Healthcare

Meetings
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During the Workshop participants will learn about list of the documents required for recognition procedure as well as advantages and disadvantages of recognition conformity assessment procedure

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The meeting was devoted to the healthcare reform in general as well as its various particular aspects, such as National Essential Medicines List, reimbursement and procurement of medicinal products and medical services

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The Meeting has been devoted to the discussion of the joint Chamber-APRaD Draft Answer to the letter of the Antimonopoly Committee of Ukraine on the conformity assessment procedure conditions for the production of medicinal products with GMP requirements along with a request for information

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On August 23, the Cabinet of Ministers of Ukraine adopted the Concept of Reforming the Mechanisms of Public Procurement of Medicinal Products and Medical Devices, which provides the basis for forming the Central Procurement Organization. According to the Concept, public procurement of medicinal products and medical devices will be performed on international, national and regional levels on the principles of efficiency, transparency and anticorruption

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The Ministry of Health of Ukraine (MoH) published Draft CMU Resolution "On Amendments to CMU Resolutions #333 dated March 25, 2009 and #1303 dated August 17, 1998". According to the suggested amendments, National Essential Medicines List (NEML) comes into force on January 1, 2018 within the requirement for healthcare facilities to procure medicinal products firstly to meet 100% need in medicines from NEML

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The Meeting has been devoted to discussion of the role of MoH Public Health Center in the course of implementation of MoH policy

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On July 24, Ministry of Health of Ukraine published Draft (MoH) Order "On Amendments to MoH Order #1245 dated November 17, 2016" for public discussion. This Draft Order foresees amendments to the Simplified Procedure of Medicinal Products' Registration contributing to its effective functioning. Also, medicinal products' manufacturers would have a possibility to register new medicines within shorter timeframe

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President of the American Chamber of Commerce in Ukraine Andy Hunder on Healthcare reform.

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The meeting was devoted to antimonopoly aspects of doing business in pharmaceutical industry.

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On July 4, the Cabinet of Ministers of Ukraine adopted Resolution, that provides the transition period for the completion of the process of procurement of medicinal products

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The meeting has been devoted to efficiency in pharmaceutical spending and establishment of the Purchasing Agency for procurement of medicinal products

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During the meeting has been discussed harmonization of the national legislation on the technical regulation of labelling due to EU legislation

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The meeting has been exclusively devoted to technical issues of inclusion of the medicinal products to the National Essential Medicines List

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On June 14 the Chamber Healthcare Committee launched Healthcare Marketing HUB

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As a result, technical meeting with SEC regarding steps for resolving the issue of ineffective implementation of simplified procedure for registration of medicines will be held till the next MoH meeting

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Healthcare Committee representatives highlighted problems in current regulatory data protection, data exclusivity, patent protection, counterfeit and grey import etc.

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On June 8, the Verkhovna Rada of Ukraine passed Draft Law #6327 "On Governmental Financial Guarantees for the Medical Services' Provision" in the first reading as advocated by the Chamber

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Co-Chair of the Chamber Healthcare Committee, Partner at Marchenko Danevych Borys Danevych shared his view on healthcare reform in Ukraine

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Healthcare Committee representatives held a discussion regarding existing problems in IPR sphere for pharmaceutical companies

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On June 6, Parliament of Ukraine voted for including Draft Law #6327 "On Governmental Financial Guarantees for the Medical Services' Provision" and Draft Law #6329 "On Amendments to the Budget Code of Ukraine" to the agenda. Draft Laws are expected to be put to first vote later this wee

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On May 31 the Chamber Healthcare and IT Committees held a meeting with e-Health Project Office​, devoted to discussion of the Ministry of Health vision of forming the e-Health system, current state of the project and potential cooperation with the Chamber experts

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On May 23, the Chamber Healthcare Committee held a meeting with International Charitable Organization “East Europe and Central Asia Union of People Living with HIV” (ECUO) representatives

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The meeting has been devoted to discussion of implementation of international clinical protocols in Ukraine, their advantages and importance of their application in medical practice

