Track & trace for medicals

On July 1, 2019, registration will begin of pharmacies and medical institutions in the Chestny ZNAK track & trace digital system handling medications listed as high-cost nosologies.

On October 1, 2019, marking will become mandatory for medications from the list of high-cost nosologies. 

Starting on 1 February 2017, an experiment was initiated throughout the Russian Federation to mark pharmaceutical products in compliance with Decree No. 62 of the Government of the Russian Federation of 24 January 2017.

This track & trace process is designed to prevent the manufacture and circulation of counterfeit and falsified products.

To implement the experiment, a dedicated track & trace information system was developed to monitor pharmaceutical product circulation (IS MDLP). The system is intended for use in the healthcare industry and is operated by the Federal Tax Service.

Information letter from CRPT operator about introduction of Track & trace systems in health care organizations

Starting on 1 November 2018, in compliance with Decree No. 1018 of the Government of the Russian Federation of 28 August 2018, IS MDLP was transferred from FTS to CRPT Operator into the Chestny ZNAK Unified national track & trace digital system.

Additional information:
Become a participant
FAQ
Documents
- Regulations
- To developers
- Other documentation
Participants
Partners
Working subgroups
Expert opinions


How to become a participant/partner

For the successful registration of Manufacturers of pharmaceutical products in the track & trace information system for monitor the pharmaceutical product circulation.

1. An encrypted e-signature (EES) registered by the company CEO (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation).
Registration is not possible for a company with an EES registered by an employee other than the CEO. If your company has no EES, it can be registered through one of the certification centers accredited by the Russian Ministry of Digital Development. The list of accredited certification centers is available at: https://minsvyaz.ru/ru/activity/govservices/2.

2. Complete conformity of the CEO’s full name and company taxpayer identity number (INN) as specified in the EES with the information entered in the Uniform State Register of Legal Entities/Uniform State Register of Sole Proprietors/Register of Accredited Affiliates (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation).
This information can be checked in the Uniform State Register of Legal Entities on the Russian Federal Tax Service website.
This information can be checked in the State Register of Accredited Affiliates on the Russian Federal Tax Service website.

  • in the event of any discrepancies that need to be corrected in the Uniform State Register of Legal Entities, please see the Russian Federal Tax Service website for the procedure and guidelines for submitting amendments;
  • in the event any discrepancies are found in the EES, it must be re-registered.

3. The license for manufacturing pharmaceutical products and/or conducting pharmaceutical business activities registered by the corresponding executive authority (for Russian pharmaceutical manufacturers and companies involved in the circulation of pharmaceutical products in the Russian Federation).
You can check license information:

  • in the register of licenses for manufacturing pharmaceutical products on the website of the Russian Ministry of Industry and Trade;
  • in the Uniform Register of Licenses on the Roszdravnadzor website, including licenses issued by the executive authorities of constituent entities of the Russian Federation in accordance with the delegated authority for licensing certain types of activities;
  • if you don’t find the required license in the register, please contact the corresponding executive authority.

4. For licenses authorizing pharmaceutical activity, the presence of at least one trading address of the organization in the federal information address system (FIAS) with the assignment of a unique ID.
You can check the existence of the address and assigned identifier in the FIAS.

  • if even one condition is not met, your registration will be denied.

5. Information on registration as the holder of a registration certificate for a pharmaceutical product (for residents of the Russian Federation without a license and foreign legal entities that hold registration certificates for pharmaceutical products).
Data on registration certificates can be checked in the State Register of Pharmaceutical Products.

  • if you hold a registration certificate for pharmaceutical products manufactured outside the Russian Federation or by a representative of a foreign legal entity and you have no license, then your registration in the Track & trace information system for monitor the pharmaceutical product circulation system for monitoring the circulation of pharmaceutical products for medical use must be approved by Roszdravnadzor by confirming the data specified in the application.

6. A favorable decision by Roszdravnadzor following the review of the documents provided by the authorized representatives of companies (for residents of the Russian Federation without licenses and foreign companies (and their representatives) that hold registration certificates for pharmaceutical products).
The documents include an application to participate in the experiment and documents confirming the right to act on behalf of the registered organization. You can find the application form on the website of the Ministry of Health of Russia.

  • the authorized representatives of the parties to pharmaceutical product circulation whose applications are subject to approval by Roszdravnadzor shall, within ten calendar days after submitting an electronic application to the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use, send an appropriate application to Roszdravnadzor as per the form approved by the authorized executive authority along with the original copies of documents confirming their authority to act on behalf of the registered organization.

Important information

To register in an IS MDLP personal account, you must:

1. Log into the portal of the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use.

2. Install the software and e-signature verification key certificates as required and configure the software.

You need:

  • the user manual;
  • OS Windows 7 or later/Mac OS X 10.8 or later;
  • Google Chrome, Mozilla Firefox, Opera, Internet Explorer 11, or Safari;
  • the plugin of the Cryptographic Information Protection Facility (CIPF) for Internet Explorer / Safari. The list of CIPFs certified by FSS is available on the FSS website http://clsz.fsb.ru/certification.htm;
  • software of the selected CIPF;
  • drivers for the key carriers of the electronic key. You can download the driver and setup instructions on the CIPF manufacturer’s website.

    3. Click Check Access and the system will automatically check the ability to connect the PC and display instructions for further setup.

    4. Complete the necessary payment details in the electronic application depending on the type of participant and click Register.

    5. You will receive an email notification that registration was successfully completed (or that your registration was rejected, with the specified reason).

    6. You can now start working in your personal account (if no reasons are found for rejection).

How to become a partner of the Track & trace information system for monitor the pharmaceutical product circulation

To successfully register in the Track & trace information system for monitor the pharmaceutical product circulation («MDLP system»), you must meet the following conditions:

  • partnership application;
  • sign a confidentiality agreement;
  • sign a partnership agreement.

System integrators and software developers

To access the MDLP system, a system integrator or software developer must:

1. Take into account that software developers without licenses for the production of medicines, pharmaceutical, or medical activities can only access the testing environment of the MDLP system (the MDLP Sandbox test bed):

  • this test bed can be used for software debugging and user training;
  • the data contained therein has no legal value;
  • the safety of test bed data (except for the registration data of connected organizations) is not guaranteed for an extended time (they may be reset when updating the MDLP system).
2. You do not have to become a partner of CRPT to connect to the MDLP Sandbox test bed.

3. To connect to the MDLP Sandbox test bed as a system integrator or software developer, the participant of medicine circulation that is already registered in the MDLP system must contact the technical support of the CRPT Operator with a request to register this organization in the system.

For the successful registration of Pharmacies in the track & trace information system for monitor the pharmaceutical product circulation.

1. An encrypted e-signature (EES) registered by the company CEO (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation).
Registration is not possible for a company with an EES registered by an employee other than the CEO. If your company has no EES, it can be registered through one of the certification centers accredited by the Russian Ministry of Digital Development. The list of accredited certification centers is available at: https://minsvyaz.ru/ru/activity/govservices/2.

2. Complete conformity of the CEO’s full name and company taxpayer identity number (INN) as specified in the EES with the information entered in the Uniform State Register of Legal Entities/Uniform State Register of Sole Proprietors/Register of Accredited Affiliates (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation).
This information can be checked in the Uniform State Register of Legal Entities on the Russian Federal Tax Service website.
This information can be checked in the State Register of Accredited Affiliates on the Russian Federal Tax Service website.

  • in the event of any discrepancies that need to be corrected in the Uniform State Register of Legal Entities, please see the Russian Federal Tax Service website for the procedure and guidelines for submitting amendments;
  • in the event any discrepancies are found in the EES, it must be re-registered.
3. The license for conducting pharmaceutical business activities registered by the corresponding executive authority (for Russian pharmaceutical manufacturers and companies involved in the circulation of pharmaceutical products in the Russian Federation).
You can check license information:
  • in the Uniform Register of Licenses on the Roszdravnadzor website, including licenses issued by the executive authorities of constituent entities of the Russian Federation in accordance with the delegated authority for licensing certain types of activities;
  • if you don’t find the required license in the register, please contact the corresponding executive authority.

4. For licenses authorizing pharmaceutical activity, the presence of at least one trading address of the organization in the federal information address system (FIAS) with the assignment of a unique ID.
You can check the existence of the address and assigned identifier in the FIAS.

