The discussions on the validity of State Administration on Medicinal Products made a sharp come-back in view of registration on September 10, 2015 in Unified State Register of Legal Regulations of Cabinet of Ministers Decree № 647 «On Approval of Regulation on State Administration of Ukraine on Medicinal Products and Drug Control»(hereinafter referred to as «Cabinet of Ministers Decree № 647»), which has been adopted by Cabinet of Ministers in August of present year.
A year before this event, on September 10, 2014 Cabinet of Ministers adopted a Decree № 442 «On Optimizations of Central Executive Authorities System», which provided for establishment of State Administration on Medicinal Products and Drug Control through amalgamation of State Administration on Medicinal Products and State Administration on Drug Control. However, the reorganization process of State Administration on Medicinal Products was completed before implementation on August 26, 2015 of Cabinet of Ministers Decree № 609 from August 05, 2015 «On Approval of Licensing Authorities List and Revocation of Certain Cabinet of Ministers Decrees».
In accordance with this Decree exactly State Administration on Medicinal Products and Drug Control has been designated as the authority for licensing of business activity in production, wholesale and retail trade and import. Moreover, the Decree foresees that starting from the moment of its enforcement the licensing authorities shall be withdrawn from State Administration on Medicinal Products and delegated to State Administration on Medicinal Products and Drug Control. Consequently, from August 26 of present year the licensing authority for manufacturing, trading and import of medicinal products shall be State Administration on Medicinal Products and Drug Control.
However, currently State Administration on Medicinal Products and Drug Control is in fact deprived of material and legal basis for its activity. Particularly, despite of the registration of Cabinet of Ministers Decree № 647 it has not been implemented yet, which means that the regulation on newly established State Administration is also not enforced.
Thereby, it has arisen that the former licensing authority according to acting legal regulations has been withdrawn, and the establishment and structuring procedures and responsibilities list, etc. for the new authority has not been implemented yet.
Currently, the certain basis in this context is the letter from State Regulatory Service № 6 528/0 / 20-15 from 04.09.2015. State Regulatory Service admitted that central executive authorities being withdrawn continue performing the authorities and functions in certain spheres until all measures on establishment of central executive authorities which shall take the responsibilities of withdrawn authorities are taken.
In such a way, State Regulatory Service adheres to the position that State Administration on Medicinal Products should continue its licensing authorities until all measures are taken to establish State Administration on Medicinal Products and Drug Control. Such measures shall include implementation of the Regulation on State Administration on Medicinal Products and Drug Control, designation of its leadership and establishment of personnel.
It is worth to mention that the letter from State Regulatory Service shall not be considered as a legal regulation act, it has explanatory and recommendation character and shall not be obligatory executed.
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