Update-2024-May-en

LEGAL UPDATE

May 2024

LEGAL ACTS SUBJECT TO CHANGE

1. RA LAW ON AMENDMENTS TO THE LAW "ON JOINT STOCK COMPANIES"

2. RA LAW ON AMENDMENTS TO THE LAW "ON TRADE AND SERVICES"

3. RA LAW ON AMENDMENTS AND CHANGES TO THE LAW "ON DRUGS"

4. RA LAW ON AMENDMENTS AND ADDITIONS TO THE LAW "ON STATE DUTY"

5. LAW ON AMENDMENTS TO THE LAW "ON MEDICAL AID AND SERVICE OF THE

POPULATION"

LEGAL ACTS SUBJECT TO CHANGE

Name of the legislative act

RA LAW ON AMENDMENTS TO THE LAW "ON JOINT STOCK COMPANIES"

The status of the change

The law entered into force on May 27, 2024, the tenth day following the date of official publication.

What are the changes related to?

As a result of the changes, legal conditions have been created to attract investments in Armenian companies through the Safe agreement, which defines the concept of the SAFE agreement and the main conditions for its application, taking as a basis the already formed business practice in the world and the Republic of Armenia.
Legally, a Safe agreement is an agreement under which an investor invests money in a company at an early stage of development, usually proportionally in a small amount, provided that in case of success of the company (attracting much larger investments, acquiring a larger company, etc.), the investor will receive a certain amount shares in exchange for their investments. In case the company fails (finds itself in the process of bankruptcy or liquidation, etc.), the amount of the contribution will be refunded.

Suggestions

The contract in question can become one of the important tools for attracting funds to your
commercial activities. The convenience of the SAFE contract lies in the fact that it allows you to
avoid the negative aspects of both debt (in particular, a convertible bond) and equity, assimilating the positive aspects of both. In particular, unlike a bond, a SAFE contract does not have a term and, as a rule, does not cause the need to pay interest. At the same time, unlike cases of direct sale of shares, the investor does not immediately acquire rights to participate in management and receive dividends and other rights, and in case of bankruptcy, he does not appear on equal terms with other shareholders, but receives a higher priority.

Article 38.2. The SAFE contract

1. Under the SAFE contract, one party, the investor, undertakes to invest in the Company's equity capital of the amount specified by the contract, and the Company undertakes to issue in the future and allocate to the benefit of the other party (the investor) the amount determined by the contract or determined in accordance with the procedure specified by the contract, type and class of shares.

2. In the case of signing a SAFE contract, the investor hands over to the Company funds of the amount specified in the contract, but the increase of the Company's authorized capital in the appropriate amount is made only in the case of the issuance of the Company's shares in the manner specified in the contract and allotment in favor of the investor. The SAFE contract comes into force at the time of its conclusion, but in the case of the Company's shares being issued and allocated in favor of the investor based on it, the shares are considered paid at the time of their allocation.

3. In case of meeting the conditions for the issuance of shares of the Company and allotment in favor of the investor defined by the SAFE contract, the Company is obliged to issue the shares specified in the SAFE contract and allocate them to the investor within 60 days.

4. In case of issuance of shares and placement in favor of the investor on the basis of the SAFE contract, the right of preference to acquire the shares by other shareholders of the Company or by the Company shall not be applied.

5. Relations related to attracting investments or making investments by the organizations provided for in Article 39.1, Part 1 of the Law of the Republic of Armenia "On the Central Bank of the Republic of Armenia" are regulated by the laws and normative legal acts regulating the activities of these organizations.

6. The SAFE contract also defines conditions, upon reaching which the amount equal to the amount invested by the investor based on the SAFE contract is subject to return to the investor, in which case the increase of the Company's authorized capital and allocation of additional shares are not carried out. The SAFE contract may also specify that in case of return of the invested funds, the Company is obliged to pay interest on them to the investor.

7. The SAFE contract is a security.

Name of the legislative act

RA LAW ON AMENDMENTS TO THE LAW "ON TRADE AND SERVICES"

The status of the change

This amendment entered into force three months after its publication, that is, 06.05.2024. In the case of obligations arising before the entry into force of the law, the terms defined by Article 15.12, part 1 of the Law, supplemented by Article 2 of the Law, are calculated from the date of entry into force of this Law.

What are the changes related to?

