From November 05, 2014 Ukrainian pharmaceutical market has received a nice gift from the legislator – an unlimited period of administration of medicinal products that undergone the re-registration procedure. Furthermore, according to the provisions of the Law No. 1707-VII, which provided for these innovations, medicinal products in Ukraine can be administered until the expiration date set by the manufacturer and indicated on the package if they were released into circulation in the period during which medicinal products were approved for use in Ukraine .
Earlier it was provided for mandatory re-registration of medicinal products every five years in Ukraine, and medicinal products, the term of the registration certificate of which had expired, could not have been sold on the territory of Ukraine.
These innovations have certainly been positively received by the market. However, a month later, the regulatory authority still has not explained the order of application of the new procedure, leaving unanswered many matters important for the market. Thus, the Law has not resolved the issues associated with the presence of valid registration certificates, which confirm the fact of state the re-registration and re-registration procedure of medicinal products has been initiated. As legally uncertain remain also technical issues concerning the indication in the registration certificate of their validity for those medicinal products, which have undergone re-registration before the entry into force of the Law, as well as the procedures of state re-registration that took place until May 11, 2014.
Market participants are in need of this explanation, since at the time of entry into force of innovations, many of them were in the middle of re-registration of medicinal products and their sales have been stopped. Some of such medicinal products had previously been re-registered at least once after the initial registration.
Taking the aforesaid into consideration, the attorneys-at-law of the Legal Alliance Company have submitted a respective attorney's request to the Ministry of Health of Ukraine.
According to Ukrainian legislation, the Ministry of Health of Ukraine shall provide the answer to the attorney's request within five days. We expect to obtain the necessary clarification, about which promptly inform the market.
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