  • if even one condition is not met, your registration will be denied.

5. A favorable decision by Roszdravnadzor following the review of the documents provided by the authorized representatives of companies (for residents of the Russian Federation without licenses and foreign companies (and their representatives) that hold registration certificates for pharmaceutical products).

The documents include an application to participate in the experiment and documents confirming the right to act on behalf of the registered organization. You can find the application form on the website of the Ministry of Health of Russia.

  • the authorized representatives of the parties to pharmaceutical product circulation whose applications are subject to approval by Roszdravnadzor shall, within ten calendar days after submitting an electronic application to the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use, send an appropriate application to Roszdravnadzor as per the form approved by the authorized executive authority along with the original copies of documents confirming their authority to act on behalf of the registered organization.

Important information

To register in an IS MDLP personal account, you must:

1. Log into the portal of the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use.

2. Install the software and e-signature verification key certificates as required and configure the software.

You need:

  • the user manual;
  • OS Windows 7 or later/Mac OS X 10.8 or later;
  • Google Chrome, Mozilla Firefox, Opera, Internet Explorer 11, or Safari;
  • the plugin of the Cryptographic Information Protection Facility (CIPF) for Internet Explorer / Safari. The list of CIPFs certified by FSS is available on the FSS website http://clsz.fsb.ru/certification.htm;
  • software of the selected CIPF;
  • drivers for the key carriers of the electronic key. You can download the driver and setup instructions on the CIPF manufacturer’s website.

    3. Click Check Access and the system will automatically check the ability to connect the PC and display instructions for further setup.

    4. Complete the necessary payment details in the electronic application depending on the type of participant and click Register.

    5. You will receive an email notification that registration was successfully completed (or that your registration was rejected, with the specified reason).

    6. You can now start working in your personal account (if no reasons are found for rejection).

For the successful registration of wholesalers in the track & trace information system for monitor the pharmaceutical product circulation.

1. An encrypted e-signature (EES) registered by the company CEO (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation). 
Registration is not possible for a company with an EES registered by an employee other than the CEO. If your company has no EES, it can be registered through one of the certification centers accredited by the Russian Ministry of Digital Development. The list of accredited certification centers is available at: https://minsvyaz.ru/ru/activity/govservices/2.

2. Complete conformity of the CEO’s full name and company taxpayer identity number (INN) as specified in the EES with the information entered in the Uniform State Register of Legal Entities/Uniform State Register of Sole Proprietors/Register of Accredited Affiliates (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation). 
This information can be checked in the Uniform State Register of Legal Entities on the Russian Federal Tax Service website.
This information can be checked in the State Register of Accredited Affiliates on the Russian Federal Tax Service website.

  • in the event of any discrepancies that need to be corrected in the Uniform State Register of Legal Entities, please see the Russian Federal Tax Service website for the procedure and guidelines for submitting amendments;
  • in the event any discrepancies are found in the EES, it must be re-registered.
3. The license for manufacturing pharmaceutical products and/or conducting pharmaceutical business activities registered by the corresponding executive authority (for Russian pharmaceutical manufacturers and companies involved in the circulation of pharmaceutical products in the Russian Federation). 
You can check license information:
  • in the Uniform Register of Licenses on the Roszdravnadzor website, including licenses issued by the executive authorities of constituent entities of the Russian Federation in accordance with the delegated authority for licensing certain types of activities;
  • if you don’t find the required license in the register, please contact the corresponding executive authority.

4. For licenses authorizing pharmaceutical activity, the presence of at least one trading address of the organization in the federal information address system (FIAS) with the assignment of a unique ID. 
You can check the existence of the address and assigned identifier in the FIAS.

  • if even one condition is not met, your registration will be denied.

5. Information on registration as the holder of a registration certificate for a pharmaceutical product (for residents of the Russian Federation without a license and foreign legal entities that hold registration certificates for pharmaceutical products). 
Data on registration certificates can be checked in the State Register of Pharmaceutical Products.

  • if you hold a registration certificate for pharmaceutical products manufactured outside the Russian Federation or by a representative of a foreign legal entity and you have no license, then your registration in the Track & trace information system for monitor the pharmaceutical product circulation system for monitoring the circulation of pharmaceutical products for medical use must be approved by Roszdravnadzor by confirming the data specified in the application.

6. A favorable decision by Roszdravnadzor following the review of the documents provided by the authorized representatives of companies (for residents of the Russian Federation without licenses and foreign companies (and their representatives) that hold registration certificates for pharmaceutical products). 
The documents include an application to participate in the experiment and documents confirming the right to act on behalf of the registered organization. You can find the application form on the website of the Ministry of Health of Russia.

  • the authorized representatives of the parties to pharmaceutical product circulation whose applications are subject to approval by Roszdravnadzor shall, within ten calendar days after submitting an electronic application to the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use, send an appropriate application to Roszdravnadzor as per the form approved by the authorized executive authority along with the original copies of documents confirming their authority to act on behalf of the registered organization.

Important information

To register in an IS MDLP personal account, you must:

1. Log into the portal of the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use.

2. Install the software and e-signature verification key certificates as required and configure the software.

You need:

  • the user manual;
  • OS Windows 7 or later/Mac OS X 10.8 or later;
  • Google Chrome, Mozilla Firefox, Opera, Internet Explorer 11, or Safari;
  • the plugin of the Cryptographic Information Protection Facility (CIPF) for Internet Explorer / Safari. The list of CIPFs certified by FSS is available on the FSS website http://clsz.fsb.ru/certification.htm;
  • software of the selected CIPF;
  • drivers for the key carriers of the electronic key. You can download the driver and setup instructions on the CIPF manufacturer’s website.

    3. Click Check Access and the system will automatically check the ability to connect the PC and display instructions for further setup.

    4. Complete the necessary payment details in the electronic application depending on the type of participant and click Register.

    5. You will receive an email notification that registration was successfully completed (or that your registration was rejected, with the specified reason).

    6. You can now start working in your personal account (if no reasons are found for rejection).

For the successful registration of Medical organizations in the track & trace information system for monitor the pharmaceutical product circulation.

1. An encrypted e-signature (EES) registered by the company CEO (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation). 
Registration is not possible for a company with an EES registered by an employee other than the CEO. If your company has no EES, it can be registered through one of the certification centers accredited by the Russian Ministry of Digital Development. The list of accredited certification centers is available at: https://minsvyaz.ru/ru/activity/govservices/2.

2. Complete conformity of the CEO’s full name and company taxpayer identity number (INN) as specified in the EES with the information entered in the Uniform State Register of Legal Entities/Uniform State Register of Sole Proprietors/Register of Accredited Affiliates (for residents of the Russian Federation and representative offices of foreign companies in the Russian Federation). 
This information can be checked in the Uniform State Register of Legal Entities on the Russian Federal Tax Service website.
This information can be checked in the State Register of Accredited Affiliates on the Russian Federal Tax Service website.

  • in the event of any discrepancies that need to be corrected in the Uniform State Register of Legal Entities, please see the Russian Federal Tax Service website for the procedure and guidelines for submitting amendments;
  • in the event any discrepancies are found in the EES, it must be re-registered.

3. The license for manufacturing pharmaceutical products and/or conducting pharmaceutical business activities registered by the corresponding executive authority (for Russian pharmaceutical manufacturers and companies involved in the circulation of pharmaceutical products in the Russian Federation). 
You can check license information:

  • in the Uniform Register of Licenses on the Roszdravnadzor website, including licenses issued by the executive authorities of constituent entities of the Russian Federation in accordance with the delegated authority for licensing certain types of activities;
  • if you don’t find the required license in the register, please contact the corresponding executive authority.

4. For licenses authorizing pharmaceutical activity, the presence of at least one trading address of the organization in the federal information address system (FIAS) with the assignment of a unique ID. 
You can check the existence of the address and assigned identifier in the FIAS.

  • if even one condition is not met, your registration will be denied.

5. A favorable decision by Roszdravnadzor following the review of the documents provided by the authorized representatives of companies (for residents of the Russian Federation without licenses and foreign companies (and their representatives) that hold registration certificates for pharmaceutical products).

The documents include an application to participate in the experiment and documents confirming the right to act on behalf of the registered organization. You can find the application form on the website of the Ministry of Health of Russia.

