LEGAL UPDATE
February 2024
Part I. LEGAL ACTS THAT HAVE BEEN AMENDED
1. THE RA LAW "ON TRADE AND SERVICES"
2. THE DECISION OF THE RA GOVERNMENT ON MAKING CHANGES AND
ADDITIONS IN DECISION N 1080 OF THE RA GOVERNMENT OF AUGUST 15, 2019 ON
ESTABLISHING THE PROCEDURE FOR PRESCRIBING, DISPENSING MEDICINES
(INCLUDING ELECTRONICALLY)
3. THE DECISION OF THE GOVERNMENT OF THE RA ON MAKING ADDITIONS AND
CHANGES IN DECISION N 2087 OF THE GOVERNMENT OF THE RA OF DECEMBER 16,
2021 ON DETERMINING THE PROCEDURE FOR INVOLVING FOREIGN EMPLOYEES
4. DECISION OF THE COMMISSION FOR THE PROTECTION OF COMPETITION NO. 71-N
ON THE ESTABLISHMENT OF THE NECESSARY REVENUE FOR THE BUYER AND
SELLER, WHO HAVE A STRONG NEGOTIATING POSITION IN THE
RELATIONS ON THE PURCHASE OF AGRICULTURAL
PRODUCTS IN ARMENIA.
PART II. LEGISLATIVE DRAFTS
1. DRAFT LAW ON AMENDMENT TO THE LAW ON DRUGS, THE LAW ON
ADVERTISING AND RELATED LAWS
2. DRAFT LAW ON AMENDMENT TO THE LAW "ON PUBLIC AND
PRIVATE NOTICEON THE INTERNET"
3. DRAFT LAW TO AMEND AND SUPPLEMENT THE CIVIL
PROCEDURE CODE
4. DRAFT LAW ON AMENDING THE ADMINISTRATIVE
PROCEDURE CODE
Part I. LEGAL ACTS THAT HAVE BEEN AMENDED
Name of the legislative act
THE RA LAW ON AMENDMENTS TO THE LAW "ON TRADE AND SERVICES"
The status of the change
This amendment shall enter 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.
Old version.
Previously absent.
New version.
«2.1) trading network: An economic entity that meets the criteria defined by Article 11, Part 1, Clause 2 or 3 of the Law "On Protection of Economic Competition", «2. Other concepts and terms used in this Law are applied in the sense established by the Civil Code of the Republic of Armenia, the laws "On Protection of Economic Competition", "On Protection of Consumer Rights", as well as other laws and regulations".
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
DECISION OF THE RA GOVERNMENT REGARDING CHANGES AND ADDITIONS TO DECISION N 1080 OF RA GOVERNMENT OF AUGUST 15, 2019
Change status
The amendment was adopted on 29.02.2024 and entered into force on 01.03.2024.
Sub-paragraph 4 of the decision enters into force:
a. regarding the writing of prescriptions for drugs given free of charge or on preferential terms, from March 1, 2024,
b. regarding the writing of prescriptions for systemic anti-infective (antibacterial, antifungal,
antimycobacterial, antiviral drugs, immune sera and immunoglobulins, vaccines), hormonal and
misoprostol-containing drugs, from March 1, 2024,
c. regarding prescriptions for other drugs not included in subparagraphs 1 and 2, as well as drugs containing psychotropic (psychoactive) substances, starting from January 1, 2025.
Subparagraph 25 comes into force on January 1, 2025.
What are the changes related to?
With the changes and additions made, it is planned to write prescriptions for medicines dispensed free of charge or on preferential terms, as well as for medicines with systemic anti-infective effects (antibacterial, antifungal, antimycobacterial, antiviral drugs, immune serums and immunoglobulins, vaccines) and medicines containing misoprostol in electronic form. The purpose of this change is to introduce an electronic prescription, which is aimed at avoiding unnecessary queues in medical organizations, raising public awareness, and improving the quality of medical care and services in medical organizations. The provisions and settings of the Armed e-health system, established by the current legal act, will be brought into line with the current program.
