The state continues to implement the initiative regarding the extension of medicinal products list liable to simplified state registration. In view of this, the Cabinet of Ministers Resolution № 312 “On Amendments to State Registration (Re-registration) Procedures for Medicinal Products”, adopted on April 20, 2016, has been published on the official CMU web-site. Please note that the draft of this Resolution was developed and published for public considerations by the Ministry of Economic Development.
The abovementioned Resolution proposes to simplify the state registration procedure for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU. Thus, the term for materials expertise conducted by the State Expert Center has been reduced to 20 business days. The term for making the decision on or the rejection of the state registration has been reduced to 10 business days. At the same time, in case the State Expert Center does not submit to the Ministry of Health its conclusions and recommendation on the registration based on the expertise results the expertise shall be automatically deemed as conducted.
It is worth to mention that in accordance with the Law of Ukraine “On Medicinal Products” the simplifies registration procedures are foreseen not for all products registered in the USA, Switzerland, Japan, Australia, Canada, and the EU, but only for those used for the treatment of public health hazardous diseases (AIDS, tuberculosis, viral hepatitis, oncological diseases, etc.). At that, according to the Law of Ukraine “On Medicinal Products” the Ministry of Health should make a decision on the registration of these medicinal products within 7 business days, in comparison to 10 business days that are envisaged by the Resolution. In such a way the Resolution extends the list of medicines liable to simplified state registration regardless of the Law and provides other terms for the registration.
Novelties in materials expertise for the abovementioned category of medicines and requirements to such materials deserve a special attention. The Resolution proposes the Ministry of Health to establish the expertise procedures for the abovementioned products, but with an approval of the Ministry of Economic Development. Please note, that the Ministry of Economic Development is mentioned for the first time in the context of the state registration of medicinal products and previously was not involved into any step of the registration process. Currently the possible participation of the Ministry of Economic Development in the process of state registration remains unclear.
It is worth to mention that despite the fact that the Resolution has not come into effect yet, the text of this legal regulation published on the CMU web-site should be considered as final.
Please note that previously we have already informed on the initiative regarding the inclusion of the mentioned category of medicinal products to those that are liable to simplified registration, which was embodied in the Draft Law of Ukraine “On Amendments to Aricle 9 of the Law of Ukraine “On Medicinal Products” (regarding State Registration (Re-registration) of Medoconal Products)” (№ 4484), registered on April 20, 2016. This Draft Law also proposes to establish the simplified registration procedures for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU. Check the main innovations of the Draft Law by referring to the following link: http://l-a.com.ua/eng/news/2740/.
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