Track & trace for medicals

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 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.

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
- Other documentation
Participants
Partners
Working subgroups
Expert opinions


Conditions for registering in the system for monitoring the circulation of pharmaceutical products for medical use:

1. Availability of encrypted e-signature (EES) registered for the company CEO. No registration is possible for a company with an EES registered for an employee other than the CEO (for residents of the Russian Federation and representative offices of foreign organizations in the Russian Federation). If your company has no EES, it can be registered through one of the certification centres accredited by the Russian Ministry of Digital Development. The list of accredited certifications centres is available at: https://minsvyaz.ru/ru/activity/govservices/2

2. Full compliance of the CEO's full name and the company's INN, specified in EES, with the information entered in the Uniform State Register of Legal Entities. You can check the information in the Uniform State Register of Legal Entities at the Russian Federal Tax Service website: https://egrul.nalog.ru/.

  • In case the check reveals any discrepancies to be corrected in the Uniform State Register of Legal Entities, please see the Russian Federal Tax Service website for procedure and guidelines for submitting amendments
  • In case any discrepancies are found in EES, it is required to be reregistered.

3. Availability of at least one license for manufacturing pharmaceutical products and/or the pharmaceutical business, registered by an appropriate executive authority. You can check license information:

  • in the register of licenses for manufacturing pharmaceutical products at the Russian Ministry of Industry and Trade website: http://minpromtorg.gov.ru/activities/services/licensing/1_8/
  • in the Uniform register of licenses, including licenses issued by the executive authorities of constituent Russian Federation territories per the delegated authority for licensing specific activities, at the Roszdravnadzor website: http://www.roszdravnadzor.ru/services/licenses. To obtain test access without a license (e.g. for developers), please contact the tech support operator – CRPT.

Important information

  • If you don't find the required license in the register, please contact the appropriate federal executive authority;
  • Even if only one condition is not met, your registration will be denied;
  • If you are a registration certificate holder for pharmaceutical products manufactured outside the Russian Federation and you are not licensed, then your registration in the system for monitoring human-use pharmaceutical product circulation must be approved by Roszdravnadzor by virtue of accepting your application;

To register in IS MDLP, you need to do as follows:

1. Enter the system for monitoring of human-use pharmaceutical product circulation

2. Install software and e-signature verification key certificates as required, and perform the setup.
You need:

  • OS Windows 7 or higher/Mac OS X 10.8 or higher;
  • Internet Explorer 10 or higher / Safari 10 or higher;
  • CryptoPro plugin for Internet Explorer / Safari browser ( Download, Setup Instruction);
  • CryptoPro software ( Download distribution, Setup Instruction);
  • Drivers for the eToken or RuToken key carrier. You can download driver and setup instructions at the manufacturer's website.

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

Important information

4. Now you can start working in your Personal Account.


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.

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 system and enterprise systems?

    You must configure the interfaces to the Chestny ZNAK 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 , a.kharitonov@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.

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

    — Acquire 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).

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 system 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 system 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 system operator (requesting identification tools, information about their use, notifications) and for working within the Personal Account.

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.

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

    Right now, contact Anton Kharitonov, Head of the Pharma business line (a.kharitonov@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).

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
Other documentation
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
1C

Focuses on the development, distribution, release and support of business and home computer software

Parus Corporation

One of the largest Russian developers of information systems for public administration and business

ECOM (Exite)

International provider of e-document flow services

Taxcom

Electronic accounting, e-signature key retrieval, sale of 1 °C products, migration to e-document flow, FDO

TrekMark

Founded by the Center for Research in Perspective Technologies, Switzerland-based SIPCA company and Russian direct investment fund sponsored by Rostec, in order to provide businesses across Russia the equipment and software needed for goods marking

ATOL

Focused on developing and selling equipment and software solutions for front office automation for chain and independent (food and non-food) retailers, cafes, restaurants, hotels and service companies

Shtrih-M

Leading Russian developer and manufacturer of high-tech business automation systems, one of the pioneers in the Russian trade automation industry. Priority business line — the manufacture and implementation of cash register equipment per Federal Law No. 54-FZ

Cleverence

For more than 10 years, Cleverens has been working in the market for automating mobile workstations and specializes in software for data collection terminals, mobile printers and RFID. Cleverens software works with most models of modern equipment presented on the Russian market and used for solving mobile automation tasks of data collection, labeling and accounting

KORUS Consulting GKeta

Russian system integrator, offering services for creating, optimizing and automating business processes, implementing information systems, IT outsourcing and creating IT infrastructure. The company has significant experience with state information systems and successfully implements projects for their integration with the internal systems of retailers, distributors, importers and manufacturers of veterinary products

IS MDLP
Head of the Pharma business line, CRPT Anton Yuryevich Kharitonov
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 Anton Yuryevich Kharitonov

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 Anton Yuryevich Kharitonov
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 Anton Yuryevich Kharitonov
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 Anton Yuryevich Kharitonov
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
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
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
13 660

Participants of the experiment

19 106 456

Marked packages

2 002

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.