LAW OF UKRAINE

of March 19, 2015 No. 269-VIII

About introduction of amendments to some laws of Ukraine concerning ensuring timely access for patients to necessary medicines and medical products by implementation of public procurements with involvement of the specialized organizations which conduct procurement

The Verkhovna Rada of Ukraine decides:

I. Make changes to the following laws of Ukraine:

1. In the Law of Ukraine "About medicines" (Sheets of the Verkhovna Rada of Ukraine, 1996, No. 22, Art. 86 with subsequent changes):

Part third of Article 2 to add 1) with the new first offer of the following content:

"The term "the specialized organizations conducting procurements" is used in the value given in the Law of Ukraine "About implementation of public procurements";

2) in Article 9:

a) after part four to add with two new parts of the following content:

"Materials of the registration file and the report on assessment of this medicine constituted by regulatory body of the country where this medicine is registered, or issued by the World Health Organization are applied to the statement for state registration of the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care and the relevant specialized organization conducting procurement if medicine is prekvalifitsirovanny, and also the methods of quality control of medicine (end product) and the instruction about use of medicine stated in language according to the requirements concerning language determined by this Law the sample of the original of packaging of medicine, transfers of the text of marking of packaging of medicine and the instruction for use of medicine in Ukrainian certified by the authorized signature of the applicant. Collection is not paid for state registration of the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care and the relevant specialized organization conducting procurement.

Applicant (the owner of the registration certificate) and/or his representative for implementation of the procedure of state registration of the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care and the relevant specialized organization conducting procurement is the legal entity or physical person responsible for efficiency, safety and quality of medicine according to the procedure, determined by the current legislation, and performs pharmakonadzor in Ukraine, and also bears responsibility for accuracy of the information, containing in the materials provided to them to the statement".

With respect thereto the fifth - the twenty fourth to consider parts respectively parts seven - the twenty sixth;

b) the seventh to add part with offers of the following content: "The decision on registration or refusal in registration of the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care and the relevant specialized organization conducting procurement is accepted by results of the carried-out expertize of the registration materials on such medicine in their authenticity determined by part five of this Article, in time, not exceeding seven working days. The term of examination of registration materials on their authenticity concerning such medicines shall not exceed seven working days";

c) part the fourteenth after words" (except AFI" to add with the words "and the medicines which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care, and the relevant specialized organization conducting procurement)";

d) the twenty second to add part with the offer of the following content: "The basis for refusal in state registration of the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care and the relevant specialized organization conducting procurement is non-presentation of the corresponding materials on such medicine determined by part five of this Article or their representation in incomplete amount, identification in the specified documents of unreliable or incomplete information, detection of not authenticity of transfer of the text of marking of packaging of such medicine or the instruction for use of such medicine";

ґ) the twenty fourth to state part in the following edition:

"About refusal the central executive body which provides forming and realizes state policy in the field of health care in ten-day time sends to medicine registration to the applicant the written motivated answer. For the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization which conducts procurement on agreement performance on purchase between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care and the relevant specialized organization conducting procurement, term for the answer about refusal shall not exceed three working days. The decision on refusal can be appealed in the procedure established by the law";

Article 12 to add 3) with part seven of the following content:

"Requirements of parts one, the second, third and fifth this Article do not extend to medicines which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement on agreement performance on purchase between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care, and the relevant specialized organization conducting procurement";

Article 17 after part two to add 4) with new part of the following content:

"Requirements of parts one and the second this Article do not extend to medicines which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care, and the relevant specialized organization conducting procurement. On the territory of Ukraine the medicines registered in Ukraine which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement only on agreement performance on purchase between the central executive body of Ukraine which provides forming and realizes state policy in the field of health care, and the relevant specialized organization conducting procurement in the presence of the quality certificate of series of medicine which is issued by the producer can be imported".

With respect thereto the third or fifth to consider parts respectively parts of the fourth or sixth.

2. Part third of article 26 of the Law of Ukraine "About fundamentals of the state language policy" (2013, No. 23, the Art. 218) to add sheets of the Verkhovna Rada of Ukraine with the paragraph the second the following content:

"Marking of medicines, the medical products which are subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement for the definitions given in the Law of Ukraine "About implementation of public procurements" in pursuance of the agreement on purchase between the central executive body of Ukraine realizing state policy in the field of health care and the relevant specialized organization conducting procurement, and also the instruction for use of such medicines, medical products are carried out in original language".

3. Actually ceased to be valid according to the Law of Ukraine of 25.12.2015 No. 922-VIII.

II. Final provisions

1. This Law becomes effective from the date of its publication and is effective till April 1, 2023.

2. To the Cabinet of Ministers of Ukraine in a month from the date of entry into force of this Law:

develop and approve the resolution of the Cabinet of Ministers of Ukraine which to determine features of the choice of the specialized organizations conducting procurement and the conclusions the Ministry of Health of Ukraine of agreements on purchases of medicines and medical products by the specialized organizations which conduct procurement, and implementation of purchases according to procedures of such specialized organizations, including to establish requirements of rather obligatory promulgation of information on purchase on the official site of the Ministry of Health of Ukraine and on the web portal of the central executive body realizing state policy in the field of public procurements and also the list of medicines and medical products which are bought based on purchase agreements with the specialized organizations which conduct procurement, and also the list of services which can be provided by such organizations; provide the mechanism of maintenance of each packaging of medicines and also each medical product which are bought based on the agreements on purchase signed between the Ministry of Health of Ukraine and the specialized organizations conducting procurement, transfers of the instruction for use of medicine or medical product in language according to requirements of the Law of Ukraine "About fundamentals of the state language policy";

