of November 3, 2016 No. 87
About approval of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union
According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 12 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 81 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 108:
1. Approve the enclosed Rules of proper practice of pharmakonadzor of the Eurasian Economic Union (further - Rules).
2. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.
Section 4 of Rules becomes effective since January 1, 2017.
The paragraph the fifth subitem 7.2.1 of Item 7.2 and Item 7.4 of Section 7 of Rules become effective since June 1, 2016.
|
Members of council of the Eurasian economic commission: From the Republic of Armenia |
V. Gabriyelyan |
|
From the Republic of Belarus |
V. Matyushevsky |
|
From the Republic of Kazakhstan |
A. Mamin |
|
From the Kyrgyz Republic |
O. Pankratov |
|
From the Russian Federation |
I. Shuvalov |
Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 87
1. These rules are developed according to article 12 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and determine pharmakonadzor procedure in state members of the Eurasian Economic Union (further respectively - state members, the Union).
The purposes of pharmakonadzor are:
prevention of adverse effects of the undesirable reactions at the person developing after use of the registered medicines in compliance or not in accordance with the terms of the registration certificate or as a result of the impact connected with professional activity;
ensuring safe and effective use of medicines, in particular by means of provision of timely information on safety of medicines to patients, specialists of health care system and the population.
2. For the purposes of these rules concepts which mean the following are used:
"audit" (audit) - the systematic, arranged, independent and documentary process of obtaining and objective assessment of the auditor facts characterizing system operation of pharmakonadzor for the purpose of determination of extent of accomplishment of criteria of audit;
"the important identified risk", "important potential risk" (important identified risk and important potential risk) - the identified risk or potential risk of use of medicine which can exert impact on ratio "advantage - risk" or to implicate for public health. Risk identification as important depends on several factors, including extent of influence per capita, gravity of risk and influence on public health (health of the population). Any risk which needs presumably to be included in the Section on contraindications and precautionary measures is among important risks if the holder of the registration certificate other is unreasonable;
"validation of signal" (signal validation) - process of assessment of data on the revealed signal for the purpose of verification and confirmation of that fact that available information contains sufficient evidences for confirmation of identification of new potential cause and effect relationship or new aspect of the known interrelation and, therefore, is reasons for need of implementation of complex of further actions according to the analysis of signal;
"validirovanny signal" (validated signal) - signal for which in the course of accomplishment of validation and assessment of confirmatory data it is determined that the available documentation is sufficient for the assumption of availability of new potential cause and effect relationship or new aspect of the known interrelation between acceptance of the suspected medicine and development of adverse effect and, therefore, need of implementation of complex of further actions according to signal is determined;
"the impact connected with occupation" (occupational exposure) - impact of medicine to which the person as a result of accomplishment underwent to both professional activity, and other activities. This impact does not include cases of impact of one of medicine ingredients at production phase before release as ready medicine;
"identification of signal" (signal detection) - process of search and (or) identification of signal with use of any data sources of safety;
"end date of data collection" (data lock point) - the date of completion of data collection for inclusion in the periodic updated report on safety based on the international registration date. Within the report on safety of the developed medicine - the date of completion of data collection for inclusion in the report based on the international date of approval of the developed medicine. End date of data collection includes day and month;
"complete clinical trial" (completed clinical trial) - research on which the final report about clinical trial is prepared;
"the closed signal" (closed signal) - signal which assessment was complete during the accounting period of creation of the periodic updated report on safety;
"abuse of medicine" (abuse of a medicinal products) - the permanent or one-time deliberate excessive use of medicine which is followed by harmful physiological or psychological effects;
"the identified risk" (identified risk) - undesirable effect of pharmacotherapy concerning which sufficient evidences of availability of interrelation with the suspected medicine are obtained;
"the individual message on undesirable reaction" (individual case safety report (ICSR) (adverse (drug) reaction report)) - information transferred according to established by form and content, about one or several suspected undesirable reactions to medicine arising at the certain patient at a given time;
"incident on medicine" (incident) - situation in case of which there is event or arrives new information concerning the registered medicine irrespective of whether it is or is not public which can have serious influence on public health (health of the population);
"sources of receipt of individual messages on undesirable reactions on demand" (solicited sources of individual case safety reports) - organized systems on data collection which include clinical testing (researches), registers, post-registration programs the personalized medicine uses, other programs for support of patients and monitoring of diseases, poll of patients or attending physicians or for information collection about efficiency of therapy and commitment of patients to treatment;
"quality of system of pharmakonadzor" (quality of a pharmacovigilance system) - all characteristics of system of pharmakonadzor which according to assessment of probability result in the results answering the purpose of system of pharmakonadzor;
"clinical trial" (clinical trial (study)) - the clinical studying of medicine satisfying at least to one of the following conditions:
appointment to the subject of clinical trial of specific therapeutic strategy (intervention) happens in advance and is not routine clinical practice (that is sample (same) medical diagnostic and medical procedures, technologies or actions which are performed for this group of patients or this standard of delivery of health care) in state member which research centers take part in this clinical trial;
the decision on purpose of the researched medicine is made together with the decision on inclusion of the subject in clinical trial;
concerning subjects of clinical trial, in addition to procedures of routine clinical practice, supplementary procedures of diagnosis or monitoring are performed;
"control and quality assurance of system of pharmakonadzor" (quality control and assurance) - monitoring, assessment, ensuring efficiency and compliance of structural elements and processes of system of pharmakonadzor to the established requirements;
"medicine" (medicinal product)" - the means representing or containing the substance or combination of substances intended for treatment, prevention of diseases of the person or recovery, correction or change of physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;
"medicine" (drug, remedy) - the medicine in the form of dosage form coming into contact with human body;
"the master file of system of pharmakonadzor" (pharmacovigilance system master file (PSMF)) - the detailed description of the system of pharmakonadzor applied by the holder of the registration certificate concerning data on one or several registered medicines;
"the international date of approval of the developed medicine" (development international birth date (DIBD)) - date of the first approval (or authorizations) performing intervention clinical trial in any country of the world;
"the international registration date" (international birth date (IBD)) - date of the first registration (approval to use) in any state of the medicine containing certain active ingredient;
"risk minimization measures" (risk minimization measure, risk minimization activity) - complex of the actions directed to prevention or reduction of probability of emergence of the undesirable reactions connected with medicine impact or to reduction of severity or influence of undesirable reactions to the patient in case of their development;