With this amendment:
 - general requirements for trading network and supplier relations are defined,
 - a list of information to be published on the official website of the trading network was fixed,
 - the criteria and conditions for choosing a supplier's product were provided for,
 - the essential terms of the contract concluded with the trading network were clarified,
 - the conditions for displaying products in the trading network, including the conditions and
procedures for advertising products, carrying out promotions, setting privileges or other
activities aimed at promoting products, are provided for.

It is expected that as a result of the adoption of the law, the necessary, predictable and definite legislative framework will be created for relations between the trading networks and suppliers, as well as for the market for agricultural products, which will contribute to the implementation of fair trade, including improving the competitive environment and improving consumer protection.

Suggestions:

To ensure that the activities of an economic entity comply with the changes under discussion, it is necessary to:
1) The following information is necessarily posted on the official website of the trading network:
 - minimum requirements and principles for choosing a potential supplier's product,
 - the list of products to be sold by the trading network,
 - the conditions of displaying the product in the trading network,
 - grounds for termination of supply relations.
2) In connection with the display of products, we should note that from now on, issues related to the display of products can be regulated exclusively by a written contract, which must define:
 - detailed description of the product demonstration, specifications and conditions for the
implementation of product promotion measures,

- the price of the contract, which includes, among other things, all fees related to the terms of the display or pricing procedure,
 - payment terms, deadlines or the procedure for determining them.
3) As a result of the supplement, the relationship between trading networks and suppliers shall be regulated by a written contract concluded between the latter, which shall contain the
following essential terms:
 - the price of the contract, which includes, among others, all the fees or the procedure for
setting the price by the trading network,
 - the payment procedure, deadlines, or the procedure for determining them,

- the procedure and grounds for making changes to the non-disclosure contract, as well as
unilateral termination and termination of the contract,

- If the possibility of return of products not sold within the expiration date is provided, the
procedure for their return.

CHAPTER 4.4

FAIR TRADE RULES BETWEEN THE TRADING NETWORKS AND SUPPLIERS

Article 15.8. General requirements for the relationship between the trading network and suppliers

1. It is forbidden to set and apply discriminatory conditions by the trading network in the process of establishing, current and termination of relations with suppliers, unless there is a reasoned decision of the Competition Protection Commission for a reasonable and objective basis of difference, also due to economic conditions (factors) or the status of a separate group.

Article 15.9. The official website of the trading network

1. The trading network has an official website.

2. The trading network publishes on the official website:
1) minimum requirements and principles for product selection of a potential supplier,
2) the list of goods to be sold by the trading network,
3) terms of product demonstration in the trading network,
4) grounds for termination of the supply relationship.

Article 15.10. Minimum requirements and principles of supplier's product selection, entry of new suppliers into the trading network

1. Trade networks define minimum requirements and principles for product selection of potential suppliers. Minimum requirements and principles may be defined by product type, provided that the supplier can understand the relevance of the given requirement or principle to a specific product type.

2. The selection of the supplier's product is carried out at the initiative of the trading network or as a result of the study of the written commercial proposal of the potential supplier, taking into account the minimum requirements and principles for the supplier's product published by the trading network.

3. The trading network considers the written commercial proposal after receiving it, no later than within 15 working days. In the event that additional actions are necessary for the selection of the supplier's product (examination, etc.), the period can be extended up to 15 working days, if no other period is necessary for the implementation of the specified action, about which the trading network informs the prospective business offer in writing.

4. The trading network informs the proposer in writing about the negative decision on the selection of the product of the potential supplier, justifying the non-compliance with the minimum requirements and principles published by the trading network.

5. It is prohibited for the trading network to impose additional services unrelated to the supply contract on the potential supplier or to refuse to conclude a supply contract on the basis of their refusal.

Article 15.11. Essential terms of the contract to be concluded with the trading network

1. The supply contract is concluded in writing.

2. The contract shall contain at least:
1) the price of the contract, which includes, among other things, all fees or pricing procedures made by the trading network,
2) the order, terms of payment or the procedure for determining them,
3) the procedure and grounds for amending the contract, as well as for unilaterally terminating and terminating the contract,
4) if the possibility of return of products not delivered within the expiration date is provided, the
procedure for their return.

3. The trading network can publish the content of the contract with the suppliers on the official website.

Article 15.12. Terms and procedure of payment for goods supplied to the trading network

1. The trading network makes the payment to the supplier no later than:

1) for foodstuff, within 30 days,
2) for non-food items within 60 days.

