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Russian State Duma to ease imports of APIs

11 January 2018

Remedium

The Russian national Parliament (State Duma) plans to approve a bill that will ease imports of active pharmaceutical ingredients (APIs) to the country, according to press-service of the Russian Duma, reports The Pharma Letter’s local correspondent.

Under the current Russian legislation, the country’s state register of drugs usually contains information about an active substance of the drug, instead of a finished product. Therefore drug imports to Russia are usually associated with the need to conduct several examinations of these products. The first of them involves checking the quality of the substance in the composition of the drug, while the second one checking an actual presence of an active substance.

A spokesman of the Russian State Duma said the new state initiative could be beneficial for domestic drugmakers, as it will provide significant savings for them, both in terms of finance and timing. According to him, the existence of such checks significantly slows down and increases the cost of import substitution for the Russian pharmaceutical industry. This leads to discrimination against domestic producers, and significantly increases the time and cost of finished products.

At the same time, such requirements do not apply to foreign manufacturers, which are only required to register a finished product in the state register.

In this regard, the State Duma proposes to determine that an active pharmaceutical ingredient is considered included in the state register of drugs since the inclusion of a drug (in which composition it included) into it. Such a rule is proposed to extend to the purchases, imports and any other use of such substances.

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