Suggestions:
Subjects selling drugs free or preferentially, as well as systemically active anti-infective drugs
(antibacterial, antifungal, antimycobacterial, antiviral drugs, immune sera and immunoglobulins, vaccines) and drugs containing misoprostol, only in case of electronic prescription.
In the absence of certain data specified in this decision and/or errors and/or corrections and/or incompatible ingredients, the pharmacy employee may dispense the drug after checking with the doctor writing the prescription. However, in case of errors and/or corrections in the amount of medicine to be omitted, the prescription should be recognized as invalid by the pharmacy employee, informing the doctor of the need to write a new prescription.
Accept the prescription in paper form only if the system was not available due to technical problems.
Old version.
4. The issuing, numbering, accounting of electronic prescriptions, as well as the dispensing of their corresponding drugs is carried out through the electronic system, in accordance with the guidelines approved by the Ministry of Health of the Republic of Armenia (hereinafter referred to as the Ministry).
New version.
4. The numbering and accounting of electronic prescriptions, as well as the discharge and dispensing of their corresponding drugs are carried out through the electronic healthcare system (hereinafter referred to as the system). E-prescription, dispensing and accounting of medicines are carried out through the system in accordance with the order of the Minister of Health of the Republic of Armenia No. 99-N of December 28, 2021.
Old version.
Previously absent.
New version.
5.1. Prescriptions are written only in the electronic version, except for the case mentioned in clause 6 of this order, as well as prescriptions for drugs containing narcotics specified in sub-clause 1 of clause 10 of this order, which are written only in paper version.
Old version.
6. A paper prescription is issued only when the electronic system is not available. In the presence of an electronic prescription, the paper version is printed from the electronic system and provided to the patient or his legal representative upon their request.
New version.
6. The prescription is written in paper form when the system is not available due to technical problems. After solving the technical problem, it is entered into the system, after the access to the latter is restored, within the same day. In the presence of an electronic prescription, the paper version is printed from the system and provided to the patient or his legal representative upon their request.
Old version.
8. The prescription must contain the following information:
1) the name of the medical institution, license number, location (individual entrepreneur - residence) and telephone number.
New version.
8. The prescription must contain the following information:
1) the name of the medical institution, license number or taxpayer registration number, location (individual entrepreneur - residence) and telephone number.
Old version.
8. The prescription must contain the following information:
4) in case of prescription of drugs containing narcotic drugs and psychotropic (psychoactive) substances, the data of the patient's passport
or identification card,
New version.
8. The prescription must contain the following information:
4) in case of prescription of drugs containing narcotics and psychotropic (psychoactive) substances, data of the patient's identity document or public service number (hereinafter referred to as PSN) or, in case of refusal of PSN, reference number of not receiving PSN,
Old version.
9. The electronic prescription, in addition to the data specified in point 8 of this order, must also contain:
1) diagnosis code according to the
International Classification of Diseases,
2) the anatomical-medical-chemical code of the drug according to the register,
3) Patient identification card number, date of birth, gender,
4) doctor's specialization and email address,
5) the number of the document confirming the issuance of medicines with full or partial reimbursement (hereinafter referred to as reimbursable), the date of issue and the validity period, with the attachment of the relevant document to the system.
New version.
9. The electronic prescription, in addition to the data specified in point 8 of this order, must also contain:
1) diagnosis code according to the
International Classification of Diseases,
2) the anatomical-medical-chemical code of the drug according to the register,
3) the patient's PSN or, in case of refusal of PSC, reference number of non-receipt of PSN, date of birth, gender,
4) doctor's specialization,
5) the number of the document confirming the issuance of medicines with full or partial reimbursement (hereinafter referred to as reimbursable), the date of issue and the validity period,
6) in the case of an authorized person, the
name, surname, data of the identity document, or the number of the PSN, or, in case of refusal of the PSN, the number of the certificate of non-receipt of the PSN,
7) in case of submitting the electronic
prescription in paper version, the QR code for document authentication in order to verify the validity of the prescription in the unified system of verification of the validity of official documents of the Republic of Armenia.
