of November 26, 2025 No. 93
About modification of Rules of registration and examination of medicines for medical application
According to article 7 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and Item 84 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission DECIDED:
1. Bring in the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, of change according to appendix.
2. This Decision becomes effective after 30 calendar days from the date of its official publication.
|
Members of council of the Eurasian economic commission: From the Republic of Armenia |
M. Grigoryan |
|
From the Republic of Belarus |
N. Petkevich |
|
From the Republic of Kazakhstan |
S. Zhumangarin |
|
From the Kyrgyz Republic |
D. Amangeldiyev |
|
From the Russian Federation |
A. Overchuk |
Appendix
to the Decision of Council of the Eurasian economic commission of November 26, 2025 No. 93
1. In the text:
the words "Sphere of Design" shall be replaced with words "The project field";
the words "sphere of design" in the corresponding case shall be replaced with words "the project field" in the corresponding case;
the words "sphere of design (project field)" in the corresponding case shall be replaced with words "the project field" in the corresponding case;
the words "project field (sphere of design)" in the corresponding case shall be replaced with words "the project field" in the corresponding case.
2. Item 51 in paragraph three "hospital" shall be replaced with words the word "treatment and prevention facility".
3. To add Item 19 after the paragraph of the twentieth with the paragraph of the following content:
"confidential data" – personal data and data which are not in public access and which disclosure can entail negative effects for economic interest and competitive line item of the owner of such data. The detailed process description of production, these specifications, the strategy of the applicant or holder of the registration certificate on further registration actions concerning the considered medicine, information concerning the notes received in the course and by results of pharmaceutical inspections of production sites and other pharmaceutical inspections, the name and the location of the production sites exercising quality control belong to confidential data including;".
4. To add Item 47 after paragraph two with the paragraph of the following content:
"the written confirmation of intention of the applicant to approve absence in the draft of the final expert valuation report of the confidential information containing in the registration file of medicine (in the presence of such intention);";
5. Add Item 60 with paragraphs of the following content:
"In the presence in the registration file of documentary confirmed intention of the applicant to approve absence in the draft of the final expert valuation report of confidential information, the authorized body (the expert organization) of the reference state sends to the applicant the draft of the final expert valuation report for the purpose of ensuring confidentiality of information containing in the registration file of medicine in case of the publication of the final expert valuation report in the unified register. The draft of the final expert valuation report is transferred to the applicant in electronic form and it is considered received after 1 working day from the date of its direction.
No more than 10 working days from the date of receipt of the draft of the final expert valuation report which are not entering in time registration and examinations of medicine on approval of the specified project and representation of reasons for withdrawal of the confidential data including which are trade secret are provided to the applicant. The applicant has the right to note independently the confidential information which is not subject to publication by its allocation in the reviewing mode in the draft of the final expert valuation report intended for the subsequent publication in the unified register and to send this report to authorized body (the expert organization) of the reference state in electronic form.
Assessment of the answer of the applicant is performed in time, not exceeding 5 working days from the date of receipt of the answer of the applicant, and conducting examination and registration of medicine does not join in time.
Based on the carried-out assessment the authorized body (the expert organization) has the right to accept the withdrawal of information offered by the applicant. In this case in case of adoption by authorized body of the reference state of the positive decision on medicine registration the authorized body of the reference state places in the unified register the final expert valuation report constituted according to appendix No. 16 to these rules after withdrawal of confidential data. In case of non-presentation by the applicant of information stated above at the scheduled time the final expert valuation report is considered the approved applicant.".
6. The subitem "b" of Item 63 after the words "about experts" to add with the word "summary".
7. To add the subitem "v" of Item 76 after the word of "packagings" with the word "summary".
8. The paragraph of the sixth of Item 81 of the word of "packagings" to add with the word "summary".
9. To add Item 86 after paragraph two with the paragraph of the following content:
"the written confirmation of intention of the applicant to approve absence in the draft of the final expert valuation report of the confidential information containing in the registration file of medicine (in the presence of such intention);".
10. Add Item 105 with paragraphs of the following content:
"In the presence in the registration file of documentary confirmed intention of the applicant to approve absence in the draft of the final expert valuation report of confidential information, no more than 10 working days from the date of receipt of the draft of the final expert valuation report which are not entering in time registration and examinations of medicine on approval of the purpose of ensuring confidentiality of information containing in the registration file of medicine and provision of reasons for withdrawal of the confidential data including which are trade secret are provided to the applicant.
