process).
3 . This Regulation defines the requirements for the procedure and
conditions for performing operations of the general process, directly aimed at
the implementation of information interaction between participants in the
general process.
4 . This Regulation is applied by the participants of the general process
when monitoring the procedure for performing procedures and operations
within the framework of the general process, as well as when designing,
developing and finalizing the components of information systems that ensure
the implementation of this general process .
III . Basic concepts
5. For the purposes of this Regulation, concepts are used that mean the
following:
" Attribute of an electronic document (information) " - a data unit of an
electronic document (information), which in a certain context is considered
inseparable ;
" state of the information object of the general process " - a property
that characterizes the information object at a certain stage of its life cycle,
changing when performing operations of the general process .
The terms "initiator", "initiating operation", "accepting operation",
"respondent", "message of the general process" and "transaction of the
general process" are used in these Regulations in the meanings determined by
the Methodology for the analysis, optimization, harmonization and
description of general processes within the framework of of the Eurasian
Economic Union, approved by the Decision of the Board of the Eurasian
4
Economic Commission dated June 9, 2015
No. 63.
Other concepts used in this Regulation shall be used in the meanings
defined in paragraph 4 of the Rules for Information Interaction when
implementing by means of an integrated information system for foreign and
mutual trade the general process "Formation, maintenance and use of a
unified register of registered medicines of the Eurasian Economic Union",
approved by the Decision of the Board Eurasian Economic Commission от
25 октября 2016 г. № 122от 20 г. № (hereinafter referred
to as the Rules for Information Interaction).
IV . Basic information about the information

interaction within the overall process
1. Participants of information interaction
6 . The list of roles of participants in information interaction

within the overall process is given in Table 1 .
Table 1
List of roles of participants in information exchange
Role name Role Description Role Member
one 2 3
Information owner submits information about changes to notified body of a member

update the general register, requests state ( P . MM .01. ACT .001)
up-to-date information from the authorized body of the
general register, provides information reference state ( P . MM .01.
from the registration file or ACT .002)
registration dossier upon request
Coordinator is responsible for the formation and Eurasian Economic

maintenance of the general register, Commission ( P. ACT .001 )
provides access to the information
contained
in the general register, requests
5
Role name Role Description Role Member
one 2 3
information from the registration file

or registration dossier
2. Structure of information exchange
7 . Information interaction within the framework of the overall process

is carried out between the authorized bodies of the Member States of the
Union and the Eurasian Economic Commission (hereinafter, respectively, the
authorized body of the Member State, the Commission) in accordance with
the procedures of the overall process:
information interaction during the formation and maintenance of the
general register ;
information exchange upon receipt of information from the general
register ;
information interaction upon receipt by the Commission of information
contained in the registration file or registration dossier .
The structure of information interaction between the authorized bodies
of the Member States and the Commission is shown in Figure 1.
6
Rice. 1 . The structure of information interaction between the authorized bodies of the Member
States and the Commission
8 . Information interaction between the authorized bodies of the

Member States and the Commission is carried out within the framework of
the general process. The structure of the overall process is defined in the
Communication Rules .
9 . Information interaction determines the order of execution of
transactions of the common process, each of which is an exchange of
messages in order to synchronize the states of the information object of the
common process between participants in the common process. For each
informational interaction, the relationships between operations and the
transactions of the general process corresponding to such operations are
determined .
10 . When executing a general process transaction, the initiator
sends a request message to the respondent as part of the operation it is
performing (initiating operation) , in response to which the respondent, as
7
part of the operation it is performing (receiving operation), may or may not
send a response message,
depending on the general process transaction template . The data structure in
the message must match On the description of the formats and structures of
electronic documents and information used for the implementation by means
of an integrated information system of foreign and mutual trade of the
general process " Formation, maintenance and use of a unified register of
registered medicines of the Eurasian Economic Union ", approved by the
Decision of the Board of the Eurasian Economic Commission от 25 октября
2016 г. № 122от 20 г. № (hereinafter - Description of
formats and structures of electronic documents and information) .
11 . Transactions of the common process are performed in accordance
with the specified parameters of transactions of the common process, as
defined by these Regulations.
V. _ Information exchange within procedure groups
one. Information interaction in the formation and maintenance of the general

register
12 . The scheme for performing transactions of the general process

during the formation and maintenance of the general registry is shown in
Figure 2. For each procedure of the general process, Table 2 shows the
relationship between operations, intermediate and resulting states of
information objects of the general process and transactions of the general
process .
8
Rice. 2 . The scheme for performing transactions of the general process during the formation and
maintenance of the general register
9
Table _ 2
List of transactions of the general process in the formation and maintenance of the general register
No. Operation performed by the Intermediate state of the The operation performed The resulting state of Shared Process
p/p initiator common process information by the respondent the common process Transaction
object information object
one 2 3 four 5 6
one Inclusion of information in the general registry (P.MM.01.PRC.001)
1. Submission of information general registry receiving and processing general register transfer of
one for inclusion in the general (P.MM.01.BEN.001): information about the (P.MM.01.BEN.001): information on the
registry (P.MM.01.OPR.001). inclusion information application included in application number registration of a
Receiving a message submitted the general register submitted. medicinal product for
containing information about (P.MM.01.OPR.002) general registry inclusion in the
the unique registration (P.MM.01.BEN.001): general register
number assigned to the information received (P.MM.01.TRN.001)
application
(P.MM.01.OPR.003)
2 Changing the information contained in the general registry (P.MM.01.PRC.002)
2. Submission of information general registry receiving and processing general registry transfer of
one for making changes (P.MM.01.BEN.001): change information for making (P.MM.01.BEN.001): information on the
to the general registry information submitted changes to the general updated registration of a
(P.MM.01.OPR.004). registry medicinal product for
Receive notification of the (P.MM.01.OPR.005) change in the general
results of changes to the registry
general registry (P.MM.01.TRN.002)
(P.MM.01.OPR.006)
10
one 2 3 four 5 6
3 Exclusion of information from the general registry (P.MM.01.PRC.003)
3. Submission of information general registry receiving and processing general registry transfer of
one for exclusion from the (P.MM.01.BEN.001): information about an (P.MM.01.BEN.001): information on the
general register exclusion details passed application being updated registration of a
(P.MM.01.OPR.009). excluded from the medicinal product for
Receive notification of the general register exclusion from the
results of deleting application (P.MM.01.OPR.010) general register
details from the general (P.MM.01.TRN.003)
registry (P.MM.01.OPR.011)
eleven
2. Information exchange when obtaining information

from the general register
13 . The scheme of execution of transactions of the general process

when obtaining information from the general registry is shown in Figure 3.
For each procedure of the general process, Table 3 shows the relationship
between operations, intermediate and resulting states of information objects
of the general process and transactions of the general process .
12
Rice. 3 . Scheme of executing transactions of the general process when obtaining information
from the general registry
13
Table _ 3
The list of transactions of the general process when obtaining information from the general registry
one 2 3 four 5 6
one Obtaining information about the date and time of updating the general registry (P.MM.01.PRC.007)
1. Request information about general registry preparation and general registry obtaining information
one the date and time of updating (P.MM.01.BEN.001): update submission of (P.MM.01.BEN.001): about the date and
the general registry date and time information information on the date update date and time time of updating the
(P.MM.01.OPR.020). requested and time of updating the information received general registry
Reception and processing of general registry (P.MM.01.TRN.004)
information on the date and (P.MM.01.OPR.021)
time of updating the general
registry (P.MM.01.OPR.022)
2 Obtaining information from the general registry (P.MM.01.PRC.008)
2. Request for information from general registry preparation and general registry obtaining information
one the general registry (P.MM.01.BEN.001): submission of (P.MM.01.BEN.001): from the general
(P.MM.01.OPR.023). information requested information from the no information registry
Reception and processing of general register available. (P.MM.01.TRN.005)
information from the general (P.MM.01.OPR.024) general registry
register (P.MM.01.OPR.025) (P.MM.01.BEN.001):
information provided
14
one 2 3 four 5 6
3 Obtaining information about changes made to the general registry (P.MM.01.PRC.009)
3. Request for changed general registry preparation and general registry getting changed
one information from the general (P.MM.01.BEN.001): submission of modified (P.MM.01.BEN.001): information from the
registry (P.MM.01.OPR.026). modified information information from the no information general registry
Acceptance and processing of requested general registry changed. (P.MM.01.TRN.006)
changed information from the (P.MM.01.OPR.027) general registry
general registry (P.MM.01.BEN.001):
(P.MM.01.OPR.028) modified information
provided
four Obtaining a registration certificate number (P.MM.01.PRC.010)
4. Registration certificate general registry preparation and general registry obtaining a

