On November 12, 2014, the Cabinet of Ministers of Ukraine adopted Decree 601 “On amendments to the procedure of government quality control of medicinal products imported into Ukraine.”
The Decree expanded the list of persons exempt from the obligation to apply to the State Medicines Agency to confirm quality of imported medicinal products after customs clearance, who have the right to control quality on their own.
In particular, after the adoption of these amendments these include domestic manufacturers of medicinal products who import products “in bulk”. This right is granted to them only in case of compliance with the following requirements:
Thus, the right to perform self-sustained control of the laboratory is not absurd and depends on the compliance with a comprehensive list of the above requirements.
Manufacturers who import products "in bulk", shall submit a monthly report on the results of the laboratory analysis, and in case of defective products they shall notify the territorial agency of the State Medicines Agency within 3 working days of measures taken.
The Decree also provides for the possibility of accommodation during the state of quality control “in bulk” in a special area (room) at a manufacturer’s storage. It refers to the cases where a business entity imports these products not for its own needs, but for a purpose their further sale in full to manufacturers who use them for their own production and possess their own certified laboratory or collaborates with such a laboratory under the contract.
It should be noted that before the adoption of regulations only the domestic manufacturers of medicines who imported active pharmaceutical ingredients had the right to perform self-sustained quality control.
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