The applicant has the right to note independently the confidential information which is not subject to publication by its allocation in the reviewing mode, in the draft of the final expert valuation report intended for the subsequent publication in the unified register and to send this report to authorized body (the expert organization) in electronic form.
Assessment of the answer of the applicant is performed in time, not exceeding 5 working days from the date of receipt of the answer of the applicant, and conducting examination and registration of medicine does not join in time.
Based on the carried-out assessment the authorized body (the expert organization) has the right to accept the withdrawal of information offered by the applicant. In this case in case of adoption by authorized body of the reference state of the positive decision on medicine registration, in the unified register the authorized body of the reference state places the final expert valuation report constituted according to appendix No. 16 to these rules after withdrawal of confidential data. In case of non-presentation by the applicant of information stated above at the scheduled time the final expert valuation report is considered the approved applicant.".
11. Add Item 152 with the paragraph of the following content:
"When updating by authorized body (the expert organization) of the reference state of the expert valuation report after modification of the registration file the confidential data which are earlier approved with the applicant are also subject to withdrawal. If the made changes in the registration file affect Sections of the expert valuation report which require withdrawal of confidential data, withdrawal of such data is performed according to the procedure and terms of interaction with the applicant specified in Item 60 – in case of registration only in the reference state and Item 105 – in case of registration in several state members.".
12. In appendix No. 1 to the specified Rules:
a) to add Item 1.10.3 after the words "risk managements" with the words "and the summary of the approved risk management plan";
b) in paragraph seven of subsection 11 of the Section II "hospital" shall be replaced with words the word "treatment and prevention facility".
13. In subitems 2.3.1 and 3.3.1 of appendix No. 2 to the specified Rules shall be replaced with words the word of "hospital" "treatment and prevention facility".
14. Item 1.10.3 of appendix No. 4 to the specified Rules after the words "risk managements" to add with the words "and summary of the risk management plan".
15. In the name of amendment No. 2 to appendix No. 14 to the specified Rules of the word" (the sphere of design)" to exclude.
16. In appendix No. 19 to the specified Rules:
a) the paragraph one of Item 1.7.2 to state in the following edition:
"1.7.2. According to the procedure of exception in case of filing of applications about entering of identical multiple changes of IA of type and (or) IANU of type into registration files of medicines which holder of registration certificates is one organization or if changes concern change of this holder or information on him and also if groups of changes according to amendment III such changes move it is allowed to present one-timely in the document package form in form of amendment IV and with the cover letter constituted in form according to amendment of VII to this appendix.";
b) in amendment of V:
to state the text of amendment in the following edition:
"Amendment of V
Classification of changes in the registration file
medicine
Changes in the registration file of medicines are classified according to this amendment on the changes caused:
administrative changes;
quality changes;
changes of safety, efficiency and pharmakonadzor;
certain changes of the master files of plasma (MFP) and master files of vaccinal antigen (MFVA).
In case of classification of separate changes of this amendment the considered change should be coded, using the following structure:
X.N.x.n ("change code"),
where:
Specifies X capital letter of the Section of amendment which contains change (for example, "And", "B", "In" or "")
N specifies the Roman figure of subsection of that Section which contains change (for example, I, II, III etc.)
x specifies letter in Item of subsection which contains change (for example, "and", "in" etc.)
n specifies the subitem figure appropriated in amendment to separate change (for example, 1, 2, 3 etc.).
Contains in each Section of this amendment:
the list of the changes classified as insignificant changes of IA of type and significant changes of the II type according to determinations of Item 1.2 of this appendix and amendment of II to this appendix. In it it is also specified what of changes of IA of type require according to Items 2.1.1 and 3.1.1 of this appendix of the immediate notification;
the list of examples which should be considered as insignificant changes of IB of type. According to Item 1.3 of this appendix, this category is appropriated by default. In this regard this amendment is not intended for establishment of the exhaustive list of such category of changes.
In this amendment expansions of registration as they are properly described in amendment of I to this appendix are not considered. All changes described in amendment of I to this appendix should be considered as expansions of registration. All other changes shall not be considered as registration expansion.