2. The calculation of the time limits provided for in paragraph 1 of this article begins from the moment of acceptance of the delivered goods in accordance with the procedure established by law and the contract.

3. By written agreement of the parties, shorter payment terms may be established than provided for in paragraph 1 of this Article.

Article 15.13. Terms of product demonstration in the trading network

1. The trading network sets conditions for product demonstration, including conditions for product promotion, promotions, benefits or other measures aimed at promoting the product, including display options and fees charged for them:

2. The relationship related to the product demonstration is regulated by a written contract, which may also be part of a supply contract.

3. The contract regulating the relationship related to the product demonstration at least contains:
1) product display description, features and conditions for product promotion activities,
2) the contract price, which includes, among other things, any fees incurred by the trading network related to the terms of the display or pricing procedure;
3) the order, terms of payment or the procedure for determining them.

Name of the legislative act

RA LAW ON AMENDMENTS AND CHANGES TO THE LAW "ON DRUGS"

The status of the change

This Law entered into force on the day following its official publication, that is, on 08.05.2024.

What are the changes related to?

The adoption of the RA Law "On Amendments to the Law on Drugs" aims to more clearly and comprehensively regulate the sphere of circulation of medicines, ensuring the introduction of unified rules of the EAEU.
The draft law was developed by the Department of Drug Policy and Medical Technologies of the
Ministry of Health of the Republic of Armenia and CJSC "Expert Center for Medicines and
Medical Technologies named after Academician Emil Gabrielyan" of the Ministry of Health of the Republic of Armenia.
The amendments made to the Law "On Drugs" aim to improve the tools of state control over the circulation of medicines. The two aforementioned acts provide for additional restrictions to comprehensively control the advertising, import, and export of drugs, pharmaceuticals, investigational pharmaceutical products, and herbal raw materials.

Article 7. Implementation of examinations and professional observations in the field of state regulation of drug circulation

2. For examinations in the field of state regulation of drug circulation, a state fee shall be charged in the manner and amount determined by the Law of the Republic of Armenia "On State Duty", except for the cases provided for by law.

3. The expert organization established by the decision of the Government of the Republic of Armenia carries out the examinations and professional observations in the field of state regulation of drug circulation.

Article 16. State registration of drugs

3. In the Republic of Armenia, drugs are registered according to general and simplified procedures, as well as according to the rules of the EAEU. The simplified procedure is applied to medicines registered by the competent authority of the member country of the international professional organizations established by the decision of the Government of the Republic of Armenia or subjected to examination or pre-qualified by the World Health Organization (hereinafter referred to as pre-qualified). The drug to be registered under the simplified procedure must be registered (tested) or pre-qualified by the reference authority, except for the holder of the drug's trade name or registration certificate. Regardless of the procedure, the packaging and labeling of the drug registered in the Republic of Armenia must comply with the requirements established by the legislation of the Republic of Armenia.
(…)

16. The applicant has the right to refuse the examination at any stage. Based on the withdrawal letter, the examination is terminated and the registration process is completed. And within 60 calendar days after the first notification of the examination results, or within 120 calendar days after the second notification, the requested additional or unsatisfactory documents or data or samples or standards or specific reagents or other materials necessary for laboratory examination are not submitted or in the amount and manner prescribed by law. If the state duty is not paid, the examination is stopped, and registration, re-registration, extension of the certificate period, post- registration change are rejected. In the cases defined by this part, the state fee paid for the examination is not subject to return.
(…)

18. The period of drug registration is five years, which is calculated from the date of entry into force of the order of the Authorized Body on drug registration. As a result of the registration, a registration certificate is issued, and the registered medicine is included in the register. The authorized body approves the form of the registration certificate, the form of the register and the procedure of management. Along with the registration certificate, the applicant is provided with the electronic versions of the drug's primary, outer package, label, Armenian instructions for medical use (general characteristics of the drug) and Armenian instructions for use (insert-leaflet) and quality indicators
(specifications) or quality normative documents, which are also the basis of Armenia. For drug identification, quality control or official information at all stages of drug circulation in the Republic. The primary and outer packages of the registered drug with their marking, label and leaflet are considered as registration. The authorized body ensures the publication and posting of the register, the register and the Armenian instructions for medical use (general characteristics of the drug) on the official website of the authorized body.