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The event has been devoted to discussion of the agenda for the meeting with the profile Deputy Minister of Economic Development and Trade of Ukraine

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In the light of launch of the Chamber Healthcare Marketing HUB, this meeting has been an excellent opportunity to review key market trends in EU and Eastern Europe, trends and challenges on the Ukrainian pharmaceutical market, and impact of the EU trends on the Ukraine

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The Chamber welcomes entering into force of Order #122 “On Approving the Procedure of Maintaining the Register of Persons Responsible for the Introduction of Medical Devices, Active Implanted Medical Devices, and Medical Devices for in vitro Diagnostics in Turnover, Forms of Communication and List of Data Stored therein and Access to Them” adopted by the Ministry of Health of Ukraine

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During the meeting has been discussed Implementation of the National Essential Medicines List

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Agenda of the meeting included discussion of the last working version of Draft Law “On Information for Consumers regarding Food Products” with participation of representatives of the Ministry of Health of Ukraine, State Service of Ukraine on Food Safety and Consumer Protection and EU Project "Improvement of Food Products Safety Control System in Ukraine"

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The meeting has been devoted to discussion of the WHO vision of reforming healthcare sector in Ukraine

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On April 6, Chamber Healthcare Committee held its regular meeting with participation of representatives of Association of Pharmaceutical Research and Development (APRaD) and healthcare professionals moderated by Committee Co-Chair Vitaliy Gordienko, AbbVie Biopharmaceuticals GmbH

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On March 29, the Chamber Healthcare Committee held a meeting with Pavlo Kovtonyuk, Deputy Minister of Health of Ukraine, devoted to discussion of implementation of healthcare insurance system in Ukraine as well as MoH vision of the necessary legislation to be adopted by the Parliament this year

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Read the article on Ukrainian language version of the website

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Participants discussed the mechanism for future cooperation on the issues related to competence of the National Police of Ukraine that Chamber Members face and reached a number of agreements. In particular, issue of access of attorneys during searches was discussed

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On March 16, the Cabinet of Ministers of Ukraine approved reimbursement of medicinal products that introduces a mechanism of refunding during outpatient treatment of patients suffering from cardiovascular disease, type II diabetes, asthma by setting wholesale prices for these medicines which are calculated as median reference prices for the same medicinal products in approved reference countries list

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On March 16, the Chamber participated in a meeting devoted to the National Essential Medicines List which will enter into force on April 1, 2017

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On March 9, the Chamber participated in a meeting devoted to the Draft Regulation on introduction of reference pricing and reimbursement since April 1, 2017 which was held in the Ministry of Health of Ukraine (MoH). The meeting gathered representatives of the MoH, Cabinet of Ministers of Ukraine (CMU), Ministry of Economic Development and Trade of Ukraine (MEDT) and pharma market operators

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On February 24, the Chamber participated in a meeting devoted to the Draft Regulation on introduction of reference pricing and reimbursement since April 1, 2017 which was held in the Ministry of Health of Ukraine (MoH). The meeting gathered representatives of the MoH, Cabinet of Ministers of Ukraine (CMU), Ministry of Economic Development and Trade of Ukraine (MEDT) and pharma market operators

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The agenda of the meeting has been devoted to the discussion and analysis of the recent presentation of the Expert Committee on selection and application of medicinal products regarding National List of Essential Medicinal Products formation

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The agenda of the meeting has been devoted to discussion of the State Expert Center’s vision regarding facilitation of registration of medicinal products procedure

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On February 1, the Cabinet of Ministers of Ukraine approved a compromise to amend Order #862 "On State Regulation of Prices for Medicinal Products" and postponed the start of its implementation to April 1, 2017

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On January 13, Chamber Healthcare Committee held its regular meeting with participation of representatives of U.S.-Ukraine Business Council (USUBC) and Association of Pharmaceutical Research and Development (APRaD) moderated by Committee Co-Chairs: Vitaliy Gordienko, AbbVie Biopharmaceuticals GmbH, Guilhem Granier, Sanofi-Aventis Ukraine LLC and Borys Danevych, Marchenko Danevych