If one or several conditions established in this amendment concerning insignificant changes of IA of type are not carried out, such change is allowed to be provided as change of IB of type ("change of IB of type by default") if such change in this amendment or the recommendation constituted according to Item 1.5 of this appendix is not treated as change of the II type or if the applicant does not consider that changes can exert considerable impact on quality, safety and efficiency of medicine.
If the authorized body in case of consideration of the application on modification considers that the change given as change of IB of type by default is capable to exert considerable impact on safety, efficiency or quality, medicine, he has the right to refer this change to change of the II type and to send inquiry to the applicant with the requirement about change of type of the statement for modification and submission of the documents necessary for this change. The subsequent consideration of the changed statement is carried out in the terms established for change of the II type from the date of receipt of reply to the request.
"Procedure of testing" (test procedure) knows the same value, as "analytical technique" (analytical procedure), the concept "limits" (limits) – matters too, as "eligibility criterions" (acceptance criteria). "Specification parameter" is understood as indicator of quality concerning which the analytical technique and eligibility criterions, for example, quantitative determination, authenticity and content of water are established. Thus, addition or exception of parameter of the specification includes the corresponding analytical technique and eligibility criterions.
The concept "information on medicine" is understood as general characteristic of medicine, the instruction on medical application (leaf insert), prototypes of packagings of medicine and its regulating document on quality.
The concept "license for production" is understood actually as the license or other permission to the production issued according to the procedure, established by the legislation of the country in which there is production.
The documents proving modification of IB and the II types depend on nature of such changes.
It is not required notify authorized bodies of state members on updated Article of the Pharmacopoeia of the Union or pharmacopeia of state member if in the registration file of the registered medicine the reference to urgent edition is specified. Applicants should remember that compliance to updated Article shall be realized within 180 calendar days from the date of its publication.
In the Section G of this amendment the list of the changes characteristic of MFP and MFVA is provided. After examination of such changes any registration file containing references to these MFP and MFVA is subject to updating according to B.'s subsection of the V this amendment. If documentation on the plasma of the person used as initial material of the medicine received from plasma is not submitted as MFP, changes of such initial material described in the registration file also shall passes the examination according to this amendment.
In the absence of special instructions of the reference in this amendment to changes of the registration file of medicine imply addition, replacement or exception. If amendments to the registration file are exclusively editorial changes (correction of technical mistakes and typographical errors), such changes are considered by authorized bodies (the expert organizations) as editorial in the presence of detailed explanations in the Cover letter to the statement (Section 1.0 OTD), otherwise – as not declared changes and, therefore, false information
In such cases in the application form it is necessary to specify accurately such changes as editor's alterations and to provide guarantees in the Cover letter to the statement (Section 1.0 OTD), confirmatory that the provided editor's alterations do not influence change like classification of the given change. The editor's alterations represented by the applicant allow exception of the obsolete or excessive text, but not exception of parameters of the specification and descriptions of production.";
in the Section A of the table:
subsections A.1 – State A.7 in the following edition:
"A. Administrative changes
|
А.1. Change of the holder of the registration certificate |
Necessary conditions |
Documents and data |
Procedure |
|
a) change of the name and (or) address of the holder of the registration certificate |
1 |
1, 3 |
IANU |
|
b) transfer of the registration certificate from one holder of the registration certificate to other legal entity |
2 |
1, 2, 3, 4 |
IANU |
|
Conditions 1. The holder of the registration certificate shall remain the same legal entity. 2. The holder of the registration certificate is other legal entity. | |||
|
