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Legislative news for pharmaceutical and healthcare companies, Q2 2012

Legislative news


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Effective laws and other regulatory acts

  • State supervisory officials have obtained the right to freely access buildings/structures used by entities involved in the circulation of medicines and sample medicines for quality assurance purposes when exercising control over the circulation of medicines
  • Extension of the transition period for the circulation of medical devices not registered in accordance with the new procedure
  • The state register of medical devices and their manufacturers comes into effect on 1 July 2012
  • Effective as of 1 June 2012, the purchase of medicines containing low concentrations of codeine or codeine salts by individuals now requires a medical prescription

Draft laws and other regulatory acts in process

  • Proposed draft rules governing the circulation of medical devices

Clarifications of competent state authorities

  • Position of the RF Ministry of Finance: the 10% VAT rate only applies to the import and sale of pharmaceutical substances where a registration certificate is available
  • Position of the RF Ministry of Finance: the import and sale of vital and essential medical equipment as listed by the RF Government is free from VAT
  • Position of the RF Ministry of Finance: the costs of medicines which are required to be destroyed due to expiry, as well as all costs incurred in destroying them, are deductible for income tax purposes
  • Position of the RF Ministry of Finance: amounts received by healthcare entities from lessees are taken into account when determining the percent of income from healthcare activities to qualify for a zero tax rate
  • The Federal Antimonopoly Service publishes a presentation on Pharmaceuticals Competition Development
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