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New Russian law tightens the procedure for putting medicines on the market and complicates ending distribution agreements

From 29 November 2019, medicines for human use will no longer be put on the market based on declarations of compliance and certification. More complex quality control requirements will be introduced. Pharmaceutical companies will have to submit documents on the quality of each batch of medicines to the Russian pharmaceutical regulator (Roszdravnadzor), conduct tests of the first three batches produced or imported and periodically submit test reports of batches of any medicine put into circulation.

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