Typical mistakes when submitting documents related to the passage of authorization according to the requirements of the EAEU

1.

MINISTRY
OF HEALTH
OF THE RUSSIAN FEDERATION
RegLek
Typical mistakes while submitting a package
of documents related to the procedure of
authorization according to the EAEU
requirements, amendment of
registration dossiers
Aisylu Abrarovna Kamaletdinova,
Deputy Director of the Department of
State Regulation of Medicines and Medical
Devices Distribution
Ministry of Health of the Russian Federation

2.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Legal regulation of the circulation of
medicines
1
Federal Law No. 61-FZ dated April 12, 2010 "On Circulation of Medicines"
2
Decision of the Council of the Eurasian Economic Commission No. 78 dated November 3, 2016
"On the Rules for Registration and Expert Evaluation of Medicinal Products for Human Use"
3
Decree of the Government of the Russian Federation No. 441 dated April 3, 2020 "On the peculiarities of the circulation of medicinal products
for human use, which are intended for use in conditions of a threat of the emergence, occurrence and elimination of an emergency situation
and for organizing the provision of medical assistance to persons affected by emergencies,
preventing emergencies, preventing and treating diseases that pose a danger to others, diseases and injuries resulting from exposure to adverse chemical,
biological, radiation factors"
4
Decree of the Government of the Russian Federation No. 593 dated April 5, 2022 "On special considerations relating to medicinal products circulation in
case of shortage or risk of shortage of medicinal products
due to restrictive economic measures imposed against the Russian Federation"
5
Decree of the Government of the Russian Federation No. 440 dated March 23, 2022 "On adoption of specific requirements for variations to registration
dossier documents in case of shortage or risk of shortage of medicinal products
due to restrictive economic measures imposed against the Russian Federation"
RegLek

3.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Adopted Normative Legal Acts related to
medicines circulation
Decision of the Council of the Eurasian Economic Commission
No. 36 d a t e d March 17, 2022 "On amendments to the rules for
registration and expert evaluation of medicinal products for
human use"
Decree of the Government of the Russian Federation No.2056
d a t e d November 14, 2022 "On amending
some
of the Acts
of the Government
of the Russian
Federation"
Amending the Decree of the Government of the
Russian Federation No. 593 dated April 5, 2022 "On
special
considerations relating to medicinal products circulation in case of
shortage or risk of shortage of medicinal products due to restrictive
economic measures imposed against the Russian Federation"
Decree
of the Government
of the Russian
Federation
No.2537 d a t e d December 30, 2022 "On amending the Decree
of the Government of the Russian Federation No. 441 dated
April 3, 2020"
RegLek
Accelerated authorization (for orphan DPs; DPs intended exclusively for use by the minor; DPs of
particular importance to public health); authorization on conditions (lack of exhaustive data, but
the applicant is able to provide them as soon as possible (DPs intended for treatment, prevention
or diagnosis of serious (severe) disabling diseases; DPs used in emergency situations recognized by
the WHO or Competent Authorities (CA) of the Member States; orphan DPs); authorization in
exceptional cases (inability to provide complete data (rare diseases; comprehensive information
about the DP efficacy or safety cannot be provided; obtaining the information about the DP
efficacy or safety would be contrary to generally accepted principles of medical ethics).
Presentation of a letter on non-violation of the third parties intellectual property rights while
applying for authorization; regulation of the choice of a reference preparation and harmonization
of the requirements according to those of the Union; labeling and regulation of the registration
within the monitoring system of the imported unauthorized DPs movement; accompanying
presentation of the PIL in Russian for imported unauthorized DPs or authorized DPs in packages
intended for circulation in other countries.
Amendments made, which stipulate the possibility of changing the antigen (strain) composition of
the immunobiological DP used for prevention of a new coronavirus infection.