one number request (P.MM.01.BEN.001): submission of the (P.MM.01.BEN.001): registration certificate
(P.MM.01.OPR.029). marketing authorization marketing authorization marketing number for a
Receipt and processing of the number requested number authorization number medicinal product
registration certificate (P.MM.01.OPR.030) provided (P.MM.01.TRN.007)
number (P.MM.01.OPR.031)
16
3. Information interaction upon receipt by the Commission of information

contained in the registration file
14 . The scheme for performing transactions of the general process

when the Commission receives the information contained in the registration
file or registration dossier is shown in Figure 4. For each procedure of the
general process, Table 4 shows the relationship between operations,
intermediate and resulting states of information objects of the general process
and transactions of the general process .
Rice. 4 . Scheme of execution of transactions of the general process upon receipt by the
Commission of the information contained in the registration file or registration dossier
16
Table _ four
List of transactions of the general process upon receipt by the Commission of the information contained
in the registration file or registration dossier
one 2 3 four 5 6
one Obtaining information from the registration file or registration dossier by the Commission (P.MM.01.PRC.011)
1. Request by the Commission registration dossier or file preparation and information of the receipt by the
one for information from the information submission registration dossier or Commission of
registration file or registration (P.MM.01.BEN.004): to the Commission of file information from the
dossier (P.MM.01.OPR.032). information requested information from the (P.MM.01.BEN.004): registration file or
Reception and processing by registration file or no information. registration dossier
the Commission of registration dossier registration dossier or (P.MM.01.TRN.008)
information from the (P.MM.01.OPR.033) file information
registration file or registration (P.MM.01.BEN.004):
dossier (P.MM.01.OPR.034) information submitted
17
VI . Description of general process messages
15 . The list of messages of the general process transmitted as part of

the information exchange during the implementation of the general process is
given in Table 5. The data structure in the message must comply with the
Description of formats and structures of electronic documents and
information. The link to the corresponding structure in the Description of
formats and structures of electronic documents and information is established
by the value of column 3 of the table 5.
Table 5
Common process message list
code designation Name The structure of the electronic
document (information)
one 2 3
P.MM.01.MSG.001 information on the registration information on the registration of

of the medicinal product for the medicinal product
inclusion in the general register (R.HC.MM.01.001)

of a medicinal product for the medicinal product
changes in the general register (R.HC.MM.01.001)

of a medicinal product for the medicinal product
exclusion from the general (R.HC.MM.01.001)
register
P.MM.01.MSG.004 notification of acceptance and notification of the result of

processing of information processing (R.006)
P.MM.01.MSG.005 request for information about share update state (R.007)

the date and time of updating
the general registry
P.MM.01.MSG.006 information about the date and share update state (R.007)
time of updating the general
registry
18
code designation Name The structure of the electronic
document (information)
one 2 3
P.MM.01.MSG.007 request for information from the information on the registration of

general register the medicinal product
(R.HC.MM.01.001)
P.MM.01.MSG.008 information from the general information on the registration of

register the medicinal product
(R.HC.MM.01.001)
P.MM.01.MSG.009 notification of the absence of notification of the result of

information in the general processing (R.006)
register
P.MM.01.MSG.010 requesting changed information share update state (R.007)
P.MM.01.MSG.011 changed information information on the registration of

from the general registry the medicinal product
(R.HC.MM.01.001)
P.MM.01.MSG.013 information about the information about the registration

application number certificate number for the
medicinal product
(R.HC.MM.01.004)
P.MM.01.MSG.014 request for information about information about the registration

the registration certificate certificate number for the
number of the medicinal medicinal product
product (R.HC.MM.01.004)
P.MM.01.MSG.015 information about the information about the registration

registration certificate number certificate number for the
of the medicinal product medicinal product
(R.HC.MM.01.004)
P.MM.01.MSG.018 missing information notice notification of the result of

processing (R.006)
P.MM.01.MSG.019 request for information from the information of the registration file
registration file or registration or registration dossier for the
dossier medicinal product
(R.HC.MM.01.003)
P.MM.01.MSG.020 information from the information of the registration file

registration file or registration or registration dossier for the
dossier medicinal product
(R.HC.MM.01.003)
19
VII . Description of general process transactions
one. Transaction of the general process "Transfer of information about the

registration of a medicinal product for inclusion
in the general registry" ( P . MM .01. TRN .001)
16 . Transaction of the general process "Transfer of information about

the registration of a medicinal product for inclusion in the general registry"
( P.MM.01.TRN.001 ) is performed for the initiator to transfer to the
respondent information about a new application for updating the general
registry. Execution scheme The specified t transaction of the general process
is shown in Figure 5. The parameters of the t transaction of the general
process are given in Table 6 .
Rice. 5. Scheme for executing the transaction of the general process " Transfer of information
about the registration of a medicinal product for inclusion
in the general registry " ( P.MM.01.TRN.001)
20
Table 6
Description of the transaction of the general process "Transfer of information
about the registration of a medicinal product for inclusion

in the general registry" (P.MM.01.TRN.001)
No. Required element Description
p/p
one 2 3
one code designation P.MM.01.TRN.001
2 The name of the transaction of transfer of information on the registration of a

the general process medicinal product for inclusion in the general register
3 Generic Process Transaction request/response

Template
four Initiating role initiator
5 Initiating operation sending information for inclusion in the general

register
6 Responsive role respondent
7 Accepting operation receiving and processing information for inclusion

in the general register
eight The result of the execution of general registry ( P . MM .01. BEN .001) :
the transaction of the general application number submitted
process general register ( P . MM .01. BEN .001) :
information received
9 General process transaction

parameters:
time to confirm -
receipt
acceptance 1 minute
confirmation time
response time 5 minutes
authorization sign Yes
number of 2
repetitions
21
p/p
one 2 3
ten Shared Process Transaction

Messages:
trigger message information on the registration of a medicinal product
for inclusion in the general registry ( P . MM .01.
MSG .001 )
response message information about the application number ( P . MM
.01. MSG .013 )
notification of receipt and processing of information (
P . MM .01. MSG .004 )
elev General process transaction

en message parameters:
EDS sign no - for P . MM.01 . MSG .001 _
no - for P . MM.01 . MSG.013 _

transfer of an -
electronic document with an
incorrect digital signature
2 . Transaction of the general process "Transfer of information about the

registration of a medicinal product for change
in the general registry" ( P . MM .01. TRN .002)
17 . Transaction of the general process "Transfer of drug registration

information for changes in the general registry" ( P.MM.01.TRN.002 ) is
performed for the initiator to send the changed drug registration information
to the respondent in order to update the general registry . Execution scheme
the specified t transaction of the general process is shown in Figure 6. The
parameters of the t transaction of the general process are given in table 7 .
22
about the registration of a medicinal product for changes
in the general registry " ( P.MM.01.TRN.002)
Table 7
about the registration of a medicinal product for change

in the general registry" (P.MM.01.TRN.002)
p/p
one 2 3

the general process medicinal product for change in the general register

Template
5 Initiating operation sending information for making changes

to the general register
7 Accepting operation receiving and processing information for making

changes to the general register
eight The result of the execution of general registry ( P . MM .01. BEN .001) : updated
the transaction of the general
process
23
p/p
one 2 3

parameters:
time to confirm -
receipt
acceptance 20 minutes
confirmation time
response time 4h
number of 3
repetitions

Messages:
for change in the general registry ( P . MM .01. MSG
.002 )
response message notification of receipt and processing of information (
P . MM .01. MSG .004 )

no - for P . MM.01 . MSG.004 _

transfer of an -
3. Transaction of the general process "Transfer of information about the

registration of a medicinal product for exclusion
from the general register" ( P . MM .01. TRN .003)
18 . Transaction of the general process “Transfer of information on

registration of a medicinal product for exclusion from the general register”
( P.MM.01.TRN.003 ) is performed for the initiator to transfer to the
24
respondent information on registration of a medicinal product to be excluded
from the general register for updating the general register. Execution scheme
the specified t transaction of the general process is shown in Figure 7. The
parameters of the t transaction of the general process are given in Table 8 .
about the registration of a medicinal product for exclusion
from the general register " ( P.MM.01.TRN.003)
Table eight
about the registration of a medicinal product for exclusion

from the general register" (P.MM.01.TRN.003)
p/p
one 2 3

the general process medicinal product for exclusion from the general
register

Template
5 Initiating operation sending information for exclusion from the general

register
25
p/p
one 2 3
7 Accepting operation acceptance and processing of information for

exclusion from the general register
the transaction of the general
process

parameters:
time to confirm -
receipt
confirmation time
response time 4h
number of 3
repetitions