Old version.
10. In the Republic of Armenia, the following forms of paper prescription approved by Annex
No. 2 of this decision are used:
1) N 1 prescription form for narcotic drugs,
2) N 2 prescription form for drugs containing psychotropic (psychoactive) substance,
3) N 3 prescription form for reimbursed drugs,
4) N 4 prescription form for single or multiple dispensing of drugs and pharmaceuticals.
New version.
10. In the Republic of Armenia, the following forms of paper prescription approved by Annex
No. 2 of this decision are used:
1) N 1 prescription form for narcotic drugs in paper version,
2) N 2 prescription form for drugs containing a psychotropic (psychoactive) substance, in electronic or paper version,
3) N 3 prescription form for reimbursable drugs in electronic or paper version,
4) N 4 prescription form for one-time or multiple dispensing of drugs and pharmaceuticals in electronic or paper form.
Old version.
11. The prescription form shall be filled with the data specified in sub-item 1 of Clause 8 of this order regarding the medical facility or a stamp containing such data shall be placed.
New version.
11. The prescription form shall be filled with the data specified in sub-item 1 of Clause 8 of this order regarding the medical facility or a stamp containing such data shall be placed. In the case of an electronic prescription, the data
defined by sub-clause 1 of Clause 8 of this
Order are automatically downloaded from the system.
Old version.
22. Prescriptions for reimbursable drugs can be issued only by a doctor of a medical institution with an appropriate license to patients who have the right to receive a reimbursable drug according to the legislation of the Republic of Armenia. Drugs containing narcotic drugs and reimbursed at the same time are prescribed on prescription form N 1,
drugs containing psychotropic (psychoactive) substances and reimbursed at the same time are prescribed on prescription form N 2.
New version.
22. According to the legislation of the Republic of Armenia, prescriptions for reimbursed drugs can be written for one month only by a doctor of a medical institution with an appropriate license. In the absence of patient complaints, prescriptions for the second and third months can be duplicated the physician's nurse through the system without any changes and approved by the doctor. Drugs containing narcotic drugs and reimbursed at the same time are prescribed on prescription form N 1,
drugs containing psychotropic (psychoactive) substances and reimbursed at the same time are prescribed on prescription form N 2.
Old version.
30. A paper prescription is confirmed by a
doctor's signature. A prescription for a medicine containing narcotic drugs and
psychotropic (psychedelic) substances is
certified by the signature of the director of the medical institution, and in case of his absence
- by the person replacing the director. The first copy and copy(s) of multiple prescriptions must bear the original signature of the doctor.
New version.
30. A paper prescription is confirmed by a
doctor's signature. A prescription for a medicine containing narcotic drugs and
psychotropic (psychedelic) substances is
certified by the signature of the director of the medical institution, and in case of his absence
- by the person replacing the director. The
original signature of the doctor must be present on the first copy and copies (copies) of prescriptions issued in several copies.
Old version.
31. The doctor who prescribes prescriptions registers prescriptions written on forms N 1, N 2 and N 3 in separate accounting journals by type, the pages of which are numbered, stitched and certified with the signature of the
director of the medical institution. The
prescription month, date, patient's name, surname, place of residence, medical document number, discount basis and amount (in percentage), prescription number, content and patient's signature are noted in the log.
New version.
31. The doctor who prescribes prescriptions registers prescriptions written on forms N 1, N 2 and N 3 in separate accounting journals by type, the pages of which are numbered, stitched and certified with the signature of the
director of the medical institution. The
prescription month, date, first name, last name, place of residence of the patient, number of the medical document, the basis and amount of the discount (in percent), prescription number, content and signature of the patient are marked in the journal with a pen. The register
of electronic prescriptions written on forms N 2 and N 3 is created automatically in the electronic system. A register of electronic prescriptions written on form N 4 is not maintained.
Old version.
Previously absent.
New version.