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Meeting has been devoted to reconciliation of positions among the Working Group on the possible ways of avoiding the double regulation

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On December 1, Steering Committee of the Chamber Healthcare Committee met with Oleksandr Saienko, Minister of the Cabinet of Ministers of Ukraine and Ulana Suprun, Acting Minister of Health of Ukraine

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On November 24, Vaccines Summit dedicated to the issues of establishing a long-term strategy for protecting the population against vaccine preventable diseases was held in Kyiv

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The agenda of the meeting has been devoted to discussion of possible ways of cooperation between business and government in solving urgent problems in the healthcare sector

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The agenda of the meeting has been devoted to the discussion, with representatives of APRaD and other associations, of the most recent Government decisions in the healthcare sector

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The agenda of the meeting has been devoted to the discussion of the current situation in the healthcare sector

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Participants with Chamber Healthcare Committee experts explored the practical aspects of conformity assessment of medical devices

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The agenda of the meeting has been devoted to the discussion of the development of the regulation of the registry of medical devices, as well as illegal imports of medicinal products

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The agenda of the meeting was devoted to the election of the Head and defining main priorities for newly established Working Group

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Participants met with the newly appointed Acting Minister of Health of Ukraine Ulyana Suprun, who shared her vision on the healthcare system reform and plans to be accomplished in her role within the Ministry of Health of Ukraine

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The agenda of the meeting has been devoted to discuss the concept of import substitution recently announced by the Ministry of Health of Ukraine

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Specific discussion regarding reimbursement of insulins in terms of launching a specific pilot project in Kyiv, implementation of medical insurance mechanisms and electronic healthcare system

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On July 8, the Chamber participated in the meeting devoted to clarifications of procedures of Conclusions of the State Sanitary-Epidemiological Expertise (hereinafter – Conclusions) issuance and signing held by the State Regulatory Service of Ukraine

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Participants had an opportunity to contribute to the establishment of a new Working Group on Healthcare Hardware Manufacturing

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On June 23, Steering Committee of the Chamber Healthcare Committee met with Viktor Shafransky, Acting Minister of Health of Ukraine

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Order #359 of the Ministry of Health of Ukraine on Adoption of the Regulation on the Register of Reference Prices for Insulins and the Rules of Reference Prices Calculation for Insulins was published in the Official Bulletin of Ukraine

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We aimed to define major pain points faced by investors in the sphere of IPR and raised awareness among the general public of Ukraine

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Verkhovna Rada of Ukraine adopted Draft Law #4484 “On Amendments to Article 9 of the Law of Ukraine "On Medicinal Products" on Simplification of State Registration of Medicinal Products”

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Join us to find the possible ways cooperation within the Project and get the update on the SIAPS activities in Ukraine.

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Presentation of United Nations Development Programme approach to anti-corruption in healthcare sphere.

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The agenda of the meeting has been devoted to presentation of the State Expert Center’s vision of working process of specialized expertise on quality of medicinal products for 2016

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It was a discussion on current issues in illegal imports, improvement of legal framework of procurements, and advertising of medicinal products

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It was an ad-hoc expert Meeting on Draft CMU Resolution “On Approval of License Conditions of Production...

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Please read the news on Ukrainian version of the website.

 

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Mr. Rachman, CEO, Immix Biopharma, Inc a Los Angeles, CA  shared his experience on...

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Chamber welcomes the signing of Laws in the sphere of Public Procurements of Medicinal Products via International Organizations.

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Please read the news on Ukrainian version of the website.

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Chamber welcomes CMU Resolution #125 “On Amendments to the Procedure of State Registration (Re-Registration) of Medicinal Products”.

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Business community appreciates yesterday’s adoption of amendments to the CMU Resolution #376 which repeal reregistration of medicines for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancer and rare diseases registered in the United States, Switzerland, Japan, Australia, Canada and the EU countries.

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