  • the authorized representatives of the parties to pharmaceutical product circulation whose applications are subject to approval by Roszdravnadzor shall, within ten calendar days after submitting an electronic application to the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use, send an appropriate application to Roszdravnadzor as per the form approved by the authorized executive authority along with the original copies of documents confirming their authority to act on behalf of the registered organization.

Important information

To register in an IS MDLP personal account, you must:

1. Log into the portal of the Track & trace information system for monitor the pharmaceutical product circulationsystem for monitoring the circulation of pharmaceutical products for medical use.

2. Install the software and e-signature verification key certificates as required and configure the software.

You need:

  • the user manual;
  • OS Windows 7 or later/Mac OS X 10.8 or later;
  • Google Chrome, Mozilla Firefox, Opera, Internet Explorer 11, or Safari;
  • the plugin of the Cryptographic Information Protection Facility (CIPF) for Internet Explorer / Safari. The list of CIPFs certified by FSS is available on the FSS website http://clsz.fsb.ru/certification.htm;
  • software of the selected CIPF;
  • drivers for the key carriers of the electronic key. You can download the driver and setup instructions on the CIPF manufacturer’s website.

    3. Click Check Access and the system will automatically check the ability to connect the PC and display instructions for further setup.

    4. Complete the necessary payment details in the electronic application depending on the type of participant and click Register.

    5. You will receive an email notification that registration was successfully completed (or that your registration was rejected, with the specified reason).

    6. You can now start working in your personal account (if no reasons are found for rejection).

To obtain test access to the track & trace Information system for monitor the pharmaceutical product circulation use without a license, you must contact the technical support of the CRPT Operator.

You need:

  • the user manual;
  • OS Windows 7 or later/Mac OS X 10.8 or later;
  • Google Chrome, Mozilla Firefox, Opera, Internet Explorer 11, or Safari;
  • the plugin of the Cryptographic Information Protection Facility (CIPF) for Internet Explorer / Safari. The list of CIPFs certified by FSS is available on the FSS website http://clsz.fsb.ru/certification.htm;
  • software of the selected CIPF;
  • drivers for the key carriers of the electronic key. You can download the driver and setup instructions on the CIPF manufacturer's website.
About the experiment
  • How is the experiment regulated?

    — Federal Law «On drugs circulation» No. 61-FZ of 12 April 2010;
    — Federal Law «On amendments to the Federal Law on drugs circulation» No. 425-FZ of 28 December 2017;
    — Decree of the Russian Federation Government No. 1018 of 28 August 2017;
    — Guidelines for conducting an experiment to apply control (identification) marks and monitor specific types of human-use pharmaceutical products in civil circulation within Russia
    — other normative legal documents contained in the section Documents.

  • Where can I find the list of participants in the pilot project?

    The current list of pharmaceutical product manufacturers taking part in the experiment is available on the Participants in the Experiment for Marking Pharmaceutical Products with Control (Identification) Marks tab in the Pharmaceutical Products Track & Trace System section of the Roszdravnadzor website http://www.roszdravnadzor.ru/marking/participants.

  • When will marking become mandatory for all pharmaceutical products?

    The track & trace experiment for pharmaceutical product has been extended until late 2019, and after that marking will turn from an experimental to a mandatory procedure without any pause or delay.

    Marking becomes mandatory for all pharmaceutical products starting on 1 January 2020. This requirement was introduced by Federal Law No. 425-FZ of 28 December 2017.
    For the drugs included on the list of cost-intensive nosology and vital & essential pharmaceutical products, marking will become mandatory at an earlier time (the exact date to be determined by the Government of the Russian Federation).

  • For what reasons might a registration be denied?

    There may be a number of reasons for denying the registration for a participant in the experiment depending on the participation type:

    a) in IS MDLP registration based on the completed application to participate in the experiment filed by Russian PP manufacturers that are implementing either the «PP prepackaging/packaging into secondary and/or tertiary packaging» or the «outgoing quality control» stage, may be denied for the following reasons: — the unavailability of an encrypted e-signature for the applicant company’s CEO, or a discrepancy between the qualified certificate owner details and the information about the applicant company’s CEO; — no information available on valid entries in the Uniform State Register of Legal Entities/Uniform State Register of Individual Entrepreneurs maintained by the Federal Tax Service; — no information available about valid licenses in the Uniform register of licenses for manufacturing pharmaceutical products maintained by the Ministry of Industry and Trade;

    b) registration in IS MDLP based on an application to participate in the experiment filed by a foreign holder of PP registration certificates may be denied for the following reasons: — no information about the PP registration certificate specified in the application available in the State register of human-use pharmaceutical products; — a lack of information about a positive decision by Roszdravnadzor to participate in the experiment;

    c) a registration in IS MDLP based on an application to participate in the Experiment filed by the representative offices of foreign registration certificate holders may be denied for the following reasons: — unavailability of an encrypted e-signature for the applying company’s CEO, or a discrepancy between the qualified certificate owner details and the information about the applying company’s CEO; — no information about valid entries is available in the State Register of Accredited Branches, Representative Offices of Foreign Legal Entities maintained by the Federal Tax Service;

    d) registration in IS MDLP based on an application to participate in the experiment filed by PP wholesale companies, retailers, or medical institutions may be denied for the following reasons: — no information is available about a valid certificate for an encrypted e-signature issued to the applying company’s CEO; — no information about valid entries is available from the Uniform State Register of Legal Entities/Uniform State Register of Individual Entrepreneurs maintained by the Federal Tax Service; — no information about a valid license is available from the Uniform State Register of licenses for medical and pharmaceutical businesses maintained by Roszdravnadzor.

  • How can I take part in the pilot project?

    1. To be a participant in the experiment, you should submit a proper request to Roszdravnadzor. This will enable the participant to register in the IS MDLP and begin preparing for mandatory marking.

    2. Then you should file an application on the Chestny ZNAK website.

    3. To complete the registration, the company must register an EES for its CEO. The registration is carried out based on the electronic application. Residents of the Russian Federation and representatives of a foreign registration certificate holder must file an electronic application to participate in the experiment. A foreign registration certificate holder shall, upon filing an electronic application, submit original documents to confirm his right to represent the interests of a foreign registration certificate holder and properly apply for voluntary participation in the experiment no later than 10 calendar days after filing an electronic application to Roszdravnadzor at the following address: 4 Slavyanskaya Ploschad, Bldg. 1, 109074 Moscow Information about the results of the review and the decision to register the foreign registration certificate holder as a participant in the experiment will be entered by the Track & trace IS operator based on Roszdravnadzor’s representation. In the event that registration is denied, Roszdravnadzor will send an explanation of the reasons to the applicant’s email address.

    4. Have a hardware-software complex connected to communication channels that provides automated interaction with the Track & trace IS operator to obtain marking codes.

    5. Have a computing system able to create and certify electronic documents with an encrypted e-signature which is required for interacting with the Chestny ZNAK Track & trace IS operator (requesting identification tools, information about their use, notifications) and for working within the Personal Account.

Encrypted e-signature (EES) and the participant's Personal Account
  • What e-signature is required to work with the track & trace digital system?

    Only an encrypted e-signature may be used in the track & trace system. Registration in the Personal Account of the track & trace system needs to be performed using the EES registered for the CEO (Director General) of the company! At the time of registration, the full name and INN will be double-checked for compliance with the Uniform State Register of Legal Entities.

  • Is there any opportunity to delegate rights in the track&trace system?

    Currently, the Personal Account of the experiment participant may be opened using the CEO’s EES. Then, the CEO may add other e-signatures with assigned rights and permissions. Delegating rights up to and including detailed setup — no.

  • How are the acquisition and use of an EES regulated?

    Any relations in the area of electronic signature usage are governed by Federal Law No. 63-FZ of 6 April 2011 (rev. 23 June 2016) «On electronic signatures» and Decree No. 634 of the Government of the Russian Federation of 25 June 2012 «On electronic signature types permitted for applying to state or municipal services».

  • How many Personal Accounts should I register if I have legal relationships with multiple companies?

    If you are bound in legal relationships with multiple companies, you should register a dedicated Personal Account for each legal entity.

  • How many Personal Accounts do I need to register?

    If a legal entity represents multiple foreign registration certification holders, they must be registered on a case-by-case basis.
    If a legal entity represents both a foreign manufacturer and registration certificate holder, they must be registered on a case-by-case basis (see Guidelines section).