19. After the registration period ends, the drug can be re-registered for a period of five years in accordance with the procedure established by the Government of the Republic of Armenia, re-evaluating the safety, effectiveness and quality of the product. After the expiration of the re- registration period, with the consent of the holder of the registration certificate, the registration certificate may be extended every five years, based on the results of post-registration safety professional observations by the Authorized Body. Re-registration of the drug, extension of the term of the registration certificate is carried out by the Authorized Body on the basis of a positive expert opinion. The maximum duration of the drug re-registration process is 120 calendar days, including the examination period of 110 calendar days. The maximum duration of the process of extending the term of the drug registration certificate is 30 calendar days, in which the examination period is calculated 20 calendar days. The application for re-registration and the application for extension of the term of the certificate of registration shall be submitted before the expiry of the term of the certificate of registration, but not earlier than 210 calendar days and not later than the day of the expiry of the term of the certificate of registration. After the certificate expires, a new registration application is submitted.
(…)

35. The registration documents of drugs registered in the Republic of Armenia, which have not been registered by EAEU procedures, must comply with EAEU rules, except for the cases defined by those rules. In order to keep valid the indefinite registration certificate issued in accordance with the EAEU rules, the right holder of the registration certificate pays an annual state fee in the manner and amount determined by the Law of the Republic of Armenia "On State Duty". If the annual state fee is not paid within the specified time, the registration of the drug is suspended, about which the Authorized Body publishes information on its official website and makes a note in the register. To restore the registration, the right holder of the certificate submits an application, attaching the document confirming the payment.
(…)

Article 17. Reporting Side Effects and Counterfeit Products

2. The right holder of the drug registration certificate is obliged to have a pharmacovigilance system in accordance with the "Proper pharmacovigilance activities" defined by the Authorized Body, to record the cases of side effects, to evaluate the risk-benefit ratio of the drug and to report them according to the procedure defined by the Authorized Body. The right holder of the registration certificate means the qualified person who is responsible for pharmacovigilance, and in the case of the qualified person acting outside the territory of the Republic of Armenia, also the person responsible for pharmacovigilance in the Republic of Armenia. The requirements for qualified and responsible persons are defined by the Authorized Body. The rules of "Proper pharmacovigilance activities" adopted by the authorized body are posted on the official website of the authorized body.

Article 25. Retail sale of drugs

8. The sale of prescription drugs without a prescription or with prescriptions written on forms that do not meet the requirements established by the legislation of the Republic of Armenia is prohibited.

9. It is prohibited to issue prescriptions on forms that do not meet the requirements established by the legislation of the Republic of Armenia.

Article 28. Advertisement of drugs

2. The permission to advertise the drug is given by the Competent Authority on the basis of expert opinion. The Government of the Republic of Armenia defines the procedure for advertising permission, examination of advertising material and the list of necessary documents. In case of
advertising of drugs through electronic or printed means of mass information, the number, day, month, year, validity period of the drug's state registration certificate in the Republic of Armenia, authorization number and day, month, year of the Authorized Body must be indicated. External advertising of medicines is prohibited in the Republic of Armenia. The permission to advertise veterinary vaccines, serums and diagnostic means is granted by the state authorized body in the field of agriculture, in accordance with the procedure established by the Government of the Republic of Armenia.

Article 29. State control in the field of drug circulation

1. State control in the field of drug circulation is carried out by the inspection body authorized by the Government of the Republic of Armenia (hereinafter referred to as the Inspection Body) in accordance with the procedure established by the legislation of the Republic of Armenia.

2. The quality, packaging, labeling, marking and instructions for use (insert-leaflet) of drugs, medicinal substances, herbal raw materials and researched pharmaceutical products circulated in the Republic of Armenia must comply with the requirements established by this law.

3. Medicines, medicinal substances and herbal raw materials taken by an official of the inspection body within the framework of control or purchased through control purchase are submitted to the expert organization defined by Article 7 of this law in case of need for examination. The examinations defined by this article are carried out within the framework of the state order.

4. To record inconsistency as a result of comparing the drug taken by an official of the inspection body within the framework of control or obtained through controlled purchase and the data in the register, including the data of the registered drug (primary and (or) outer package, label, stamp or instructions for use (insert-leaflet)) in this case, the fact that the drug is not registered in the Republic of Armenia is considered to be established. In the mentioned case, the drug can be submitted for examination in accordance with the procedure defined by part 3 of this article only for the study of other factual circumstances.

