The Ministry of Healthcare of Ukraine published at its web-site two drafts of the Decree of the Cabinet of Ministers of Ukraine “On amendments to the Order of state quality control of imported medicinal products”, elaborated for simplifying of import procedure for API (substances) and production in bulk.
At present clause 7 of mentioned Order has a requirement of the placement of imported medicinal products in the specially designated area at the pharmaceutical warehouse and of the mark “Quarantine” at such freight. In addition, in the case of import of API (substances) and production in bulk for full realization to producer of medicinal products, who uses such products for own producing and has own laboratory attested in order established by the Ministry of Healthcare of Ukraine, or cooperates with such laboratories according to the contract, the freight can be placed in the specially designated area (building) at the producer’s warehouse with the opportunity to chose samples for laboratory analysis.
One of the drafts – the draft of the Decree of the Cabinet of Ministers of Ukraine, dated 21.04.2015, prescribes the exemption of API and production in bulk from the action of current Order of state quality control. We would like to notice that in this case production is not checked by quality control during import at the custom territory of Ukraine and thus there is the risk of receiving by consumers products of doubt quality and security.
The second draft published at the web-site of the Ministry of Healthcare of Ukraine on 30.04.2015 does not deny the requirement of quality check of API and production in bulk for further realization, but proposes some changes in the procedure of this check.
In particular, unlike the current edition of the Order, the draft prescribes the exemption of the state quality control for all business entities (residents and non-residents) importing API and production in bulk as well as for producers using these products for own producing. In addition, the draft reserves requirements of quality control of imported products by subjects themselves and of monthly notifications to the State Administration of Ukraine on medicinal products.
We inform that unlike current edition of the Order, the draft does not prescribe any requirements on placement of such products after importing.
The draft dated 30.04.2015 prosed to change the general procedure of state quality control of medicinal products. The draft establishes the opportunity to issue the decision at the same batch of medicinal product imported by several business entities based on results of laboratory analysis of samples recovered from one of mentioned entities. It is based on the submission of the application of owner of registration certificate or its legal representatives with documents proving import of medicinal products as entire batch and storage at one customary license warehouse.
Such procedure demonstrates the departure from formal approach and complies with business and consumers’ interests. In other words, mentioned changes will allow avoiding reaffirmation of quality of checked medicinal product and encouraging provision of essential products for consumers.
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