Documentation 1. The copy of the document issued by the relevant authorized body of country of incorporation of the legal entity of the holder of the registration certificate (for example, tax authority) in which the name and the address of the legal entity of the new holder of the registration certificate or the new name and (or) the address of the holder of the registration certificate is specified. 2. The documents proving transfer of the registration certificate (certificates) and confirming possibility of the new holder of the registration certificate to provide proper accomplishment of all obligations of the holder of the registration certificate; the copy of the document confirming transfer of the registration certificate from one legal entity to other legal entity; the reviewed short characteristic of system of pharmakonadzor or the reviewed master file of system of pharmakonadzor if it is included in the registration file; data on the organization responsible for work with claims in the Eurasian Economic Union. 3. Information on medicine reviewed in appropriate sections. 4. The document (documents) provided by the legal entity to whom powers of the holder of the registration certificate are delegated, confirming lack of the changes in information on medicine which are not relating to transfer of the registration certificate. | |||
|
А.2. Change (trade) name of medicine |
Necessary conditions |
Documents and data |
Procedure |
|
a) the medicines registered according to Rules of registration and examination |
1 |
1, 2 |
Ianu |
|
b) the medicines registered only in the reference state |
– |
1, 2 |
IB |
|
Conditions 1. Confirmation of authorized body (expert organization) of the reference state of the acceptability of the new (trade) name. | |||
|
Documentation 1. Reasons for the applicant of the acceptability of the new (trade) name. 2. The reviewed information on medicine. | |||
|
А.3. Change of the name of active pharmaceutical substance or excipient |
Necessary conditions |
Documents and data |
Procedure |
|
1 |
1, 2 |
IANU | |
|
Conditions 1. Active pharmaceutical substance (excipient) does not change. | |||
|
Documentation 1. Reasons for change of the name of active pharmaceutical substance of WHO. For excipient – reasons for change of the reference book (qualifier) for excipients of the Union. Confirmation of the fact that change corresponds to the Pharmacopoeia of the Union (when applicable), and in case of absence in it – state member pharmacopeia. The declaration that the name of medicinal vegetable medicines corresponds to acts of bodies of the Union in the field of drug circulation. 2. The reviewed information on medicine. | |||
|
А.4. Change of the name and (or) address: the producer (including, when applicable, platforms on quality control), either the holder of MFAFS, or the supplier of active pharmaceutical substance, initial materials, reactants or intermediate products used in production of active pharmaceutical substance (if it is specified in the registration file) if in the registration file there are no certificates of conformity to the European pharmacopeia, or producer of new excipient (if it is specified in the registration file) |
Necessary conditions |
Documents and data |
Procedure |
|
1 |
1, 2, 3 |
IA | |
|
Conditions 1. The production site and any of production operations does not change. | |||
|
Documentation 1. The official document from authorized body (for example, tax authority) in which the new name and (or) the address is specified. 2. Amendment to appropriate section of the registration file. 3. In case of change of the name of the holder of the master file of active pharmaceutical substance (MFAPS) – updated "permission to access". | |||
|
А.5. Change of the name and (or) the address of the producer of medicine, including the issuing platforms and platforms on quality control |
Necessary conditions |
Documents and data |
Procedure |
|
a) actions for which the producer (importer) is responsible include release of series |
1 |
1, 2 |
IANU |
|
b) actions for which the producer (importer) is responsible do not include release of series |
1 |
1, 2 |
IA |
|
Conditions 1. The production site, the name and (or) the address of which change, and any of production processes do not change. | |||
|
А.6. Change of the ATH code |
Necessary conditions |
Documents and data |
Procedure |
|
a) change owing to approval or change of WHO of the ATH code |
1 |
1 |
IA |
|
b) change at the initiative of the applicant of the code which is not the code assigned for WHO |
– |
1 |
IB |
|
Conditions 1. Change owing to approval or change of WHO of the ATH code. | |||
|
Documentation | |||
|
А.7. Exception of the production site (including for active pharmaceutical substance, intermediate products, the medicine, the packer, the producer responsible for release of series, quality control of series or the supplier of initial material, reactant or excipient (if are specified in the registration file)) |
Necessary conditions |
Documents and data |
Procedure |
|
1, 2 |
1, 2 |
IA | |
|
Conditions | |||
|
Documentation 1. In Item on the made changes of the statement for modification it is necessary to specify accurately the producers which are earlier approved and offered to removal as it is specified in Section 2 of the application form. 2. The amendment to appropriate section (Sections) of the registration file, including the reviewed information on medicine. | |||
declare the subsection A.8 invalid;
add with the subsections A.9 – A.11 of the following content:
|
А.9. Changes for the purpose of correction of the made typographical errors and mistakes in documents of the registration file |
Necessary conditions |
Documents and data |
Procedure |
|
a) the changes affecting information on medicine |
1 |
1, 2 |
IANU |
|
b) the changes which are not affecting information on medicine |