50.1. Numbering of electronic prescriptions is carried out automatically by the system. Invalid e-prescription numbers are no longer used. At the beginning of each reporting year, the numbering of electronic prescription forms starts from the beginning (zero). The number includes the taxpayer's registration number of the medical institution, the date of the given year, a letter characterizing the prescription, a six-digit number, the calculation of which starts from 000001.
Old version.
53. In the absence of certain data specified in this order and/or errors and/or corrections and/or incompatible ingredients, the pharmacy employee may dispense the drug after checking with the doctor writing the prescription. In case of errors and/or corrections in the amount of medicine to be omitted, the prescription is recognized as invalid by the pharmacy employee and the doctor is informed about the need to issue a new prescription.
New version.
53. In the absence of certain data specified in this order and/or errors and/or corrections and/or incompatible ingredients, the pharmacy employee may dispense the drug after checking with the doctor writing the prescription. In case of errors and/or corrections in the amount of medicine to be omitted, the prescription is recognized as invalid by the pharmacy employee and the doctor is informed about the need to issue a new prescription. When an e-prescription is
invalidated, it is stored in the system, and the invalidation date and information about the invalidator is stored in the system event log.
Old version.
54. When the medicine is prescribed, the trade name, dosage, pharmaceutical form, quantity, date of prescription, name and surname of the person who prescribed is indicated on the back
of the prescription and signed by the person
who prescribed it.
New version.
54. When a medicine is prescribed by a paper prescription, the name of the missed medicine, dosage, dosage form, quantity, date of prescription, name and surname of the person who prescribed it are indicated on the back of the prescription and signed by the person who prescribed it. In the case of an electronic prescription, the quantities of prescribed medicine are fixed in the system.
Old version.
60. In case of prescribing the drug with an
incomplete consumer package or multiple
prescribing, the remaining amounts can be continuously dispensed from the same
pharmacy, indicating on the reverse side of the prescription the commercial name of the drug, the dosage, the prescribed amount, the date, the names of the person who prescribed it and the recipient and their signatures.
New version.
60. In the case of prescribing a paper
prescription drug in an incomplete consumer package or multiple prescribing, the remaining quantities can be continuously dispensed from the same pharmacy, indicating the name of the drug, dosage, missed quantity, date, the names of the person who prescribed it and recipient and signatures on the back of the prescription. In the case of an electronic prescription, the prescription remains active for the pharmacy employee until the entire amount specified in the prescription is issued and the information about the issue is recorded in the system, or until the prescription expires, specified in paragraph 33 of this Decision.
Old version.
64. If it is impossible to visit the pharmacy, the drugs containing narcotics and psychoactive (psychoactive) substances are obtained by the person authorized by the patient or the legal representative with an identity document. In that case, on the reverse side of the prescription, the commercial name of the drug, the dosage, the prescribed amount, the date, the names of the person who prescribed it and the recipient and their signatures are indicated.
New version.
64. In case of impossibility of visiting the
patient's pharmacy, the medicines are received by the person authorized by the patient or the legal representative with an identity document. In that case, on the reverse side of the prescription, the commercial name of the drug, the dosage, the pharmaceutical form, the prescribed amount, the date and the name, surname, signature of the person who prescribed it, and first name, last name, signature of an authorized person or legal representative, data of the identity document, the number of PSN or the certificate of non-receipt of the PSN are indicated.
Old version.
68. All paper prescriptions, including those
recognized as invalid, are kept at the
pharmacy that dispensed the medicine,
according to the dates of prescribing, within the
terms set by Clause 69 of this Decision, under
conditions that ensure their preservation.
New version.
68. All paper prescriptions, including those
recognized as invalid, are kept at the
pharmacy that dispensed the medicine,
according to the dates of prescribing, within the
terms set by Clause 69 of this Decision, under
conditions that ensure their preservation.
Electronic prescriptions are automatically
stored in the system indefinitely.
Name of the legislative act
DECISION OF THE GOVERNMENT OF RA REGARDING ADDITIONS AND CHANGES IN
DECISION N 2087 OF DECEMBER 16, 2021
The status of the change
This amendment came into effect on March 1, 2024.
What are the changes related to?