Messages:
for exclusion from the general register ( P . MM .01.
MSG .003 )
response message notification of receipt and processing of information (
P . MM .01. MSG .004 )

no - for P . MM.01 . MSG.004 _

transfer of an -
26
4 . Transaction of the general process "Obtaining information about the date
and time of updating the general registry" ( P . MM .01. TRN .004)
19 . The transaction of the general process "Getting information about

the date and time of the update of the general registry" ( P.MM.01.TRN.004 )
is performed to provide the respondent, at the request of the initiator , with
information about the date and time of the update of the general registry.
Execution scheme the specified t transaction of the general process is shown
in Figure 8. The parameters of the t transaction of the general process are
given in table 9 .
Rice. 8. Scheme for executing the transaction of the general process " Obtaining information
about the date and time of updating the general registry " ( P.MM.01.TRN.004)
Table 9
Description of the transaction of the general process "Obtaining information
about the date and time of updating the general registry"
(P.MM.01.TRN.004)
p/p
one 2 3
2 The name of the transaction of obtaining information about the date and time of
the general process updating the general registry
27
p/p
one 2 3
3 Generic Process Transaction question answer

Template
5 Initiating operation requesting and receiving information about the date

and time of updating the general registry
7 Accepting operation providing information on the date and time of

updating the general registry
the transaction of the general date and time information received
process

parameters:
time to confirm -
receipt
acceptance -
confirmation time
response time 4h
number of 3
repetitions

Messages:
trigger message request for information on the date and time of
updating the general registry ( P . MM .01. MSG
.005 )
response message information about the date and time of updating the
general registry ( P . MM .01. MSG .006 )
28
p/p
one 2 3

EDS sign No
transfer of an -
5 . Transaction of the general process "Getting information

from the general registry" ( P . MM .01. TRN .005)
20 . The transaction of the general process "Getting information from

the general registry" ( P.MM.01.TRN.005 ) is performed for the respondent
to provide information from the general registry at the request of the initiator.
Execution scheme the specified t transaction of the general process is shown
in Figure 9. The parameters of the t transaction of the general process are
given in table 10 .
Rice. 9. Scheme of execution of the transaction of the general process " Obtaining information
from the general registry " ( P.MM.01.TRN.005)
29
Table ten
Description of the transaction of the general process "Obtaining information
from the general registry" (P.MM.01.TRN.005)
p/p
one 2 3
2 The name of the transaction of obtaining information from the general register
the general process

Template
5 Initiating operation requesting and obtaining information from the

general register
7 Accepting operation submission of information from the general register
eight The result of the execution of general registry ( P . MM .01. BEN .001) : not
the transaction of the general available
process general registry ( P . MM .01. BEN .001) :

parameters:
time to confirm -
receipt
confirmation time
response time 4h
number of 3
repetitions
30
p/p
one 2 3

Messages:
trigger message request for information from the general registry ( P .
MM .01. MSG .007 )
response message notification of the absence of information in the
information from the general register ( P . MM .01.
MSG .008 )

EDS sign No
transfer of an -
6 . Transaction of the general process "Receiving changed information

from the general registry" ( P . MM .01. TRN .006)
21 . The transaction of the general process "Receiving changed

information from the general registry" ( P.MM.01.TRN.006 ) is performed
for the respondent to submit , at the request of the initiator, the changed
information from the general registry. Execution scheme the specified t
transaction of the general process is shown in Figure 10. The parameters of
the t transaction of the general process are given in table 11 .
31
Rice. 10. Scheme of execution of the transaction of the general process " Obtaining changed
information from the general registry " ( P.MM.01.TRN.006)
Table eleven
Description of the transaction of the general process "Receiving changed
information from the general registry" (P.MM.01.TRN.006)
p/p
one 2 3
2 The name of the transaction of getting changed information from the general registry
the general process

Template
5 Initiating operation requesting and receiving changed information

7 Accepting operation submission of changed information from the general

register
32
p/p
one 2 3
eight The result of the execution of general registry ( P . MM .01. BEN .001) : no
the transaction of the general information changed
process general registry ( P . MM .01. BEN .001) : modified

parameters:
time to confirm -
receipt
confirmation time
response time 4h
number of 3
repetitions

Messages:
trigger message request for changed information from the general
registry ( P . MM .01. MSG .010 )
response message notification of the absence of information in the
modified information from the general registry ( P .
MM .01. MSG .011 )

EDS sign No
transfer of an -
33
7. Transaction of the general process "Obtaining a registration certificate
number for a medicinal product" ( P . MM .01. TRN .007)
22 . The transaction of the general process “Obtaining a registration

certificate number for a medicinal product ” ( P.MM.01.TRN.007 ) is
performed for the respondent to provide , at the request of the initiator, the
registration certificate number. Execution scheme of the specified t
transaction of the general process is shown in Figure 11. The parameters of
the t transaction of the general process are given
in table 12 .
Rice. 11. Scheme of execution of the transaction of the general process " Obtaining the
registration certificate number of the medicinal
product " ( P.MM.01.TRN.007)
Table _ 12
Description of the transaction of the general process "Obtaining a registration
certificate number for a medicinal
product " (P.MM.01.TRN.007)
p/p
one 2 3

34
p/p
one 2 3
2 The name of the transaction of obtaining a registration certificate number for a

the general process medicinal product

Template
5 Initiating operation requesting and obtaining a registration certificate

number for a medicinal product
7 Accepting operation presentation of the registration certificate number of

the medicinal product
eight The result of the execution of general registry ( P . MM .01. BEN .001) : marketing
the transaction of the general authorization number submitted
process

parameters:
time to confirm -
receipt
acceptance 1 minute
confirmation time
number of 2
repetitions

Messages:
trigger message request for information about the registration
certificate number of the medicinal product ( P . MM
.01. MSG .014 )
response message information about the registration certificate number
of the medicinal product ( P . MM .01. MSG .015 )
35
p/p
one 2 3

EDS sign No
transfer of an -
eight. Transaction of the general process "Reception by the Commission of

information
from the registration file or registration
dossier" ( P . MM .01. TRN .008)
23 . The transaction of the general process “Obtaining information from

the registration file or registration dossier by the Commission”
( P.MM.01.TRN.008 ) is performed for the respondent to provide information
(documents) from the registration file or registration dossier at the request of
the initiator. Execution scheme the specified t transaction of the general
process is shown in Figure 12. The parameters of the t transaction of the
general process are given in table 13 .
36
Rice. 12. Scheme of execution of the transaction of the general process " Obtaining by the
Commission of information from the registration file or registration dossier "
( P.MM.01.TRN.008)
Table 13
Description of the transaction of the general process "Receiving by the
Commission of information from the registration file or registration
dossier" (P.MM.01.TRN.008)
p/p
one 2 3
2 The name of the transaction of receipt by the Commission of information

the general process from the registration file or registration dossier
3 Generic Process Transaction mutual obligations

Template
5 Initiating operation requesting and obtaining information from the

registration file or registration dossier
7 Accepting operation submission of information from the registration file

37
p/p
one 2 3
eight The result of the execution of information of the registration dossier or file ( P .
the transaction of the general MM .01. BEN .004) : no information
process details of the registration dossier or file ( P . MM .01.
BEN .004) : details provided

parameters:
time to confirm -
receipt
acceptance 1 minute
confirmation time
number of 2
repetitions

Messages:
trigger message request for information from the registration file or
registration dossier ( P . MM .01. MSG .019 )
response message information from the registration file or registration
dossier ( P . MM .01. MSG .020 )
missing information notification ( P . MM .01. MSG
.018 )

EDS sign No
transfer of an -
VIII . Procedure for emergency situations
24 . During information interaction within the framework of the general

process , emergency situations are probable when data processing can not be
38
carried out in the usual mode. Abnormal situations occur in case of technical
failures, waiting time, and
in other cases . In order for a participant in the general process to receive
comments on the causes of an emergency situation and recommendations for
its resolution, it is possible to send a corresponding request to the support
service of the integrated information system for foreign and mutual trade.
General recommendations for resolving an emergency situation are given in
table 14.
25 . The authorized body of the Member State checks the message, in
connection with which the error notification was received, for compliance
with the Description of formats and structures of electronic documents and
information and the requirements for message control specified
in section IX of this Regulation. If a non- compliance with the specified
requirements is detected , the authorized body of the Member State takes all
necessary measures to eliminate the identified error. If no discrepancies are
found, the authorized body of the Member State sends a message
describing this emergency situation to the support service of the integrated
information system for foreign and mutual trade.
39
Table 14 _
Actions in emergency situations
Exception code Description of the Causes of an Description of actions
emergency emergency in case of emergency
one 2 3 four
P.EXC.002 the initiator of a two- technical failures in the it is necessary to send a

way transaction of transport system or request to the technical
the general process software system error support service of the
did not receive a national segment in which
response message the message was generated
after the agreed
number of retries
had elapsed
P.EXC.004 the initiator of the directories and the initiator of the

transaction of the classifiers are not transaction of the general
general process synchronized or XML - process needs to
received an error schemes of electronic synchronize the directories
notification documents and classifiers used or
(information) are not update the XML schemas
updated of electronic documents
(information).
If directories and
classifiers are
synchronized, XML -
schemes of electronic
documents (information)
are updated, you must
send a request to the
support service of the
receiving participant
40
IX . Requirements for filling out electronic documents and information
26. Requirements for filling in the details of electronic documents