develop and approve changes in the resolution of the Cabinet of Ministers of Ukraine of April 23, 2014 No. 117 "About implementation of advance payment of the goods, works and services which are purchased for budgetary funds" which to provide that managers of budgetary funds and receivers of budgetary funds in transactions on purchase of goods, works and services for budgetary funds which consist according to the paragraph the seventeenth parts three of article 2 of the Law of Ukraine "About implementation of public procurements" can provide advance payment in case of purchases of medicines and/or vaccines for preventive inoculations of people, medical products and the related services in the terms established by agreements on purchase, concluded according to the paragraph the seventeenth parts three of article 2 of the Law of Ukraine "About implementation of public procurements";

develop and approve changes in the resolution of the Cabinet of Ministers of Ukraine of July 2, 2014 No. 240 "About reference pricing on the medicines and products of medical appointment which are purchased at the expense of means state and local budgets" (further - the Resolution No. 240) which to provide that requirements are not applied by the Resolution No. 240 to the medicines and medical products which are purchased according to the paragraph to the seventeenth part three of article 2 of the Law of Ukraine "About implementation of public procurements";

develop and approve changes in the 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)" which to establish the procedure of registration (re-registration) of the medicines which are purchased according to the paragraph the seventeenth parts three of article 2 of the Law of Ukraine "About implementation of public procurements" according to requirements of this Law;

develop and approve changes in the resolution of the Cabinet of Ministers of Ukraine of November 9, 2004 No. 1497 "About approval of the Procedure for state registration of medical equipment and products of medical appointment" which to provide the simplified procedure for state registration of the medical products which are purchased according to the paragraph the seventeenth parts three of article 2 of the Law of Ukraine "About implementation of public procurements";

develop and approve changes in resolutions of the Cabinet of Ministers of Ukraine of October 2, 2013 No. 753 "About approval of the Technical regulation of rather medical products", of October 2, 2013 No. 754 "About approval of the Technical regulation of rather medical products for diagnostics of in vitro", of October 2, 2013 No. 755 "About approval of the Technical regulation of rather active medical products which implant" which to provide the simplified procedure for introduction into circulation of medical products which are bought according to the paragraph to the seventeenth part three of article 2 of the Law of Ukraine "About implementation of public procurements";

develop and approve changes in the resolution of the Cabinet of Ministers of Ukraine of March 31, 2004 No. 411 "About approval of the Regulations on the State register of medicines" which to provide identification of the medicines which are purchased according to the paragraph the seventeenth parts three of article 2 of the Law of Ukraine "About implementation of public procurements";

provide development and approval of changes by the Ministry of Health of Ukraine in the order of the Ministry of Health of Ukraine of August 26, 2005 to No. 426 "About approval of the Procedure for conducting examination of registration materials on medicines which move on state registration (re-registration), and also examinations of materials about modification of registration materials throughout action of the registration certificate" which to provide procedure of check of the materials determined by the subitem "an" of the subitem 2 of Item 1 of the Section I of this Law according to the subitem "b" of the subitem 2 of Item 1 of the Section I of this Law;

provide development and approval of changes by the Ministry of Health of Ukraine in the order of the Ministry of Health of Ukraine of December 30, 2011 to No. 1019 "About ensuring planning and accomplishment of budget programs, the main manager of budgetary funds on which is MZ of Ukraine", providing that the structure of the Commission of the Ministry of Health of Ukraine on development of basic data shall include (in consent) representatives of the public (patient) organizations, and also representatives of the specialized organizations conducting procurement;

provide the development and approval of changes by the Ministry of Health of Ukraine in the Regulations on the Permanent work group of the Ministry of Health of Ukraine concerning profile maintenance of public procurements approved by the order of the Ministry of Health of Ukraine of March 15, 2012 No. 166 "About ensuring profile maintenance of the public centralized procurements on accomplishment of the state target programs and complex actions" providing that the structure of permanent work group of MZ of Ukraine concerning profile maintenance of the public procurements which are carried out for the purpose of accomplishment of budget programs shall include (in consent) representatives of the specialized organizations conducting procurement;

provide development and approval by the ministries, other central executive bodies of regulatory legal acts for the purpose of realization of Item 1 of the Section I of this Law;

bring the regulatory legal acts into accord with this Law;

provide review and reduction by the ministries and other central executive bodies of their regulatory legal acts in compliance with this Law.

3. To the National Bank of Ukraine in a month from the date of entry into force of this Law to develop and approve changes in the resolution of Board of the National Bank of Ukraine of March 3, 2015 No. 160 "About settlement of situation in the monetary and currency markets of Ukraine" (further - the Resolution No. 160) which to provide that requirements of Item 1 of the Resolution No. 160 do not extend to the import transactions of residents performed on the terms of delivery delay according to provisions of the paragraph of the seventeenth of part three of article 2 of the Law of Ukraine "About implementation of public procurements".

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