DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of January 30, 2020 No. 9

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

I. Petrishenko

From the Republic of Kazakhstan

A. Smailov

From the Kyrgyz Republic

Zh. Razakov

From the Russian Federation

A. Overchuk

 

Appendix

to the Decision of Council of the Eurasian economic commission of January 30, 2020 No. 9

The changes made to rules of registration and examination of medicines for medical application

1. In the text:

a) the words "the risk management plan in case of use of medicine" in the corresponding case shall be replaced with words "risk management plan";

b) to replace the word "request" in the corresponding number and case with the word "statement" in the corresponding number and case.

2. In Item 38 of the word "provided to participants" shall be replaced with words "represented to subjects".

3. In paragraph four of Item 66 of the word "on the electronic medium" shall be replaced with words "on paper and electronic carriers".

4. The fourth Item 86 to add the paragraph with words: "(in addition the module of 1 registration file is represented on paper (except for the risk management plan, the main file (master file) of the production site (production sites) and the master file on pharmakonadzor))".

5. In the paragraph the second Item 91 "calendar" to replace the word with the word of "workers".

6. In Item 102 "information" to exclude the word.

7. In the offer the first Item 120 of the word "according to Item 118" shall be replaced with words "according to Item 119".

8. Add Item 180 with paragraphs of the following content:

"After reduction of the registration file of medicine in compliance with requirements of the Union production and import of medicine with the registration certificate issued according to the legislation of state member, within 180 calendar days from the date of reduction of the registration file in compliance with requirements of the Union are allowed (date of reduction date of entering of the corresponding data into the unified register is considered).

Simultaneous realization of medicine before the termination of term of its validity in packaging and with the instruction on medical application, corresponding to documents and data from the registration file approved according to the legislation of state members, and the registration file of the Union brought into accord with requirements is allowed.".

9. In appendix No. 1 to the specified Rules:

a) in the paragraph the second Item 1.6.1 of the word "to proper production practice" shall be replaced with words the producer "the production site of the producer to requirements of proper production practice";

b) in Item 1.6.3 of the word "on different stages" shall be replaced with words "at different stages";

c) in Item 1.7.2 of the word "according to preclinical data" shall be replaced with words "preclinical researches";

d) in paragraph one of Item 1.7.3 of the word "according to clinical data" shall be replaced with words "clinical trials";

e) in paragraph one of subsection 2 of the Section I to replace the word of "data" in the corresponding case with the word of "researches";

e) in paragraph three of Item 2.3 of the word "and installations" shall be replaced with words "and managements";

g) in paragraph three of Item 2.5 of the word "for application" words "to application";

h) in Item 2.6: in paragraph one of the word "on preclinical researches" shall be replaced with words "preclinical researches"; in the paragraph the second shall be replaced with words words of "preclinical data" "preclinical researches";

i) in Items 2.6.1 - to replace 2.6.6 word of "data" with the word of "researches";

j) Item 2.7 in paragraph one to replace the word of "data" with the word of "researches";

k) in Items 3.2.s.2.b) and 3.2.p.3.a) "each used production site" shall be replaced with words words to "each used production site";

l) in paragraph one of Item 3.2.R.1 of the word "File of Production Site" shall be replaced with words "Records (reports) on the made product series";

m) in paragraph five of Item 4.2.1 of the word "for application" shall be replaced with words "to application";

o) in the paragraph the second the subitem "d" of Item 5.2 of the word "for application" shall be replaced with words "to application";

o) in the paragraph the second Item 5.3.1 of the word "bioveyver" to replace applications of the procedure with the word of "bioveyver";

p) in paragraph one of Item 5.3.5.1 of the word "for application" shall be replaced with words "to application";

c) in the paragraph the second Item 6.4 of the word "according to the procedure bioveyver" shall be replaced with words "on bioveyver";

r) in paragraph three of Item 10.2 of the word "In the Report of Research" shall be replaced with words "In the report on research";

s) in Item 12.2.2 of the word "Examination and Issue of the Conclusion." to exclude;

t) add with Item of the following content: "12.2.3. Examination and issue of the conclusions.";

x) in paragraphs six and the seventh Item 15.1.1 of the word "each production site" shall be replaced with words "each production site";

v) in paragraph one of Item 16 of the word shall be replaced with words "(exceptional circumstances)" "(the registration file for registration applications with establishment of post-registration measures (registration on conditions))".

