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Requirements for import of drugs are changed

On March 1, 2018, changes in The License Conditions for the Implementation of Economic Activities for the Production of Drugs, Wholesale and Retail Trade of Drugs, and the Import of Drugs (other than Active Pharmaceutical Ingredients) in the part provided for in the Decree of the Cabinet of Ministers of Ukraine No. 929 dated November 30, 2016, will come into force.

In particular, from March 1, 2018, the import of drugs to Ukraine can be carried out only if the contract specifies that the good manufacturing practice is harmonized with the EU legislation. Each licensee is obliged to establish and maintain a pharmaceutical quality system, the responsibility for the operation of which is assigned to the management personnel.

In addition, the manufacturer or importer should monitor the stability of the drug after entering the market, including further stability testing[1].

[1] http://zakon2.rada.gov.ua/laws/show/929-2016-%D0%BF

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