Unofficial translation
THE MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION
ORDER
Dated November 30, 2015 N 866
ON APPROVAL OF THE CONCEPT OF CREATING
THE FEDERAL STATE INFORMATION SYSTEM
FOR MONITORING OF DRUGS CIRCULATION
FROM A MANUFACTURER TO A FINAL CONSUMER
WITH THE USE OF LABELING
Inpursuanceofparagraph 5 oftheinstructions of the President of the Russian Federation dated February 20, 2015 N Пр-285 following the results of the meeting with the members of the Government of the Russian Federation on February 4, 2015,I order:
ToapprovetheproposedConceptof creating the Federal State Information System for Monitoring of Drugs Circulation from a Manufacturer to a Final Consumer with the Use of Labeling.
Minister
V.I.SKVORTSOVA
Approved
by the Order of the Ministry
of Healthcare
of the Russian Federation
on November 30, 2015 N 866
THE CONCEPT
OF CREATING THE FEDERAL STATE INFORMATION
SYSTEM FOR MONITORING OF DRUGS CIRCULATION
FROM A MANUFACTURER TO A FINAL CONSUMER
WITH THE USE OF LABELING
(FSIS MDC)
1. GENERAL INFORMATION
1.1. The System’s name
Thefullnameofthesystemisthe Federal State Information System for Monitoring of Drugs Circulation from a Manufacturer to a Final Consumer with the Use of Labeling.
The system’s abbreviated name is FSIS DCM.
1.2.JustificationofFSIS DCM development
Paragraph5 oftheInstructionofthePresidentoftheRussianFederationПр-285 datedFebruary20, 2015: “TheMinistryofHealthcareoftheRussianFederationshallensurethedevelopmentandphasedimplementation of the automated system for monitoring of drugs circulation from a manufacturer to a final consumer with the use of labeling (coding) and identification of drug packages in order to ensure effective quality control of drugs in circulation and counteract their falsification”.
1.3. Legislative environment for FSIS DCM
TheResolutionoftheCommissionoftheCustomsUniondatedAugust 16, 2011 N 769On Approval of Technical Regulation of the Customs Union On Safety of Packages.
The FederalLaws:
datedDecember26, 2008 N 294-ФЗOntheProtectionofRightsofLegalEntitiesandIndividualEntrepreneursintheExerciseoftheStateControl (Supervision) andMunicipalControl;
datedApril12, 2010 N 61-ФЗOnDrugsCirculation (hereinafter – the Law N 61-ФЗ);
datedApril6,2011N 63-ФЗOn Electronic Signature.
The Resolutions of the Government of the Russian Federation:
datedJuly6, 2012 N 686OnApprovalofthe Regulation on Licensing Drugs Manufacture;
datedSeptember3, 2010 N 674On Approval of the Guidelines for Disposal of Poor-quality Drugs, Falsified Drugs and Counterfeit Drugs;
datedOctober15, 2012 N 1043On Approval of the Regulation on the Federal State Surveillance in Drugs Circulation;
datedDecember22, 2011 N 1081On Licensing Pharmaceutical Activities.
TheOrderoftheMinistryofHealthcareoftheRussianFederationdatedFebruary13, 2013 N 66 On Approval of the Strategy of Drug Provision for the Population of the Russian Federation till 2025 and the Plan of its Implementation.
The Orders of the Ministry of Health and Social Development of the Russian Federation:
dated September 29, 2011 N 1090нOn Approval of the Administrative Procedure of the Federal Service for Surveillance in Healthcare and Social Development in Execution of the State Function on Control in Application of Drugs Disposal (registered in the Ministry of Justice of Russia on January 18, 2012 N 22945);
dated August 26, 2010 N 757нOn Approval of the Procedure for Monitoring the Safety of Drugs for Medical Use, Registration of Adverse Effects, Serious Adverse Reactions, Unexpected Adverse Reactions in Application of Drugs for Medical Use (Registered in the Ministry of Justice of Russia on August 31, 2010 N 18324).
TheOrderoftheFederalServiceforSurveillanceinHealthcaredatedAugust7, 2015 N 5539On Approval of the Procedure for Execution of Selective Quality Control of Drugs for Medical Use (registered in the Ministry of Justice of Russia on October 9, 2015 N 39263).