  • Procedure to acquire an EES

    — select a certification centre (the list of accredited certifying centres is available on the website of the Russian Federation Ministry of Digital Development (http://minsvyaz.ru/ru/activity/govservices/2/);

    — submit an application for an EES (this service is mainly provided remotely, on the certifying centre’s website);

    — pay the invoice after the application is confirmed;

    — gather the set of documents and provide them to the certifying centre;

    — scquire an encrypted e-signature certificate;

    — for working with EES, you may need cryptography software (its composition may change depending upon the EES application);

    — an EES is issued on electroniс keys. Key models must be certified by FSTEC and/or FSS (e.g. eToken or RuToken electronic keys).

Digital code: generation, application, reading
  • When and how can I start digital code API-based cloud- or black box-enabled testing?

    Right now, contact Sergey Kholkin, Head of the Pharma business line (s.kholkin@crpt.ru) and then submit a request at  https://честныйзнак.рф website.

  • What information does the Data Matrix code contain?

    The marking code contains the following mandatory fields: serial number, global trade item number (GTIN). The code may also contain the following (optional) fields: expiration date, batch number, FEACN as per agreed format.
    The marking code must contain the key ID and verification code that provide cryptographic information protection based on an open key encryption algorithm (GOST 34.10–2012).

  • We conducted a code print test on our line, but it didn't pass. What are we doing wrong?

    Any attempt to reconfigure the lines in the process window and without help from the serialisation equipment manufacturer tech specialists may not only be unsuccessful but may also result in violating the manufacturer’s service and warranty conditions. We do not recommend conducting any tests by your own independent efforts. Contact CRPT; the issue may be addressed over the telephone or with the help of equipment manufacturer technical specialists or their representative/integrator within a half hour.

  • Is automatic aggregation and layered crypto-code-based reading supported?

    Yes, of course.

  • How many requests to issue crypto tails may an operator receive from a single manufacturer daily?

    Unlimited.

  • Will we obtain 2 million codes immediately upon request, or will each production line request the required quantity based on the size of batches, quantity of numbers, etc.?

    If you use a single ERP system for managing production sites, the system will take it into account, and generated codes will automatically be distributed across the addresses of the sites specified in the Personal Account.

  • If we require over 2 million serial numbers daily, should we submit multiple requests within 24 hours?

    You may submit a request for one month or one year in advance. According to the technical documents, the server is capable of generating 2 million codes within 10 minutes. Codes will arrive at your monitor in proportion to volume freed up.

  • What protocol is used for data exchange with the equipment? Will any tools for exchanging data with the most popular systems in Russia be immediately available?

    Currently, an all-purpose API protocol is available which you may request from CRPT, try to connect through it and test it for your system (it is compatible with all systems). If you have a self-writing system, you may configure it using a detailed instruction or contact our specialists.

  • What percentage of packaging is rejected when crypto-protection is applied?

    We achieved less than a 1% rejection level due to express configuration of the line (basically 0.7%). For lines where we have more time for line configuration, the rejection level is even lower.

  • Do I need to modify the size of pharmaceutical product packaging due to applying additional crypto protection marks in the digital marking code?

    These extra 92 symbols only increase the density of the Data Matrix code, which means that they don’t need to be additionally printed somewhere else on the package, but are embedded into the code itself. The recommended code size by the GS1 documentation for Data Matrix code of this density is 16×16 mm. CRPT successfully conducted tests on 10×10 and 12×12 mm code size applications. This size is generally applicable and does not imply any increase in the PP packaging size.

  • Will I have to arrange for a designated communication channel between the factory and Russia in order to acquire generated codes?

    There’s no need for a designated communication channel, but you will need a stable web connection. To operate with crypto-protected codes across Russia, the existing communication channel is sufficient. According to our calculations, less than 1% of capacity is consumed by a 10 Mbit channel. However, the company may allocate the channel as required, but again, there’s no need to do it in Russia. Foreign companies only need to have web access and request the code from the service located in one of the European countries.

  • If crypto-protection is implemented, will it impact the process of delivery and acceptance of pharmaceutical products at the warehouses?

    Crypto-protection is not applied for the warehouses. Warehouses use aggregation codes without any crypto-protection, which are further distributed across the system.

  • What minimum aggregation level is required to implement the project?

    The number of aggregations with CIM (control identification marks) assignment must exactly coincide with the number of packaging nesting levels. Thus the first level is the minimum level (secondary packaging for small parcel, display).

  • To what levels of packaging must special codes be applied?

    As part of the experiment, the code is only applied to secondary and tertiary packaging.

  • How many pixels should 1 Data Matrix code element contain when machine vision is applied?

    At least 3 pixels with linear resolution (when 12×12 mm code is printed in 300 dpi). Recommended — 6 pixels (the same size code printed in 600 dpi).

Emission Recorders
  • How does an emission monitor function?

    An emission monitor is an industrial software and hardware complex built up based on a Russian element base. It functions as a key and verification code generator and storage for crypto-protected marking codes. An emission monitor for a Russian-based company must be located directly at the production site. All Russian-based manufacturers may only connect to the system via an emission monitor (or a «black box»). Exceptions like requesting codes from the cloud may only be made for foreign manufacturers.

  • Will an emission monitor function without web connection?

    An emission monitor is able to properly function even without a web connection. A monitor supports storing up to 2 million codes without connecting to the Internet. On average, this amount is sufficient for 1 week of operation for a pharmaceutical company.

  • What if the emission monitor goes out of order?

    In this case, redundant hardware and servers are available. The project operator not only supplies emission monitors but also provides technical support under the terms of the public-private partnership agreement.

  • Who will integrate an emission monitor to the enterprise IT architecture, and setup the interfaces to the Chestny ZNAK track & trace system and enterprise systems?

    You must configure the interfaces to the Chestny ZNAK track & trace system by your own effort. Emission monitors are connected via an all-purpose API (descriptions are provided by us) with our help (if required). The operator’s responsibility is focused on the emission monitor, we do not intervene in your local area network.

  • What procedure should I follow to acquire emission monitors for testing purposes?

    For testing an emission monitor, submit a request to the CRPT, and we will agree on a remote connection via API, and deliver a low power monitor to the site as required. Uniform call centre: 8-800-222-15-23 E-mail: info@crpt.ru, s.kholkin@crpt.ru.

  • When and how can I obtain a permanent emission monitor?

    An emission monitor protected with a FSS license will be issued per the established connection schedule, according to the stages specified in the regulations. For the detailed consultation please contact the CRPT uniform call centre.

  • Will I have to let FSS crypto-protection experts into my factories in order to install emission monitors?

    To install and configure the equipment, you will have to let the track & trace digital system operator’s specialists into your facilities. The equipment will be physically located inside the factory, but it will virtually be outside of the local area network and have no access to sensitive information or information that is generally stored within the enterprise system. Yes, our service specialists will have access to the installed equipment, in addition to Rostelecom employees and A/C system configuration managers, etc. CRPT has already started working through this issue together with pharma representatives, and they are satisfied with the fact that no modifications must be made to the enterprise local area network. We understand that the enterprise local area network of the foreign manufacturer is a part of the global area network for the same manufacturer and may contain sensitive company information that is pertinent not only to the Russian market. We understand the anxiety of our partners, and we assure you that any concerns in this regard are unwarranted.

Equipment
  • What type of equipment do I need for purposes of pharmaceutical product track&trace?

    For the purposes of code printing, manufacturers need serialisation and aggregation equipment (if not previously purchased), and an emission monitor — equipment that issues a crypto-tail. The CRPT operator shall, at their own expense, provide emission monitors to all pharmaceutical manufacturers.

  • Equipment from which manufacturers was checked for crypto-protected code printing?

    From almost all manufacturers present in the Russian market. Currently, this involves over 15 serialisation equipment manufacturers, over 10 printer (printing system) manufacturers and over 20 scanner manufacturers.

  • Are there any preferential terms available for equipment purchase?

    An industry development fund launched a credit programme in April 2018, in order to grant loans for purchasing pharmaceutical product track&trace equipment. It offers preferential loan terms — you can borrow from RUB 5 million to RUB 50 million with a 1% annual interest rate for up to 2 years. Repayment of the principle will begin only in year two. IDF has already approved a loan for the St. Petersburg pharmaceutical company Polysan,
    Ozon Pharm and Ozon (both from Samara Region — RUB 50 million), Pharmacor Production (St. Petersburg, RUB 50 million), AVVA RUS (Kirov Region, RUB 50 million), Medisorb (Perm-based low-end pharmaceutical products manufacturer, RUB 34.5 million), etc.