"the minimum requirements to information in the message on undesirable reaction" (minimum criteria for reporting) - the minimum data set of the suspected undesirable reactions represented to authorized bodies in the field of pharmakonadzor about cases of identification (including the identifiable reporter, the identifiable patient, undesirable reaction and the suspected medicine);
"data set for the analysis" - the minimum data set which is required for accomplishment of the statistic analysis necessary for receipt of results on primary research purposes;
"proper practice of pharmakonadzor" (good pharmacovigilance practices (GVP)) - management on implementation of pharmakonadzor in state members which requirements extend to holders of registration certificates and authorized bodies in the field of pharmakonadzor;
"the beginning of research" - start date of data collection;
"the beginning of data collection" - registration date of data on the first patient included in research in documentary form (electronic base of data collection) or start date of extraction of data (in case of reuse of data);
"the nevalidirovanny signal" (non-validated signal) - signal for which by results of accomplishment of validation and assessment of confirmatory data it is determined that the available data are insufficient for the assumption of availability of new potential cause and effect relationship or new aspect of the known interrelation and, therefore, the further analysis of signal is not reasonable;
"undesirable reaction" (adverse reaction) - the inadvertent adverse reaction of organism connected using medicine and assuming interrelation availability using the suspected medicine. In case of receipt of the spontaneous message on development of the undesirable phenomenon in which cause and effect relationship is unknown or is not specified by the specialist of health care system or the consumer, being the primary source this undesirable phenomenon is considered as undesirable reaction. All arriving spontaneous messages represented by specialists of health care system or consumers are considered as the suspected undesirable reactions proceeding from the fact that their representation contains the assumption of the primary source of interrelation availability. The exception is constituted by messages in which the primary source makes specifying on lack of interrelation between the undesirable phenomenon and acceptance of the suspected medicine. Undesirable reactions can arise in case of use of medicine according to the approved medicine use conditions, or in connection with their violation, or as a result of the impact connected with occupation. Use cases with violation of the approved conditions of use of medicine include use not according to general characteristic of medicine or the instruction on medical application, overdose, abuse, the wrong use and errors of use;
"the undesirable phenomenon" (adverse event) - any adverse change in the state of health of the patient or the subject of clinical trial which happened after medicine use irrespective of cause and effect relationship with its use. The undesirable phenomenon can represent any adverse and inadvertent change (including variation of laboratory indicator from regulation), symptom or disease which time of origin does not exclude communication using medicine, regardless of availability or lack of interrelation using medicine;
"the undesirable phenomenon after immunization" (adverse event following immunization) - any undesirable phenomenon which developed after immunization regardless of availability or lack of interrelation using vaccine. The undesirable phenomenon after immunization can represent any adverse and inadvertent change (including variation of laboratory indicator from regulation), symptom or disease;
"not intervention research" (non-interventional studies) - research in case of which the following conditions are satisfied:
medicine is appointed according to general characteristic of medicine;
the decision on appointment to the patient of certain treatment is made according to the protocol of research not in advance, and according to routine clinical practice, and purpose of medicine is accurately separated the decision on inclusion of the patient in research;
any supplementary diagnostic or control procedures are not applied to patients, and for the analysis of the obtained data epidemiological methods are used;
"the wrong use" (misuse) - the intended inadequate use of medicine which is not corresponding to the conditions established in case of medicine registration;
"the wrong use with the illegal purpose" (misuse of a medicinal product for illegal purposes) - the wrong use with the additional hidden intention of inadequate use of medicine for the purpose of rendering impact on other person. The wrong use with the illegal purpose includes sale to other person of medicines for the recreational purposes and use of medicine for making of criminal acts;
"unexpected undesirable reaction" (unexpected adverse reaction) - undesirable reaction, nature, severity or outcome of which does not correspond to information containing in the operating general characteristic of medicine. The effects, inherent for pharmacological class, specified in general characteristic of medicine which were not described as connected with direct use of medicine are among unexpected undesirable reactions. The general characteristic of medicine approved by authorized body in the field of pharmakonadzor of state member to which the message on undesirable reaction is sent is applied to the medicines registered according to the legislation of state member;
"the new revealed signal" (newly identified signal) - the signal for the first time revealed during the accounting period of the periodic updated report on safety, which is the basis for further actions or its assessment;
"the end of data collection" - date as of which the base of data collection suitable for carrying out the analysis is for the first time completely available;
"organization" - the legal entity, competent to carry out activities for pharmakonadzor and bearing responsibility for accomplishment of these activities;
"the main information on safety of the holder of the registration certificate" (company core safety information (CCSI)) - the information concerning safety of medicine, containing in the list of specification on medicine of the holder of the registration certificate of medicine, developed by it and represented according to its statement to authorized bodies in the field of pharmakonadzor of state members in which markets this medicine is implemented, except as specified, when changes upon the demand of these authorized bodies in the field of pharmakonadzor are made to information. The main information on safety of the holder of the registration certificate represents information of help nature which determines the status of the listed and not listed undesirable reactions for the purpose of creation of the periodic updated report on safety of medicine, but does not determine the expected and unexpected undesirable reactions for fulfillment of requirements by immediate submission of messages on undesirable reactions;
"specification on medicine of the holder of the registration certificate" (company core data sheet) - the document developed by the holder of the registration certificate and containing information on safety, indications to use, the dosing mode, pharmacological properties and the other information concerning medicine;
"rejected signal" (refuted signal) - validirovanny signal which by results of subsequent assessment was determined as false in connection with impossibility of confirmation of availability of cause and effect relationship on current period of time;
"the absent information" (missing information) - lack of data on safety or about features of use of medicine for certain groups of patients which can be clinically significant;
"the report on safety of the developed medicine" (development safety update report (DSUR)) - the periodic updated report on safety of the medicine which is in development;
"signal assessment" (signal assessment) - process of further assessment of validirovanny signal with use of all available data for the purpose of studying of proofs of cause and effect relationship of new risk with active ingredient or medicine or determinations of change of the characteristic of the known risk;
"the medicine use error" (medication error)" - inadvertent mistake in the course of medicine use which brought or could lead to damnification to the patient;
"overdose" (overdose) - use of medicine for 1 acceptance or cumulatively in quantity which exceeds recommended maximum dose according to the operating general characteristic of medicine;
"the periodic updated report on safety" (periodic safety update report (PSUR)) - the report for representation of assessment of ratio "advantage - risk" medicine the holder of the registration certificate of medicine during certain period of time during post-registration stage;
"the plan of audit" (audit plan) - the description of the planned activities and the organization of separate audit;
"risk management plan" (risk management plan) - the detailed description of risk management system;
