On 5 October, 2014 Resolution of the Law of Ukraine from 12.08.2014 No1637-VII On making amendments to Law of Ukraine On medicinal products concerning improvement the procedure of procurement population with medicinal products prescripted to socially dangereous and severe diseases treatment will come into force.
In accordance with the decision about registration or refusal in registration aimed at tuberculosis, HIV/AIDS, viral hepatitis, oncological diseases and rare (orphan) disease registered by authority body of the USA, Switzerland, Japan, Australia, Canada or EU as medicinal product is making during 7 days.
Herewith the necessary changes were not added to the Order of state registration of medicinal products (order of CMU on May 26, 2005 No376) and Order of examination of registering materials (Order of MOH on August 26, 2005 No 426).
In accordance with the Law of Ukraine on August 12,2014 No 1637-VII
The Cabinet of Ministers of Ukraine was given directions to harmonize legislative acts accordance to the Law, giving an opportunity to promulgate at the same time with the current law and guarantee adoption of legislatives acts, review and cancelation by MOH legislative acts which contradict with the current Law.
At the same time by the Order of Ministry of Health of Ukraine on August 11,2014 No566 were made amendments to the Order of examination of registration materials of medical immunobiological drugs which are during immunoprophylaxis of infectious diseases included to the calendar of immunization in Ukraine, registered in countries with the high standards of quality, recommended by World Health Organizations and going through the procedure of re-qualification by WHO and included to the list of re-qualification of medicinal products.
Features of examination of registering materials of original (innovative) medicinal products used for Socially dangerous diseases (tuberculosis, HIV/AIDS, viral hepatitis herewith the medicinal products with original units for rare diseases treatment), registered in the USA, EU, Switzerland, Japan, Great Britain and Australia were included to the Order of MOH from 26.08.2005 No 426 and earlier (from 4.01.2013).
In other words adoption of the Order of MOH on August 11,2014 No 566 doesn’t depend on the latest amendments to the Law of Ukraine ‘On medicinal products’.
It should be emphasized that provisions of law have legal force in clause 5 of Procedure of examination of registering materials included the dates of examination.
List of the documents which is enclosed to the application of state registration of medicinal products for Socially dangerous diseases treatment was approved by the law of Ukraine on August 12,2014, No 1637-VII.
It follows that from 5.10.2014 the duration of state registration or refusal of state registration of medicinal products shouldn’t exceed 7 working days. At the same time we can assume that state authorities can take other position in this question.
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