  • What cardboard quality is required for crypto-protected code printing?

    CRPT can now print digital codes on any type of cardboard based on specific features for ink selection, etc. Contact out CRPT information centre, and we will inform you of the equipment setup methods based on your cardboard quality.

  • How much does the marking equipment cost?

    The average price of the equipment for small pharmaceutical manufacturers may vary from RUB 3.1 million to RUB 6 million, for high-speed production lines used by Big Pharma — from RUB 7.5 million to RUB 14 million.
    The TrekMark company was founded in order to provide Russian manufacturers with high-quality hardware and software. Due to the localisation of Russian-based manufacturing, prices for TrekMark equipment are 30% lower than those of their foreign counterparts, and the lead time has been optimized.

  • My company has already purchased the equipment in order to participate in the experiment. Do I have to purchase new equipment?

    If the company is already a participant in the experiment, there’s no need to change the marking equipment. Crypto-protection may be embedded in the existing business processes, minimum changes are required. No significant costs are implied.

  • Will I have to replace warehousing scanners?

    If your warehousing scanner supports reading Data Matrix, you won’t have to replace it.

  • What equipment do I need to implement marking across pharmacies and medical institutions?

    Pharmacies System implementation does not require any additional retooling: for Data Matrix code recognition, all-in-one scanners are used that are available in each pharmacy, there’s no need to replace them. According to Federal Law No. 54-FZ, business owners must start implementing an online cash register. Modern cash registers support reading digital codes, there’s no need to replace them. Pharmacies will only need to replace fiscal memory devices in online cash registers on a scheduled basis. Hospitals: CRPT shall, at their own expense, equip all medical institutions with retirement registrars (they are similar to cash registers in medical institutions that register the retirement of pharmaceutical products) CRPT plans to invest RUB 10 bln in this initiative. Approximately 260,000 devices will be required for this purpose.

Automated processes and registration of information in the IS MDLP
  • How will logistics workflow change after marking is implemented?

    The implementation of an appropriate methodology across the company helps accelerate and automate logistics workflow, which leads to the optimisation of a manufacturer’s costs related to these workflows. Businesses will be able to save significantly on logistics: the implementation of full goods traceability, the manufacturer or logistics company obtaining the most current statistics for the sale geography, the performance and seasonality will enable the modification of logistics systems and the optimisation of shipments and inventory. By various estimates, optimising the shipment structure, forecasting demand and distributing the marketing effort will help companies save at least 10–12% of costs for these items.

  • When and how must importers mark their goods?

    Importing companies are responsible for marking goods until they are submitted to customs procedures. The goods delivered for actual customs control clearance must be delivered with identification tools and marking codes in the form of a Data Matrix barcode. The existing business workflow for the pharmaceutical industry only requires the direct application of a code to the recycled (retail) package, which may only be performed by a company that specialises in this type of work.

Regulations
Загрузить
DECREE 1556 On Approval of the Regulations on the System for Monitoring of Flow of Medicinal Products for Human Use
Download
Загрузить
DECREE 1557 On the Peculiarities of Implementation of the System for Monitoring of Flow of Medicinal Products for Human Use
Download
Загрузить
DECREE 1558 On Approval of the Rules for Publishing Publicly Available Information Contained in the System for Monitoring of Flow of Medicinal Products for Human Use on the Internet
Download
Загрузить
Guidelines for participants of the experiment on marking with identification tools and monitoring the circulation of certain types of pharmaceutical products for medical use
Download
Загрузить
Regulation on the experiment on marking with control (identification) marks and monitoring certain types of pharmaceutical products for medical use
Download
To developers
Загрузить
Passports of Processes_v1.31_ENG
Download
Загрузить
Order management station
Download
Загрузить
Administrator's Manual
Download
Загрузить
Operator's Manual
Download
Загрузить
API Connect Reference Guide
Download
Загрузить
Interface Level Communication Protocol
Download
Загрузить
Manual for API
Download
Other documentation
Загрузить
CZ-check-list-pharma-eng
Download
Загрузить
Test methodology in TT pilot project with crypto_ver 7_english_final 5.02.19
Download
Загрузить
questionnaire_equipment_RU_en
Download
Загрузить
Oder_791_r_EN
Download
Загрузить
2018_10_17_Methodology_of_testing_from_CRPT_1st_draft
Download
Загрузить
10.10.2018_CRPT_tests_equipment_RU_en
Download
Federal executive authorities
The Ministry of Healthcare of the Russian Federation
The Ministry of Industry and Trade of the Russian Federation
The Ministry of Finance of the Russian Federation
Federal Tax Service
Federal Customs Service
Federal Service for Supervision in the Health Care field, local compliance authorities
Pharmaceutical product manufacturers
Pfizer Manufacturing Deutschland GmbH
Actavis Italy S.p.A.
Chemical Diversity Research Institute JSC
BioIntegrator Ltd.
NearMedic Ltd.
ORTAT PJSC
GEROPHARM Ltd.
Sintez PJSC
BIOCAD CJSC
NPO Petrovax Pharm LLC
Pharmstandard – Ufa Vitamin Factory JSC
Dobrolek Ltd.
AstraZeneca Industries Ltd.
Chemopharm Ltd.
Nizhpharm JSC
Gedeon Richter Rus JSC
FGUP NPO Microgen of the Russian Federation Ministry of Health
Serdix Ltd.
Takeda Pharmaceuticals Ltd.
Nativa LLC
Amgen Europe B.V.
Hoffmann-La Roche Ltd.
LEK
KRKA pharma, d. d. Novo Mesto
Boehringer Ingelheim Pharma Gmbh & Co.KG
Bayer Weimar GmbH and Co. KG
Novartis Pharma Stein AG
Dr. Reddy's Laboratories Ltd.
Gedeon Richter Hungary
Johnson & Johnson
Bosnalijek
Nobel Ilac Sanayii ve Ticaret A.S.
Canonpharma CJSC
Abbott Laboratories
Partners
Checkout equipment
ATOL

ATOL is the leading Russian manufacturer of cash register equipment and software. The company offers a wide range of fiscal solutions, from simple cash registers to smart terminals and fiscal monitors, as well as rentals of online cash registers for ATOL Online stores.

JSC SHTRIKH-M

SHTRIKH-M is the leading Russian developer and manufacturer of high-tech business automation systems and a pioneer of the trade automation industry on the Russian market. Its partner network includes over 600 authorized organizations and over 1500 service centers in Russia and the CIS.

Dreamkas

Dreamkas is a manufacturer of online cash registers and fiscal storage devices. The company develops cash register software and services for business automation. It is a fiscal data operator and an accredited certifying center, as well as an official distributor of equipment for acquiring and scanners for alcohol and marking.

EVOTOR LLC

Evotor is a joint enterprise of Sberbank, Andrey Romanenko and ATOL Group developing the ecosystem for micro, small, and medium-sized enterprises. This IT company offers smart-terminals, or online cash registers meeting 54-FZ requirements, as well as various services for business management and development which can be installed through the Evotor. Market app store, fiscal storage devices, and FDO Platform services.

Mercury-equipment

Mercury Equipment is a software developer and large supplier of cash register equipment under the Mercury, MPRINT and M-ER brands. The company supplies bar code scanners and printers, online cash registers and fiscal recording units, weighing equipment (trade, laboratory, floor, table, built-in weighing machines), and bank equipment (counters, banknote authenticity control units).

Software
1C CJSC

1C specializes in the development, distribution, release, and support of computer programs, working with users through an extensive partner network of over 10,000 permanent partners in 25 countries, including over 7000 1C: Franchises firms certified by 1C offer comprehensive enterprise automation services.
1C’s flagship development is the 1C: Enterprise program, a collection of ERP-class solutions to boost enterprise and agency efficiency powered by an innovative platform ensuring the high flexibility, scalability and productivity of corporate solutions, as well as operations on the cloud (SaaS) and mobile devices. 1C: Enterprise is successfully used in management and accounting automation in over 1,500,000 organizations, including the largest corporations and state structures. The system leads the Russian ERP market in the number of automated working places.

