RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of May 26, 2005 No. 376

About approval of the Procedure for state registration (re-registration) of medicines and the amount of collection for their state registration (re-registration)

According to articles 9 and 9-1 of the Law of Ukraine "About medicines" the Cabinet of Ministers of Ukraine decides:

1. Approve applied:

Procedure for state registration (re-registration) for medicines;

the amount of collection for state registration (re-registration) of medicines.

1-1. Determine that for action of warlike situation:

and within six months from the date of the termination or cancellation of warlike situation the current of term for filing of application about re-registration of the medicine determined by the paragraph the seventh Item 10 of the Procedure approved by Item 1 of this resolution stops. After six months from the date of the termination or cancellation of warlike situation the current of the specified terms proceeds taking into account time which passed to their stop;

the term of application, import and address in the territory of Ukraine of medicines is prolonged, including those which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization which conducts procurement in pursuance of the transaction on purchase between the Ministry of Health, and the relevant specialized organization which conducts procurement and/or are bought by person authorized on implementation of purchases in health sector, effective period of registration certificates on which expired during the period of action of warlike situation and/or within six months from the date of the termination or cancellation of warlike situation, by prolongation of effective period of the registration certificate on such medicines for one year from expiry date of the registration certificate of medicine and/or effective period of warlike situation, and/or for six months from the date of the termination or cancellation of warlike situation, with introduction of data on prolongation of effective period of the registration certificate on such medicine in the State register of medicines of Ukraine. Information on the extended validity of the registration certificate updated in the State register of medicines of Ukraine on such medicine certifies action of state registration of such medicine and does not require issue new or replacements of the existing registration certificate;

the medicine registered according to requirements of the Procedure approved by Item 1 of this resolution in case of its purchase by results of the procurement procedure which is carried out by the specialized organization which conducts procurement in pursuance of the transaction on purchase between the Ministry of Health, and the relevant specialized organization which conducts procurement can be imported and be applied in the foreign packaging intended for requirements of the markets of other countries which does not correspond to the approved registration materials on medicine, accompanied by the instruction approved in Ukraine for medical application and the guaranty letter of the producer/applicant in which it is specified that the imported medicine is identical registered in Ukraine;

the state company “State Expert Centre of the Ministry of Health of Ukraine” does not carry out expertize of the registration materials given prior to introduction of warlike situation for the purpose of re-registration of medicines about day of the termination or cancellation of warlike situation, except the cases determined by this Item and undertakes number of the measures directed to conducting examination of registration materials for the purpose of modification of registration materials on medicines except those medicines which applicants stopped the activities for action of warlike situation in the territory of Ukraine and informed on it the Ministry of Health and the state company “State Expert Centre of the Ministry of Health of Ukraine”, and for the purpose of state registration of medicines, including the emergency state registration of medicines, medical immunological supplies, blood medicines which are made or delivered to Ukraine during the period of action of warlike situation, under obligations. At the request of the applicant and in case of its capability to provide the corresponding interaction with the state company “State Expert Centre of the Ministry of Health of Ukraine” conducting examination of registration materials can continue the state company “State Expert Centre of the Ministry of Health of Ukraine” according to requirements of the Procedure for conducting examination of registration materials of medicines which move on state registration (re-registration), and also examinations of materials about modification of registration materials during effective period of the registration certificate approved by the Ministry of Health.

2. Recognize invalid:

the resolution of the Cabinet of Ministers of Ukraine of September 13, 2000 No. 1422 "About approval of the Procedure for state registration (re-registration) of medicine and the amount of collection for state registration (re-registration) of medicine" (The Official Bulletin of Ukraine, 2000, No. 37, the Art. 1587);

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