Pharmaceutical manufacturers may be fined 5 million rubles for false information

The Russian Ministry of Health elaborated amendments to the Code of Administrative Offenses of the Russian Federation.

According to released explanatory note, this draft of the Federal Law introduces two following amendments to the Code of Administrative Offenses of the Russian Federation:

  • Establishing administrative liability for failure to provide or untimely provision, or incomplete or distorted provision of details (information) stipulated by the laws of the Russian Federation on circulation of medicinal products
  • Establishing administrative liability for incomplete or distorted provision of details (information) during the state registration (re-registration) of maximum ex-works prices set by manufacturers for medicinal products included in the List of Vital and Essential Drugs (VED List).

The draft of the Federal Law proposes to establish administrative liability of entities involved in the circulation of medicinal products for failure to provide or untimely provision of details (information) stipulated by the laws of the Russian Federation on circulation of medicinal products in the form of a fine ranging from six hundred thousand to one million rubles. For incomplete or distorted provision of details (information), which caused harm to the life or health of citizens, the draft law establishes the administrative liability in the form of a fine ranging from one million to five million rubles.