This amendment clarified the procedure for granting temporary residence status based on workactivity or voluntary work.
The need for this amendment was due to the adoption of the Law "On Voluntary Work", as a result of which an amendment was made to Part 1 of Article 15 of the Law "On Foreigners", according to which the basis for granting temporary residence status to a foreigner can also be the performance of voluntary work in the Republic of Armenia.
Suggestion:
As a result of the changes made, organizations involving volunteers in the framework of their
activities can apply for temporary residence status through a unified electronic platform.
Old version.
5) In accordance with the procedure provided
for by the law "On Foreigners" and this
decision, decision on the satisfaction,
rejection of an application for granting, refusal to grant a temporary residence permit or
extension of the validity period of the
residence status to a foreigner on the basis of
employment, on termination, suspension or
extension of the term of administrative
proceedings initiated on the basis of the
application, as well as on satisfaction,
rejection or termination of administrative
proceedings initiated on the basis of an
application, a certificate confirming the legality
of residence, satisfaction, rejecting or
extending a certificate certifying the legality of
residence, or on terminating, suspending, or
extending the period of the administrative
proceedings initiated on the basis of the
application, is made within 30 days from the
date of receiving the application through the
platform.
New version.
5) In accordance with the procedure provided
for by the law "On Foreigners" and this
decision, decision on the satisfaction,
rejection of an application for granting, refusal to grant a temporary residence permit or
extension of the validity period of the
residence status to a foreigner on the basis
of work activity or voluntary work, on
termination, suspension or extension of the
term of administrative proceedings initiated on
the basis of the application, as well as on
satisfaction, rejection or termination of
administrative proceedings initiated on the
basis of an application, a certificate confirming
the legality of residence, satisfaction, rejecting
or extending a certificate certifying the legality
of residence, or on terminating, suspending,
or extending the period of the administrative
proceedings initiated on the basis of the
application, is made within 30 days from the
date of receiving the application through the
platform.
Old version.
2. Migration and Citizenship Service:
(…)
10) collects, processes, summarizes
statistical data on foreigners working in the
Republic of Armenia and provides it to the
Statistical Committee of the Republic of
Armenia.
New version.
2. Migration and Citizenship Service:
(…)
10) collects, processes, summarizes
statistical data on foreigners performing
work or voluntary work in the Republic of
Armenia and provides it to the Statistical
Committee of the Republic of Armenia.
Old version.
1) employer registration on the platform.
a. for registration, the employer undergoes
strict identification by submitting an
identification card, a mobile ID card, and in
case the head of the executive body of the
employer is a foreign citizen, by personally
submitting the data specified in paragraph "b"
of this subsection to the Migration and
Citizenship Service, (…).
New version.
1) employer registration on the platform.
a․ for registration, the employer or, in the case
of volunteer work, the head of the executive
body of the organization undergoes strict
identification using an identification card,
mobile card (mobile ID), and in the case of an
employer or volunteer work, if the head of the
executive body of the organization is a foreign
citizen, by personally submitting the data
specified in paragraph "b" of this
subparagraph, to the Migration and
Citizenship Service, (...).
Name of the legislative act
DECISION OF THE COMMISSION FOR THE PROTECTION OF COMPETITION NO. 71-N ON
THE ESTABLISHMENT OF THE NECESSARY REVENUE FOR THE BUYER AND PRODUCER,
WHO HAVE A STRONG NEGOTIATING POSITION IN THE RELATIONS ON THE PURCHASE
OF AGRICULTURAL PRODUCTS IN ARMENIA.
The status of the change
This decision was adopted on 27.02.2024 and will enter into force on May 6, 2024.
What are the changes related to?
The decision defines the amount of the necessary revenue of the acquirer and the seller who have
a strong negotiating position in the relations of the purchase of agricultural products in the Republic
of Armenia.
Suggestion:
Business entities acquiring or selling agricultural products produced in the Republic of Armenia
must compare their revenue with the amount of revenue provided by the Commission's decision
71-N, which in case of exceeding, the business entity will be considered to have a strong
negotiating position, being subject to restrictions arising from that status.