4.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Adopted Normative Legal Acts related to
medicines circulation
Order of the Ministry of Health of the Russian Federation No. 724n
d a t e d November 3, 2022 "On amending the Regulations for the
Interdepartmental Committee in terms of defining the shortage or
risk of shortage of medicinal products due to restrictive economic
measures imposed against the Russian Federation approved by the
Order of the Ministry of Health of the Russian Federation No. 339n
dated May 19, 2022.
Decree of the Government of the Russian Federation No. 558
d a t e d April 7, 2023 "On amendments to the Rules for formation of
a list of alcohol-containing medicinal products, the activities for
the production, manufacture and (or) turnover of which are not
covered by the Federal Law “On state regulation of the production
and turnover of ethyl alcohol, alcohol and alcohol-containing
products and on limiting the consumption (drinking) of alcoholic
products"
Order of the Ministry of Health of the Russian Federation No. 959n
d a t e d March 6, 2023
"On introduction of changes into the
classification of changes to be introduced into the documents of the
registration dossier of the authorized medicinal product for human
use approved by the Order of the Ministry of Health of the Russian
Federation No. 959н dated December 13, 2016 "On approval of
classification of changes to be introduced into the documents of the
registration dossier of the authorized medicinal product for human
use"
RegLek
The criteria for making a decision on defining the shortage or a risk of shortage of
medicinal products for human use have been established; a recommended template for
providing the information has appeared; posting the DP on the website, in respect of which
a proposal has been received included in the agenda of the Interdepartmental Committee
meeting, and the date of the next meeting; the possibility of a decision on withdrawal of a
previously issued conclusion and exclusion of the DP from the list.
Extending the options for inclusion into the List of alcohol -containing DPs, as well
as into the Common Register of the Authorized Medicinal Products of the Union; a
calculation formula has appeared, the results of which are taken into account
while including products into the List; extension of concepts in terms of the
characteristics of the inclusion criteria.
Extending the nomenclature of possible administrative changes without an
expertise; a list of changes that are made without the expertise of quality
of the drug product samples has been supplemented.

5.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Interdepartmental Committee for defining the
shortage or a risk of shortage
RegLek
Order of the Ministry of Health of the Russian Federation No. 339n dated May 19, 2022
"On the Interdepartmental Committee for defining the shortage or a risk of shortage of
medicinal products for human use... due to restrictive economic measures imposed against
the Russian Federation, as well as on approval of the forms of such opinions"
Decisions taken by the Interdepartmental Committee:
• DP authorization — 50 DPs
The
Interdepartm
ental
Committee
has held
23 meetings
• Amending the registration dossier of the
authorized DP — 94 drug products (DPs)
• Possibility of circulation of the DP batch (lot) in the Russian
Federation in the packaging intended for circulation in the
territory of foreign countries — 5 DPs
• Possibility of issuing a permission for temporary circulation
of the unauthorized DP batch (lot) — 9 DPs
• Decision on the cancellation of previously issued opinion
and
exclusion from the List — 1 DP

6.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Statistics on authorized drug products for 2022
RegLek
In total, 1,143 drug products have been authorized pursuant to the following procedures:
• based on the requirements of the Eurasian Economic Union — 172
• based on the requirements of the Federal Law No. 61 — 950
• based on the requirements of the Decree of the Russian Federation No. 441 — 19
• (17 ones of domestic manufacture, 2 ones of foreign manufacture)
• based on the requirements of the Decree of the Russian Federation No. 593 — 2
In total, 7,115 changes have been made to the registration dossiers of the authorized drug products;
Authorization of 255 drug products has been confirmed;
In total, the registration dossiers of
brought into compliance with the
891 drug products have been
requirements of the Eurasian Economic Union;
Based
Federation
on the requirements of the
Decree
No. 440,
41 changes have been made
to the registration dossiers of the authorized drug products.
of
the
Russian

7.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Typical mistakes while authorizing the drug products
according to the requirements of the Eurasian
Economic Union
RegLek
When submitting an application, there is no attachment to the application, which is an integral part of the
application;
When filling in the application, there are no stated e-mail addresses, 24-hour telephone and fax numbers, holder
and representative of the marketing authorisation holder, as well as no e-mail addresses, 24-hour telephone and
fax numbers, legal and actual addresses, legal and actual addresses of the qualified person of the marketing
authorisation holder responsible for
pharmacovigilance;
There is no power of attorney, which confirms that the authorized person has the powers to carry out legally
significant actions while authorizing drug products in the Eurasian Economic Union;
There is no signature of the Qualified Person and no notarization in the submitted copy of the letter (according to
paragraph 1.5.2 of Appendix No. 1 to the Rules) of the holder of the Active Substance Master File indicating the obligation
to report all changes to the manufacturer of the drug product and the Competent Authority of the Member State before any
significant changes are made to the Active Substance Master File;

