Product purpose:

The Medicrime Convention Combating counterfeiting of medical products and similar crimes (MEDICRIME) was approved by the Committee of Ministers of the Council of Europe on December 9, 2010 in Strasbourg.

This document is the first international instrument of the criminal law obliging the participant-states to make a criminal offense for the following:

  • Manufacture of counterfeit medical products
  • Faking of documents
  • Unauthorized manufacture or supply of the medical products, rollout of the health care products not complied with the regulations requirements

MEDICRIME Convention also provides a basis for national and international cooperation between different sectors of the state management, coordination on the national level, protection of victims and witnesses of crimes related to falsification of medical products. Moreover, it provides for creation of the control body for supervision of implementation of its provisions by the participating states.

According to Chapter V, the country which joined the convention should make its own decision on the preventative measures:

  • to identify a quality and safety of the medical products
  • to prevent faking of the medicinal products, active substances, fillers, parts, materials, and accessories
  • to prevent illegal supply of the counterfeit medicinal products, active substances, fillers, parts, materials, and accessories

The main purpose of the product is to ensure tracking of each indivisible unit of the medicinal products and health care products (MP and HCP) within the country with an option to find a counterfeit and render impossible its sale. It will allow to settle the above-mentioned clauses of the convention regarding ensuring of the preventative measures.

Scope:

The software product is used as a unified system of tracking medications in the country and includes the following participants:

  • Manufacturer
  • Importer/Distributer
  • Pharmacy institutions
  • End buyers of MP's and HCP's

The basis of the software product is its data warehouse. It stores the data of each product, its data matrix code, date of registration in the data base, date of final sale to the consumer, etc.The following services are provided for the external systems:

  • The authorized service of registration of the data-matrix code is available only for certain organizations (they can include manufacturers and obviously CBW's)
  • An accessible service for check of data by the data-matrix code confirms that this code is available in the data base and provides information on the time and place the product was written off
  • Authorized service of writing off products – available for organizations-end sale points – the mark appears on the product notifying that it has been sold, where and when.
  • The Internet services and software for the mobile devices designed for the end buyers of MP and HCP are built on the basis of the generally accessible service for check of data by the data-matrix code and provide similar data.

Main benefits:

Comprehensive centralized software solution is an up-to-date MP and HCP data warehouse and source:

  • The software product completely complies with the concept of Medicrime
  • The system is centrally deployed on server, server cluster, or in virtual environment
  • A modern system architecture provides high running speed and reliable performance of the system
  • A wide range of services for integration with the external systems

 

Functional structure:

Subsystem

Description

Unified data base Medicrime (UDBM)

Maintenance, change and storage of the up-to-date information on MP and HCP, its data matrix code, circulation history within the country beginning from the date of its registration in the base to the date of its final selling to the consumer.

Identification of MP's and HCP's

Registration of MP and HCP with the full data on MP/HCP and generation of GTIN codes.

Data matrix codes

Maintenance and record keeping of organizations which can apply data matrix codes on the packs/boxes of MP/HCP for their registration in the data base using matrix codes services.

MP and HCP flow

The subsystem for the organizations-end-sale points (drugstores, hospitals, clinics, etc.) where the information on the product circulation is maintained.

Web portal

Services for check of data by the data-matrix code on availability of the product in the Medicrime data base, time and place the product was written off.

Reporting

Informational and analytical processing of data for all subsystems considering communications, including secure communications. Presentation of the received dependencies, prognoses, assessments in the form of corporate standard reports, including graphic elements: graphs, charts, tables.

Administration and setting up

The subsystem provides a standard set of options of the system administration:

  • Allocation of rights to access
  • Authentication
  • Audit

and setting up options:

  • Maintenance of the reference guides
  • Printed forms, etc.