1 |
1, 2 |
IB |
|
Conditions 1. Mistakes or typographical errors have technical character and do not exert impact on quality and safety and (or) efficiency of medicine. | |||
|
Documentation 1. The amendment to appropriate section (Sections) of the registration file, including the reviewed information on medicine (when applicable), and also changes in the editing mode. 2. Reasons for technical nature of the revealed mistake or typographical error. | |||
|
А.10. Change of the name, form of business or the address of authorized body or the organization performing examination and registration of medicines |
Necessary conditions |
Documents and data |
Procedure |
|
– |
1 |
IA | |
|
Documentation | |||
|
А.11. Change of material name of primary package of medicine |
Necessary conditions |
Documents and data |
Procedure |
|
1 |
1, 2, 3 |
IA | |
|
Conditions | |||
|
Documentation | |||
to state the Section B of the table in the following edition:
"B. Quality changes
B. I. Active pharmaceutical substance
B.I.a) Production
|
B.I.a.1. 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, platforms on quality control) if in the registration file there is no certificate of conformity to the European Pharmacopoeia |
Necessary conditions |
Documents and data |
Procedure |
|
a) the offered producer belongs to the same group of the pharmaceutical companies, as the approved producer |
1, 2, 3 |
1, 2, 3, 4, 5, 6, 7, 9 |
IANU |
|
b) introduction of the new producer of the active pharmaceutical substance proved by MFAFS * |
– |
– |
II |
|
c) the offered producer uses sharply different method of synthesis or conditions of production which can change important indicators of quality of active pharmaceutical substance, such as the high-quality and (or) quantitative profile of impurity requiring qualification, or physical and chemical properties influencing bioavailability * |
– |
– |
II |
|
d) new producer of the material requiring assessment of virus safety and (or) risk of GE |
– |
– |
II |
|
e) change affects biological active pharmaceutical substance (including initial material, reactant, the intermediate product which is used in production of biological medicine) |
– |
– |
II |
|
e) change of procedure for quality control of active pharmaceutical substance: change or addition of the platform on which control (testing) of series is exercised |
2, 4 |
1, 5 |
IA |
|
g) introduction of the new producer of the active pharmaceutical substance which does not have MFAFS and requiring updating of Section 3.2.S of the registration file of medicine * |
– |
– |
II |
|
h) inclusion of the alternative platform on sterilization of active pharmaceutical substance with use of method of the Pharmacopoeia of the Union, and in case of absence in it – with use of methods of other pharmacopeias according to the Concept of the harmonization of pharmacopeias of state members of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of September 22, 2015 No. 119 (further – the Concept of harmonization) |
– |
1, 2, 4, 5, 8 |
IB |
|
i) introduction of the new platform on micronization * |
2, 5 |
1, 4, 5, 6 |
IA |
|
j) changes of procedure for 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 |
– |
– |
II |
|
k) the new platform on storage of the main bank of cages and (or) working bank of cages |
– |
1, 5 |
IB |
|
Conditions 1. Specifications of initial materials and reactants (including intra production supervisions, methods of the analysis of all materials) are identical to earlier approved. Specifications (including intra production supervision, methods of the analysis of all materials), preparation methods (including the series size) and detailed method of synthesis of intermediate products and active pharmaceutical substances are identical to earlier approved. 2. Active pharmaceutical substance is not biological or sterile. 3. If in production process materials of human or animal origin and producer of active pharmaceutical substance are used: does not use the new supplier concerning whom need assessment of virus safety and assessment of conformity the Pharmacopoeia of the Union or other pharmacopeias according to the Concept of harmonization of pharmacopeias and Chapter 24 of Rules of carrying out researches of biological medicines, on risk minimization of transfer of agents of spongy encephalopathy of animals by means of medicines for medical and veterinary application; uses the new supplier concerning whom such assessment is carried out. 4. The method transfer with old on the new platform is made successfully. 5. The specification of particle size of active pharmaceutical substance and the corresponding analytical method do not change. | |||
|