8.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Typical mistakes while authorizing the drug products
according to the requirements of the Eurasian
Economic Union
RegLek
Instead of a duly certified copy of the current document confirming the compliance of the manufacturer
(manufacturing site) with the requirements of the Rules of Good Manufacturing Practice (paragraph 1.6.1 of
Appendix No. 1 to the Rules), a draft is submitted;
The submitted copy of the current document confirming the compliance of the manufacturer (manufacturing site)
with the requirements of the Rules of Good Manufacturing Practice (paragraph 1.6.1 of Appendix No. 1 to the
Rules) is void;
There is no Appendix in the license copy (paragraph 1.6.2 of the Appendix No. 1 to the Rules);
A document on the renewal of the license is attached, but the license itself is missing;
There is no copy of the report (copies of reports) on the inspection of the manufacturing site (manufacturing sites
at different manufacturing stages) for compliance with GMP conducted by the authorized body of the
manufacturing country or other authorized body over the past 3 years (paragraph 1.6.3 of Appendix No. 1 to the
Rules);
The submitted state duty does not correspond to the type of application for authorization filed (for example, the
registration dossier indicates that a well-studied DP is being presented, and the state duty in the amount of
325,000 is attached instead of 250,000), or the state duty is not presented in full;

9.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Typical mistakes while authorizing the drug products
according to the requirements of the Eurasian
Economic Union
RegLek
In the registration dossier, there is no executive summary (up to 5 pages), as well as no actual specific
requirements for various types of applications (generic, biosimilar, hybrid, well-studied drug product
(Sections 1.8.2.5 — 1.8.2.9 of Appendix No. 1 to the Rules);
In the registration dossier, there is no risk management plan for the drug product according to paragraph 1.10.3
of Appendix No. 1 to the Rules, that shall be prepared based on the Rules of Good Pharmacovigilance Practice
of the Union. Pursuant to clause 349 of the Decision of the Council of the Eurasian Economic Union No. 87
dated November 3, 2016 (as amended on May 19, 2022) "On approval of the Rules for Good Pharmacovigilance
Practice of the Eurasian Economic Union", when filing an application for authorization of the drug product, the
risk management plan with a description of the risk management system and a summary of the plan shall be
submitted for all medicinal products;
Non-compliance of the presented information within the registration dossier (for example, the application
includes one drug formulation, and the draft ND and PIL include another one; non-compliance of the
declared manufacturing site location with that stated in the license or GMP certificate, etc.).

10.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Typical mistakes while submitting a package of documents for
registration dossier amending
RegLek
No drug product manufacturing license and its translation into Russian;
No
data on
the
date of
submission
and registration
number
the Decision of
the Authorized Federal Executive Body on conducting the inspection of the
manufacturer of the drug product in case such manufacturing is carried out outside the Russian
Federation (GMP);
of
No power of attorney;
No approved normative documents for a new manufacturing site;
The submitted documents do not support the invariability of actual location of the manufacturing site;
The submitted documents do not support the legal relationship between the companies; there is no
manufacturing agreement for drug product release;
No agreement on pharmacovigilance.

11.

MINISTRY
OF HEALTH
OF THE RUSSIAN
FEDERATION
Simplification of the procedure of bringing the registration
dossier in compliance with the requirements of the
Eurasian Economic Union
1. The EAEU MAs are issued for all DPs (for 5 years or with unlimited validity)
2. Reduction of the volume and period of the expertise Implementation of the riskoriented approach.
3. Reduction of the number of submitted documents. Module 2 is optional, and
modules 1 and 3 are shortened.
4. No user testing is required.
5. No need for notarial certification of documents.
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12.

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THANK YOU FOR YOUR ATTENTION!
MINISTRY
OF HEALTH
OF THE RUSSIAN FEDERATION