On June 25, 2014 the State Service of Ukraine for Medicinal Products has promulgated the draft resolution of the Cabinet of Ministers of Ukraine "On Amendments to the Order of the state quality control of medicinal products imported into Ukraine concerning active pharmaceutical ingredients and in bulk products” (hereinafter - Draft).
According to the proposed amendments, in the case of the importation of active pharmaceutical ingredients (substances) (hereinafter - APIs) and in bulk products for sale in the full amount to the manufacturer of medicinal products who uses them for its own production and has its own laboratory certified in the prescribed manner by the Ministry of Health of Ukraine or works with such laboratories under the contract, the cargo may be placed on the licensed stock of the manufacturer allowing the sampling for their laboratory analysis by the manufacturer.
It is also proposed to exclude the following ground for mandatory laboratory control: "obtainment of information about the quality of medicinal products”.
The document envisages that the cost of samples for quality control is included in the production costs of business entities, from which the samples are selected. Expenditures related to the selection, delivery and the examination (testing) of samples of the products are funded by the state supervision (control) body.
However, if the violation of legal requirements is confirmed by the results of the examination (testing) business entity, the company will be obliged to reimburse the costs of the examination (testing) according to the procedure established by the Cabinet of Ministers of Ukraine.
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