Number N63 Type Primary: Type Determination Status Not applicable Origin: ASA 2002.02.14 / 7 (182) Place of receipt: Yerevan Article 104 Adoption body The Government of the Republic of Armenia 24.01.2002 Signatory body Prime Minister of the Republic of Armenia Date of signature 24.01.2002 Ratifying body The President of the Republic of Armenia Ratification Date 24.01.2002 Effective Date 24.01.2002 Effective Date 30.03.2019 Modifiers and incorporations RA GOVERNMENT'S DECISION ON CLINICAL RESEARCH OF NEW MEDICINES IN RA ON APPROVING THE ORDER "I ratify" Republic of Armenia President Kocharyan January 24, 2002 GOVERNMENT OF THE REPUBLIC OF ARMENIA WHAT AND M? N 63 of January 24, 2002 mouse. Yerevan: CLINICAL PARTICULARS OF NEW DRUGS IN THE REPUBLIC OF ARMENIA ON APPROVING THE ORDER Republic of Armenia “On medical care and services for the population” In accordance with Article 21 of the Law, the Government of the Republic of Armenia decides. 1. Approve new clinical drugs in the Republic of Armenia procedure for conducting surveys (attached). 2. This Decision shall enter into force on 24 January 2002. Republic of Armenia Prime Minister Margaryan Is approved The Government of the Republic of Armenia 2002 by decision N 63 of January 24 ORDER: CLINICAL PARTICULARS OF NEW DRUGS IN THE REPUBLIC OF ARMENIA HOLDING: I. GENERAL PROVISIONS 1. This Order of the Republic of Armenia on Medical Care and Services of the Population In accordance with Article 21 of the Law of the Republic, defines Armenia Clinical trials of new drugs in the Republic (hereinafter referred to as clinical) procedures). 2. Clinical trials are conducted on drug safety and safety about establishing efficacy as well as potential side effects to get data. 3. Permission to conduct clinical trials is granted by Armenia Ministry of Health of the Republic (hereinafter Ministry). 4. Clinical trials shall be conducted in a medical setting selected for this purpose on the basis of institutions. Conduct clinical trials The list of eligible medical institutions is approved by the Ministry by taking into account: a) Experience in conducting scientific research in a given medical institution; (b) the equipment of the medical establishment concerned; c) the level of professional and scientific training of medical personnel. II. BASIC CONCEPTS USED IN THIS ORDER 5. The basic terms used in this Procedure are: clinical trial (testing) on ​​the safety of a human-tested drug; an efficacy study aimed at the drug being studied detection of clinical, pharmacological, pharmacodynamic properties or confirmation and / or detection of side effects, absorption into the body, Distribution, bioremediation and (or) organism study; Effectiveness of the drug - positive effect of the drug on the course of the disease Characteristics: drug safety - the danger to the effectiveness of the drug and to the body Characteristics of comparative evaluation of evaluation. Adverse effects: prevention, diagnosis, treatment or treatment of the disease therapeutic doses of drugs used to regulate physiological functions negative or unpredictable effects caused by imports; side effect - any undesirable effects on the body of the person being examined a phenomenon that may be unrelated to drug use: Pre-clinical examination - an unrelated biomedical examination with human experiments; Clinical Trials Program - Research Tasks describing the methodology, procedure, statistics, and organization document: Researcher responsible for conducting clinical research physical person. research person (tested) - a patient or participant in a clinical trial a healthy volunteer undergoing a trial or comparative drug trial; clinical activity - planning, conducting clinical research, to conduct, observe, conduct independent evaluation, with documentation the principle of formulating and presenting its results; Ethics Committee - an independent body responsible for testing health, safety, human rights and population to provide appropriate guarantees. III. EXAMINATION OF CLINICAL RESEARCH MATERIALS 6. The researcher has permission to conduct clinical trials submits an application to the Ministry, which is attached to the clinic The package of documents required for research by the Ministry according to the approved list. 7. The documents submitted by the researcher should contain the following: data: a) Pre-clinical study of drug safety and efficacy results: (b) Persuasive data on the positive effect of drug use in excess of the drug the danger to the individual; c) positive opinion of the Ethics Committee. 8. The Ethics Committee provides clinical trials of drugs volunteering, security of participants and rights protection, giving the danger and effectiveness of clinical research assessment of the ratio, as well as compliance with ethics. Ethics: The Committee on Issues operates on a public basis and is not remunerated. Ethics: The composition and the Charter of the Committee on Issues shall be approved by the Ministry. 9. The documents submitted by the researcher are kept in the Ministry 2 stages of expertise a) In the first stage a preliminary examination is carried out which clarifies Compliance of submitted documents with approved requirements in terms of design accuracy and completeness; b) The second phase is the implementation of a clinical research program examination to confirm it. The examination period is 60 days. 10. Clinical evaluation of medicines during examination of submitted documents if necessary or provided additional data related to the study If the Ministry has any comments on the materials The customer may require additional documents or disclosures defect elimination. Additional Documentation and Defects the time spent on elimination does not fall within the prescribed forensic examination in due time. 11. If the customer does not correct the defects discovered within 60 days, he / she will not provide any additional information required or justification for delay; then the clinical trial materials are removed from the examination. Later, At the request of the client, clinical trial materials may be prescribed re-submitted for expert examination. 12. The Ministry makes a decision based on the results of the examination about clinical trial authorization and within three days in writing informs the customer. 13. In the clinical research program approved by the Ministry If the customer needs to make any changes, he or she shall apply submits to the Ministry, where the materials are presented in the prescribed manner are reviewed and a decision is made to adopt these changes. IV. PROCEDURE OF CLINICAL RESEARCH 14. Accuracy and accuracy of data obtained from clinical trial the researcher is responsible for reliability. 15. The researcher must: a) immediately inform the Ministry, Ethics Committee changes to the clinical trial plan, as well as: and unpredictable side effects during research about phenomena: b) immediately terminate the clinical trial of the person being examined in case of danger to life or health; c) ensure the confidentiality of the data concerning the person under investigation; d) record, process and record data obtained as a result of a clinical trial maintain it in such a way that their accuracy and reliability can be monitored. 16. Clinical trial person (s) involved The doctor conducting the study is informed in advance the nature, significance, methods and potential hazards of the study, as well as is informed of its right to refuse it at any stage of the trial; after which he gives his written consent to participate. 17. It is forbidden to conduct clinical trials: a) Pregnant women, except where necessary information is available only when pregnant women are tested and when pregnant or pregnant for a minimum. b) military servicemen; (c) persons in places of detention as well as in detention facilities on. 18. Clinical trials are underway in the Ministry and Ethics under the constant supervision of the Commission. Research observations are held every 3 months or as needed. Verification: in the event of detection of non-compliant phenomena a protocol is drawn up which is submitted to the researcher and / or client: to get acquainted: 19. The researcher and / or the client are obliged to cancel within 30 days deficiencies and shortcomings found during clinical trial examination to inform the Ministry. 20. The Ministry is not in the position to detect violations of the approved plan confirm the results of the clinical trial of the drug. Ministry accepted notifies the researcher in writing within three days of the decision and / or to the customer. 21. Violations of Ethics and Clinical Research Program data falsification, unpredictable side effects and phenomena, the person being examined the ministry suspends in the event of a threat to life or health test procedure. 22. The researcher obtained as a result of a clinical trial based on data submitted to the Ministry. 23. The Ministry shall submit the report submitted within one month confirmation in case of professional expertise and positive conclusion. The Ministry shall inform in writing within three days of the decision to the customer.