"quality planning" (quality planning) - creation of structure of the quality system of system of pharmakonadzor and planning of the integrated and approved processes of the quality system of system of pharmakonadzor;
"post-registration research of safety" (postauthorisation safety study (PASS)) - the research concerning the registered medicine, conducted for the purpose of determination of the characteristic or quantitative assessment of safety hazard, confirmation of profile of safety of medicine or efficiency evaluation of measures for risk management. The post-registration research of safety will be organized as intervention clinical trial or conducted as research of the observation not intervention design, including with use of data of real clinical practice;
"potential risk" (potential risk) - undesirable effect of pharmacotherapy concerning which there are bases for suspicions on availability of interrelation with medicine which properly was not confirmed;
"consumer" (consumer) - the patient, the person performing care of the patient, interacting with it who at the same time is not the specialist of health care system;
"commitment to quality" (quality adherence) - accomplishment of tasks and obligations according to quality requirements;
"use not according to general characteristic of medicine or the instruction on medical application (off-label) - intended use of medicine with the medical purpose not in accordance with the terms, determined by general characteristic of medicine or the instruction on medical application;
"use of the medicine appointed in connection with exceptional circumstances for compassion reasons" (compassionate use of a medicinal product) - prescription of medicine for reasons of compassion to group of patients with chronic, disabling or life-threatening diseases, and also with diseases which cannot be cured by the registered medicines (the corresponding medicine shall be at stage of registration or clinical trials);
"prioritization of signal" (signal proritisation) - process which is carried out continuously at all stages of management of signal and which purpose is identification of signals of expected risks with potential important influence on health of patients or public health (health of the population) or signals which can have significant effect on ratio "advantage - risk" medicine and, respectively, without delay require actions and taking measures of risk management;
"problem on safety" (safety concern) - the important identified risk, important potential risk or the absent information;
"the program of audit" (audit programme) - the sequence consisting of one or more audits planned for a certain period of time and having specific purpose;
"the continuing clinical trial" (ongoing clinical trail) - research in which inclusion of patients began even if the research is suspended or its analysis is complete, but the closing statement on it is absent;
"direct informing specialists of health care system" (direct healthcare professional communication) - means of information exchange by means of which important information is provided directly to certain specialists of health care system from the holder of the registration certificate or authorized body in the field of pharmakonadzor for the purpose of their informing on need of acceptance of certain measures or change of routine practice in connection with the obtained new important data on medicine;
"the considered signal" (ongoing signal) - signal which undergoes assessment procedure as of end date of data collection for the periodic updated report on safety;
"the reaction caused by concern about immunization" (immunisation anxiety-related reaction) - the undesirable phenomenon after immunization developing owing to concern about immunization;
"register" (registry) - organized system in which observation methods for collection of the standardized data on the analyzed outcomes in population of patients with certain diseases, conditions or the patients who are exposed to certain impact are used;
"results of audit" (audit findings) - results of assessment of conformity of the facts received by results of audit, to criteria of audit;
"recommendations of audit" (audit recommendation) - the description of the direction of actions which the management has the right to undertake for correction of the shortcomings revealed by results of audit, discrepancies and for minimization of weaknesses of systems of managerial supervision;
"reportirovaniye" - process of transfer in the established form of information on undesirable reactions to authorized bodies in the field of pharmakonadzor or the expert organizations within which remit the pharmakonadzor is;
"the risks connected using medicine" (risks related to use of a medicinal product) - the risks connected with quality, safety or efficiency of medicine in relation to health of patients or the populations or leading to undesirable impact on the environment;
"serious undesirable reaction" (serious adverse reaction) - undesirable reaction which leads to death poses threat for the patient's life, requires hospitalization of the patient or its prolongation, results in the resistant or expressed disability or disability, to congenital anomalies or malformations. Any inadvertent suspected transfer of the infectious agent through medicine is also considered serious undesirable reaction.
The condition posing threat for life in this context is understood as reaction in case of which life of the patient was under the threat at the time of reaction development. This condition does not belong to reaction which hypothetically could lead to death in case of more severe disease.
The decision concerning reference of situations to number of serious undesirable reactions, for example, of events, significant from the medical point of view, which do not represent direct threat for the patient's life is not led to death or hospitalization, but put the patient at risk or require intervention for prevention of one of the outcomes given in the specified determination is accepted on the basis of medical and scientific assessment, including for the conditions requiring carrying out intensive care in reception or in house conditions in case of allergic bronchospasm or spasms which do not lead to hospitalization, and also development of dependence or abuse of medicine which also should be considered the serious undesirable phenomena;
"signal" (signal) - information arriving from one or several sources including observations and experiments which assumes availability of new potential cause and effect relationship or new aspect of the known interrelation between impact of medicine and the phenomenon or set of the interconnected phenomena undesirable or favorable, estimated as sufficient for further actions for verification of signal. New aspects of the known interrelation can include changes of frequency, distribution of undesirable reaction (for example, on sex, age, the territory), to duration, severity or the result of undesirable reaction);
"the quality system of system of pharmakonadzor" (quality system of a pharmacovigilance system) - organizational structure, obligations, procedures, processes and resources of system of pharmakonadzor, including proper resource management, documentation and compliance to regulation regulations;
"risk management system" (risk management system) - complex of the actions and actions for pharmakonadzor directed to identification, the characteristic, prevention or risk minimization, connected with medicines including efficiency evaluation of these actions and actions;
"system of pharmakonadzor" (pharmacovigilance system) - the system organized by holders of registration certificates of medicines and authorized bodies in the field of pharmakonadzor for accomplishment of tasks and obligations on pharmakonadzor, intended for control of safety of medicines, early detection of all changes in ratio assessment "advantage - risk" medicines, for development and deployment of measures for ensuring use of medicines in case of excess of advantage over risk;
"the specialist of health care system" (healthcare professional) is persons having medical qualification (for example, doctors, pharmacists, druggists, nurses and forensic scientists). This determination is used, including, within submission of information on the suspected undesirable reactions;
"the spontaneous message (the spontaneous notice)" (spontaneous report (spontaneous notification)) - voluntary transfer by the specialist of health care system or the consumer to authorized body in the field of pharmakonadzor, to the holder of the registration certificate of medicine or other authorized organization (including the World Health Organization, the regional centers of pharmakonadzor, the toxicological centers) data which contain the description of one or several undesirable reactions at the patient accepting one or several medicines and which were not obtained during conduct of clinical trial or use of other method of organized data collection;