SKB Kontur

SKB Kontur is one of the largest developers of software for large and medium-sized enterprises, as well as online services for entrepreneurs. It is a large certifying center with the status of an e-document flow operator and fiscal data operator, and is also an equipment supplier and integrator providing a range of services to support a full traceability cycle.

Dreamkas

Dreamkas is a manufacturer of online cash registers and fiscal storage devices. The company develops cash register software and services for business automation. It is a fiscal data operator and an accredited certifying center, as well as an official distributor of equipment for acquiring and scanners for alcohol and marking.

Tenzor Company LLC

Tenzor is a federal IT holding. The company is a fiscal data and e-document flow operator. It offers turnkey solutions for the automation of trade, catering, and services powered by SBIS. The company is an authorized service center and specializes in the repair of cash register equipment. It is also a certifying center and creates e-signatures for use all over the country.

SEPTAGON LLC

Septagon is an international startup specializing in a new system for small and medium-sized enterprise management called Torgovlya.Online with support from the Skolkovo innovative center.

Mercury-equipment

Mercury Equipment is a software developer and large supplier of cash register equipment under the Mercury, MPRINT and M-ER brands. The company supplies bar code scanners and printers, online cash registers and fiscal recording units, weighing equipment (trade, laboratory, floor, table, built-in weighing machines), and bank equipment (counters, banknote authenticity control units).

CDC Group

CDC is a Russian group of companies, developer and integrator of high-load client-server and multi-level solutions with mobile work places and IoT. The software is designed for the automation of such business processes as technical maintenance and equipment repair, planning routes and satellite monitoring of transport and staff, canvassing and merchandising, remote training, etc.

Cleverence Soft LLC

Cleverence Soft is a developer of mobile accounting systems using bar codes and RFID tags for retail and wholesale trade, industrial enterprises, oil-mining companies, as well as the public sector.

Service Plus LLC

Service Plus is a Russian company developing and launching software and hardware solutions for various retail trade networks, catering, and the pharmaceutical industry. It provides printer equipment for marking and marking identification—from scanners to data collection terminals—and offers technical support services in 16 regions of Russia.

Advanco SA

Advanco is the leading provider (ISV) for Item Level Serialization and Track & Trace throughout the entire supply chain around any ERP system. Advanco is focusing now for over 10 years on customers in the pharmaceutical industry. The software solution called ARC, it interacts with all the different technology components in the customer’s solution stack (packaging hardware, shop floor technology, ERP, etc.). In addition, the ARC solution is the gateway to the national databases used for verification. ARC is installed at over 30 customers around the globe, at more than 50 sites and controls over 300 package lines. The entire solution is built to and complies with strict international regulatory standards. The core expertise in barcode, RFID and supply chain solutions has been built with experience over the last 37 years.

SAP CIS LLC

SAP is the world leader in enterprise applications in terms of software and software-related service revenue. SAP solutions and services are used by more than 413,000 customers in 180 countries around the world. In 1992, the SAP SE office was opened in Moscow, now the number of SAP CIS employees is about 1,300 people, the company is represented in all CIS countries. In 2012, SAP Labs opened a research and development center in Moscow, which now has 2 divisions in St. Petersburg and Izhevsk.

SAP is the only international developer that has its own data center in Russia and is constantly expanding its capacity.

Agile Soft Technologies LLC

Agile Soft Technologies specialises in software products for automation of pharmacies that meet the modern needs of the retail pharmacy business. The Company’s key product is SmartApteka software for the automation of pharmacy chains.

M-Apteka Style

M-Apteka Style is a company engaged in the automation of pharmacies and pharmacy chains.

Parus Corporation

Parus Corporation is a major Russian developer of information systems for public administration and business. Over 25,000 companies choose applications by Parus. The Company’s partner chain comprises 20 regional departments and 200 partners in Russia’s largest cities.

Uniko-Informatsionniye Sistemy LLC

The Uniko-Apteka software package is a modern, reliable automation system for the pharmacy business. The main features of the system make it possible to automatically receive and price vendor invoices with full monitoring of restrictions on vital and essential medicines, to check for counterfeit materials with daily updates of the Withdrawn Medicines and Maximum Prices on Vital & Essential Medicines databases, to create revaluation orders based on the analysis of market prices, to integrate with promo offer broadcasters and marketing associations, to create flexible discounts and customer loyalty bonus systems, to comply with the requirements of 54-FZ, and to integrate the track & trace system along the entire flow of goods.

BEST LLC

BEST is one of the leading software developers in Russia creating solutions in accounting and workflow management for companies concerned with manufacturing, commerce and services and for government agencies.

Integrators
Perviy BIT

Perviy BIT is a leader in the automation of retail and wholesale trade of any scale. It has been providing turnkey IT solutions for various business industries for over 20 years, including sales, and software and trade equipment integration. The company has 88 offices in 5 countries around the world.

KORUS Consulting Group

KORUS Consulting Group is a Russian system integrator implementing projects for the creation of comprehensive IT infrastructure and services for the outsourcing of all IT functions. Its information systems include ERP and CRM systems, solutions for business analysis, planning and budgeting, automated warehouse and transport activity control systems, e-document flow, and platforms for e-commerce and corporate portals. The group is a partner of CRPT, Rosselkhoznadzor, Rosalcoholregulirovaniye.

Brand Select Group

Brand Select Group specializes in the supply and integration of equipment for bar-coding and cash register equipment, and also provides automation for commercial and service companies. It is an ATOL and EVOTOR distributor and holds the status of an Authorized service center and Service partner.

Navicon

Navicon is a Russian leader in the sphere of IT consulting and systems integration. The company specializes in projects in the sphere of artificial intelligence, machine learning, business analytics and management of large data; automation of accounting, customer relations, integration and reference data solutions, as well as roll-outs of information systems in Russia for global international companies.

BALLUFF LLC

BALLUFF is a global leader in the production of equipment sensors and components for various industrial sectors. This German brand subsidiary (BALLUFF LLC) is focused on developing and implementing systems for barcode inventory.

Advanco SA

Advanco is the leading provider (ISV) for Item Level Serialization and Track & Trace throughout the entire supply chain around any ERP system. Advanco is focusing now for over 10 years on customers in the pharmaceutical industry. The software solution called ARC, it interacts with all the different technology components in the customer’s solution stack (packaging hardware, shop floor technology, ERP, etc.). In addition, the ARC solution is the gateway to the national databases used for verification. ARC is installed at over 30 customers around the globe, at more than 50 sites and controls over 300 package lines. The entire solution is built to and complies with strict international regulatory standards. The core expertise in barcode, RFID and supply chain solutions has been built with experience over the last 37 years.

SAP CIS LLC

SAP is the world leader in enterprise applications in terms of software and software-related service revenue. SAP solutions and services are used by more than 413,000 customers in 180 countries around the world. In 1992, the SAP SE office was opened in Moscow, now the number of SAP CIS employees is about 1,300 people, the company is represented in all CIS countries. In 2012, SAP Labs opened a research and development center in Moscow, which now has 2 divisions in St. Petersburg and Izhevsk.

SAP is the only international developer that has its own data center in Russia and is constantly expanding its capacity.

GK Escape

The Escape Group of Companies has been a leader in the field of automation of pharmacies and medical organisations for over 27 years.

FDO
Fiscal data operator OFD.ru

OFD.ru processes, stores, and transmits receipts from online cash registers to the Federal Tax Service of Russia, and also provides services to facilitate compliance with Federal Law No. 54-FZ «On the Application of Cash Register Equipment.» It supports all cash registers and fiscal storage devices of format versions 1.0, 1.05, 1.1 approved by the Order of the Federal Tax Service.

OFD Platform

OFD Platform is an accredited fiscal data operator in compliance with 54-FZ requirements. The company provides services for the transfer of data to the Federal Tax Service of Russia and tools for the analysis and control of data retrieved from cash register equipment.

Dreamkas

Dreamkas is a manufacturer of online cash registers and fiscal storage devices. The company develops cash register software and services for business automation. It is a fiscal data operator and an accredited certifying center, as well as an official distributor of equipment for acquiring and scanners for alcohol and marking.

Tenzor Company LLC

Tenzor is a federal IT holding. The company is a fiscal data and e-document flow operator. It offers turnkey solutions for the automation of trade, catering, and services powered by SBIS. The company is an authorized service center and specializes in the repair of cash register equipment. It is also a certifying center and creates e-signatures for use all over the country.