Name of the legislative act

RA LAW ON AMENDMENTS AND ADDITIONS TO THE LAW "ON STATE DUTY"

The status of the change

This amendment entered into force on 08.05.2024.

What are the changes related to?

Adoption of the draft law aims to more clearly and comprehensively regulate the sphere of
circulation of drugs, ensuring the introduction of unified rules of the EAEU. The development of the draft law "On Amendments and Additions to the Law on State Duties" was due to the fact that according to the new regulations, a state duty should be charged for examinations in the field of circulation of drugs and medical factories.

You can find the full version of the legislative act at the link below:
https://www.arlis.am/DocumentView.aspx?DocID=192548

Article 20. State duty rates for other services or activities

For other services or activities, the state duty is charged at the following rates:

52.2. to issue a certificate of proper laboratory activity

in the amount of 30 times the base fee

52.3. to grant permission for advertising of drugs, medical products and therapeutic methods

10 times the base fee.

Article 20.3. State fee rates for examinations in the field of regulation of the circulation of drugs and medical products, keeping the registration in force under the EAEU procedure and accepting the notification of a change that does not require an examination

1. In cases of examinations of drug registration, re-registration, extension of the certificate period, compliance of the drug dossier registered in the Republic of Armenia with the rules of the Eurasian Economic Union (hereinafter EAEU) or mutual recognition, and post-registration changes, as well as other drugs registered only in the Republic of Armenia according to the EAEU procedure or adjusted to the dossier the state fee for re-examination for the purpose of mutual recognition of countries, keeping the registration under the EAEU procedure in force and accepting the notification of the change not requiring an examination is charged at the following rates:

1) The first dosage form, dosage, form of use, each subsequent dosage form and/or dosage, and/or form of use of a reproduced (generic) drug or hybrid drug that does not differ in composition, dosage and dosage form from the original with the active ingredient(s)

a. for the examination carried out for the purpose of registration under the general procedure or under the EAEU procedure only for use in the Republic of Armenia, in the amount of 1100 times the base fee

b. for examination carried out for the purpose of registration under a simplified procedure, in the amount of 500 times the basic fee

c. for the purpose of re-registration and extension of the certificate period for the examination carried out only for use in the Republic of Armenia, in the amount of 500 times the base fee

d. For the examination carried out for the purpose of registration (referent country) under the EAEU procedure, in the amount of 2100 times the base fee

e. For the examination carried out for the purpose of registration (non-referent country) under the EAEU decentralized or mutual recognition procedure, in the amount of 1500 times the base fee

f. For the examination of a drug dossier registered in the Republic of Armenia for compliance with EAEU rules (referent country) or mutual recognition, in the amount of 1200 times the basic fee

g. For the examination of the drug dossier registered in the Republic of Armenia for the purpose of compliance with the EAEU rules for use only in the Republic of Armenia, in the amount of 900 times the base fee

h. For the examination carried out for the purpose of re-registration under the EAEU procedure, in the amount of 1000 times the base fee
i. For maintaining registration in operation in accordance with the EAEU procedure, in the amount of 1000 times the base fee

j. only for the re-examination of a drug registered in the Republic of Armenia under the EAEU procedure or dossier matched for the purpose of mutual recognition of other countries, in the amount of 1000 times the base fee

10. In the Republic of Armenia, the state duty for the examination and safety monitoring of the researched product for the purpose of granting a permit for clinical trials (research) of a medical product is charged at the following rates:

1) For the examination carried out for the purpose of granting a permit for clinical trials (research) in the Republic of Armenia, in the amount of 200 times the base fee

2) For the examination of changes made to documents after obtaining permission for clinical trials, in the amount of 50 times the base fee

3) For the safety monitoring of the research product, in the amount of 50 times the base fee:

Article 33.1. Peculiarities of charging the state fee for examinations in the field of regulation
of circulation of drugs and medical products

1. If the amount of the state duty paid for any action provided for in Article 20.3 of this law does not correspond to the prescribed amounts, the less paid state duty is subject to payment within 5 days from the date of receipt of the notification.

2. To keep the registration valid, the annual state fee is paid for each subsequent year after the registration until the end of the current year.

3. The annual state fee for safety monitoring of research products during clinical trials is paid for each subsequent year after receiving the clinical trial authorization until the end of the current year. The annual state fee is not payable upon completion or termination of the clinical trial.