"reference information about safety of medicine" (reference safety information) - information on safety of medicine which is included in the main information on medicine of the holder of the registration certificate (for example, the list of specification on medicine of the holder of the registration certificate) and which the holder of the registration certificate shall specify in the periodic updated reports on safety in all states in which medicine is implemented, except as specified, when the authorized body in the field of pharmakonadzor requires modification of reference information;
"essential changes of the protocol of research" - changes of the protocol of research which can exert impact on safety, physical or mental wellbeing of subjects of research or influence interpretation of results of research (for example, change of primary and secondary research purposes, the researched population, amount of selection, design of research, source of the obtained data, method of data collection, determination of the main impact, outcomes and the combined variables in the statistical plan of data analysis);
"quality requirements" (quality requirements) - the characteristic of the quality system which with certain probability lead to achievement of required results or are more whole than the quality system;
"quality improvement" (quality improvement) - entering of necessary changes into structure and processes of the quality system of system of pharmakonadzor for the purpose of improvement of the quality system;
"management of signal" (signal management) - complex of the events held for the purpose of determination of availability of the new risks connected with active ingredient or medicine or change of the known risks by results of studying of individual messages on undesirable reactions, the cumulative data obtained from the operating systems of active monitoring or researches, scientific medical literature or other data sources and also for the purpose of adoption of necessary recommendations, decisions, exchange of information and tracing;
"pharmakonadzor" (pharmacovigilance) - the type of scientific and practical activities directed to identification, assessment, understanding and prevention of undesirable effects of use of medicines. The Pharmakonadzor represents the activities directed to protection of health of patients and the population;
"target population" (target population (treatment) (treatment population target)) - patients to whom medicine according to indications to use and the contraindications provided by the operating general characteristic of medicine is appointed;
"the emergency problem connected with safety" (emerging safety issue) - the problem connected with safety, estimated by the holder of the registration certificate as "the advantage requiring urgent attention of authorized body in the field of pharmakonadzor because of potential considerable influence on ratio - risk" medicine and (or) on health of patients or public health (health of the population) and because of potential need of immediate acceptance of regulatory actions and informing patients and specialists of health care system.
The concept "ratio" advantage - risk", used in these rules, is applied in the value determined by the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further - Rules of registration and examination).
3. The quality system is the integral component of system of pharmakonadzor. In relation to the proper practice of pharmakonadzor determining requirements to structure and processes of system of pharmakonadzor, quality is determined as set of the characteristics of system of pharmakonadzor allowing according to expected probability to achieve the results of system operation consistent with the pharmakonadzor purposes. Need of assessment of extent of achievement of the required quality level of system determines need of availability of previously determined quality requirements. Quality requirements represent the established characteristics of system which accomplishment with certain probability allows to achieve the planned results, that is quality systems are more whole. General purposes of the quality system in system of pharmakonadzor are determined in Item 6 of these rules. The specific purposes and quality requirements for separate structures and processes of system of pharmakonadzor are determined in the Sections IV-VII and the IX-XIII of these rules.
4. The quality system shall cover organizational structure, areas of responsibility, the procedure, processes and resources of system of pharmakonadzor. The quality system shall include:
proper resource management;
control of compliance to requirements of acts of bodies of the Union and legislation of state members;
and also management of documentation.
5. The quality system provides cyclic holding the following events:
a) quality planning of works on pharmakonadzor;
b) accomplishment of tasks and obligations according to quality requirements (commitment to quality);
c) monitoring and efficiency evaluation of the organization and work of structures and processes of system of pharmakonadzor (control and quality assurance);
d) adjustment and improvement of structure and processes of system of pharmakonadzor (quality improvement).
6. General purposes of the quality system in system of pharmakonadzor are:
a) fulfillment of requirements and obligations on pharmakonadzor according to acts of bodies of the Union and the legislation of state member;
b) prevention of undesirable effects of use of the registered medicines;
c) ensuring use of medicines in case of excess of advantage over risk;
d) assistance to protection of health of patients and public health (health of the population).
7. For accomplishment of the purposes specified in Item 6 of these rules it is necessary to adhere to the following principles in case of development of structures and processes of system of pharmakonadzor, and also in case of accomplishment of all tasks and obligations:
a) ensuring requirements satisfaction of patients, health workers and society in general concerning safety of medicines;
b) ensuring effective management on implementation of the quality system and motivation of personnel concerning the quality system purposes;
c) involvement of all staff of the organization (company) in process of support of system of pharmakonadzor at the level of the obligations assigned to them;
d) involvement of all staff of the organization (company) in permanent process of improvement of quality of system of pharmakonadzor according to recurrence of the actions specified in Item 5 of these rules;
e) the organization of resource base and the solution of the tasks set for system of pharmakonadzor in the form of structures and processes so that to provide the active, corresponding to risk level, continuous work on pharmakonadzor;
e) accounting and assessment of the available evidential data on ratio "advantage - risk". For adoption of further decisions all data which can exert impact on this ratio and use of medicine shall be considered and be estimated;
g) assistance to development of effective cooperation between developers, holders of registration certificates of medicines, authorized bodies in the field of pharmakonadzor (further - authorized bodies), healthcare institutions, patients, health workers, the scientific organizations and other interested persons according to the legislation of state members.
8. All specialists performing work on the organization of the quality system bear responsibility for ensuring system operation of pharmakonadzor according to requirements to the quality system. The organization shall provide enough the competent and trained specialists having the corresponding professional training for accomplishment of required amount of works on pharmakonadzor at the proper level. Observance of the actions stated in Item 5 of these rules shall belong to their duties.
9. System approach to quality assurance of system of pharmakonadzor shall be provided with heads of the organizations. Heads of the organizations within accomplishment of functions for ensuring system approach bear responsibility for providing:
a) documentation of the quality system according to requirements of subsections 9 - 11 these Sections;
b) proper control and documentation of all changes in system of pharmakonadzor and quality system of pharmakonadzor;
c) required resources for proper training;
d) required resources (including necessary rooms and equipment, etc.);
e) proper management of compliance;
e) proper management of records;
g) accomplishment of regular job evaluation of system of pharmakonadzor, including the integrated quality system, with confirmation of its efficiency. If necessary corrective and precautionary actions shall be implemented;
h) availability of the effective mechanism of realization of adequate measures in case of identification of changes of profile of safety of the developed and produced drugs;
i) early detection and acceptance in need of adjustment and preventive measures in case of non-compliance with quality requirements of system of pharmakonadzor;
j) carrying out regular audits of system.