10. In appendix No. 2 to the specified Rules:

a) to add the table of Item 1.1.3 with line item of the following content:

"

other state members of the Eurasian Economic Union for filing of application (in the presence)

";

b) in Item 2.5.5 of the word "active pharmaceutical substance" shall be replaced with words "active pharmaceutical substance".

11. In the table of the Section I of appendix No. 4 to the specified Rules:

a) add with line item of the following content:

"

1.5.7.

The draft of the regulating document on quality prepared according to the Management on creation of the regulating document on quality of medicine approved by the Decision of Board of the Eurasian economic commission of September 7, 2018 N 151

";

b) in line item 1.6.1:

shall be replaced with words words of "the producer (production site)" "the production site of the producer";

the words "compliance of the producer to requirements" shall be replaced with words "compliance of the production site of the producer to requirements";

c) 1.6.9 to replace line item with line item of the following content:

"

1.6.9.

consent to conducting pharmaceutical inspection to compliance to requirements of the international treaties and acts constituting the right of the Union

";

d) 1.7.2 and 1.7.3 to replace line items with line items of the following content:

"

1.7.2.	information (the short summary) on the specialist who prepared the summary of preclinical researches
1.7.3.	information (the short summary) on the specialist who prepared the summary of clinical trials

";

e) 2.6 - 2.7 to replace line items with line items of the following content:

"

2.6.	Summary of preclinical researches
2.6.1.	Introduction
2.6.2.	The summary of pharmacological researches in text format
2.6.3.	The summary of pharmacological researches in the form of tables
2.6.4.	The summary of pharmacokinetic researches in text format
2.6.5.	The summary of pharmacokinetic researches in the form of tables
2.6.6.	The summary of toxicological researches in text format
2.6.7.	The summary of toxicological researches in the form of tables
2.7.	Summary of clinical trials

";

e) 3.2.P.5.2 to replace line item with line item of the following content:

"

3.2.P.5.2.

Analytical techniques

";

g) 3.2.A.3 to replace line item with line items of the following content:

"

3.2.A.3.	New excipients
3.2.A.3.1.	Data on excipients (reducers, solvents, thinners, carriers)
3.2.A.3.2.	Description and composition of excipient (reducer, solvent, thinner, carrier)
3.2.A.3.3.	Pharmaceutical development of excipient (reducer, solvent, thinner, carrier)
3.2.A.3.4.	Excipient production process (reducer, solvent, thinner, carrier)
3.2.A.3.5.	Structure on series (production compounding) of reducer, the solvent, thinner, the carrier
3.2.A.3.6.	Excipient quality control (reducer, solvent, thinner, carrier)
3.2.A.3.7.	Microbiological characteristics of reducer, solvent, thinner, carrier
3.2.A.3.8.	System of packaging (packing) for excipient (reducer, the solvent, thinner, the carrier)
3.2.A.3.9.	Stability of excipient (reducer, solvent, thinner, carrier)
3.2.A.3.10.	Data on compatibility of reducer, solvent, thinner, carrier

";

h) 3.2.R to replace line item with line items of the following content:

"

3.2.R.	Regional information
3.2.R.1.	Records (reports) on the made product series
3.2.R.2.	Validation master plan
3.2.R.3.	The last overview on quality of medicine
3.2.R.4.	Quality manual (laboratory management) of laboratory of quality control of the producer
3.2.R.5.	The list of analytical techniques which are carried out by laboratory of quality control of the producer

";

i) "***" to exclude footnote with sign.