(information) "Information on registration of a medicinal product"
(R.HC.MM.01.001) transmitted in the message "Information on registration
of a medicinal product for inclusion in the general register" (P.MM.01.
MSG.001) are shown in Table 15.
Table fifteen
Requirements for filling in the details of electronic documents (information)
"Information on registration of a medicinal product" (R.HC.MM.01.001)
transmitted in the message "Information on registration of a medicinal
product for inclusion in the general register" (P.MM.01.MSG. 001)
Requireme Statement of requirement
nt Code
one 1 copy of the requisite "Drug Registration Details"

(hccdo:DrugRegistrationDetails) must be sent in the e-mail
2 1 copy of the requisite "Information on the registration of the medicinal product

in
the Member State" (hccdo:DrugCountryRegistrationDetails) must be transmitted
in the electronic message
3 1 copy of the "Application" requisite (hccdo:DrugApplicationDetails) must be

sent in the e-mail
four the attribute "Start date and time" (csdo:StartDateTime) must be filled
5 attribute "End date and time" (csdo:EndDateTime) is not filled
6 if the requisite "Application type code" (hcsdo:DrugApplicationKindCode)

corresponds to the values "01 - application for registration of a medicinal
product" or "04 - application for bringing the registration dossier of a medicinal
product in accordance with the requirements of the Union", then the requisite
"Ordinal number of the registration certificate of the medicinal product »
(hcsdo:RegistrationNumberId) not populated
7 if the requisite "Application type code" (hcsdo:DrugApplicationKindCode)

corresponds to the values "02 - application for confirmation of registration (re-
registration)" or "03 - application for amendments to the registration dossier",
then the requisite "Ordinal number of the registration certificate of the medicinal
product" (hcsdo :RegistrationNumberId) must be filled
41
nt Code
eight if the value of the "Member State Role Code" (hcsdo:CountryKindCode)

attribute corresponds to the value "01 - reference country", then the "Application
number" (hcsdo:ApplicationId) attribute is not filled
9 if the value of the "Member State Role Code" variable

(hcsdo:CountryKindCode) corresponds to the value "02 - State of Recognition",
then the "Application Number" variable (hcsdo:ApplicationId) must be filled in
ten if the "Application Number" (hcsdo:ApplicationId) variable is filled in, then the
general registry should not contain information for which the values of the
"Country Code" (csdo:UnifiedCountryCode) and "Application Number"
(hcsdo:ApplicationId) details in the "Information on registration of a medicinal
product in a Member State” (hccdo:DrugCountryRegistrationDetails) match the
transmitted values of the specified requisites
eleven if the value of the "Member State Role Code" variable

(hcsdo:CountryKindCode) corresponds to the value "02 - state of recognition",
then the "Information about the registration file (dossier)" variable
(hccdo:RegistrationFileDetails) is not filled in
12 if the value of the requisite "Application type code"

(hcsdo:DrugApplicationKindCode) corresponds to the values
"01 - application for registration of a medicinal product" or "04 - application for
bringing the registration dossier of a medicinal product in line with the
requirements of the Union", then the requisite "Information on the registration
certificate for medicinal product" (hccdo:DrugRegistrationCertificateDetails) is
not filled
13 if the value of the attribute "Application type code"

(hcsdo:DrugApplicationKindCode) corresponds to the values
"02 - application for confirmation of registration (re-registration)" or "03 -
application for amendments to the registration dossier", then the attribute
"Information on the registration certificate for the medicinal product"
(hccdo:DrugRegistrationCertificateDetails) must be filled and correspond to the
value of this attribute in a single registry
fourteen the value of the variable "Code of the stage of consideration of the registration
dossier" (hcsdo:ApplicationStatusCode) must correspond to the value
"01 - application acceptance"
fifteen if the value of the variable "Application type code for a medicinal product"
(hcsdo:DrugApplicationKindCode) corresponds to the value "01 - application
for registration of a medicinal product", then the "Registration procedure type
code" variable (hcsdo:RegistrationKindCode) must be filled in
16 the attribute "Drug Details" (hccdo:DrugDetails) is not filled in
17 the attribute "Details about the general characteristics of the medicinal product"
42
nt Code
(hccdo:DrugGeneralCharacteristicDetails) is not filled in
eighteen the attribute "Information about the instructions for the medical use of the
medicinal product" (hccdo:DrugUsageInstructionDetails) is not filled in
19 the attribute "Information about the final expert report"

(hccdo:ExpertReportDetails) is not filled in
twenty the "Risk Management Plan Details" attribute

(hccdo:RiskManagementPlanDetails) is not filled in
21 the attribute "Information about the regulatory document on the quality of the
medicinal product" (hccdo:QualityRegulatoryDocDetails) is not filled in
22 the attribute "Information about the holder (applicant) of the registration

certificate" (hccdo:RegistrationCertificateHolderDetails) is not filled in
23 if the "Application number" variable (hcsdo:ApplicationId) is filled in, the

general register must contain information for which the "End date and time"
(csdo:EndDateTime) variable is not filled, and the value of the "Application
number" variable (hcsdo:ApplicationId) matches with the transferred
24 _ attribute "Document in PDF format" (hcsdo:PdfBinaryText) is not filled
25 _ attribute "Document in XML format" (hccdo:AnyDetails) is not filled
26 if the value of the variable "Code of the type of the drug registration file
document" (hcsdo:DrugRegistrationFileCode) or the variable "Name of the drug
registration file type document" (hcsdo:DrugRegistrationFileName) corresponds
to the value of "Request for missing additional information, necessary
clarifications or clarifications of documents and the data presented in the
registration dossier" and the "Document element description" attribute
(hcsdo:AttributeText) is filled, then the value of the "document element type
code" attribute (AttributeKindCode attribute) or the "document element type
name" attribute (AttributeKindName attribute) must correspond to the value
"Request response time"
27 if the value of the variable "Code of the drug registration file type document"
(hcsdo:DrugRegistrationFileCode) or the variable "Name of the drug
to the value "Response to a request for missing additional information,
necessary clarifications or clarifications of documents and data presented in the
name" attribute (AttributeKindName attribute) must match the “Foundation
document number”
43
nt Code
document" (hcsdo:DrugRegistrationFileCode) or the variable "Name of the type

of the drug registration file document" (hcsdo:DrugRegistrationFileName)
corresponds to the value "Request for submission of a copy of the
pharmacovigilance system master file" and the attribute “Document element
description” (hcsdo:AttributeText) is filled, then the value of the “Document
element type code” attribute (AttributeKindCode attribute) or the “Document
element type name” attribute (AttributeKindName attribute) must correspond to
the “Request response time”
29 the value of the attribute "identifier of the directory (classifier)"

(attribute codeListId) as part of the complex variable "Country code"
(csdo:UnifiedCountryCode), which is part of any complex variable , must
contain the code designation of the classifier of countries of the world specified
in Section VII of the Rules for Information Interaction
thirty if the attribute "Country code" (csdo:UnifiedCountryCode) as part of any

complex attributes is filled in, then its value must correspond to the country
code from the classifier of countries of the world, which contains a list of codes
and names of countries of the world in accordance with the ISO 3166-1 standard

(hcsdo:DrugApplicationKindCode) corresponds to the value "other", then the
attribute "Application type name" (hcsdo:DrugApplicationKindName) must be
filled in
32 if the value of the variable "Marketing authorization status code for the
medicinal product" (hcsdo:RegistrationStatusCode) corresponds to the value
"other", then the variable "Name of the status of the registration certificate for
the medicinal product" (hcsdo:RegistrationStatusName) must be filled in
33 if the value of the attribute "Special condition type code for the registration of
the medicinal product" (hcsdo:DrugUsageRestrictionKindCode) corresponds to
the value "other conditions or restrictions for the safe and effective use of the
medicinal product", then the attribute "Name of the type of special condition for
the registration of the medicinal product"
(hcsdo:DrugUsageRestrictionKindName) is required
34 if the requisite “Information about the change made to the registration dossier
for the medicinal product” (hccdo:DrugApplicationChangeDetails) is filled in,
then the requisite “Code of the type of change made to the registration dossier”
(hcsdo:ChangeTypeCode) and (or) the requisite "Name of the type of change
made to the registration dossier" (hcsdo: Change ‌Type ‌Name )
35 if the value of the variable "Code of the type of change made to the registration
dossier" (hcsdo:ChangeTypeCode) corresponds to the value "other", then the
variable "Name of the type of change made to the registration dossier"
(hcsdo:ChangeName) must be filled in
44
nt Code
36 if the attribute "Information about the change made to the registration dossier for
the medicinal product" (hccdo:DrugApplicationChangeDetails) is filled in, then
it must contain requisite "Registration dossier section code"
(hcsdo:DossierSectionCode) and (or) requisite "Registration dossier section
name" (hcsdo:DossierSectionName)
37 if the value of the attribute "Registration dossier section code"