10. The possibility of ensuring required quality of accomplishment of the processes connected with pharmakonadzor, and the received results is directly connected with availability of enough the competent, skilled and trained staff.
11. In the organization shall be the training plan of specialists in pharmakonadzor is developed and shall be implemented, and also conducting records on training documentation, maintenance and development of level of competence of personnel shall be provided. The training plan shall be based on assessment of need of training. Development and accomplishment of the plan are subject to control and monitoring.
12. Training shall include introduction training and the subsequent training at extent of the entire period of work according to the carried-out functions and objectives. Training shall be directed to increase in the corresponding professional skills, implementation of scientific achievements in practice and the performed procedures, ensuring compliance of all specialists to requirements to qualification, professional skills, knowledge and understanding of the performed procedures connected with pharmakonadzor. All employees shall be trained in performing procedures, provided in case of receipt of information on the problem connected with safety of medicines.
13. The processes operating in the organization for carrying out training shall provide elements of control of results of training in achievement of required understanding and accomplishment of functions on pharmakonadzor, and also to determine need of the subsequent training according to plans of professional development of the organization and specialists.
14. In the organization carrying out the corresponding training in certain aspects of pharmakonadzor of specialists of other divisions which activities are capable to affect indicators of system of pharmakonadzor and accomplishment of functions on pharmakonadzor is required. The specified activities include including conduct of clinical trials, work with claims, preparation of medical information, sale and marketing, preparation of registration documents, legal issues and audit.
15. Achievement of the required quality level of implementation of processes of pharmakonadzor and the received results is connected also with providing system with the necessary means and the equipment used in these processes.
16. Means and the equipment shall be located, be designed, adapted and serviced so that to answer effective objective according to the quality purposes in pharmakonadzor. The means, the equipment and their functional properties important for implementation of pharmakonadzor are subject to the corresponding check, qualification and (or) validation for confirmation of conformity of the purpose. For determination of scale of check, qualification or validation it is necessary to use documentary risk assessment. This risk management method needs to be applied during all useful life of means and the equipment taking into account such factors as influence on patient safety and quality of data, and also complexity of appropriate means and the equipment. The organization of functioning of information systems shall provide availability of processes of ensuring compliance to the used terminology to the existing updated versions of the used international terminology with implementation of timely changes in the used information systems.
17. For the purpose of ensuring compliance to requirements of acts of bodies of the Union and the legislation of state members with holders of registration certificates of medicines processes of quality assurance of system which purposes are shall be carried out:
a) accomplishment of permanent monitoring of data on pharmakonadzor, development and deployment died risk minimizations in case of determination of their need, proper assessment of data on safety regardless of source of their obtaining (from patients, health and pharmaceutical workers published in scientific medical literature, revealed during the post-registration researches);
b) accomplishment of scientific assessment of all information on profile of safety of medicine, including information on the undesirable reactions which developed including in case of use in compliance and not according to the approved general characteristic of medicine or the instruction on medical application (leaf insert) (further - the instruction on medical application);
c) fulfillment of requirements of acts of bodies of the Union and the legislation of state member on submission to authorized body of complete, exact and reliable information about undesirable reactions and other information on safety of medicines according to the reportirovaniye terms established by the legislation of state member;
d) quality assurance, integrity and completeness of the provided information on risks of medicines, including processes of exception of duplicative information and proper validation of signals;
e) ensuring effective interrelation with authorized bodies, including informing on changes of profile of safety of medicines and new risks, the master file of system of pharmakonadzor, risk management system, measures of risk minimization, the periodic updated report on safety, adjustment and preventive measures, post-registration researches of safety;
e) ensuring compliance of information on medicines (general characteristic of medicine, instruction on medical application) to the modern level of scientific knowledge;
g) providing health workers and patients with information on safety.
18. Authorized bodies shall have the corresponding system of quality assurance of processes for the purpose of:
a) quality evaluations of the represented data on pharmakonadzor;
b) estimates and data processing about pharmakonadzor according to requirements of acts of bodies of the Union and the legislation of state members;
c) ensuring the guaranteed independence in accomplishment of activities for pharmakonadzor;
d) effective information exchange with patients, health workers, holders of registration certificates and society in general;
e) conducting inspections, including doregistratsionny inspection.
19. Independence of accomplishment of activities for pharmakonadzor is determined by adoption of all regulatory decisions only for the benefit of health of the patient and public health (health of the population).
20. The management system documentation is part of the quality system, extends to all documents of system of pharmakonadzor and provides possibility of search of the data and traceability of the performed procedures, including assessment procedures of new data and investigation of problems, connected with safety in relation to correctness of accomplishment of processes, time of accomplishment of investigations and decision making.
21. The management system shall provide with documentation:
a) quality management of data on pharmakonadzor, including their completeness, accuracy and integrity;
b) timely access to all records;
c) effective internal and external data transmission;
d) document storage, concerning systems of pharmakonadzor and implementation of pharmakonadzor on each of medicines, according to applicable storage durations.
22. The holder of the registration certificate of medicine (further - the holder of the registration certificate) shall provide proper documentation, the address and storage of all information on pharmakonadzor for the purpose of performing procedures of exact reportirovaniye, interpretation and verification of data. The system of traceability and the subsequent observation of undesirable reactions shall be provided with the holder of the registration certificate.
23. The management system documentation shall include package of measures for safety and confidentiality of data for the purpose of fulfillment of requirements on personal data protection of patients according to requirements of the legislation of state member. The management system documentation shall provide special measures at each stage of storage, processing and data transmission about pharmakonadzor with safety and confidentiality of data. The specified measures shall include strict restriction of access to data according to which access to documentation and databases shall be limited by the authorized persons.
24. The management system documentation shall include processes of ensuring information security about pharmakonadzor from loss and destruction.
25. The management system shall be described by documentation in policy of management of documentation.
26. All elements, requirements and provisions of the quality system shall be documented and systematized as appropriate in the form of the plan for quality, the quality manual, procedures for quality and reports on quality.
27. The plan for quality determines main objectives of the quality system and processes which shall be implemented for achievement of effective objectives. Procedures for quality represent the description of established procedure of accomplishment of processes and can have the form of standard operational procedures and work instructions or managements. The quality manual determines the field of distribution of the quality system, processes of the quality system and their interrelation. Reports on quality include the received results of system operation or confirmation of the carried-out activities.