12. In appendix No. 5 to the specified Rules:

a) in the name of appendix to replace the word "appointments" with the word "applications";

b) state the Section VI in the following edition:

"VI. The OTD organization for registration of medicines for medical application

Module 1. Administrative information

1.1. Content

1.2. General documentation

Module 2. Summary of the general technical document

2.1. Content of modules 2 - 5

2.2. Introduction in OTD

2.3. The general summary on quality

2.4. Overview of preclinical data

2.5. Overview of clinical data

2.6. Summary of preclinical researches

Summary of pharmacological researches

Summary of pharmacokinetic researches

Summary of toxicological researches

2.7. Summary of clinical trials

Summary of biopharmaceutical researches and related analytical methods

Summary of researches on clinical pharmacology

The summary by clinical efficiency

The summary on clinical safety

Copies of the used references

Brief summary of individual researches

Module 3. Quality

3.1. Content of the module 3

3.2. Main data

3.3. Copies of the used references

Module 4. Reports on preclinical (not clinical) researches

4.1. Content of the module 4

4.2. Reports on researches

4.3. Copies of the used references

Module 5. Reports on clinical trials

5.1. Content of the module 5

5.2. The list of all clinical trials (testing) in the form of tables

5.3. Reports on clinical trials (testing)

5.4. Copies of the used references";

c) 3.2.A.3 and 3.2.R of the Section VII to state line items in the following edition:

"

			3.2.A.3	3.2.A.3.1. \\\\\\\\\\\\\\
				3.2.A.3.2. \\\\\\\\\\\\\\
				3.2.A.3.3. \\\\\\\\\\\\\\
				3.2.A.3.4. \\\\\\\\\\\\\\
				3.2.A.3.5. \\\\\\\\\\\\\\
				3.2.A.3.6. \\\\\\\\\\\\\\
				3.2.A.3.7. \\\\\\\\\\\\\\
				3.2.A.3.8. \\\\\\\\\\\\\\
				3.2.A.3.9. \\\\\\\\\\\\\\
				3.2.A.3.10. \\\\\\\\\\\\\\
		3.2.R	3.2.R.1 \\\\\\\\\\\\\\
			3.2.R.2 \\\\\\\\\\\\\\
			3.2.R.3 \\\\\\\\\\\\\\
			3.2.R.4 \\\\\\\\\\\\\\
			3.2.R.5 \\\\\\\\\\\\\\

".

13. In appendix No. 10 to the specified Rules:

a) in the first column of the table the letter "C" to replace 2 amendments No. 1 with the letter "S";

b) in the Section "The Table of Changes between Different Versions of MFAFS" of amendment No. 3:

"body - state member" shall be replaced with words words "body of state member";

"TABLE CHANGE" to replace line item with line item "the TABLE of CHANGES".

14. In the paragraph the second the subsection "Questions of Development" of the Section II of appendix No. 13 to the specified Rules of the word of "the indication on application" shall be replaced with words "indications to application".

15. In the Section II of appendix No. 15 to the specified Rules:

a) in the paragraph the second Item 1.1.3 of the word "on application" shall be replaced with words "to application";

b) in the subitem "an" of Item 2.1.1 to replace the word "reviews" with the word "summary";

c) in paragraph four of Item 3.2 of the word "on application" shall be replaced with words "to application".

16. In subsection II.4. the Section II of appendix No. 16 to the specified Rules:

a) in paragraph one the word "sites" to replace with the word "platforms", words of "this site" words of "this platform";

b) in the paragraph the second "sites" to replace the word with the word "platforms";

c) in paragraph three of the word of "sites" to replace with the word of "platforms", "sites" to replace the word with the word "platforms".

17. In appendix No. 17 to the specified Rules:

a) replace the words "REGISTRATION CERTIFICATE of medicine" with the text of the following content:

"EURASIAN ECONOMIC UNION ____________________________________________ name of authorized body

The REGISTRATION CERTIFICATE of medicine for medical application";

b) add with line item of the following content:

"

14

Expiration date

".

