Order of the Ministry of Health “On Amending the Procedure for Examination of Registration File of Medicines for State Registration (Re-Registration) and Examination of File on Changes to Registration File During the Validity Period of Registration Certificate” No. 711 as of April 13th, 2018 (hereinafter – the Procedure) became effective on May 15th, 2018.
The right of the applicant to file registration file with the State Expert Centre not only in paper but also in electronic form is one of the major novelties.
Besides, order of the Ministry of Health of Ukraine has changed peculiarities of re-registration of medical biological drugs, some terms of registration of biosimilars and medicines for treatment of virus hepatitis which underwent the procedure of requalification and were included to the WHO list of requalified medicines.
The Procedure has also changed the procedure for examination of case file of a biological medicine. In particular legislation established a new term of non-comparative biotechnological medicine – medicine which was developed without full comparative research of safety and effectiveness and which does not demonstrate its similarity in all three fundamental areas (safety, quality, effectiveness) to reference (biotechnological) medicine.
Now, if biological drugs meet the criteria of non-comparative biotechnological medicine, registration file is examined in the same manner as for the medicine submitted for registration based on expert assessment of the updated date as for correlation usefulness/risk. Expert assessment is carried by the State Expert Centre in accordance with Chapter IV of the Procedure. Registration certificate for such biological drugs is issued for 5 years taking into consideration obligations to provide results of full comparative research of quality, safety and effectiveness which confirm similarity of the biological drugs to reference (biotechnological) medicine.
At registration of biological drugs as medicines, term of examination should not exceed 90 working days starting on the date when registration file arrived at the State Expert Centre.
Some amendments relate the change in the order of biosimilars registration procedure: the provision which required confirmation of biosimilar’s registration/beginning of the registration in countries regulatory bodies of which apply high standards in compliance with those recommended by WHO was excluded.
Registration file for a biosimilar satisfies general requirements to registration file given peculiarities specified in para 1.3 of Chapter III of the Procedure. The term of the examination is 210 working days.
The following category of changes concerns drugs for virus hepatitis. Registration of such medicines which underwent the procedure of requalification and are included to the WHO list of requalified medicines now is carried in the manner prescribed for requalified medicines against tuberculosis and HIV/AIDS.
Thus, a medicine submitted for registration must be manufactured in the production site inspected by the WHO within the requalification program and is recorded in the WHO list; type and size of package of a medicine claimed for registration are specified in WHO list. Further, the following should be submitted:
1) official WHO report on medicine assessment (WHOPAS(s))certified by seal of an applicant/applicant’s representative (if any);
2) official WHO report on inspection of producers and clinical trials departments (WHOPIR(s)) certified by seal of an applicant/applicant’s representative;
3) official letter from the applicant (in the form approved by WHO) on start of the procedure of state registration of the medicine in Ukraine upon obtaining access code to the official website of WHO requalification program;
4) written confirmation from the applicant that the medicine claimed for registration corresponds to the medicine which underwent requalification and is included to the WHO official list based om the abovementioned WHO reports.
Registration file for such medicines should be submitted to the State Expert Centre in the same form as it was submitted to WHO to carry requalification procedure. Term of examination in this case should not exceed 45 working days.
Contact the author: Zoya Zamikhovska, associate at Legal Alliance Company, zamikhovska@l-a.com.ua
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