28. For ensuring system approach in case of quality planning the organization shall determine:
a) the purposes in area of quality according to common goals of system to quality of system of pharmakonadzor according to Item 6 of these rules and the purposes in area of quality, specific to separate structures and processes, according to appropriate sections of these rules;
b) methods of monitoring of system effectiveness of pharmakonadzor.
29. Availability and system operation of quality is documented with the help:
a) documentation on organizational structure and obligations of personnel;
b) training plans and records about the provided training;
c) instructions for accomplishment of management processes according to the legislation of state member;
d) instructions for accomplishment of the processes realized in the conditions of the situation requiring acceptance of urgent measures including procedures of providing going concern;
e) indicators of accomplishment of processes which are used for permanent monitoring of proper accomplishment of functions on pharmakonadzor;
e) reports on audit and the subsequent audit of the quality system, including obtained yielded and results.
30. Documentation on the quality system shall include also:
a) methods of monitoring of system effectiveness of quality and, in particular, its capability to achieve the quality system goal;
b) policy of management of documentation;
c) the documents on results of the performed procedures for pharmakonadzor confirming accomplishment of the provided stages and actions;
d) documents and reports on means and the equipment, including check of functional properties, activities for qualification and validation which confirm accomplishment of all stages provided by relevant requirements, protocols and procedures;
e) the documents confirming control of shortcomings and variations from the installed quality system, acceptance of the precautionary and adjusting actions, efficiency evaluation of the taken measures.
31. In addition to required documentation on the quality system the holder of the registration certificate shall document:
a) human resources management;
b) obligations and functions of personnel of system of pharmakonadzor;
c) the organizational structure determining hierarchical interrelation of supervision and supervisory personnel, and also resource management system;
d) instructions for accomplishment of critical processes;
e) management system documentation.
32. In addition to required documentation on the quality system the authorized body shall document organizational structure, task allocation and responsibility between all personnel of system of pharmakonadzor, and also to determine contact persons for ensuring interaction between authorized bodies, holders of registration certificates and persons providing information on risks of medicines in relation to their influence on health of patients and public health (health of the population).
33. Critical processes in pharmakonadzor include:
a) continuous monitoring of profile of safety and ratio "advantage - risk" the registered medicines;
b) implementation, realization and assessment of risk management system (including efficiency evaluation of measures of risk minimization);
c) work with individual messages on undesirable reactions (collection, processing, management, quality control, receipt of missing data, assignment of number, classification, detection of repeated messages, assessment and timely representation);
d) management of signals;
e) development, preparation (including assessment of data and quality control), representation and assessment of the periodic updated reports on safety;
e) accomplishment of obligations and representation of replies to the requests of the authorized bodies containing the reliable and complete information;
g) ensuring interaction between pharmakonadzor and quality control system of medicines;
h) informing authorized bodies on all problems connected with safety (including changes in ratio assessment "advantage - risk" the registered medicines);
i) informing health and pharmaceutical workers, patients on changes in ratio assessment "advantage - risk" for the purpose of ensuring safe and effective use of medicines;
j) ensuring compliance of information on medicine (including general characteristic of medicine for medical application) to the modern level of scientific medical knowledge, including the conclusions about assessment and recommendations of authorized bodies;
k) realization of changes of the registration file for the reasons connected with safety according to terms of accomplishment of necessary actions.
34. The plan of providing continuity of processes shall be developed on basis risk - the oriented approach and shall include:
a) determination of events which can influence significantly personnel of the organization in general or structures and processes of pharmakonadzor in particular;
b) reserve systems on case of need of the emergency exchange of information in the organization, with other organizations performing functions on pharmakonadzor with other developers, holders of registration certificates and authorized bodies.
35. Control methods of activities and system effectiveness of pharmakonadzor shall include:
a) overview and analysis of system persons responsible for management of system;
b) audits;
c) control of compliance to requirements;
d) inspections;
e) efficiency evaluation of the taken measures of risk minimization and to ensuring safe and effective use of medicines.
36. For the purpose of accomplishment of monitoring in the organization indicators on which the continuous efficiency evaluation of functioning of system of pharmakonadzor from the point of view of quality requirements is carried out shall be in advance determined.
37. Efficiency of functioning of the quality system shall be estimated regularly by the head who is carrying out the overview of documentation of the quality system which frequency and degree of intensity are determined by the preliminary planning proved by risk, and the developed programs of the overview of system. The overview of the quality system shall include assessment of standard operational procedures and work instructions, variations of functioning of system from the established indicators, reports on audit and inspection, and also process performance indicators.
38. The audit of the quality system based on risk assessment shall be carried out regularly through certain intervals of time for the purpose of confirmation of conformity to the established quality requirements and efficiency determinations. Audit of the quality system shall include audit of system of pharmakonadzor into which the quality system is integrated. Methods and processes of audit are stated in the Section V of these rules. By results of each audit of the quality system and the subsequent audit the report which is subject to assessment by persons responsible for the organization of the corresponding audited processes shall be constituted. The report shall include results of audit of the organizations or persons which the holder of the registration certificate delegated functions on pharmakonadzor as they are part of system of pharmakonadzor of the holder of the registration certificate.
39. By results of accomplishment of monitoring of system of pharmakonadzor and the quality system of system of pharmakonadzor, including results of audits, in case of need it is necessary to develop and implement the adjusting and preventive measures.
40. Authorized bodies shall provide monitoring of accomplishment by holders of registration certificates of the state members of functions and obligations established by the legislation on pharmakonadzor. Inspection of holders of registration certificates from authorized bodies is among measures for ensuring monitoring.
41. Holders of registration certificates are actionees of tasks and obligations on pharmakonadzor determined by these rules and the legislation of state members, for the purpose of the guaranteed accomplishment of obligations and acceptance in need of required measures for pharmakonadzor concerning the registered medicines. For this purpose holders of registration certificates shall provide functioning of system of pharmakonadzor in the territories of state members, including implementation of the proper and effective quality system of system of pharmakonadzor.
42. Under certain circumstances holders of registration certificates allow to organize more than one system of pharmakonadzor, for example, in case of forming of separate system of pharmakonadzor for certain groups of medicines (in particular for vaccines, nonprescription medicines).
43. The description of system of pharmakonadzor is created by the holder of the registration certificate in format of the master file of system of pharmakonadzor and supported throughout the entire period of action of registration certificates concerning all registered medicines. The holder of the registration certificate also bears responsibility for development, accomplishment and maintenance of the risk management systems adapted for each of the registered medicines.