(hcsdo:DossierSectionCode) corresponds to the value "other", then the attribute
"Registration dossier section name" (hcsdo:DossierSectionName) must be filled
in
38 if the attribute "Document element description" (hcsdo:AttributeText) is filled

in, then it must contain the attribute "document element type code"
(AttributeKindCode attribute) and (or) the "document element type name"
attribute (AttributeKindName attribute)
39 if the value of the "document element type code"

attribute (AttributeKindCode attribute) corresponds to the value "other", then
the "document element type name"
attribute (AttributeKindName attribute) must be filled in
document" (hcsdo:DrugRegistrationFileCode) corresponds to the value "other",
then the variable "Name of the drug registration file type document"
(hcsdo:DrugRegistrationFileName) must be filled in
41 if the value of the variable "Code of the document type of the registration
dossier for the medicinal product" (hcsdo:DrugRegistrationDocCode)
corresponds to the value "other", then the variable "Name of the document type
of the registration dossier for the medicinal product"
(DrugRegistrationDocName) must be filled in

of a medicinal product for change in the general register" (P.MM.01.
45
Table 16
product for change in the general register" (P.MM.01.MSG. 002)
nt Code

2 1 copy of the requisite "Information on the registration of the medicinal product

in
the Member State" (hccdo:DrugCountryRegistrationDetails) must be transmitted
in the electronic message
3 1 copy of the "Application" requisite (hccdo:DrugApplicationDetails) must be

sent in the e-mail
four if in the electronic message the value of the variable “Member State Role Code”
(hcsdo:CountryKindCode) corresponds to the value “01 – reference country”
and the value of the variable “Registration Dossier Consideration Stage Code”
(hcsdo:ApplicationStatusCode) corresponds to the value “06 – approval of the
expert report” , then the value of the variable "Ordinal number of the registration
certificate of the medicinal product" (hcsdo:RegistrationNumberId) must
correspond to the value of this variable obtained as a result of the procedure of
the general process "Obtaining a registration certificate number"
(P.MM.01.PRC.0 10)
5 the value of the attribute "identifier of the directory (classifier)"

(attribute codeListId) as part of the complex variable "Country code"
(csdo:UnifiedCountryCode), which is part of any complex variable, must
contain the code designation of the classifier of countries of the world specified
in Section VII of the Rules for Information Interaction
6 if the attribute "Country code" (csdo:UnifiedCountryCode) as part of any

code from the classifier of countries of the world, which contains a list of codes
and names of countries of the world in accordance with the ISO 3166-1 standard
7 the e-mail must contain the "Application Number" (hcsdo:ApplicationId) and/or

the "Registration Certificate Number" (hcsdo:RegistrationCertificateId)
46
nt Code
eight the general registry must contain information for which the values of the
following requisites coincide with the transmitted, not filled in requisite "End
date and time" (csdo:EndDateTime), as well as a smaller value of the requisite
"Start date and time" (csdo:StartDateTime):
"Number Application" (hcsdo:ApplicationId); "Registration Certificate
Number" (hcsdo:RegistrationCertificateId); "Country Code"
(csdo:UnifiedCountryCode);"Member State Role Code"
(hcsdo:CountryKindCode)
9 if the value of the variable "Code of the stage of consideration of the registration
dossier" (hcsdo:ApplicationStatusCode) corresponds to the value "06 - approval
of the expert report" and the value of the variable "Member state role code"
(hcsdo:CountryKindCode) corresponds to the value "01 - reference state", then
the variable "Drug Details" (hccdo:DrugDetails) is required
ten if the value of the variable "Code of the stage of consideration of the registration
the variable "Information about the holder (applicant) of the registration
certificate" (hccdo:RegistrationCertificateHolderDetails) is required
eleven if the value of the variable "Code of the stage of consideration of the registration
the variable “Drug Registration Certificate Details”
(hccdo:DrugRegistrationCertificateDetails) is mandatory
12 if the value of the "Member State Role Code" (hcsdo:CountryKindCode)

variable corresponds to the value "02 - State of Recognition", then the "Drug
Product Details" (hccdo:DrugDetails) variable is not filled in
13 if the value of the variable "Member State role code" (hcsdo:CountryKindCode)

corresponds to the value "02 - state of recognition", then the following nested
details can be filled in the complex variable "Medicinal product registration
information in the Member State" (hccdo:DrugCountryRegistrationDetails) :
"Trade name of the medicinal product" (hcsdo:DrugTradeName); "Information
on the documents of the registration dossier of the medicinal product entered in
the unified register" (hccdo:DrugDocumentsDetails); "Information on the
registration certificate for the medicinal product"
(hccdo:DrugRegistrationCertificateDetails);
" Statement " ( hccdo:‌Drug‌Application‌Details )
fourteen if the value of the variable "Code of the stage of consideration of the registration
dossier" (hcsdo:ApplicationStatusCode) corresponds to the value
"06 - approval of the expert report", then the variable "Details of the registration
47
nt Code
certificate for the medicinal product"

(hccdo:DrugRegistrationCertificateDetails) must be filled in
fifteen if the value of the variable "Application type code"

(hcsdo:DrugApplicationKindCode) corresponds to the value
"02 - application for confirmation of registration (re-registration)" and the value
of the variable "Registration dossier review stage code"
(hcsdo:ApplicationStatusCode) corresponds to the value "06 - approval of the
expert report" , then the attribute "Date" (csdo:EventDate) as part of the attribute
"Details of the registration certificate for a medicinal product"

(hcsdo:DrugApplicationKindCode) corresponds to the value
"03 - application for amendments to the registration dossier" and the value of the
attribute "Code of the registration dossier review stage"
expert report" , then the attribute "Information about the change made to the
registration dossier for the medicinal product"
(hccdo:DrugApplicationChangeDetails) must be filled in
17 if the value of the variable "Status code of the registration certificate for the
medicinal product" (hcsdo:RegistrationStatusCode) corresponds to the value "02
- canceled", then the attribute "Note" (csdo:NoteText) as part of the variable
"Information about the registration certificate for the medicinal product" (hccdo:
DrugRegistrationCertificateDetails) is required
eighteen if the value of the attribute "Marketing authorization status code for a medicinal
product" (hcsdo:RegistrationStatusCode) corresponds to the value "02 -
canceled", then the attribute "Date of cancellation of the registration certificate"
(hcsdo:CertificateCancelDate)
is required
19 if the “Drug product information” (hccdo:DrugDetails) variable is filled in, then

one of the “Dosage form code” (hcsdo:DosageFormCode), “Drug form name”
(hcsdo:DosageFormName) or “Raw material” herbal ingredient"
(hcsdo:RawPartMaterialText)
twenty if the "Details of the registration file document (dossier)" attribute

(hccdo:RegistrationFileDetails) is filled in, then the value of the "Member State
role code" (hcsdo:CountryKindCode) attribute must correspond to the value "01
- reference country"
21 if the value of the "Member State Role Code" variable

(hcsdo:CountryKindCode) corresponds to the value "02 - state of recognition",
then the "Information about the registration file (dossier)" variable
(hccdo:RegistrationFileDetails) is not filled in
48
nt Code
22 the attribute "Start date and time" (csdo:StartDateTime) must be filled
23 attribute "End date and time" (csdo:EndDateTime) is not filled
24 if the value of the variable "Application type code for a medicinal product"
(hcsdo:DrugApplicationKindCode) corresponds to the value "01 - application
for registration of a medicinal product", then the "Registration procedure type
code" variable (hcsdo:RegistrationKindCode) must be filled in
25 if the value of the variable “Member State Role Code”

(hcsdo:CountryKindCode) corresponds to the value “01 – reference state”, the
value of the variable “Registration dossier review stage code”
expert report”, then the attribute Drug General Characteristic Details
(hccdo:DrugGeneralCharacteristicDetails) must be completed
26 if the value of the attribute “Member State Role Code”

(hcsdo:CountryKindCode) corresponds to the value “01 – reference state” and
the value of the attribute “Registration Dossier Consideration Stage Code”
expert report”, then the attribute "Details of the final expert report"
(hccdo:ExpertReportDetails) must be filled
27 if the value of the variable “Member State Role Code”