Documentation 3. The certificate of conformity to the European Pharmacopoeia on GE for any new source of material, or (when applicable) documentary confirmation of the fact that the material source subject to risk of GE, was researched earlier by authorized body also was confirmed its compliance to the Pharmacopoeia of the Union or to other pharmacopeias according to the Concept of harmonization of pharmacopeias and Chapter 24 of Rules of carrying out researches of biological medicines on risk minimization of transfer of agents of spongy encephalopathy of animals by means of medicines for medical application. At the same time, such documentary confirmation shall include including the following data: the name of the producer, type of animal and his fabric from which material is received; material country of source, use of this material in the past and its acceptability. 4. Data of the analysis of series (in the form of the comparative table) at least two series (at least, trial) active pharmaceutical substance from the flowing and offered producers (platforms). 5. In the statement for modification and in the cover letter it is necessary to specify accurately earlier approved and offered producers. 6. If active pharmaceutical substance is used as initial material, the declaration of the authorized person of each holder of the license for production of the medicine specified in the statement, or the authorized person of each holder of the license for production specified in the statement as the carrying out issuing medicine quality control performing stage. In declarations it is necessary to specify that the producer of active pharmaceutical substance specified in the statement performs the activities according to Rules of proper production practice. Under certain circumstances it is allowed to represent 1 declaration (see the note to change B.Ii.b. 1). 7. The obligation (if necessary) of producer of active pharmaceutical substance to notify the holder of the registration certificate on any changes of production process, specifications and analytical techniques of active pharmaceutical substance. 8. Confirmation that the offered platform properly is licensed concerning the considered production operation. 9. The documents confirming belonging of the producer of active pharmaceutical substance to one group of the pharmaceutical companies (for example, the letter confirmation). | |||||
|
* Note |
In applicable cases also the test of comparative kinetics of dissolution for medicine with the active pharmaceutical substance made on the former platform and 2 series of the medicine made with the active pharmaceutical substance made on the new production site is submitted. | ||||
|
B.I.a.2. Changes of production process of active pharmaceutical substance |
Necessary conditions |
Documents and data |
Procedure | ||
|
a) insignificant change of production process of active pharmaceutical substance |
1, 2, 3, 4, 5, 6, 7 |
1, 2, 3 |
IA | ||
|
b) considerable change of production process of active pharmaceutical substance which can have significant effect on quality, safety or efficiency of medicine |
– |
– |
II | ||
|
c) change affects biological substance or use of other substance received by chemical synthesis in case of production of biological medicine which can have significant effect on quality, safety or efficiency of medicine and is not connected with the protocol of management of post-registration changes |
– |
– |
II | ||
|
d) change affects medicinal vegetable medicine, namely geographical source of origin of medicinal vegetable raw materials, method of production or preparation |
– |
– |
II | ||
|
e) insignificant change of the closed part of MFAFS |
– |
1, 2, 3, 4 |
IB | ||
|
Conditions 1. Undesirable change of high-quality or quantitative profile of impurity or physical and chemical properties is absent. 2. The method of synthesis remains to the same, that is intermediate products do not change and new reactants, catalysts or solvents are not entered into process. The geographical source of origin of medicinal vegetable raw materials, preparation of medicinal vegetable raw materials and method of production of medicinal vegetable medicines do not change. 3. Specifications of active pharmaceutical substance and intermediate products do not change. 4. Change is completely described in open part (part of "applicant") of MFAFS (when applicable). 5. Active pharmaceutical substance is not biological substance. 6. Change does not affect geographical source of origin of medicinal vegetable raw materials, method of production or preparation of medicinal vegetable medicine. 7. Change does not affect the closed part of MFAFS. | |||||
|
Documentation 1. The amendment to appropriate section (Sections) of the registration file, including direct comparison of the current and new processes. 2. Data of the analysis of series (in the form of the comparative table) at least 2 series (at least, trial) made by means of the approved and offered processes. 3. Copies of the approved specifications of active pharmaceutical substance (in the form of the reference to the relevant document in the sequence of the registration file or appendix to the cover letter). 4. Confirmation of the holder of the registration certificate or the holder of MFAFS respectively that change of high-quality and quantitative profile of impurity or physical and chemical properties is absent, method of synthesis, the specification of active pharmaceutical substance and intermediate products do not change. | |||||
|
Note |
Considerable changes of the active pharmaceutical substances received by chemical synthesis are implied as changes of method of synthesis or conditions of production which are capable to change important indicators of quality of active pharmaceutical substance, such as the high-quality and (or) quantitative profile of impurity requiring qualification, or physical and chemical properties influencing bioavailability. | ||||
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