Pharma in Russia | Serialization: Law on mandatory labeling of medicines adopted

On December 28, 2017, Federal Law No. 425-FZ “On Amendments to the Federal Law “On the circulation of medicines” (hereinafter – Law No. 425) was adopted. So, in Russian legislation the requirements of the serialization of medicines come into force.

Requirements to medicine manufacturers

In accordance with Law No. 425, effective January 1, 2020, the legal entities which manufacture, store, import to the Russian Federation, dispatch, sell, transfer, use and destroy medicinal products will have to ensure that the information on medicinal products is included in the traffic monitoring system of medicinal products for medical use. Starting from January 1, 2018, it is planned to create a state information system for monitoring the movement of medicinal products from the manufacturer to the end user.

For the purposes of identifying packages of medicinal products for medical use, medicines manufacturers put on the primary and secondary packaging the means of identification. Characteristics of the means of identification, the procedure for its imposition and the requirements to the structure and format of the information that the identification means contain, will be determined by the Russian Government in the near future.

At the same time, the Russian Government is empowered to determine the specifics of introducing the system for medicines from the Seven Nosologies program and a list of vital and essential drugs (VED).

What are the risks?

For the production or sale of medicinal products without applying the means of identification or in violation of the established procedure for their application, as well as for the late entry of information into the monitoring system, the legal entities will be liable in accordance with the legislation of the Russian Federation.

To date, the State Duma of the Russian Federation adopted in the first reading the Bill [1] that provides for the following dimensions of liability:

  • For public officials – up to 10 000 RUB
  • For legal entities – up to 100 000 RUB

Also, Law No. 425 specifies that before January 1, 2019, information on registration as a taxpayer in the country of registration must be sent to the public authority “Roszdravnadzor” by:

  • the holders or owners of registration certificates of medicinal products, manufacturers of medicinal products for medical use, registered before January 1, 2018
  • manufacturers of pharmaceutical substances included in the state register of medicinal products for medical use before January 1, 2018.

Such information includes:

  • for Russian legal entities – INN
  • for foreign legal entities – country of registration, name of the registration authority, registration number, taxpayer’s code in the country of incorporation (incorporation) or its equivalent

Which steps are required

In connection with these changes SCHNEIDER GROUP recommends:

  • Sending in advance to Roszdravnadzor the information on the registration as a taxpayer
  • Until 2020 carrying out the activities during the production to introduce the system for special marking medicinal products and ensure entering of the information on medicinal products into the monitoring system
  • To assess by 2020 the possibilities of your IT systems with regard to the entry of required information into the control system. If necessary, optimize the IT systems or set up the corresponding functions

The procedure for the creation, development and commissioning of a system for monitoring the movement of medicinal products is subject to approval by the Government of the Russian Federation.

SCHNEIDER GROUP continues to monitor the development of the legislation in this area and will further inform the clients about the current changes and the required actions.

We can also check for you if your IT systems are ready to provide the required information to the above mentioned control system.

[1] Draft Federal Law No. 231630-7 “On Amendments to the Code on Administrative Offenses of the Russian Federation “.

SCHNEIDER GROUP has extensive knowledge in the pharma industry.
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