Checkout equipment
ATOL

  • fiscal recorders to dispose of marked products;
  • barcoding equipment;
  • solutions helping retailers organize the correct operation of the track & trace system at minimum cost (under development).

JSC SHTRIKH-M

Solutions for all marking types:

  • VMC BurstScan V and VMC BurstScan X;
  • SHTRIKH-NANO-F mobile online cash register;
  • SHTRIKH-ON-LINE stationary online cash register;
  • KKT SHTRIKH-SMARTPOS-F smart terminal;
  • Elves-MF + Online Trade—mobile online cash register for small enterprises;
  • SHTRIKH-MARK 2.0—solution for marked product sales.

EVOTOR LLC

Smart terminals for asset retirement and document flow: Evotor 5, Evotor 7.2, Evotor 7.3, Evotor 10.

Dreamkas

Dreamkas implemented solutions for acceptance at cash registers in the free Dreamkas Account cloud service, as well as a mobile device:

  • acceptance at a cash register works with the Rutoken EDS hardware encryption provider. Cash registers are integrated with several EDF operators, as well as with the track & trace marking system;
  • acceptance in your personal account: using hardware, software, and cloud-based crypto-providers. To verify the marking codes, scanners can be connected to a computer or a webcam can be used for this purpose;
  • the full acceptance from a mobile device with the signing of UTD using the «cloud» DCEO and verification of marking codes using the camera on the device;
  • disposal using all Dreamkas online cash register terminals;
  • disposal through Dreamkas OFD.

Mercury-equipment

Manual and stationary barcode scanners, label printers, integration of cloud services for Mercury, Neva and Meschera cash registers.

Software
1C CJSC

  • 1C: Retail is designed for retail stores;
  • 1C: Trade Management is designed for chain retailers and wholesale companies;
  • 1C: Mobile Cash Register is designed for small business;
  • 1C: Small Business is designed for small companies;
  • 1C:Comprehensive Automation is designed for manufacturing companies;
  • 1C: ERP is designed for holdings and large companies.

Tenzor Company LLC

The company offers a full SBIS-based monitoring cycle for tobacco products starting from the supplier, to transmitting receipt data in the Track & trace information system for marking and monitor the tobacco products circulation:

  • e-document flow for dispatching and accepting marked products via data transfer equipment;
  • full range of FDO services, including online transfer of receipts with marking codes to MOTP, and cash register setup and maintenance;
  • turnkey solutions for trade automation make it possible to accept marked products and sell them via a cash register in a single workplace (including Mercury, EGAIS);
  • supply of scanners and terminals for marking codes;
  • service offices and stations in all regions of Russia;
  • warehouse and accounting, codes and aggregation state storage, write-offs, posting, inventory (including Mercury, EGAIS);
  • the Market is a unified catalog of goods for ordering and exchanging EDI documents.

Dreamkas

Dreamkas implemented solutions for acceptance at cash registers in the free Dreamkas Account cloud service, as well as a mobile device:

  • acceptance at a cash register works with the Rutoken EDS hardware encryption provider. Cash registers are integrated with several EDF operators, as well as with the track & trace marking system;
  • acceptance in your personal account: using hardware, software, and cloud-based crypto-providers. To verify the marking codes, scanners can be connected to a computer or a webcam can be used for this purpose;
  • the full acceptance from a mobile device with the signing of UTD using the «cloud» DCEO and verification of marking codes using the camera on the device;
  • disposal using all Dreamkas online cash register terminals;
  • disposal through Dreamkas OFD.

SKB Kontur

SKB Kontur offers a range of services and equipment for a full traceability cycle:

  • enhanced, certified e-signature for data transfer device verification and the use of a personal account of an information system for the circulation of marked goods;
  • e-document flow for any legally valid documents, including data transfer devices containing marking codes;
  • integration modules, connectors, and API for incoming and outgoing e-document processing, automation of goods acceptance and shipment, marking code reconciliation;
  • Kontur.Market is a comprehensive solution for small retail stores that support e-document receipt, code reconciliation, inventory accounting, and a cash register program for reading Data Matrix codes and sending them to a goods monitoring system via OFD;
  • cash register equipment and 2D scanners for reading markings in the Data Matrix format.

Mercury-equipment

Manual and stationary barcode scanners, label printers, integration of cloud services for Mercury, Neva and Meschera cash registers.

SEPTAGON LLC

Trade.online, a product for retail trade including a cash register program with extensive analytic functions.

CDC Group

  • The OPTIMUM AMTMS (Automated Mobile Trade Management System) is designed to manage such activities as order collection, mobile trade, and merchandising;
  • OPTIMUM Mobile Cashier is a hardware and software system providing for the creation and printing of receipts at points of sale and the automatic transfer of the electronic versions of checks to the tax authorities in accordance with 54-FL.

Service Plus LLC

  • proprietary cash register equipment (SP101-F, SP402-F, SP801-F, SP802-F) ready for the transfer of marking tags to federal accounting systems;
  • mobile application for collecting data on marking and the creation of documents of income-expenditure-inventory accounting for SuperMag Mobile marked products;
  • the SuperMag+ product accounting system provides control for all logistics of marked goods.

Cleverence Soft LLC

  • Mobile SMARTS: Shop 15 is a mobile system for accounting by barcodes and radio frequency tags in market outlets;
  • Mobile SMARTS: Warehouse 15 is a mobile system for the warehouses of wholesale and manufacturing companies;
  • Mobile SMARTS: Courier is a mobile system for online store couriers and sales representatives of manufacturing companies. 


Advanco SA

  • ARC MESs: ARC Manufacturing Execution System for Serialization as Level-3. Site Management System for managing Packaging Order, Master Data, Sales Order, Serial Number Management, Monitoring and OEE Dash-Board. This includes Russian MDLP system reporting, Crypto Code integration with other Level-4 systems and direct Crypto Code integration as requesting CC and reporting back to CRPT;
  • ARC LESs: ARC Logistics Execution System for Serialization. Warehouse system includes Sales Order Management, Rework, Status Changes, Returns, Goods Received and shipments;
  • ARC OEE Dashboard® and HMI: ARC OEE Dashboard and Human Machine Interface;
  • ARC Manual Workstations: ARC Manual workstation for serialized warehouse operations;
  • ARC Mobile: ARC Mobile provides the same functionalities with ARC LESs.

SAP CIS LLC

SAP Advanced Track&Trace for Pharmaceuticals enables companies around the world to effectively manage the serialization and traceability of products. Country Package Russia allows participants in the turnover of labeled products to comply with legal requirements for any industry, and the wide integration possibilities minimize the costs of integrating the system into the current Logistics landscape.

Agile Soft Technologies LLC

  • the SmartApteka goods accounting system is integrated with the solutions of Chestny ZNAK track & trace system for marking pharmaceutical products;
  • the SmartApteka cash register module is integrated with the solutions of online cash register manufacturers (Atol and Shtrikh-M) for the digital marking of goods.

M-Apteka Style

Enables the use of an API to work with the system without any third-party software (implemented via a fiscal data recorder).

Parus Corporation

The Accounting of Marked Goods module of Parus—Budget 8 software was created for participants of the circulation of medicines, including health care organisations. The module makes it possible to track pharmaceutical products, their strength and dosage, international non-proprietary names, and operations with packages, and to exchange data on the movement of packages with FSIS MPPC as part of the Track & trace Information system for marking.

BEST LLC

BEST-5.Pharmacy is a ready-to-use automated solution for pharmacies and pharmacy chains across Russia. BEST-5.Pharmacy software focuses on accounting for digitally marked products. It has earned a great reputation on the pharmaceutical market. Only secure technologies are used for automated pharmacy operations.

Integrators
Perviy BIT

  • product marking equipment: label printers, barcode scanners, data collection terminals;
  • specialized software.

Brand Select Group

Scanners for reading EGAIS codes, integratable track & trace marking systems for tobacco, medicine and tires.

Navicon

Utrace is Russian L2-L4 software to automate the process of marking and tracking the movement of goods. The system is quickly configured and deployed in the cloud or locally thanks to its significant out-of-the-box functionality. The basic version includes ready-made connectors for ERP and WMS systems, and typical integration with large 3PL and international production. The system is delivered with GAMP documentation in Russian and English.