NECESSARY REVENUE DIMENSIONS OF THE BUYER AND THE PRODUCER HAVING A
STRONG NEGOTIATING POSITION IN THE RELATIONS OF ACQUISITION OF
AGRICULTURAL PRODUCT IN THE REPUBLIC OF ARMENIA
1. In relation to the purchase of agricultural products produced in the Republic of Armenia, the acquiring business entity has a strong negotiating position if the following conditions are present at the same time
1) The amounts of revenue of the selling and acquiring business entities correspond to the following
amounts of income:
a. the amount of revenue of the selling economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products did not exceed 25,000,000 (twenty-five million) AMD, and the amount of revenue of the acquiring economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 25,000,000 (twenty-five million) AMD, or
b. the amount of revenue of the selling economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 25 000 000 (twenty-five million) AMD, but did not exceed 100 000 000 (one hundred million) AMD, and the amount of revenue of the acquiring economic entity exceeded AMD 100,000,000 (one hundred
million) in the last fiscal year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products, or
c. the amount of revenue of the selling economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 100 000 000 (one hundred million) AMD, but did not exceed 500 000 000 (five hundred million) AMD, and the revenue of the acquiring economic entity the amount exceeded AMD 500,000,000 (five hundred million) in the last fiscal year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products, or
d. the amount of revenue of the selling economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 500 000 000 (five hundred million) AMD, but did not exceed 1 500 000 000 (one billion five hundred million) AMD, and the amount of revenue of the acquiring economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 1 500 000 000 (one billion five hundred million) AMD, or
e. the amount of income of the selling economic entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 1 500 000 000 (one billion five hundred million) AMD, but did not exceed 3 500 000 000 (three billion five hundred million) AMD, and the amount of revenue of the acquiring business entity in the last financial year or in the 12 months preceding the conclusion of the contract for the purchase of agricultural products exceeded 3 500 000 000 (three billion five hundred million) AMD.
2) the amount of revenue of the acquiring economic entity is at least ten times higher than the amount of income of the selling economic entity, except for the case provided for in point 2 of this appendix.
2. In case of purchase of agricultural products from individuals selling agricultural products, the amount of revenue of individuals selling agricultural products is not considered to confirm the existence of a strong negotiating position of the buyer, and in the case of the buyer, the required amount of revenue is considered to be the amount of revenue exceeding AMD 25,000,000 (twenty- five million) for the last financial year or 12 months prior to the conclusion of the contract for the purchase of agricultural products.
PART II. LEGISLATIVE DRAFTS
Name of the draft law
DRAFT LAW ON AMENDMENT TO THE LAW "ON PUBLIC AND PRIVATE NOTICE ON THE
INTERNET" AND THE RELEVANT LAWS
What are the changes related to?
The package of drafts offers:
- To distinguish the ways of individual notification via the Internet for individuals, individual
entrepreneurs and legal entities,
- to establish an individual notification method exclusively via the Internet for legal entities and
individual entrepreneurs, which will be carried out in the form of an electronic notification,
- to establish that a legal entity or an individual entrepreneur is considered to be duly notified
from the date of posting the information to be provided on the personal page of the electronic
reporting management system of the tax authority, as provided for by the Tax Code, which is
confirmed by the electronic system,
- to establish that this legal entity or individual entrepreneur is notified of the placement of
information at the e-mail address specified in the "Personal Account" section of the electronic reporting management system of the tax authority.
The mentioned change is the basis for implementing changes in a number of material and
procedural acts related to the methods of notification for legal entities and individual
entrepreneurs, in particular, in the Tax Code, Civil Procedure Code, Administrative Procedure
Code, etc. In this connection, it should be noted that the digitization of notifications is a natural, necessary and legal process, which should be extended in the future also in relations with natural persons. However, certainty and propriety are also important in this process as a prerequisite for effective protection of the subject's rights and legal interests. Therefore, in this regard, if the personal page of the tax authority is defined as the only option, the interests of those legal entities or individual entrepreneurs who have not been active for a long time and are not registered on the platform of the tax authority are undermined. As a result, there would be no legal basis for notifying such entities and any notification could easily be deemed inappropriate.
