of April 24, 2018 No. 65
About approval of the qualifier of types of changes of the registration file of medicine
In co compliance article 30 of the Agreement on the Eurasian Economic Union of May 29, 2017, items 4 and 7 Protocols on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 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 Eurasian economic commission of November 17, 2015 No. 155, Board of the Eurasian economic commission solved:
1. Approve the enclosed qualifier of types of changes of the registration file of medicine (further – the qualifier).
2. Turn on the qualifier in structure of resources of single system of normative reference information of the Eurasian Economic Union.
3. Determine that:
the passport of the qualifier is applied from the 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 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 April 24, 2018, No. 65
|
Code of group of types of changes |
Code of subgroup of types |
Change type code |
Name |
Designation |
Code like changes |
|
01 |
Administrative changes | ||||
|
010100 |
change of information about the holder of the registration certificate (on condition of invariance of the legal entity) | ||||
|
010101 |
change of the name and (or) address of the holder of the registration certificate |
А.1 |
IA (WELL) | ||
|
010200 |
change (trade) name of medicine | ||||
|
010201 |
change (trade) name of the medicine registered according to Rules of registration and examination of medicines for medical application |
А.2.а |
IA (WELL) | ||
|
010202 |
change (trade) name of the medicine registered according to the national procedure (registration only in the reference state) |
А.2.б |
IB | ||
|
010300 |
change of the name of active pharmaceutical substance or excipient | ||||
|
010301 |
change of the name of active pharmaceutical substance or excipient |
А.3 |
IA (WELL) | ||
|
010400 |
change of the name and (or) address of producers and suppliers | ||||
|
010401 |
change of the name and (or) address: the producer (including, when applicable, platforms on quality control), either the holder of the master file of active pharmaceutical substance, or the supplier of active pharmaceutical substance, initial materials, reactants or intermediate products used in production of active pharmaceutical substance (specified in the technical file) if in the registration file there are no certificates |
А.4 |
IA | ||
|
|
|
excipient compliance (specified in the technical file) |
|
| |
|
010500 |
change of the name and (or) the address of the producer of medicine, including the issuing platforms and platforms on quality control | ||||
|
010501 |
actions for which the producer (importer) is responsible include release of series |
А.5.а |
IA (WELL) | ||
|
010502 |
actions for which the producer (importer) is responsible do not include release of series |
А.5.б |
IA | ||
|
010600 |
change of the ATH code | ||||
|
010601 |
change of the ATH code of medicine owing to approval or change of the ATH WHO code |
А.6 |
IA | ||
|
010700 |
exception of the production site on condition of preserving at least 1 earlier approved production the site (producer), performing the same functions, as subject to exception | ||||
|
010701 |
exception of the production site (including active pharmaceutical substance, intermediate products, the medicine, the packer, producer responsible for release of series, quality control of series or the supplier of initial material, reactant or excipient (if are specified in the file) |
А.7 |
IA | ||
|
010800 |
changes of date of audit | ||||
|
|
010800 |
changes of date of audit for verification of compliance of the producer of active pharmaceutical substance to rules of proper production practice |
А.8 |
IA | |
|
02 |
quality change. Active pharmaceutical substance. Production | ||||
|
020100 |
change of the producer of the initial material (reactant, intermediate product) used in production process of active pharmaceutical substance or change of the producer of active pharmaceutical substance (including, when applicable, quality control) if in the registration file there is no certificate of conformity of the monograph of the European pharmacopeia. | ||||
|
020101 |
the offered producer belongs to the same pharmaceutical group, as the approved producer |
B.I.a.1 |
IA (WELL) | ||
|
020102 |
introduction of the new producer of the active pharmaceutical substance proved by the master file of active pharmaceutical substance |
B.I.a.1 |
II | ||
|
020103 |
the offered producer uses sharply different method of synthesis or conditions of production which can change such important indicators of quality of active pharmaceutical substance as the high-quality and (or) quantitative profile of impurity requiring qualification, or physical and chemical properties influencing bioavailability |
B.I.a.1 |
II | ||
|
020104 |
new producer of the material requiring assessment of virus safety and (or) risk of transmissible spongy encephalopathy |
B.I.a.1 |
II | ||
|
020105 |
change affects biological active pharmaceutical substance or initial material (reactant, intermediate product) which is used in production of biological (immunological) medicine |
B.I.a.1 |
II | ||
|
020106 |
change of procedure for quality control of active pharmaceutical substance: change or addition of the platform on which control (testing) of series is exercised |
B.I.a.1 |
IA | ||
|
020107 |
introduction of the new producer of the active pharmaceutical substance which does not have the master file of active pharmaceutical substance and requiring essential updating of appropriate section of the file on active pharmaceutical substance |
B.I.a.1 |
II | ||
|
020108 |
inclusion of the alternative platform on sterilization of active pharmaceutical substance with use of the method established in the Pharmacopoeia of the Eurasian Economic Union |
B.I.a.1 |
IB | ||
|
020109 |
introduction of the new platform on micronization |
B.I.a.1 |
IA | ||
|
020110 |
change of the agreement on testing on quality control of biological active pharmaceutical substance: replacement or inclusion of the platform on which control (testing) of series, including biological (immunological, immunochemical) method is exercised |
B.I.a.1 |
II | ||
|
020111 |
the new platform on storage of the main bank of cages and (or) working banks of cages |
B.I.a.1 |
IB | ||
|
020200 |
change of production process of active pharmaceutical substance | ||||
|
020201 |
insignificant change of production process of active pharmaceutical substance |
B.I.a.2 |
IA | ||
|
020202 |
considerable change of production process of active pharmaceutical substance which can have significant effect on quality, safety or efficiency of medicine |
B.I.a.2 |
II | ||
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