TheOrderoftheMinistryofIndustryandTradeoftheRussianFederationdatedOctober4, 2013 N 1607 OnApprovaloftheAdministrativeProcedurefortheFulfillment bytheMinistryof Industry and Trade of the Russian Federation of the State Function on the Execution of Licensing Supervision of the Activities on Manufacture of Drugs for Medical Use (registered in the Ministry of Justice of Russia on March 3, 2014 N 31483).
2. LIST OF THE USED ABBREVIATIONS, TERMS
AND DEFINITIONS
2.1. List of the used abbreviations
FSIS MDC / Federal State Information System for Monitoring of Drugs Circulation from a Manufacturer to a Final Consumer with the Use of LabelingAC / Aggregatecodeofdrugtransportationpackaging
USIA / Unified System of Identification and Authentication
VED / Vital and Essential Drugs (EDL, Essential Drugs List)
SC / Serialized code of a drug package
IS / Information system
INN / Internationalnonproprietaryname
D / Drug
IEIS / Interdepartmental Electronic Interaction System
ES / Electronic signature
SDR / StateDrugsRegister
RD / Reference data
URS / Unified reference system
AWS / Automated working station
2.2. List of the used terms and definitions
Drugs–medicinesas drug forms used for prevention, diagnostics, treatment of a disease, rehabilitation, for the maintenance, prevention or termination of pregnancy.
Drugform–conditionofadrugcorrespondingto theroutes of its administration and application and ensuring achievement of a required therapeutic effect.
The Listof vital and essential drugs - the list of drugs for medical use that is subject forannual approval by the Government of the Russian Federation providing for the priority needs of healthcare for the purpose of prevention and treatment of diseases, including those prevailing in the structure of morbidity in the Russian Federation.
Drug quality - compliance of a drug with the requirements of pharmacopeial monograph or, in case of its absence, with normative documentation or normative document.
Drug safety - a drug characteristics based on the comparative analysis of its efficacy and risk of causing harm for health.
Drug efficacy - a characteristic of a degree of positive impact of a drug on the course, duration of a disease and its prevention, rehabilitation, on maintenance, prevention or termination of pregnancy.
Drug batch - an amount of drug manufactured as a result of one technological cycle by its manufacturer.
Falsified drug - a drug accompanied by a false information on its composition and (or) manufacturer.
Poor-quality drug - a drug non-compliant with the requirements of the pharmacopeial monograph or, in case of its absence, with the requirements of normative documentation or normative document.
Counterfeit drug - a drug being in circulation with the breach of the civil legislation.
Drug prescription - a written prescription of a drug according to the established form, issued by a rightful healthcare or veterinary professional with the purpose of a drug provision or its preparation and provision.
Drugs circulation - development, preclinical trials, clinical trials, expertise, state registration, standardization and quality control, manufacture, preparation, storage, transportation, import to the Russian Federation, export from the Russian Federation, advertising, provision, sales, transfer, application, disposal of drugs.
Parties involved in the drugs circulation - individual persons, including individual entrepreneurs, and legal entities, carrying out activities in drugs circulation.
Drug manufacturer - an organization carrying out drug manufacture in accordance with the requirements of the Federal Lawdated April 12, 2010 #61-FZ“On Drugs Circulation”.
Drug manufacture - activities on production of drugs by organizations - drug manufacturers at one phase, several or all phases of technological process, as well as on storage and provision of drugs.
Serialized labeling of drugs–application of a special labeling by a manufacturer on the secondary (consumer) drug packaging, and in case of its absence – on a primary packaging.
Aggregate drug labeling –application of a special labeling on a drug transportation packaging by drug manufacturer, distributor, pharmacy.
Pharmaceutical activities - activities that include drugs distribution, their storage, transportation and (or) retail trade in drugs, their provision, storage, transportation, preparation of drugs.
Drugs distributor - organization engaged in drugs distribution, their storage, transportation in accordance with the requirements of federal law #61-FZ“On Drugs Circulation”.
Drugs retailer–pharmacy organizations, individual entrepreneurs having a pharmaceutical license, healthcare organizations having a license for pharmaceutical activities and their standalone subdivisions (outpatient departments, paramedic and paramedic-midwife stations, general medical (family) practice centers (departments), located in rural settlements without pharmacy organizations, carrying out retail tradeof drugs in the amount sufficient for fulfillment of physician’s (paramedic’s) prescriptions.
Pharmacy organization - organization, individual entrepreneur, structural subdivision of a healthcare organization engaged in drugs retail trade, storage, transportation, preparation and sales of drugs for medical use in accordance with the requirements of federal law #61-FZ“On Drugs Circulation”.