Name of the legislative act

RA LAW ON AMENDMENTS TO THE LAW "ON MEDICAL AID AND SERVICE OF THE POPULATION"

The status of the change

This amendment entered into force on 08.05.2024.

What are the changes related to?

The adoption of the Law of the Republic of Armenia "On Amendments to the Law On Medical Assistance and Services of the Population" is conditioned by the Agreement on the Uniform Principles and Rules of the Circulation of Medical Products (Medical Products and Medical Equipment) within the framework of the Eurasian Economic Union, adopted on December 23, 2014. hereinafter the Agreement) and with the changes made in the EEC decisions regulating the sector.

Article 45. State regulation of circulation of medical products

3. Within the framework of its jurisdiction in the field of circulation of medical products in the Republic of Armenia, the authorized body carries out regulation of the circulation of medical products, licensing of the types of activities provided for by law, state registration of medical products, certification of imported medical products, examinations and professional observations through the expert organization established by the Government's decision, application (exploitation) of medical products ) collection of information about adverse events (incidents), analysis and provision of relevant decisions and functions assigned to him by this law and other laws of the Republic of Armenia.
(…)

5. For examinations in the field of state regulation of the circulation of medical products, a state fee is charged in accordance with the procedure and amount established by the Law "On State Duty".

Name of the legislative act

RA LAW ON AMENDMENTS AND ADDITIONS TO THE LAW "ON MEDICAL AID AND
SERVICE OF THE POPULATION"

The status of the change

This amendment entered into force on 17.05.2024, except for:
1) Part 1 of Article 1, which enters into force on January 1, 2026,
2) Part 2 of Article 1, which enters into force on January 1, 2027,
3) Part 1 of Article 2, which comes into force on August 1, 2025,
4) Part 2 of Article 2, which comes into force on January 1, 2027.

What are the changes related to?

As a result of the changes and additions, the procedure and conditions for the licensing of medical workers were defined. Adoption of the law aims to improve the quality of medical services in RA.

Article 2. Basic Concepts Used in the Law

22.1) individual license - an official permit confirming the right of a senior medical worker to engage
in a certain type of professional activity in the field of health care;

22.2) transitional individual license: an official permit confirming the right to carry out professional activities under the supervision of an authorized body, not independently, on the basis of higher medical education, for persons studying in a clinical residency (clinical residency), in an institution providing post-graduate military medical training;

CHAPTER 6․1

INDIVIDUAL AND TRANSITIONAL INDIVIDUAL LICENSING OF THE NURSING PROFESSIONAL

Article 35:1. The process of organizing the individual licensing of the medical worker

1. In order to independently carry out professional activities in the field of healthcare, senior medical workers, as natural persons, must obtain an individual license, regardless of their place of work, and clinical residents (clinical residents), persons studying at a post-graduate military medical training institution, a transitional individual license.

2. An individual license and a transitional individual license are issued upon passing a centralized examination.

3. The procedure for organizing and conducting the centralized examination according to the specialties of the healthcare field, the procedure for appealing the results of the centralized examination, the procedure for forming the licensing committee that conducts the centralized
examination, the work order and the individual composition shall be determined by the authorized body.

4. The centralized examination for obtaining an individual license is carried out after the completion of the final certification of graduates of post-university educational programs, in a separate phase, by the licensing committee formed by the authorized body.

5․ The centralized examination is carried out on the basis of tasks on theoretical knowledge and practical skills, created by professional committees. The order of formation of professional commissions, individual composition and working procedure shall be determined by the authorized body.

6․ The centralized exam is organized according to the main specialties of the healthcare field.

7․ The individual license is granted to persons who have graduated from higher and post-graduate professional education institutions in the field of health care in accordance with the procedure established by the legislation of the Republic of Armenia, and who have passed the centralized examination for obtaining an individual license.

8․ The transitional individual license is granted on the basis of a graduation document (diploma) confirming the fact of higher professional education in the field of health care, from the moment of starting the studies of persons admitted to a clinical residency (clinical residency) or an institution providing military medical post-graduate training as a result of passing the centralized examination organized to obtain a transitional individual license.

9․ Conclusions on issuing individual license and transitional individual license, rejecting their issuance, suspending or terminating the operation of the license, extending the validity period of the license are issued by the licensing commission, in whose composition interdepartmental representatives may also be involved by order of the head of the authorized body.

