DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of March 17, 2022 No. 36

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 solved:

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 10 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

B. Sultanov

From the Kyrgyz Republic

A. Kozhoshev

From the Russian Federation

A. Overchuk

 

Appendix

to the Decision of Council of the Eurasian economic commission of March 17, 2022 No. 36

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

1. Add Item 3 with the subitem "a.1" the following content:

"and. 1) medicines which are intended for application in the conditions of emergency situations, threat of their origin or emergence of emergency situations, for prevention and the treatment of the diseases and defeats constituting danger to people around, received as a result of impact of chemical, biological, radiation factors which address is regulated by the legislation of state members;".

2. To add the subitem "d" of Item 5 with words of "state members".

3. Add with Item 5.1 of the following content:

"5.1. In cases and procedure, stipulated by the legislation state members, provision to patients and application concerning their unregistered medicines is allowed. Treat such medicines including:

the medicines imported into state member for delivery of health care according to vital testimonies of the specific patient or for delivery of health care to narrow group of patients with rare and (or) especially heavy pathology based on the conclusion (the allowing document) issued by authorized body of state member;

the high-tech medicines made on not standardized (not routine) basis and applied in the territory of the same state member in hospital for the purpose of execution of individual medical purpose of the medicine which is specially made for the certain patient.

Production of such high-tech medicines is allowed by authorized body of state member. State members shall provide equivalence of requirements imposed to traceability of series and batches of the medicines established by the legislation of state members and to pharmakonadzor according to acts of bodies of the Union.".

4. Add Item 6 with the paragraph of the following content:

"If medicine is intended for treatment of the orphan disease included in lists which are kept according to the legislation of separate state member registration of such medicine to data in the reference state according to these rules for the purpose of the address of medicine in the market only of this state (the national procedure of registration) is performed according to Sections V and VII or Sections VI and VII of these rules, and also according to provisions of the Section 16 of part III of appendix No. 1 to these rules.".

5. In Item 18:

a) in the offer third paragraph one of the word "the these rules specified in the Section VII, and also in cases" to exclude;

b) after paragraph one to add with paragraphs of the following content:

"Effective period of the registration certificate on the medicine registered according to the procedure of conditional registration is determined taking into account provisions of the subsection VII.III of the Section VII of these rules.

For the medicine registered according to the legislation of state member and which is traded 5 years and more on the market of this state member the termless registration certificate is issued if medicine is supposed to market circulation only of this state. In case of the planned address of such medicine in the markets of other state members the registration certificate is subject to replacement by the registration certificate with effective period of 5 years.".

6. In Item 19:

a) after the paragraph of the twelfth to add with the paragraph of the following content:

"data of real clinical practice" - the data relating to the state of health of the patient and (or) to process of delivery of health care, received from different sources;";

b) after the paragraph of the thirteenth to add with the paragraph of the following content:

"the evidence obtained on the basis of data of real clinical practice" - the clinical proofs concerning application and potential advantage or risk of use of medicine received on the basis of collection and data analysis of real clinical practice;".

7. In Item 20 of the word "consistently in several state members" and "at the same time in several state members according to" exclude.

8. To add the subitem "b" of Item 21 with the offer of the following content: "Simultaneous initiation of the procedure of mutual recognition in several states of recognition is allowed.".

9. In the paragraph the sixteenth Item 38 of the word "" shall be replaced with words inspections (unplanned or planned) "pharmaceutical inspection".

10. In Item 45 of the word "medicines and general characteristic of medicines" shall be replaced with words "medicine and general characteristic of medicine".

11. In Item 46 of the word "210 calendar days" shall be replaced with words "140 working days".

12. In Item 47:

a) state paragraph two in the following edition:

"the statement in the form established by appendix No. 2 to these rules, on paper or in the form of the electronic document signed by the digital signature (digital signature) according to the legislation of state member in which submission of such statement is performed (further - the digital signature);

b) third to add the paragraph with the words "on paper or in the form of the electronic documents signed by the digital signature";

c) the fourth to state the paragraph in the following edition:

"the registration file according to appendices No. 1 - 5 to these rules on the electronic medium in the form of set of electronic documents;";

d) in paragraph six of the word "Standard" shall be replaced with words "Samples of medicines, standard";

e) to replace the paragraph of the eighth with paragraphs of the following content:

"Representation of samples, specific reagents and other materials in case of impossibility of carrying out testing in the expert organization is not required owing to:

inaccessibility of samples of medicines of standard samples, specific reagents and other materials (including, in case of their reference to category of the orphan, high-tech, radio pharmaceutical, narcotic, psychotropic or intended for treatment highspending nozologiya owing to their high cost);

impossibility of observance of conditions of transportation of the specified samples on the territory of state member and (or) their storage;

lack of the special equipment and consumable materials in the expert organization;

and other reasons according to the decision of authorized body (the expert organization) in case of the force majeure circumstances or circumstances independent of will of the parties, including in connection with features of production and quality control of medicine.

According to requirements of the legislation of state member submission of the documents specified in paragraphs the second - the fourth this Item, can be performed with use of electronic document management without additional submission of the relevant documents and data on paper signed and (or) certified by the digital signature of the applicant in the cases provided by these rules.".

13. In Item 48:

a) "the paragraph the eighth Item 47" shall be replaced with words words "paragraphs the eighth - the eleventh Item 47";

b) add with the paragraph of the following content:

"In cases of impossibility of laboratory testing in the laboratories of quality control of the producer of medicine or contractual laboratories used by the producer (in the conditions of threat of origin, origin and liquidation of emergency situation and (or) in case of threat of spread of the diseases constituting danger to the people around, diseases and defeats received as a result of impact of adverse natural, chemical, biological, radiation factors in case of which presence of the representative of the expert organization is not possible, or under other circumstances (for example, in the paragraphs eight connected with features of production and quality control of specific medicine of categories, specified - the eleventh Item 47)) in coordination with authorized body (the expert organization) expertize of quality is carried out based on documentation of the producer (protocols of the analysis of the producer) including with use of means of remote interaction, including audio-or video conference.".

14. In the subitem "g" of Item 49 of the word "unplanned or planned" to exclude.

15. In Item 50:

a) in the offer the first shall be replaced with words the words "14 working days" "10 working days";

b) in the offer the second shall be replaced with words the words "90 calendar days" "90 working days";

c) add with the paragraph of the following content:

"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.".

16. Add Item 52 with the paragraph of the following content:

"The examination including the stages specified in subitems "b" - "д" Item 49 of these rules is carried out in time, not exceeding 105 working days from the date of assessment of completeness, completeness and correctness of document creation provided in the registration file or from the date of receipt by the expert organization of the corresponding task for conducting examination.".

17. In Item 53 of the word "90 calendar days" shall be replaced with words "90 working days".

18. In the offer the second Item 54 of the word "180 calendar days" shall be replaced with words "180 working days".

19. State Items 57 and 58 in the following edition:

"57. The request of authorized body (the expert organization) of the reference state shall be transferred to the applicant electronically on telecommunication channels and it is considered received after 1 working day from the date of its direction.

58. The decision on initiation of unplanned pharmaceutical inspection on compliance to proper pharmaceutical practicians of the Union can be made by authorized body, (the expert organization) the reference state no later than 70 working days from the date of filing of application on registration.

In case of decision making about initiation of unplanned pharmaceutical inspection the authorized body (the expert organization) of the reference state sends to the applicant inquiry for need of the organization of inspection (with indication of the reasons of initiation and references to acts of bodies of the Union). Submission of the response to the specified request is performed in time, specified in Items 53 and 54 of these rules.

Unplanned pharmaceutical inspection with the direction of the report on conducting inspection shall be carried out in time, not exceeding medicine registration term (within 180 working days from acceptance date by the relevant authorized body or the expert organization of the decision on initiation of conducting inspection).

Unplanned pharmaceutical inspection will be organized by the applicant according to rules of conducting pharmaceutical inspections.

In case of inclusion of pharmaceutical inspection in the plan of conducting inspections according to Item 31 of these rules, preparation of the report comes to the end without results of inspection.".

20. Add with Item 63.1 of the following content:

"63.1. The decision by results of conducting examination of medicine is made by authorized body of the reference state in time, not exceeding 10 working days from the date of signing of the expert report on assessment.".

21. Add Item 64 with the subitem "zh" of the following content:

"g) the applicant does not submit at the scheduled time the documents and data requested by authorized body (organization).".