(hcsdo:CountryKindCode) corresponds to the value “01 – reference state” and
the value of the variable “Registration dossier review stage code”
expert report”, then the attribute "Details of the regulatory document on the
quality of the medicinal product" (hccdo:QualityRegulatoryDocDetails) must be
completed
"06 - approval of the expert report", then the variable "Details of the registration
certificate for the medicinal product"
"06 - approval of the expert report", then the variable "Information on the
instructions for the medical use of the medicinal product"
(hccdo:DrugUsageInstructionDetails) must be filled in
thirty if the value of the attribute "Code of the registration dossier review stage"
expert report", then the attribute "DrugPackageLayoutDetails"
(hccdo:DrugPackageLayoutDetails) must be filled in
49
nt Code
31 the attribute "Document in PDF format" (hcsdo:PdfBinaryText) as part of the

complex attribute "Information about the document of the registration file
(dossier)" (hccdo:RegistrationFileDetails) is not filled
32 the attribute "Document in XML format" (hccdo:AnyDetails) as part of the

to the value of "Request for missing additional information, necessary
clarifications or clarifications of documents and the data presented in the
name" attribute (AttributeKindName attribute) must correspond to the value
"request response time"
to the value "response to a request for missing additional information, necessary
clarifications or clarifications of documents and data presented in the
name" attribute (AttributeKindName attribute) must match the value "base
document number"
document" (hcsdo:DrugRegistrationFileCode) or the variable "Name of the type
of the drug registration file document" (hcsdo:DrugRegistrationFileName)
corresponds to the value "request to submit a copy of the pharmacovigilance
system master file" and the attribute “Document element description”
(hcsdo:AttributeText) is filled, then the value of the “document element type
code” attribute (AttributeKindCode attribute) or the “document element type
name” attribute (AttributeKindName attribute) must correspond to the value
“request response time”
36 if the value of the variable "Code of the type of the registration file document
for the medicinal product" (hcsdo:DrugRegistrationFileCode) or the variable
"Name of the type of the drug registration file document type"
(hcsdo:DrugRegistrationFileName) corresponds to the value "request of the state
of recognition in relation to the documents of the registration dossier" and the
variable " Document element description (hcsdo:AttributeText) is filled, then the
50
nt Code
value of the attribute “document element type code” (AttributeKindCode

attribute) or the attribute “document element type name” (AttributeKindName
attribute) must correspond to the value “document type of the registration
dossier in respect of which the request is sent”
to the value "response to the request of the state of recognition regarding the
registration dossier documents" and the "Document element description"
attribute (hcsdo:AttributeText) is filled, then the value of the "document element
type code" attribute (AttributeKindCode attribute) or the "document element
type name" attribute (AttributeKindName attribute) must correspond to the
value of "base document number"
to the value "Response to comments from the state of recognition" and the
attribute "Element description document" (hcsdo:AttributeText) is filled, then
the value of the "document element type code" attribute (AttributeKindCode
attribute) or the "document element type name" attribute (AttributeKindName
attribute) must correspond to the value "base document number"
39 if the attribute "Address type code" (csdo:AddressKindCode) as part of the

complex attribute "Address" (ccdo:SubjectAddressDetails) is filled, then its
value must match one of the following values:
1 - "address of registration";
2 - "actual address";
3 - "postal address"
40 if the value of the "dosage and concentration measurement unit code" attribute
(the SubstanceMeasureCode attribute) corresponds to the value "other", then the
"dosage and concentration unit name" attribute (the SubstanceMeasureName
attribute) must be filled in

(hcsdo:DrugApplicationKindCode) corresponds to the value "other", then the
attribute "Application type name" (hcsdo:DrugApplicationKindName) must be
filled in
dossier" (hcsdo:ApplicationStatusCode) corresponds to the value "other", then
the variable "Name of the stage of consideration of the registration dossier"
(hcsdo:ApplicationStatusName) must be filled in
43 if the value of the variable "Marketing authorization status code for a medicinal
51
nt Code
product" (hcsdo:RegistrationStatusCode) corresponds to the value "other", then

the variable "Name of the status of the registration certificate for a medicinal
product" (hcsdo:RegistrationStatusName) must be filled in
44 if the value of the attribute "Special condition type code for drug registration"
(hcsdo:DrugUsageRestrictionKindCode) corresponds to the value "other
conditions or restrictions for the safe and effective use of the medicinal
product", then the attribute "Special condition type name for drug registration"
(hcsdo:DrugUsageRestrictionKindName) is required
45 if the requisite "Information about the change made to the registration dossier
for the medicinal product" (hccdo:DrugApplicationChangeDetails) is filled in,
then the requisite "Code of the type of change made to the registration dossier"
must be filled in its composition (hcsdo:ChangeTypeCode) and (or) the attribute
"Name of the type of change made to the registration dossier" (hcsdo: Change ‌
Type ‌Name )
46 if the value of the variable "Code of the type of change made to the registration
dossier" (hcsdo:ChangeTypeCode) corresponds to the value "other", then the
variable "Name of the type of change made to the registration dossier" (hcsdo:
Change ‌Type ‌Name ) must be filled in
47 if the value of the attribute "Registration dossier section code"

(hcsdo:DossierSectionCode) corresponds to the value "other", then the attribute
"Registration dossier section name" (hcsdo:DossierSectionName) must be filled
in
48 if the value of the "document element type code" attribute (AttributeKindCode

attribute) corresponds to the value "other", then the "document element type
name" attribute (AttributeKindName attribute) must be filled in
document" (hcsdo:DrugRegistrationFileCode) corresponds to the value "other",
then the variable "Name of the drug registration file type document"
fifty if the value of the variable "Code of the document type of the registration
dossier for the medicinal product" (hcsdo:DrugRegistrationDocCode)
corresponds to the value "other", then the variable "Name of the document type
of the registration dossier for the medicinal product"
(DrugRegistrationDocName) must be filled in
51 if the attribute “Drug product information” (hccdo:DrugDetails) is filled in, then

the attribute “ATC Code” (hcsdo:ATCCode) must be filled in it, or requisite
"Name of the medicinal product in accordance with the ATC classification"
(hcsdo:ATCName)
52 if the value of the attribute "Additional feature code of the medicinal product"
52
nt Code
(hcsdo:DrugAdditionalFeatureCode) corresponds to the value "other", then the

variable "Name of the additional feature of the medicinal product"
(hcsdo:DrugAdditionalFeatureName) must be filled in
53 if the value of the variable "Degree of refinement of the raw part of the herbal
ingredient" (hcsdo:DegreeRefinementRawMaterialCode) corresponds to the
value "other", then the prop "Name of the degree of refinement of the raw part
of the herbal ingredient" (hcsdo:DegreeRefinementRawMaterialName) must be
filled in
54 if the "Address" (ccdo:SubjectAddressDetails) attribute is filled in as part of any

complex details, then the "Country Code" (csdo:UnifiedCountryCode) attribute
must be filled in as part of it
55 if the attribute "Address" (ccdo:SubjectAddressDetails) is filled in as part of any

complex details, then the attribute "Address type code"
(csdo:AddressKindCode) must be filled in as part of it

complex details, then the attribute "City" (csdo:CityName) or the attribute
"Settlement" (csdo:SettlementName) must be filled in its composition

complex details, then the attribute "Street" (csdo:StreetName) must be filled in
as part of it
58 if the "Contact details" attribute ( ccdo : CommunicationDetails ) is filled in as

part of any complex details, then the "Communication type code" attribute
( csdo : CommunicationChannelCode ) or the "Communication type name"
attribute ( csdo : CommunicationChannelName ) must be filled in its
composition
59 if the "CommunicationChannelCode" attribute

(csdo:CommunicationChannelCode) is filled in, then its value must correspond
to one of the following values:
AO - "website address on the Internet";
TE - "telephone";
EM - "e-mail";
FX - telefax
60 if the “Drug Name Details” variable ( hccdo : ‌Drug ‌Name ‌Details ) is filled in,
then the “Drug Name Code” (hcsdo:DrugCode) variable or the “Drug Name”
(hcsdo: drug name)
61 if the attribute "Information about the active pharmaceutical substance in the

composition of the medicinal product" ( hccdo : ‌Active ‌Substance ‌Details ) is
filled in, then the attribute " Code of the active pharmaceutical substance" (
hcsdo : ‌Active ‌Substance ‌Code ) must be filled in its composition, or " Name
53
nt Code
of the active pharmaceutical substance"

