The Ministry of Health Order as of 23.07.2015 №460 «On Amendments Introduction into the Expertize Procedures for Medicinal Products Registration Materials being submitted for State Registration (Reregistration) and Expertize of the Materials on Amendments Introduction to Registration Materials over the period of Marketing Authorization Validity and Approval of Material Validation Procedures attached to the Application for State Registration of certain Medicinal Products, according to their volume (hereinafter – the Procedures)» came into effect on October 30, 2015. Therefore, the Procedures have been published in the new version which currently provides for a number of different changes.
In particular, in accordance with the new version of the Procedures the initial expertize of the application on medicinal product state registration is not provided. Hence, the expertize of medicinal products’ materials being submitted for state registration shall include two stages out of three previously foreseen, i.e.: conduct of initial and specialized expertize.
As previously, the Procedures designate that medicinal product may not be recommended for state registration provided that the results of specialized expertize have not confirmed the conclusions on its efficiency, safety and quality, i.e. if as a result of such registration the current patented property right would be violated including the production, usage and marketing of medicinal products. However, from now on such fact shall be designated by court decision. The copy of legally valid court decision shall be submitted to the Ministry of Health and State Enterprise «State Expert Center of the Ministry of Health of Ukraine».
The Procedures provide that the registration of medicinal product being submitted for state registration in Ukraine and which is not registered in the country of applicant/manufacturer or other countries shall be allowed upon availability of registration documents in the volume designated by the Procedures including the registration of medicinal products by the resident applicant/manufacturer using the contractual production sites outside of Ukraine.
As opposed to the last Expertize Procedures drafts the new version foresee that in case of the applicants failure to submit registration materials after application filing for medicinal product registration such application shall be withdrawn within 3 business days and not within 10 days.
The terms for registration materials expertize have also been reduced from 90 to 45 business days for some medicinal products, in particular for medicines being registered by European Medicines Agency (ЕMA) in accordance with a specialized procedure; vaccines, anatoxins having undergone the procedure for prequalification by World Health Organization (WHO) and being included into the WHO List of Prequalified Vaccines and Anatoxins.
Moreover, the adjusted Procedures contain the number of changes having mainly a technical character, i.e. the application for state registration of medicinal products has been renamed into Registration Form of medicinal product being submitted for state registration, etc.
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