And again about the labeling of drugs

The state Duma Committee on health protection approved the draft Federal law "on amendments to article 67 of the Federal law" on circulation of medicines " in terms of improving the implementation of the system of monitoring the movement of medicines for medical use. Currently, the bill is expected to be considered in the first reading.

The draft provides that medicines of 7 high-cost nosologies introduced into civil circulation before October 1, 2019, as well as other medicines for medical use introduced into civil circulation before July 1, 2020, shall be subject to storage, transportation, release, sale, transfer, use without applying identification means until the expiration of their shelf life.

The document defines the obligation of legal entities and individual entrepreneurs engaged in the circulation of medicines to register in the system of monitoring the movement of medicines for medical use.

As shown by the first results of the introduction of mandatory labeling for drugs of the list of 7 nosologies, manufacturers, carriers and sellers of goods that are subject to mandatory labeling laws, in addition to questions about the conversion of production, solve the problem of choosing a Track&Trace system.

When choosing a vendor/service provider to develop and maintain the system, it is important to consider the following details:

  • The system can change not only in connection with the actions of the regulator-a change of provider, for example, warehouse services, will lead to changes in the system level L3, so the corporate system level L4 must support a rapid change in the architecture of systems, so as not to stop business processes. Therefore, it is very important that the provider has a support team, development, which will be able to quickly make changes to the requirements of the regulator, configure the report and ensure that the selected provider is reliable. In addition, there must be confidence that the product will not lose the team when the supplier changes the priority of development. Therefore, it is better to choose companies that specialize in the development of marking SOFTWARE.
  • The SOFTWARE developer should show his roadmap or invite key employees to participate in the discussion of the development of solutions, i.e. strategically approaches to the development of SOFTWARE.
  • Speed of reaction to changes: the Russian legislation in the sphere of regulation of circulation of medicines is one of the most complex in the world, more complicated than in China, Europe and America. But in addition to complexity, there is another important factor — constant changes. The state platform is under development and testing, adjustments are received every 2-3 months. The regulator gives two weeks to switch from version to version and does not always guarantee backward compatibility of versions. If you do not switch to the new version in time, you will not be able to send all the information to the regulator, and this threatens with fines.
  • Language barrier: the Russian regulator issues documentation in Russian and does not always provide prompt translation into English. Therefore, many foreign manufacturers of marking systems simply refuse to work with the Russian market. All round tables with developers, all developer support goes in Russian with the opportunity to discuss something in English, but the opportunity to talk in their native language with developers greatly improves the understanding of changes. Therefore, it is worth paying attention to the fact that the company understands the specifics of Russia, is able to work in the Russian market and has Russian-speaking specialists.

According to the site http://duma.gov.ru

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