10.20.2014, the Verkhovna Rada of Ukraine adopted the Law of Ukraine "On Amendments to the Law of Ukraine "On Medicinal products" concerning turnover of medicinal products and state quality control of imported to Ukraine medicinal drugs".
In particular, the Law determines the possibility of medicinal product using after the termination of registration certificates to the end of shelf life expiration, specified by the manufacturer and indicated on the package.
Since the enactment of the Law, many questions concerning the interpretation of the definition of "use of medicinal products" have arisen, namely, does this definition concludes realization in the context of the noticed norm. For some time the provision of the Law could not be implemented in practice because of the mentioned problems.
Taking this on December 30, 2014 the Ministry of Justice of Ukraine registered the Order of the Ministry of Healthcare of Ukraine "On Amendments to the Order of prohibition (temporary prohibition) and renewal of turnover of medicinal products in Ukraine" dated 12.12.2014 No 954, which was adopted for implementation provisions of the Law.
The Order stipulates the similar provision to the Law concerning the application of medicinal products after after termination of the registration certificates. Also, it was found that the medicinal products produced into turnover during the period for which they were allowed to use in Ukraine may be applied, used and implemented to the end of shelf life expiration.
In other words, the term "use of medicinal products" in the interpretation of the Ministry of Healthcare of Ukraine includes their realization.
Thus, in the Ukraine there is allowed wholesale and retail sale of medicinal products with expired term of the registration certificate before the end of shelf life expiration.
However, this norm should be considered in conjunction with the introduction of unlimited re-registration of medicinal products.
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