44. Requirements to structures and processes of system of pharmakonadzor of the holder of the registration certificate are determined in appropriate sections of these rules.
45. The holder of the registration certificate shall appoint and have the authorized person on pharmakonadzor in state members having required qualification at the permanent order. The holder of the registration certificate gives surname and contact information on the authorized person on pharmakonadzor in authorized bodies of state members. In case of change of this information the holder of the registration certificate shall without delay, inform within 30 calendar days on it authorized bodies of state members.
46. Obligations of the authorized person shall be determined by pharmakonadzor by the job description. The arrangement of the authorized person on pharmakonadzor and its interaction with other persons shall be determined in organizational structure at the level of managerial personnel of the holder of the registration certificate.
47. Information on the authorized person on pharmakonadzor shall be included in the master file of system of pharmakonadzor of the holder of the registration certificate.
48. In each system of pharmakonadzor only one authorized person on pharmakonadzor is allowed. More than one holder of the registration certificate in general or separate systems of pharmakonadzor have the right to use services of the authorized person in pharmakonadzor, or such person has the right to perform functions of the authorized person on pharmakonadzor more than for one system of pharmakonadzor of one holder of the registration certificate provided that the authorized person on pharmakonadzor is able to carry out all the obligations. In addition to appointment of the authorized person on pharmakonadzor authorized bodies have the right to require appointment of the contact person on pharmakonadzor, accountable to the authorized person on pharmakonadzor. Accountability in this case belongs to tasks and obligations on pharmakonadzor and optionally means direct subordination. The contact person has the right to perform functions of the authorized person on pharmakonadzor. The organization of system of pharmakonadzor of the holder of the registration certificate in the territory of state member shall provide fulfillment of requirements of acts of bodies of the Union and the legislation of state members in the field of pharmakonadzor effective interaction with authorized body and lack of obstacles in collection and submission of data on the revealed undesirable reactions to the state member territories.
49. The holder of the registration certificate confers to the authorized person on pharmakonadzor sufficient powers on management of activities for pharmakonadzor and the quality system. The holder of the registration certificate provides to the authorized person on pharmakonadzor access to the master file of system of pharmakonadzor, and also appropriate authority and provides information on any changes in the master file of system of pharmakonadzor. The powers concerning system of pharmakonadzor and the master file of system of pharmakonadzor shall allow the authorized person to enter on pharmakonadzor changes into the system, risk management plans, and also into preparation of the regulating actions in response to identification of the emergency problem connected with safety.
50. The holder of the registration certificate provides availability of all systems and processes allowing the authorized person to carry out the obligations assigned to it on pharmakonadzor. For this purpose the holder of the registration certificate develops mechanisms by means of which the authorized person on pharmakonadzor has access to all data which can be required by him, and obtains all necessary information, for example:
a) information on the emergency problems on safety connected with changes of profile of safety and other information concerning ratio assessment "advantage - risk" medicines to which the system of pharmakonadzor extends;
b) information on the continuing and complete clinical trials and other researches about which the holder of the registration certificate knows and which can be related to safety of medicines;
c) information obtained from other sources except sources of the holder of the registration certificate (for example, from sources with which the holder of the registration certificate has contractual arrangements);
d) information on the procedures important for pharmakonadzor which are developed by the holder of the registration certificate at each level for the purpose of ensuring coordination and observance of requirements within the organization.
51. The authorized person on pharmakonadzor obtains information from managing personnel on results of permanent reviews of the quality system and the taken measures, this about compliance to requirements, the planned audits of system of pharmakonadzor. The authorized person on pharmakonadzor has powers to initiate audit in case of need.
52. The managing personnel provides to the authorized person on pharmakonadzor the copy of the plan of the adjusting and precautionary actions after each audit important for system of pharmakonadzor that the authorized person on pharmakonadzor could be convinced of acceptance of the adequate adjusting measures.
53. The holder of the registration certificate provides possibility of obtaining by the authorized person on information pharmakonadzor from the database of undesirable reactions which is available at its order, at any time in case of need the immediate response to the emergency request of authorized body. By the holder of the registration certificate the relevant organizational activities allowing the authorized person to have access to the database of undesirable reactions on pharmakonadzor including in time off shall be held.
54. The holder of the registration certificate provides informing the authorized person on pharmakonadzor concerning intentions on inclusion in the available list of additional medicines by acquisition of other company or separate medicines of other holder of the registration certificate. The authorized person on pharmakonadzor carries out assessment of possible influence of inclusion of new medicines on the operating system of pharmakonadzor, provides necessary adaptation of system of pharmakonadzor, and also determines data on pharmakonadzor which shall be provided by the former holder of the registration certificate, and provision terms. The holder of the registration certificate provides informing the authorized person on pharmakonadzor of rather contract commitments of the parties regarding activities for pharmakonadzor and data exchange about safety, and also gives to him the modification right in this part of contract commitments. The authorized person on pharmakonadzor informs the holder of the registration certificate in case of need of realization of additional terms for the purpose of ensuring proper accomplishment of obligations on pharmakonadzor concerning these medicines, the possibility of accomplishment of these obligations on pharmakonadzor shall be taken into account in case of decision making and determination of contract commitments of the parties.
55. The holder of the registration certificate provides informing the authorized person on pharmakonadzor of rather available intention of establishment of cooperation with other holder of the registration certificate, the organization or physical person which is capable to exert directly or indirectly impact on system of pharmakonadzor, to the conclusion of contractual arrangements in time, sufficient for accomplishment by the authorized person on pharmakonadzor of assessment of possible influence of this cooperation on system of pharmakonadzor. The holder of the registration certificate gives to the authorized person on pharmakonadzor authority on introduction of offers and changes in part of the contract commitments concerning system of pharmakonadzor.
56. The authorized person on pharmakonadzor shall have theoretical knowledge and practical experience in the field of implementation of activities for pharmakonadzor which level of training is determined by the holder of the registration certificate in the job description of the authorized person by pharmakonadzor. The authorized person on pharmakonadzor shall have skills of management of systems of pharmakonadzor, and also conducting examination or to have access to conducting examination in such areas as, medicine, pharmaceutical sciences, and also epidemiology and biostatistics.
57. The holder of the registration certificate provides training of the authorized person in pharmakonadzor in the field of the system of pharmakonadzor before the authorized person on pharmakonadzor holds position of the authorized person. Training and its results shall be documented properly.