( hcsdo : ‌Active ‌Substance ‌Name )
62 if the value of the attribute “Code of the function of a substance (substance,

material) in the composition of the medicinal product” ( hcsdo : ‌Drug ‌
Substance ‌Role ‌Code ) or the attribute “ Name of the function of the substance
(substance, material) in the composition of the medicinal product” ( hcsdo : ‌
Drug ‌Substance ‌Role ‌Name ) corresponds to the value “ active substance ”,
then as part of the complex variable “ Information about the ingredient that is
part of the medicinal product” ( hccdo : ‌Substance ‌Details ), the attribute “
Information about the active pharmaceutical substance in the composition ”
must be filled in medicinal product" ( hccdo : ‌Active ‌Substance ‌Details )

Drug ‌Substance ‌Role ‌Name ) corresponds to the value “ active substance ”,
then as part of the complex variable “ Information about the ingredient that is
part of the medicinal product” ( hccdo : ‌Substance ‌Details ) the details “
Information about the excipient in the composition of the medicinal product”
( hccdo : ‌Auxiliary ‌Substance ‌Details ) and “ Name of the reagent that is part
of the medicinal product” ( hcsdo : ‌Reagent ‌Name ) are not filled

Drug ‌Substance ‌Role ‌Name ) corresponds to the value “excipient”, then the
attribute “ Information about the excipient in the medicinal product” ( hccdo : ‌
Substance ‌Details ) must be filled in drug" ( hccdo : ‌Auxiliary ‌Substance ‌
Details )

Drug ‌Substance ‌Role ‌Name ) corresponds to the value “excipient”, then in the
complex variable “ Information about the ingredient that is part of the medicinal
product” ( hccdo : ‌Substance ‌Details ) the details “ Information about the
active pharmaceutical substance in the composition of the medicinal product” (
hccdo : ‌Active ‌Substance ‌Details ) and “ Name of the reagent that is part of
the medicinal product” ( hcsdo : ‌Reagent ‌Name )
are not filled

54
nt Code

Drug ‌Substance ‌Role ‌Name ) corresponds to the value "reagent", then as part
of the attribute " Information about the ingredient that is part of the medicinal
product"
( hccdo : ‌Substance ‌Details ) the attribute “ Name of the reagent that is part of
the medicinal product” must be filled in
( hcsdo : ‌Reagent ‌Name )

Drug ‌Substance ‌Role ‌Name ) corresponds to the value “reagent”, then as part
of the complex attribute “ Information about the ingredient that is part of the
medicinal product”
( hccdo : ‌Substance ‌Details ) Details " Details of the active pharmaceutical
substance in the composition of the medicinal product" ( hccdo : ‌Active ‌
Substance ‌Details ) and " Information on the excipient in the composition of the
medicinal product" ( hccdo : ‌Auxiliary ‌Substance ‌Details )
are not filled
68 if the attribute “Information about the excipient in the composition of the

medicinal product” ( hccdo : ‌Auxiliary ‌Substance ‌Details ) is filled in, then the
attribute “ Code of the excipient included in the medicinal product” must be
filled in its composition
( hcsdo : ‌Auxiliary ‌Substance ‌Code ) or " Name of the excipient in the
medicinal product"
( hcsdo : ‌Auxiliary ‌Substance ‌Name )
69 if the attribute “Details about the excipient in the composition of the medicinal
product” ( hccdo : ‌Auxiliary ‌Substance ‌Details ) is filled in, then the attribute “
Functional purpose code of the excipient” ( hcsdo : ‌Functional ‌Purpose ‌Code )
must be filled in its composition, or " Auxiliary function name" ( hcsdo : ‌
Auxiliary ‌Substance ‌Name )
70 if the attribute is “dosage value type code (concentration)”

(attribute Substance‌Measure‌Type‌Code ) is filled, then its value must correspond
to one of the following values:
01 - the exact dosage value is indicated;
02 - the dosage value is less than or equal to the specified value;
03 - the dosage value is greater than or equal to the specified value;
04 - dosage value is less than the specified value;
05 - dosage value is greater than the specified value
55
nt Code
71 if the attribute “Information about the unit of expression of the medicinal

product composition” ( hccdo : ‌Dosage ‌Unit ‌Details ) is filled in, then the
attribute “ Code of the type of unit of expression of the medicinal product
composition” ( hcsdo : ‌Dosage ‌Unit ‌Kind Code ) or the attribute “ Name of the
type of expression unit of the medicinal product composition” ( hcsdo : ‌Dosage ‌
Unit ‌Kind ‌Name )
72 if the attribute " Code of the type of unit of expression of the composition of the
medicinal product" ( hcsdo : ‌Dosage ‌Unit ‌Kind ‌Code ) is filled, then its value
must correspond to one of the following values:
01 - the dosage is indicated per dosage form unit;
02 - dosage is indicated per dosing unit;
03 - dosage is indicated per unit of mass;
04 - dosage is indicated per volume unit; 05 - dosage is indicated for the total
amount of the medicinal product in the primary packaging;
06 - dosage is indicated per volume unit after dissolution;
07 - dosage is indicated per volume unit before dilution;
08 - dosage is indicated per unit of time;
09 - the dosage is indicated per unit of the dosage form, coinciding with the
dosage unit
73 if the prop " Information about the manufacturer"

( hccdo : ‌Manufacturing ‌Authorization ‌Holder ‌Details ‌V 2 ) is filled in, then
the attribute “ Name of the economic entity ” ( csdo : ‌Business ‌Entity ‌Name )
and (or) the attribute “Short name of the economic entity »
(csdo:BusinessEntityBriefName)
74 if the "Information about the holder (applicant) of the registration certificate"

variable (hccdo:RegistrationCertificateHolderDetails) is filled in, then the
"Country Code" variable
must be filled in it ( csdo : ‌Unified ‌Country ‌Code )
75 if the "Information about the holder (applicant) of the registration certificate"

requisite (hccdo:RegistrationCertificateHolderDetails) is filled in, then the
requisite " Name of the economic entity " ( csdo : ‌Business ‌Entity ‌Name ) and
(or) the requisite "Short name business entity" (csdo:BusinessEntityBriefName)
76 in composition complex props « Details about manufacturer "

(hccdo:ManufacturingAuthorizationHolderDetailsV2) must to be filled props «
Code organizational - legal forms " (csdo:BusinessEntityTypeCode) or props «
Name organizational - legal forms " (csdo:BusinessEntityTypeName)
77 as part of the complex variable "Information about the packaged unit of the
medicinal product" (hccdo:PackageDetails), the variable must be filled in
“DrugPackageKindCode type code” (hcsdo:DrugPackageKindCode) or
“DrugPackageKindName” variable (hcsdo:DrugPackageKindName)
56
nt Code
78 as part of the complex variable "Information about the packaged unit of the
medicinal product" (hccdo:PackageDetails), the variable must be filled in “Code
of the type of secondary (consumer) packaging of the medicinal product”
(hcsdo:DrugSecondaryPackageKindCode) or the attribute “Name of the type of
secondary (consumer) packaging of the medicinal product”
(hcsdo:DrugSecondaryPackageKindName)

of a medicinal product for exclusion from the general register" (P.MM.01.
Table _ 17
product for exclusion from the general register" (P.MM.01.MSG. 003)
Requirement Statement of requirement
Code

2 the attribute "Start date and time" (csdo:StartDateTime) must be filled
3 the attribute "End date and time" (csdo:EndDateTime) must be filled
four the value of the variable "Code of the stage of consideration of the registration
dossier" (hcsdo:ApplicationStatusCode) must correspond to the value
"07 - refusal"
5 the value of the "Member state role code" attribute (hcsdo:CountryKindCode)

must correspond to the value
"01 - reference state"
6 the general registry must contain information that matches the excluded
information in terms of the values of the details "Application number"
(hcsdo:ApplicationId), "Country code" (csdo:UnifiedCountryCode), the empty
"End date and time" (csdo:EndDateTime) details, and also lower value of the
attribute "Start date and time" (csdo:StartDateTime) than in the excluded
57
Code
information
7 the value of the attribute "identifier of the directory (classifier)" (attribute

codeListId) as part of the complex variable "Country code"
contain the code designation of the classifier of countries of the world
specified in Section VII of the Rules for Information Interaction
eight if the attribute "Country code" (csdo:UnifiedCountryCode) as part of any

code from the classifier of countries of the world, which contains a list of
codes and names of countries of the world in accordance with the ISO 3166-1
standard

(information) "Information on the registration certificate number for a
medicinal product" (R.HC.MM.01.004), transmitted
in the message " Request for information on the registration certificate
number of a medicinal product " (P.MM. 01.MSG.014) are shown in Table
18.
Table eighteen
"Information on the registration certificate number for the medicinal product"
(R.HC.MM.01.004) transmitted in the message " Request for information on
the registration certificate number of the medicinal product " (P.MM.01.MSG
.014)
Code
one the requisite "Ordinal number of the registration certificate of the medicinal
product" (hcsdo:RegistrationNumberId) is not filled in
2 the general registry must contain information that matches the transmitted
information in terms of the values of the details "Application Number"
(hcsdo:ApplicationId) and "Country Code" (csdo:UnifiedCountryCode), for
which the value of the variable "Code of the stage of consideration of the
registration dossier" (hcsdo:ApplicationStatusCode) in the application with the
transferred number corresponds to the value "06 - approval of the expert
58
Code
report", and the code of the reference state coincides with the transferred value
of the "Country Code" variable (csdo:UnifiedCountryCode)