Article 11. Individual notification by state and local self-government bodies to legal entities
1. The individual notification of legal entities and individual entrepreneurs by state and local self-government bodies is carried out by the method of electronic notification defined in part 2 of this article.
2. A legal entity or an individual entrepreneur is considered duly notified 3 working days after the date of posting the information to be provided on the personal page of the electronic management system for submitting reports of the tax authority defined by the Tax Code, unless otherwise provided by law, which is certified by the electronic system. The given legal entity or individual entrepreneur is informed about the posting of information through the e-mail address filled in in the "Personal Office" section of the electronic management system of tax authority reporting. The person is considered duly notified in the manner defined by this part, regardless of the notification
provided for in the second sentence of this part.
3. The procedure for placing the information to be provided by the state and local self-government bodies for the purpose of individual notification of legal entities and individual entrepreneurs in the electronic management system for submission of reports of the tax authority is defined by the Government of the Republic of Armenia.
Current version.
The Civil Procedure Code of the Republic of
Armenia
Article 97.
Sending the notification by electronic communication
1. A court notifications addressed to a state and
local self-government body, a legal entity, an
individual entrepreneur, as well as a
representative of a person participating in the
case with the status of an advocate, is sent to
his official e-mail, except for the cases when
such a notification is impossible.
The Code of Administrative Procedure of
the Republic of Armenia
Article 63. Proper notice
(…)
3. Legal entities are notified in accordance with
Article 10 of the Law of the Republic of Armenia
"On Public and Individual Notification on the
Internet".
Expected change.
The Civil Procedure Code of the Republic of
Armenia
Article 97.
Sending the notification by electronic communication.
Legal entities and individual entrepreneurs are
notified in accordance with Article 11 of the Law
"On Public and Individual Notification on the
Internet".
The Code of Administrative Procedure of
the Republic of Armenia
Article 63. Proper notice
3. Legal entities and individual entrepreneurs
are notified in accordance with Article 11 of the
Law "On Public and Individual Notification on
the Internet".
Name of the draft law
DRAFT LAW ON AMENDMENT TO THE LAW ON DRUGS, THE LAW ON ADVERTISING AND
RELATED LAWS
What are the changes related to?
The adoption of draft laws "On Amendments to the Law on Advertising" aims to more clearly and comprehensively regulate the field of drug circulation, ensuring the introduction of unified rules of the EAEU.
The draft was developed by the Department of Drug Policy and Medical Technologies of the RA
Ministry of Health and the "Expert Center for Medicines and Medical Technologies named after
Academician Emil Gabrielyan" CJSC of the RA Ministry of Health.
The amendments to be made in the Law on "Advertising" and the Law on "Drugs" are aimed at improving the tools of state control over drug sales. 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.
RA LAW ON ADVERTISING
Current version.
Article 15. Features of advertising of certain
types of products
(…)
7. Advertising of medicines, medical equipment
and therapeutic methods is prohibited without
the permission of the Ministry of Health of the
Republic of Armenia.
Advertising of medicines, medical equipment
and therapeutic methods, the use of which
requires a special doctor's appointment, is
prohibited.
7.4. The Government of the Republic of
Armenia approves the procedure for issuing a
permit for the advertising of drugs, medical
equipment and therapeutic methods and the
requirements for such advertising.
Expected change.
Article 15. Features of advertising of certain
types of products
(…)
7. Advertising of drugs, medical products and
therapeutic methods is prohibited without the
permission of the Ministry of Health of the
Republic of Armenia. Advertising of
unregistered medical products and unlicensed
entities is prohibited. Advertising of medical
products that require a special appointment or
supervision by a doctor in the mass media is
prohibited.
7.4. The Government of the Republic of
Armenia defines the procedure for granting
permission for advertising of medical products
and therapeutic methods and the requirements
for such advertising. A state fee is charged for
issuing an advertising permit in accordance
with the procedure and amount established by
the Law of the Republic of Armenia "On State
Fee"
LAW "ON DRUGS"
Current version.