58. Representatives person on pharmakonadzor is physical person.
59. The authorized person on pharmakonadzor shall have qualification according to Items 56 and 57 of these rules and to be at the permanent order of the holder of registration certificates. Person authorized on accomplishment of functions of the authorized person on pharmakonadzor in the territories of state members shall live and work in one of state members. With the holder of the registration certificate availability of contingency procedures on case of temporary absence of the authorized person on pharmakonadzor with determination of person which is carrying out obligations of the authorized person on pharmakonadzor in its absence shall be provided. The possibility of accomplishment by person replacing representatives person on pharmakonadzor, obligations on pharmakonadzor shall be provided with the holder of the registration certificate. In this case replacement person shall be available when using contact information of the authorized person on pharmakonadzor.
60. The authorized person on pharmakonadzor bears responsibility for creation and functioning of system of pharmakonadzor of the holder of the registration certificate and, therefore, has enough powers for rendering influence on implementation of activities for pharmakonadzor and the quality system of system of pharmakonadzor, assistance, observance and increase in level of observance of requirements of acts of bodies of the Union and the legislation of state members. The authorized person on pharmakonadzor shall have powers and responsibility concerning the master file of system of pharmakonadzor to provide and increase the level of observance of requirements of acts of bodies of the Union and the legislation of state members.
61. Concerning medicines to which the system of pharmakonadzor of the holder of registration certificates extends the authorized person on pharmakonadzor shall:
a) have the overview of profiles of safety of the medicines and the revealed problems connected with safety;
b) possess in full information on the conditions and obligations established in case of issue of registration certificates, and other obligations concerning safety or safe use of medicines;
c) possess in full information on risk minimization measures;
d) take part in assessment and approval of protocols of post-registration researches of safety;
e) possess the complete information about post-registration researches on safety which carrying out is appointed by authorized body, including results of such researches;
e) possess information on contents of risk management plans and have sufficient powers for modification of risk management plans;
g) provide accomplishment of functions on pharmakonadzor and submission of all documents concerning pharmakonadzor according to requirements of acts of bodies of the Union and the legislation of state members;
h) provide necessary quality (including the accuracy and completeness) the data on pharmakonadzor represented to authorized bodies;
i) provide representation in full and timely replies to the requests of authorized bodies about submission of the additional information necessary for assessment of advantage and risk of medicines;
j) provide any information concerning ratio assessment "advantage - risk", in authorized bodies;
k) give help in preparation of regulatory measures in case of identification of the problems connected with safety (for example, changes in recommendations about medical application, urgent restrictions and bringing information to patients and health workers);
l) function as the single contact person on pharmakonadzor for authorized bodies of state members, and also as the contact person for inspections in the field of pharmakonadzor with ensuring the round-the-clock (24-hour) access of authorized body to the authorized person on pharmakonadzor. The authorized person on pharmakonadzor exercises control of functioning of all aspects of system of pharmakonadzor, including its quality system (for example, standard operational procedures, contractual arrangements, transactions with the database, fulfillment of requirements of the quality system, observance of requirements to reportirovaniye regarding completeness and timeliness, to submission of the periodic updated reports on safety, reports on audits and personnel training in the field of pharmakonadzor). The authorized person on pharmakonadzor shall have information on the validation status of the database of undesirable reactions to medicines (including all defects revealed during validation and taken corrective actions), and also information on all essential changes made to the database (for example, changes which can exert impact on activities for pharmakonadzor).
62. The authorized person on pharmakonadzor has the right to delegate accomplishment of specific tasks under the observation to persons with the corresponding qualification and training (for example, implementation of activities as experts in safety of certain medicines) provided that the authorized person on pharmakonadzor will exercise control of functioning of all system and profiles of safety of all medicines. Such delegation of the carried-out functions shall be properly documented.
63. The holder of the registration certificate develops additional special processes of the quality system for the purpose of:
a) data presentations about undesirable reactions in databases of state members and the single information database on the revealed undesirable reactions (actions) to medicines including messages on inefficiency of medicines in the terms established by acts of bodies of the Union and the legislation of state members;
b) the monitoring of the used terminology which is carried out on systematic or regular basis;
c) preserving documents of the master file of system of pharmakonadzor until the system described in the master file of system of pharmakonadzor and within at least 5 years after the termination of its action is effective;
d) preserving data on pharmakonadzor and the documents concerning the registered medicines within at least 10 years after cancellation of certificates of state registration;
e) updates of information on medicines according to the last scientific knowledge (including assessment of profile of safety and ratio "advantage - risk"), and also to the recommendations posted on the websites of authorized bodies on the Internet (further - the Internet). For this purpose the holder of registration certificates constantly checks the websites of authorized bodies of state members for availability of corresponding changes in assessment of profile of safety and ratio "advantage - risk", including changes in recommendations about medical application and other measures of regulatory nature.
64. During documentation storage duration holders of registration certificates provide restorability of documents.
65. Documents can be stored in electronic format on condition of proper validation of electronic system and existence of arrangements on protection of system, access and backup of data. In case of transfer of documents from paper format in electronic transfer process shall guarantee preserving all information in original format and ensuring preserving readability for all storage time with the means used for storage.
66. In case of absorption by other business organization of the holder of the registration certificate all documents shall be transferred and kept in full.
67. The holder of the registration certificate has the right to delegate everything or part of the tasks on pharmakonadzor (including functions of the authorized person on pharmakonadzor) to other organization or person (if to such person the same requirements, as can be applied to the organization). At the same time responsibility for accomplishment of tasks and obligations on pharmakonadzor, quality assurance and integrity of system of pharmakonadzor is born by the holder of the registration certificate.
68. In case of delegation of certain tasks on pharmakonadzor of other organization the holder of the registration certificate bears responsibility for use of the effective quality system of execution of these tasks. The requirements to system of pharmakonadzor determined by proper practice of pharmakonadzor are also applied to this organization.
69. In case of delegation of tasks of other organization the holder of the registration certificate provides the detailed, accurate and constantly updated documentary execution of contractual arrangements between it and other organization with the description of arrangements on the delegated tasks and responsibility of each of the parties. The description of the delegated tasks shall be included in the master file of system of pharmakonadzor (with indication of the contractual organizations in appendix to the master file). Other organization is exposed to inspection on compliance to the carried-out activities for pharmakonadzor according to requirements of these rules at the discretion of authorized body.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
Database include more 50000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.
More about search system
If you cannot find the required document, or you do not know where to begin, go to Help section.
In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.
You also may open the section Frequently asked questions. This section provides answers to questions set by users.