(information) "Information of the registration file or registration dossier for a
medicinal product" (R.HC.MM.01.003), transmitted in the message "Request
for information from the registration file or registration dossier" (P.MM.
01.MSG.019) are shown in Table 19.
Table _ 19
"Information of the registration file or registration dossier for a medicinal
product" (R.HC.MM.01.003), transmitted in the message "Request for
information from the registration file or registration dossier" (P.MM.01.
MSG.019)
Code
one details must be filled in the e-mail "Application number"

(hcsdo:ApplicationId) or "Ordinal number of the registration certificate of
the medicinal product" (hcsdo:RegistrationNumberId) prop
2 the attribute "Document in PDF format" (hcsdo:PdfBinaryText) as part of the

3 the attribute "Document in XML format" (hccdo:AnyDetails) as part of the

four the value of the attribute "identifier of the directory (classifier)" (attribute

codes and names of countries of the world in accordance with the
59
Code
ISO 3166-1 standard
6 if the attribute "Document element description" (hcsdo:AttributeText) is

filled in, then it must contain the attribute "document element type code"
(AttributeKindCode attribute) or the "document element type name" attribute
(AttributeKindName attribute)
7 if the value of the "document element type code" attribute

(AttributeKindCode attribute) corresponds to the value "other", then the
"document element type name" attribute (AttributeKindName attribute) must
be filled in
eight if the value of the attribute "Indicator of the document belonging to the
registration dossier" (hcsdo:RegistrationFileIndicator) corresponds to the
value "registration file document", then the e-mail message must contain the
attribute "Code of the drug registration file type document"
(hcsdo:DrugRegistrationFileCode) and (or ) requisite "Name of the type of
document of the registration file for the medicinal product"
(hcsdo:DrugRegistrationFileName)
(hcsdo:DrugRegistrationFileCode) corresponds to the value "other", then the
"Name of the drug registration file document type" variable
ten if the value of the attribute "Indicator of the document belonging to the
value "registration dossier document", then the e-mail message must contain
the attribute "Code of the document type of the registration dossier for the
drug" (hcsdo:DrugRegistrationDocCode) and (or ) requisite "Name of the
type of document of the registration dossier for the medicinal product"
(hcsdo:DrugRegistrationDocName)
eleven if the value of the variable “Code of the document type of the registration
dossier for the medicinal product” (hcsdo:DrugRegistrationDocCode)
corresponds to the value “other”, then the variable “Name of the document
type of the registration dossier for the medicinal product”
(hcsdo:DrugRegistrationDocName) must be filled in

(information) "Information from the registration file or registration dossier
for a medicinal product" (R.HC.MM.01.003) transmitted in the message
"Information from the registration file or registration dossier"
(P.MM.01 .MSG.020) are listed in Table 20.
60
Table _ twenty
"Information from the registration file or registration dossier for a medicinal
product" (R.HC.MM.01.003) transmitted in the message "Information from
the registration file or registration dossier" (P.MM.01.MSG .020)
Code
one in the electronic message, the

"Application number" variable (hcsdo:ApplicationId) or the "Ordinal number
of the registration certificate of the medicinal product"
(hcsdo:RegistrationNumberId) variable must be filled in
2 the attribute "Sign that the document belongs to the registration dossier"
(hcsdo:RegistrationFileIndicator) must be filled in
3 as part of the complex variable "Information about the document of the

registration file (dossier)" (hccdo:RegistrationFileDetails), the variable
"Document in PDF format" (hcsdo:PdfBinaryText) and (or) the variable
"Document in XML format" (hccdo:AnyDetails) must be filled in
four the value of the attribute "identifier of the directory (classifier)" (attribute

codes and names of countries of the world in accordance with the ISO 3166-1
standard
6 if the "Document element description" attribute (hcsdo:AttributeText) is filled

in, then it must contain the
"document element type code" attribute (AttributeKindCode attribute)
or the "document element type name"
attribute (AttributeKindName attribute)
7 if the value of the "document element type code" attribute (AttributeKindCode

attribute) corresponds to the value "other", then the "document element type
name" attribute (AttributeKindName attribute) must be filled in
eight if the value of the attribute “Indicator of the document belonging to the
registration dossier” (hcsdo:RegistrationFileIndicator) corresponds to the
value “registration file document”, then the following details must be filled in
the electronic message: “Code of the type of the registration file document for
the medicinal product” (hcsdo:DrugRegistrationFileCode) or “ Name of the
61
Code
type of the drug registration file document”

(hcsdo:DrugRegistrationFileName)
(hcsdo:DrugRegistrationFileCode) corresponds to the value "other", then the
"Name of the drug registration file document type" variable
ten if the value of the variable "Indicator of the document belonging to the
value "registration dossier document", then the following details must be filled
in the e-mail message: "Code of the document type of the registration dossier
for the medicinal product" (hcsdo:DrugRegistrationDocCode) or " Name of
the type of document of the registration dossier for the medicinal product” (
hcsdo: DrugRegistrationDocName)
eleven if the value of the variable "Code of the type of drug registration dossier
document" (hcsdo:DrugRegistrationDocCode) corresponds to the value
"other", then the variable "Name of the type of drug registration dossier
document" ( hcsdo: DrugRegistrationDocName) must be filled in

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APPROVED

1. This Regulation has been developed in accordance with the

2 . This Regulation has been developed in order to ensure the uniform

III . Basic concepts

IV . Basic information about the information

1. Participants of information interaction

6 . The list of roles of participants in information interaction

Information owner submits information about changes to notified body of a member

Coordinator is responsible for the formation and Eurasian Economic

information from the registration file

2. Structure of information exchange

7 . Information interaction within the framework of the overall process

8 . Information interaction between the authorized bodies of the

V. _ Information exchange within procedure groups

one. Information interaction in the formation and maintenance of the general

12 . The scheme for performing transactions of the general process

one Inclusion of information in the general registry (P.MM.01.PRC.001)

2 Changing the information contained in the general registry (P.MM.01.PRC.002)

3 Exclusion of information from the general registry (P.MM.01.PRC.003)

2. Information exchange when obtaining information

13 . The scheme of execution of transactions of the general process

2 Obtaining information from the general registry (P.MM.01.PRC.008)

3 Obtaining information about changes made to the general registry (P.MM.01.PRC.009)

four Obtaining a registration certificate number (P.MM.01.PRC.010)

4. Registration certificate general registry preparation and general registry obtaining a

3. Information interaction upon receipt by the Commission of information

14 . The scheme for performing transactions of the general process

VI . Description of general process messages

15 . The list of messages of the general process transmitted as part of

P.MM.01.MSG.001 information on the registration information on the registration of

P.MM.01.MSG.002 information on the registration information on the registration of

P.MM.01.MSG.003 information on the registration information on the registration of

P.MM.01.MSG.004 notification of acceptance and notification of the result of

P.MM.01.MSG.005 request for information about share update state (R.007)

P.MM.01.MSG.007 request for information from the information on the registration of

P.MM.01.MSG.008 information from the general information on the registration of

P.MM.01.MSG.009 notification of the absence of notification of the result of

P.MM.01.MSG.010 requesting changed information share update state (R.007)

from the general registry

P.MM.01.MSG.011 changed information information on the registration of

P.MM.01.MSG.013 information about the information about the registration

P.MM.01.MSG.014 request for information about information about the registration

P.MM.01.MSG.015 information about the information about the registration

P.MM.01.MSG.018 missing information notice notification of the result of

P.MM.01.MSG.020 information from the information of the registration file

one. Transaction of the general process "Transfer of information about the

16 . Transaction of the general process "Transfer of information about

about the registration of a medicinal product for inclusion

one code designation P.MM.01.TRN.001

2 The name of the transaction of transfer of information on the registration of a

3 Generic Process Transaction request/response

four Initiating role initiator

5 Initiating operation sending information for inclusion in the general

6 Responsive role respondent

7 Accepting operation receiving and processing information for inclusion

9 General process transaction

ten Shared Process Transaction

elev General process transaction

no - for P . MM.01 . MSG.013 _

2 . Transaction of the general process "Transfer of information about the

17 . Transaction of the general process "Transfer of drug registration

about the registration of a medicinal product for change

one code designation P.MM.01.TRN.002

2 The name of the transaction of transfer of information on the registration of a