Healthcare organization - a legal entity irrespective of its organizational and legal form that carries out medical activities as the main (statutory) type of activity based on the license issued according to the procedure established by the legislation of the Russian Federation, other legal entities irrespective of their organizational and legal form that carry out medical activities along with their main (statutory) activity, individual entrepreneurs carrying out medical activities are also deemed healthcare organizations.
Pharmaceutical organization - a legal entity irrespective of its organizational and legal form that carries out pharmaceutical activities (drugs distributor, pharmacy organization).
Primary or individual drug packaging - a primary (internal) packaging in the direct contact with the drug. These include vials, tubes, ampoules, packets, strip packaging, etc.
Secondary(consumer) packaging–apackageinwhichthedrug in the primary or intermediate package is placed for provision to a consumer.
Transportationpackaging –adrugpackagenotintendedforconsumers, andwherethedrugintheprimary (incasethesecondarypackagingisabsent) orthesecondary (consumer) packageisplacedwiththepurposeof further transfer to distributors, pharmacies and healthcare organizations.
7HCN–Seven High-Cost Nosologies (hemophilia, cystic fibrosis, pituitary dwarfism, Gaucherdisease, malignant neoplasms of lymphoid, hematopoieticandrelatedtissues, multiplesclerosis, personsaftertransplantationoforgansand(or) tissues).
3. GOAL AND OBJECTIVES OF FSIS MDC CREATION
3.1. The goal of FSIS MDCcreation
The goal of FSIS MDCcreationis to ensure guaranteed supply of qualitative, effective and safe drugs to consumers through protection of the legal circulation against falsified, counterfeit and poor-quality drugs.
3.2. ThepurposeofFSISMDC
FSIS MDC is designed to organize continuous monitoring of the drug circulation from a manufacturer to a final consumer with the use of serialized and aggregated coded labeling (serialization and aggregation) and identification of drug packages in order to ensure efficient quality control of drugs in circulation and to counteract their falsification.
The main objectives being achieved with the use of FSIS MDC are:
- Increased drug safety of the population of the Russian Federation.
- Decrease the threat for life and health of the population of the Russian Federation, caused by the entry in circulation of falsified, counterfeit and poor-quality drugs.
- Formation of the drug tracking system at all stages of circulation from a manufacturer to a final consumer and creation of the mechanisms of ongoing operational monitoring of drug market and its individual segments (scope, sales, stocks, etc.)
- Monitor the availability and circulation of drugs trade stock in healthcare organizations, including drugs that were purchased at the expense of the Federal Budget of the Russian Federation.
- Informational support of the Russian Federation executive bodies in their activities on counteracting circulation of falsified, non-registered, poor-quality drugs.
- Involvement of the population of the Russian Federation in counteracting the circulation of falsified, non-registered, poor-quality drugs.
- Increase the efficiency of the Federal State Surveillance in the sphere of drugs circulation.
FSIS MDC shall ensure the performance of the following functions:
- Providing all FSIS MDC participants with the possibility to register in the System of the operations on the drugs circulation at all stages of the drugs circulation (manufacturer – distributor (including those engaged in the import of drugs) – pharmacy organization, healthcare organization – sales to a final consumer).
- Monitoring of drugs circulation at all stages of the drugs circulation (manufacturer – distributor (including those engaged in the import of drugs) – pharmacy organization, healthcare organization – sales to a final consumer) in terms of the specific drug, specific drug batch, specific drug package.
- Monitoring of shelf life of drugs in circulation.
- Monitoring of withdrawal of poor-quality, falsified and non-registered drugs from circulation.
- Blocking the process of circulation of falsified, non-registered and poor-quality drugs in relation to which the competent federal executive authority has taken the decision on suspension of circulation, or which are subject to withdrawal from circulation and disposal.
- Monitoring of the process of drugs disposal in order to prevent entering in circulation of drugs due to disposal.
- Providingpossibility for all the System participants to receive different reports and analytical snapshots within the framework of their authorities.
