Amendments introduced to State Quality Control Procedures for Medicinal Products imported to Ukraine (hereinafter – the Procedures), initiated by the Cabinet of Ministers Order as of October 7, 2015 № 804came into force On October 23.
The Cabinet of Ministers Order № 804 introduces the current changes in Ukrainian legislation regarding legal entities obligation to obtain a stamp. Therefore, the Procedures provide that the copy of quality certificate issued by the manufacturer for each series of medicinal products and its translation being submitted by the applicant should be signed by the director or other authorized person, but sealed with a stamp only upon stamp availability. With regard to this stylistic deviations are allowed in the certificate given that they do not change its core meaning, which is updated in comparison to the previous version of the Procedures.
Identical in their core changes regarding the requirements to appropriate documents execution are provided by the Cabinet of Ministers Order № 804 also according the customs declaration copy stamped by the customs office which is provided by the applicant to the state control authority after customs clearance of the cargo.
Important changes were introduced to the general procedures for state control of the quality. As opposed to the previous version of the Procedures, the Cabinet of Ministers Order № 804 released from such general procedure all business entities (resident and non-resident) who import active pharmaceutical ingredients and "in bulk" products, and not only the manufacturers who use these products for their own medicines production. With that the draft left the obligation for such entities to conduct quality control of the imported products on their own and to report on a monthly basis to the State Administration on Medicinal Products the results of such control.
Moreover, the Procedures foresee the possibility to issue a conclusion for the same series of medicinal products imported by different business entities according to the results of in-vitro analysis of the samples selected from one of them. The basis for such actions is an application by the owner of marketing authorization or his official representative with additional documents confirming the fact of medicinal products delivery of the same series and their storage at the same customs licensed warehouse.
In addition to the abovementioned amendments the Cabinet of Ministers Order № 804 terminated the special conditions for “in bulk” products and active pharmaceutical ingredients quality control aimed at their further realization. In particular, it canceled the opportunity to store these products at the manufacturer’s warehouse aimed at further conduct of independent in-vitro control.
In accordance with acting Procedures the unified procedure is designated for all medicinal products imported to Ukraine should be stored at the special zone within the pharmaceutical warehouse and marked as “Quarantine”.
Please note that the adopted changes are aimed at the improvement of state quality control procedures for medicinal products.
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