22. In Item 66:

a) in the paragraph the second shall be replaced with words the words "and (or) in the form of the electronic document" "or in the form of the electronic document signed by the digital signature";

b) third to add the paragraph with words ", on paper or in the form of electronic documents";

c) the fourth to state the paragraph in the following edition:

"the module of 1 registration file on the electronic medium in the form of electronic documents (including the staticized documents relating only to the state of recognition). In the cover letter the applicant shall provide data on all changes made to the registration file if they were initiated before date of filing of application on registration to the states of recognition (with indication of numbers of statements and with application of copies of decisions (conclusions) of authorized body of the reference state).";

d) add with paragraphs of the following content:

"The application cannot be submitted to the states of recognition before date of completion of the procedures of modification initiated in the reference state (in the presence). After initiation of the procedure of registration in the states of recognition and before its completion in the states of recognition in which this procedure is initiated the applicant has no right to initiate the procedure of modification in the reference state, except for the urgent changes concerning safety.

When giving the urgent changes concerning safety in the reference state the applicant within a day shall notify the authorized body (the expert organization) of the state of recognition performing the procedure of recognition on this fact.

According to requirements of the legislation of state member submission of the documents specified in paragraphs the second - the fourth this Item, can be performed with use of electronic document management without additional submission of the relevant documents and data on paper signed and (or) certified by the digital signature of the applicant in the cases provided by these rules.".

23. Add with Item 66.1 of the following content:

"66.1. Modification of the registration file of the registered medicine in the reference state according to appendices No. 19 and 20 to these rules before date of initiation of the procedure of mutual recognition in the state (states) of recognition is allowed. At the same time to the state of recognition by the reference state the staticized expert report following the results of modification shall be submitted (when applicable).

At the choice of the applicant simultaneous initiation of the procedure of mutual recognition in several states of recognition is allowed.".

24. In Item 68 of the word "90 calendar days from the date of receipt of access to the expert report on assessment" shall be replaced with words "60 working days from the date of receipt of access of the expert organization to all versions (sequences) of the electronic registration file based on which the reference state prepares the expert report on assessment, and for the approved expert report on assessment.".

25. State Item 69 in the following edition:

"69. Examination of medicine in case of the procedure of mutual recognition in the states of recognition is performed in time, not exceeding 40 working days from the date of receipt of access to the expert report on assessment, way:

considerations of the application, the documents and data provided in the registration file urgent (taking into account the made changes in the registration file, in the presence) in the reference state at the time of filing of application in the states of recognition;

considerations of the expert valuation report prepared by the expert organization of the reference state staticized in the reference state at the time of filing of application in the states of recognition.

The expert organization of the state of recognition notifies authorized body of the state of recognition and the applicant on receipt of the specified access in full within 1 working day from the date of its obtaining.

The applicant is notified on the beginning of examination electronically on telecommunication channels. The notification is considered received after 1 working day from the date of its direction (or publications in personal account of the applicant).".

26. In Item 70:

a) shall be replaced with words the words "14 working days" "10 working days";

b) add with words ", or makes the decision on the beginning of the examination specified in Item 69 of these rules".

27. In Item 71:

a) shall be replaced with words the words "50 calendar days" "30 working days";

b) add with paragraphs of the following content:

"The request of authorized body (the expert organization) of the state of recognition to the applicant can be transferred to the authorized representative of the applicant personally under the signature, is directed by mail by the registered mail or transferred electronically on telecommunication channels. In case of the direction of this request by mail it is considered the registered mail received after 6 calendar days from the date of the direction of the registered mail. In case of the direction on telecommunication channels the request is considered received after 1 calendar day from the date of its direction.

The request of authorized body (the expert organization) of the state of recognition to authorized body of the reference state goes by means of use of the integrated system.".

28. In Item 72 of the word "90 calendar days" shall be replaced with words "90 working days".

29. Add Item 73 with paragraphs of the following content:

"In case of non-presentation of the reference state by authorized body within 100 working days requested by authorized body (the expert organization) of the state of recognition of documents and data the conclusion about impossibility of recognition of the expert report on assessment prepared by the reference state is drawn up.

The specified report goes the state of recognition for consideration by Expert committee.".

30. State Item 75 in the following edition:

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