4. CHARACTERISTICS OF THE AUTOMATION OBJECT
4.1. Description of the main participants of the informational interaction and their functions
Participants of the informational interaction within FSIS MDC are:
1. The Ministry of Healthcare of the Russian Federation.
2. Drugmanufacturers.
3. Drugs distributors, including those engaged in their import to the Russian Federation (hereinafter – drugs Importer).
4. DrugsretailersintheterritoryoftheRussianFederation/Pharmacy organizations.
5. Organizations performing drugs disposal.
6. Healthcare organizations.
7. Drugs consumers (Patients).
8. The Federal Service on Surveillance in Healthcare.
9. The Ministry of Industry and Trade of the Russian Federation.
4.2. Organizational chart of the informational interaction of the System participants
4.3. Thekey functionsof the informational interaction participants within the System functioning
N / Name of the participant / Functions1. / The Ministry of Healthcare of the Russian Federation / The Ministry of Healthcare of the Russian Federation within the projecton creating the System shall be the main functional customer and shall perform the roles of the Data Operator and the Services Operator.
Functions within the framework of the Data Operator:
- establishing and regulating the rules of forming SCs and ACs;
- forming identifiers of manufacturers;
- establishing correspondence of SCs to SDR;
- establishing the rules of participants’ interaction;
- approving policies and standards of connecting the participants to the System;
- ensuring information protection measures;
- receiving immediate and analytical reporting on purchases, circulation and residual stock of drugs;
- updating information from the State Drugs Register.
Functions within the framework of the Services Operator:
- connecting the System participants to the services, registering users and providing access to personal accounts;
- providing access for the authorized users to immediate and analytical reporting on residual stock and circulation of drugs;
- collecting, processing, storing and transferring data between the participants;
- regulating relationships of the interaction participants in the course of their performance of their functions;
- technical support of services and all subsystems included in FSIS MDC.
2. / Drugs manufacturer / - forming and assigning SCs and ACs;
- registering drugs manufacture;
- registering drugs sales;
- registeringdrugswrite-off and transfer for disposal;
- registering withdrawal from circulation and disposal of drugs;
- registrationofdrugsplaced for retained samples storage;
- registering drugs selected for confirmation of quality;
- receiving immediate and analytical reporting on drugs circulation;
- checking the authenticity of drugs in circulation;
- receivinginformationonthefactofidentifyingviolationsand detecting drugs with SCs and ACs of unestablished type.
3. / Drugs distributor, including that engaged in import to the Russian Federation / - forming and assigning ACs to form drugs transportation packaging;
- registering drugs arrival to the warehouse;
- registering drugs sales from the warehouse;
- registeringdrugs selected for confirmation of quality;
- checking the authenticity of drugs in circulation, as well as information on drugs withdrawal;
- registering transfer of drugs for disposal;
- registering returns and write-offs of drug batches.
4. / Drugretailer/ Pharmacy organization / - registering drugs arrival to a pharmacy organization;
- checkingthe authenticity of drugs in circulation, as well as information on drugs withdrawal;
- registering drugs returns to a supplier;
- forming and assigning ACs for drugs transportation packaging;
- registeringdrugs selected for confirmation of quality;
- transferring drugs for disposal;
- registering sales and provision (by prescription) of drugs to a final consumer.
5. / Organizationperformingdrugsdisposal / - registering arrival of drug batches for disposal;
- registeringinformationondisposalofadrugbatch (with annulment of SCs and ACs).
6. / Healthcare organization / - forming and placing orders for drugs;
- registering arrival of drugs batches from distributors;
- checking the authenticity of drugs in circulation, as well as information on drugs withdrawal;
- registering drugs selected for confirmation of quality;
- registering write-offs of drugs given for delivery of medical care to patients;
- registering drugs returns to a supplier;
- transferring drugs for disposal.
7. / Drugs consumers (Patients) / - searching pharmacies, where relevant drugs are available;
- checking the authenticity of drugs;
- submitting to FSIS MDC the information on detectingdrugsof unestablished authenticity.
8. / The Federal Service on Surveillance in Healthcare / - monitoringof thedrugsstatusatallstagesoftheirlifecycleintermsofthespecificbatch, specificpackage;
- approval of establishment and regulation of the rules of forming SCs and ACs;
- processing claims from consumers on detected violations;
- blocking the circulation of drugs in relation to which the decision was taken to suspend circulation, which are subject to withdrawal from circulation and disposal;
- monitoring the provision of information on drugs disposal and preventing their repeated entry in the distribution network;
- receiving immediate and analytical reporting on drugs circulation.
9. / The Ministry of Industry and Trade of the Russian Federation / - receivingreportsinordertoanalyzethe drugs market and monitor the structure of drugs state procurement;
- monitoringandrecording drugs manufacture in the territory of the Russian Federation.