10․ The Licensing Commission is also authorized to examine complaints by individuals and legal entities regarding the quality of the health worker's activities, in accordance with the quality requirements defined by the orders of the authorized body. The procedure for submitting a complaint and examining it is determined by the authorized body.

11․ As a result of the examination of complaints provided for in part 10 of this article, the licensing commission may:

1) in the event of a violation by a medical worker for the first time within a year, submit a proposal to the authorized body to suspend the operation of the individual license or transitional individual license of the medical worker for a period of one month;
2) in case of repeated violation by the medical worker within a year, submit a proposal to the authorized body regarding the suspension of the operation of the individual license or transitional individual license of the medical worker for a period of three months.

12․ In the cases provided for in part 11 of this article, after receiving the recommendation of the licensing committee, the head of the authorized body makes a decision within five days to suspend the operation of the individual license or transitional individual license of the given medical worker.

13․ The forms of applications for individual license and transitional individual license, the list of documents necessary for obtaining individual license and transitional individual license, the forms of individual license and transitional individual license, the grounds and procedure for refusing their issuance, the procedure for issuing and extending the validity period shall be determined by the
Government.

14․ Those educational institutions providing higher and post-graduate professional education in the field of health, whose 70% or more graduates pass the centralized exam and do not receive an individual or transitional license based on its results, are deprived of the possibility of financing within the framework of the state targeted programs of the given year.

15․ The individual license and the transitional individual license are issued by the authorized body electronically.

16․ An individual license is issued for a period of five years, renewable.

17․ Not later than three months before the expiration of the term provided for in part 16 of this article, the senior medical worker applies for the extension of the validity period of the individual license for the next five years.

18․ The term of validity of an individual license is extended if the health worker has passed the EMS certification and there are no legal grounds for suspending or terminating the validity of the health worker's individual license.

19․ A transitional individual license is issued for the period of study at an institution providing post- secondary professional education.

20․ Clinical residents, persons studying at an institution providing post-graduate military medical training have the right to provide medical care and service only to the extent set by the authorized body.

21․ A senior medical worker who graduated from a military medical educational institution or higher medical educational institutions by order of the state authorized body and was discharged from the contractual military service on the basis of not receiving an individual license in the prescribed manner may be granted an individual license in the prescribed manner after five years from the date of discharge from the contracted military service.

Article 35:2. Suspension of individual license of medical practitioner

1. The individual license of a medical practitioner is suspended:
1) in case of failure to pass certification in accordance with the procedure and within the periodnestablished by this law
2) in case of recognition of a person as missing according to the law
3) in the cases provided by part 11 of Article 35.1 of this law
4) in the cases provided by Article 37, Part 11, Clause 2 of this law.
5) in other cases provided by law.

2. In case of elimination of the grounds provided for in part 1 of this article, the authorized body restores the validity of the personal license of the medical worker based on the application of the medical worker whose individual license was suspended.

3. The order of the authorized body on the restoration or refusal of restoration of the individual license is adopted within five working days after accepting the application of the medical worker.

4. The order of the authorized body to refuse the restoration of the validity of the personal license of the medical worker can be appealed in accordance with the procedure established by the Law "On Basics of Administration and Administrative Procedure" or by judicial procedure..

Article 35:3. Termination of individual license of medical practitioner

1. The individual license of a medical practitioner is terminated:
1) if the person received a license in violation of the requirements of the law;
2) if the person has been recognized as incapable or limited in capacity by a court order;
3) if a person has been sentenced to prison by a legally binding court verdict, and the conviction has not been extinguished or canceled in the prescribed manner;
4) if the person has died, or the court act declaring him dead has entered into force;

5) if the person has acquired a physical disability or disease that hinders the medical professional
activity included in the list established by the Government;
6) if a person in military service was discharged from the reserve force due to the suspension of the individual license or early termination (violation) of the contract concluded with the Ministry of Defense due to failure to pass certification in accordance with the procedure and within the terms established by this law;
7) in other cases provided by law.

2. In case of termination of an individual license on the grounds provided for in Clause 1 of Part 1 of this article, a person has the right to apply for a new individual license only one year after the termination of the individual license.

3. In the case of elimination of the grounds for the termination of an individual license specified in clauses 2-7 of part 1 of this article, a person has the right to apply for an individual license after the elimination of those grounds by passing a centralized examination provided for in part 2 of article 35.1 of this law.