Article 6. The authority of the state
administration body authorized for health
issues in the field of state regulation of drug
circulation
1. The authorized state administration body for
health issues (hereinafter referred to as the
Authorized Body) in the field of state regulation
of drug circulation implements:
(…)
5) organization and implementation of
examinations in the field of state regulation of
drug circulation.
Expected change.
Article 6. The authority of the state
administration body authorized for health
issues in the field of state regulation of drug
circulation
1. The authorized state administration body for
health issues (hereinafter referred to as the
Authorized Body) in the field of state regulation
of drug circulation implements:
(…)
5) examinations and professional observations
defined by this law in the field of state
regulation of drug circulation, through the
expert organization defined by the
Government's decision.
Current version.
Article 7. Implementation of
examinations in the field of state regulation
of drug circulation
(…)
2. Examinations in the field of state regulation
of drug circulation are paid, except for cases
provided by law.
.
Expected change.
Article 7. Implementation of
examinations in the field of state regulation
of drug circulation
(…)
2. A state fee shall be charged for examinations
in the field of state regulation of drug
circulation, in the manner and amount
prescribed by the Law "On State Fee", except for the cases provided for by law.
Current version.
Article 16. State registration of
drugs
(…)
3. In the Republic of Armenia, drugs are
registered according to the general procedure
and simplified procedures. The simplified
procedure is applied to medicines registered in
the member country of international
professional organizations defined by the
decision of the Government of the Republic of
Armenia or pre-qualified by the World Health
Organization.
Expected change.
Article 16. State registration of
drugs
(…)
3. In the Republic of Armenia, drugs are
registered according to common and simplified
procedures, as well as according to the EAEU
rules. The simplified procedure is applied to
medicines registered or tested by the
competent authority of the member country of
the international professional organizations
defined by the decision of the Government of
the Republic of Armenia (hereinafter referred to
as the competent authority) 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
referring authority, except for the holder of the
drug's trade name or registration certificate.
Regardless of the procedure, the packaging and labelling of the drug registered in the
Republic of Armenia must comply with the
requirements established by the legislation of
the Republic of Armenia.
Current version.
Article 21. Import and export of
drugs, medicinal substances, researched
pharmaceutical products and herbal raw
materials
Missing in current regulation.
Expected change.
Article 21. Import and export of
drugs, medicinal substances, researched
pharmaceutical products and herbal raw
materials
(…)
18. After receiving the import certificate, the
importer carries out through his responsible
person, according to the procedure established
by the Government of the Republic of Armenia,
the release of the series of the imported drug,
certifying the compliance of the drug with the
requirements established in the Republic of
Armenia. In order to carry out batch release,
the importer must have a license for the
wholesale sale of drugs with a note on batch
release.
19. It’s prohibited,
1) administer a drug without conducting a batch
release process,
2) sell a drug without fulfilling the obligations
assumed by the bond in the cases defined by
this law during import certification.
Current version.
8. The sale of prescription drugs without a
prescription is prohibited.
Expected change.
8. It is prohibited to sell 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.
Current version.
9. It is prohibited to fill in, write out and sell
prescriptions for prescription drugs on forms
not defined by the legislation of the Republic of
Armenia.
Expected change.
9. It is prohibited to issue prescriptions on
forms that do not meet the requirements
established by the legislation of the Republic of
Armenia.
Current version.
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,
in accordance with the procedure established
by the law of the Republic of Armenia.
2. The quality of drugs, medicinal substances,
herbal raw materials and researched
pharmaceutical products circulating in the
Republic of Armenia must meet the
requirements established by this law.
Expected change.
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, labelling, 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. The drugs, medicinal substances and
medicinal plant raw materials taken by the
Inspection body within the framework of control
or acquired through control purchase are
submitted to the expert organization defined by
Article 7 of this law, if necessary for
examination. The examinations defined by this
article are carried out within the framework of
the state order.