5. REQUIREMENTS FOR FSIS MDC
5.1. Requirements for the entire system
FSIS MDC shall ensure implementation of two main functioning scenarios:
- Monitoring of circulation of drugs manufactured in the territory of the Russian Federation and imported to the Russian Federation to perform the civil circulation.
- Monitoring of drugs disposal.
5.1.1. Requirements for the System structure and functioning
Within the framework of creatingFSIS MDC it is necessary to differentiate functional and infrastructure subsystems.
The functional subsystems are:
1. Subsystem for providing information. FSIS MDC Portal.
2. Mobile application platform.
3. Subsystem for registering drugs manufacture, forming SCs and ACs
4. Subsystem for managing drugs circulation.
5. Subsystem for registering claims of consumers.
6. Subsystem for planning state procurement of the VEDs.
7. Subsystem for managing the reference data.
8. Subsystem for processing information and compiling reports.
9. Subsystem for ensuring informational interaction with external ISs.
10. Administration subsystem.
11. Information security subsystem.
The infrastructure subsystems are:
1. Infrastructure provision subsystem.
2. Subsystem for monitoring and managing the IT-infrastructure.
3. Complex of technical facilities.
4. Authentication center.
Incaseofunstableinternet connection FSIS MDC shall ensure collection, processing, storage and transfer of data in the offline mode according to the regulations.
5.1.2. Function chart of FSIS MDC
5.1.3. List of the main services provided by FSIS MDC
N / The service name / The service description / The service recipients1. / Forming identifiers of manufacturers / Sending from FSIS MDC the unique identifiers of manufacturers / - Drugs manufacturers
2. / Establishing correspondence of these SCs to SDR / SendingfromFSISMDCthedetailsofadrugregistrationcertificate on a manufacturer’s request / - Drugs manufacturers
3. / Registering SCs / SendingfromFSISMDCtheinformationonmanufactureddrugs(notification on drugs readiness for the civil circulation) / - Drugs manufacturers
4. / RegisteringACsofdrugs(connecting SCs and ACs) / Sending to FSIS MDC the information on ACs and the list of SCs that were placed in a transportation package. / - Drugs manufacturers;
- Drugs distributors, including those engaged in drugs import;
- Pharmacies;
- Healthcare organizations
5. / Drugs circulation / Receiving and sending to FSIS MDC the appropriate data on drugs circulation / - The Ministry of Healthcare of the Russian Federation;
- Roszdravnadzor;
- Drugs manufacturers;
- Drugs distributors, including those engaged in drugs import;
- Pharmacy organizations;
- Healthcare organizations;
- Organizations performing drugs disposal
6. / Condition status of drugs batches by the aggregated code / Receiving from FSIS MDC the updated information on the authenticity, current condition and location of drug batches by the aggregated code (within the limits of their authorities and access rights) / - The Ministry of Healthcare of the Russian Federation;
- Roszdravnadzor;
- Drugs manufacturers;
- Drugs distributors, including those engaged in drugs import;
- Pharmacy organizations;
- Healthcare organizations;
- Organizations performing drugs disposal
7. / Conditionstatusofdrugsindividualpackagesby SCs / ReceivingfromFSISMDCtheupdatedinformationon the authenticity, current condition and location of drug individual packages by the serialized code / - All participants of the informational interaction
8. / Residual stock by drug batches / ReceivingfromFSISMDCtheinformationonresidualstockofdrugsbatches(including those purchased under the state contracts) in accordance with the requested search criteria. / - The Ministry of Healthcare of the Russian Federation
9. / Information on drugs being purchased / ReceivingfromFSISMDCtheinformationonthe drugs being purchased (within the limits of established authorities and access rights) / - The Ministry of Healthcare of the Russian Federation;
- Roszdravnadzor;
- Minpromtorg;
- Drugs manufacturers
10. / Claims of consumers / SendingfromFSISMDCtherespectiveregisteredclaimsofdrugsconsumers, aswellasloadingin FSIS MDC the statuses of claims processing by thepublic authorities officials / - Roszdravnadzor
11. / Drugs withdrawn from circulation / ReceivingandsendingfromFSISMDCthe list of drugs withdrawn from circulation with indication of the date and the reason / Allparticipantsoftheinformationalinteraction (within the limits of their authorities and access rights)
Information exchange between the components of FSIS MDC shall be carried out by means of standard protocols and interfaces of electronic interaction. Management of FSIS MDC components shall be carried out with the use of specialized management automated working stations (AWS).