18. In appendix No. 19 to the specified Rules:

a) to add Item 1.3.4 of the Section I with the offer of the following content: "In amendment of VI classification of changes is given to the registration file which are allowed to be brought along with filing of application on reduction of the registration file in compliance with requirements of the Union, stipulated in Item 172 Rules of registration of medicines.";

b) in amendment of V:

in the Item A.7 line item "1. In the application form about modification it is necessary to designate accurately flowing and offered producers listed in Section 2.5 of the application form on registration." to replace with line item "1. In Item on the made changes of the statement for reduction of the registration file in compliance with requirements of the Union (in the cover letter, the application form about modification enclosed the cover letter) it is necessary to designate accurately earlier approved and offered producers as it is specified in Section 2.5 of the application form.";

in the Item B.I.a.1:

line item "5. In the application form about modification it is necessary to designate accurately flowing and offered producers as it is specified in Section 2.5 of the application form." to replace with line item "5. In Item on the made changes of the statement for reduction of the registration file in compliance with requirements of the Union (in the cover letter, the application form about modification enclosed the cover letter) it is necessary to designate accurately earlier approved and offered producers as it is specified in Section 2.5 of the application form.";

in line item of the 6th word of "qualified person (QP)" shall be replaced with words "authorized person";

in the subitem "an" of the Item B.Ii.a.3 in line items 1 and 2 in the column "Necessary Conditions" of figure "11" to replace with figures "10";

in the Item B.Ii.b.1 line item "3. In the application form about modification it is necessary to specify accurately "flowing" and "offered" producers of medicine (according to Section 2.5 of the application form)." to replace with line item "3. In Item on the made changes of the statement for reduction of the registration file in compliance with requirements of the Union (in the cover letter, the application form about modification enclosed the cover letter) it is necessary to designate accurately earlier approved and offered producers as it is specified in Section 2.5 of the application form.";

in the Item B.Ii.b.2 line item "2. In the application form about modification it is necessary to specify the "flowing" and "offered" producers of medicine (according to Section 2.5 of the application form)." to replace with line item "2. In Item on the made changes of the statement for reduction of the file in compliance with requirements of the Union (in the cover letter, the application form about modification enclosed the cover letter) it is necessary to designate accurately earlier approved and offered producers as it is specified in Section 2.5 of the application form.";

in the Item B.Ii.b.4:

shall be replaced with words the words "d) enlargement" "д) enlargement", shall be replaced with words the words "e) scale" "е) scale".

in the Item B.Ii.g.1:

state the subitem "i" in the following edition: "i) Article of the Pharmacopoeia of the Union "Uniformity of the dosed units" for the purpose of replacement of earlier approved registered method or the article "Uniformity of Mass of Unit of the Dosed Dosage Form (the Dosed Medicine)" is entered;

in line item of the 8th word "acting to the Pharmacopoeia" shall be replaced with words to "the operating Pharmacopoeia of the Union";

10 to state line item in the following edition:

10. The offered control completely corresponds to the table of Article of the Pharmacopoeia of the Union "Uniformity of mass of unit of the dosed dosage form (the dosed medicine)" and does not include the offer of alternative testing of uniformity of dosing by means of variation of weight or uniformity of content if these alternative testing are specified in the table of Article of the Pharmacopoeia of the Union "Uniformity of mass of unit of the dosed dosage form (the dosed medicine).";

in the Item B.III.1 line item "2. In case of addition of the production site - in the application form about modification it is necessary to designate accurately "registered" and "offered" producers as it is specified in Section 2.5 of the application form)." to replace with line item "2. In case of addition of the production site - in Item on the made changes of the statement for reduction of the registration file in compliance with requirements of the Union (in the cover letter, the application form about modification enclosed the cover letter) it is necessary to designate accurately flowing and offered producers as it is specified in Section 2.5 of the application form.";

c) add appendix No. 19 with amendment of the VI following content:

"Amendment of VI

The list of changes which according to Item 172 of Rules of registration and examination of medicines, can be brought by the applicant along with the procedure of reduction of the registration file of medicine in compliance with requirements of the Union

1. Along with giving the changes which are registration expansion, except for changes or additions of new dosage (activity) of medicine cannot be submitted to authorized body (the expert organization) of state member of the application for holding procedure of reduction of the registration file in compliance with requirements of the Union.

A. Administrative changes

А.1 Change name and (or) addresses of the holder of the registration certificate		Necessary conditions	Documents and data	Procedure
		1	1, 2	IANU
Conditions
1.	The holder of the registration certificate shall remain the same legal entity.

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