KORUS Consulting Group

  • DiState (on the LSEDI platform) is a solution to avoid transaction expenses when transferring documents, and organize the B2B exchange of documents with counterparties or a SaaS service for exchanging messages between the economic agents of marked goods;
  • IDocs: Marking (on the SAP platform) is a separate add-on module using ABAP 7.5 tools for direct message exchange with the Chestny ZNAK track & trace digital systemChestny ZNAK digital marking system;
  • IDocs: Java marking is installed as a separate on-premise system or SaaS service for exchanging messages and message exchange directly with the Chestny ZNAK information system.

BALLUFF LLC

A turnkey marking accounting system based on high-performance technical vision sensors, laser marking equipment and specially developed software.

Advanco SA

  • ARC MESs: ARC Manufacturing Execution System for Serialization as Level-3. Site Management System for managing Packaging Order, Master Data, Sales Order, Serial Number Management, Monitoring and OEE Dash-Board. This includes Russian MDLP system reporting, Crypto Code integration with other Level-4 systems and direct Crypto Code integration as requesting CC and reporting back to CRPT;
  • ARC LESs: ARC Logistics Execution System for Serialization. Warehouse system includes Sales Order Management, Rework, Status Changes, Returns, Goods Received and shipments;
  • ARC OEE Dashboard® and HMI: ARC OEE Dashboard and Human Machine Interface;
  • ARC Manual Workstations: ARC Manual workstation for serialized warehouse operations;
  • ARC Mobile: ARC Mobile provides the same functionalities with ARC LESs.

SAP CIS LLC

SAP Advanced Track&Trace for Pharmaceuticals enables companies around the world to effectively manage the serialization and traceability of products. Country Package Russia allows participants in the turnover of labeled products to comply with legal requirements for any industry, and the wide integration possibilities minimize the costs of integrating the system into the current Logistics landscape.

GK Escape

  • automated public medicine supply management system («ASULON») of M-APTEKA for automation of the public sector of health care;
  • M-APTEKA Plus software package for automation of pharmacies and pharmacy chains.

FDO
Fiscal data operator OFD.ru

  • integration with the Chestny ZNAK track & trace digital systemChestny ZNAK digital marking system;
  • recognition of UTDs with marked goods and the subsequent export of the nomenclature and codes from a UTD to a separate section of the system while tracking tracing the life cycle of the marked goods;
  • transfer of UTD with a marked product to confirm the transfer of ownership.

OFD Platform

Turnkey solutions for retail: support for test and industrial codes and fiscal drives in the cash register sales of marked goods.
Products compatible with the Chestny ZNAK information system (in development):

  • UTD support with information about marked goods;
  • support for the full cycle of marking document flow;
  • integrative solution for the reconciliation of marked goods disposal in accounting systems.

Tenzor Company LLC

The company offers a full SBIS-based monitoring cycle for tobacco products starting from the supplier, to transmitting receipt data in the Track & trace information system for marking and monitor the tobacco products circulation:

  • e-document flow for dispatching and accepting marked products via data transfer equipment;
  • full range of FDO services, including online transfer of receipts with marking codes to MOTP, and cash register setup and maintenance;
  • turnkey solutions for trade automation make it possible to accept marked products and sell them via a cash register in a single workplace (including Mercury, EGAIS);
  • supply of scanners and terminals for marking codes;
  • service offices and stations in all regions of Russia;
  • warehouse and accounting, codes and aggregation state storage, write-offs, posting, inventory (including Mercury, EGAIS);
  • the Market is a unified catalog of goods for ordering and exchanging EDI documents.

Dreamkas

Dreamkas implemented solutions for acceptance at cash registers in the free Dreamkas Account cloud service, as well as a mobile device:

  • acceptance at a cash register works with the Rutoken EDS hardware encryption provider. Cash registers are integrated with several EDF operators, as well as with the track & trace marking system;
  • acceptance in your personal account: using hardware, software, and cloud-based crypto-providers. To verify the marking codes, scanners can be connected to a computer or a webcam can be used for this purpose;
  • the full acceptance from a mobile device with the signing of UTD using the «cloud» DCEO and verification of marking codes using the camera on the device;
  • disposal using all Dreamkas online cash register terminals;
  • disposal through Dreamkas OFD.

Tested bar-code scanners

ATOL D2

ATOL SB2108 Plus

ATOL SB2109 BT

Honeywell 7580

Honeywell 1400

Youjie YJ4600-1-U

Mercury CL-2300 P2D BT

Honeywell 1450G 2HR

Honeywell 1450G

Zebra DS2208

Datalogic QD2430

Datalogic QuickScan QBT2400/QBT2430

Datalogic QuickScan QM2430

Datalogic QuickScan QD2430

Datalogic QuickScan Lite QW2420/QW2470

Datalogic Gryphon GPS4400

Datalogic Magellan 800i

Datalogic Magellan 1500i 

Datalogic Magellan 3450VSi/3550HSi 

Datalogic Magellan 9300i/9400i 

Datalogic Magellan 9800i

Zebra DS4308

Symbol 7708

VMC BurstScan Lite v2

VMC BurstScan V

VMC BurstScanX

VMC BurstScanX L

VMC BurstScanX Vb

PORT NS-10

PORT NS-20

PORT NS-30

IS MDLP
Head of the Pharma business line, CRPT Sergey Igorevich Kholkin
Project Supervisor. Pharma commodity group, CRPT Anna Pavlovna Sukhova
Coordinator for the retirement registration project, CRPT Anatoly Sergeyevich Svechin
Coordinator for the Pharma project, CRPT Grigory Vladimirovich Mileshkin
Coordinator for the IS MDLP development project, CRPT Sergey Yuryevich Zherdev
Track & trace for pharmaceutical products
Project Supervisor. Pharma commodity group, CRPT Anna Pavlovna Sukhova
Coordinator for the Pharma project, CRPT Grigory Vladimirovich Mileshkin
Head of the Pharma business line, CRPT Sergey Igorevich Kholkin

Date: 10/10/2018

Place: 5 Chistoprudny Boulevard, Moscow

Event:

  1. 1. Industry representatives: Tests and results
  2. 2. CRPT: Report on test results
  3. 3. Proposals for increasing the membership of working subgroups
  4. 4. CRPT: answering questions from industry representatives
Distribution and retirement of pharmaceutical products
Head of the Pharma business line, CRPT Sergey Igorevich Kholkin
Project Supervisor. Pharma commodity group, CRPT Anna Pavlovna Sukhova
Coordinator for the retirement registration project, CRPT Anatoly Sergeyevich Svechin
Coordinator for the Pharma project, CRPT Grigory Vladimirovich Mileshkin
Coordinator for the IS MDLP development project, CRPT Sergey Yuryevich Zherdev
Import/export of pharmaceutical products
Head of the Pharma business line, CRPT Sergey Igorevich Kholkin
Project Supervisor. Pharma commodity group, CRPT Anna Pavlovna Sukhova
Coordinator for the Pharma project, CRPT Grigory Vladimirovich Mileshkin
Coordinator for the IS MDLP development project, CRPT Sergey Yuryevich Zherdev
Medicinal gases
Head of the Pharma business line, CRPT Sergey Igorevich Kholkin
Project Supervisor. Pharma commodity group, CRPT Anna Pavlovna Sukhova
Coordinator for the Pharma project, CRPT Grigory Vladimirovich Mileshkin
Coordinator for the IS MDLP development project, CRPT Sergey Yuryevich Zherdev
Mikhail Murashko

Head of the Russian Federation Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor)

«Today, the cost advantage (of marking, ed. note) exceeds the costs incurred. This occurs due to the fact that a manufacturer can be sure of the volume of pharmaceutical products sold, can see the opportunities for cutting logistics costs or selling a product across the medical community. This represents a real cost advantage for the manufacturers».

Ivan Glushkov

Director of the External Affairs Department, Stada CIS

«Major manufacturers tend to view the individual track & trace system as a step towards increasing the transparency and effectiveness of the entire pharmaceutical market operation, while the implementation costs are considered to be promising investments».

0day
0hour
0minute
before the launch of mandatory marking on 1 January 2020
The experiment has been conducted since 1 February 2017
22 591

Participants of the experiment

26 186 328

Marked packages

4 761

Medicines

Become a participant
Experiment completion date: 12/31/2019
Have questions?
Ask a question
We use cookies to give you the best experience on our website. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our Confidentiality policy.