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Upon the consideration of the provided materials the Antimonopoly Committee has come to the conclusion that given marketing agreement does not contain any signs of the abuse of monopoly and anticompetitive concerted actions conducted by GlaxoSmithKline Ukraine. Moreover, the project team put major efforts into the materials preparation aimed at the justification of Competition Law non-infringement by the drafted marketing agreement concluded with the pharmacies and pharmacy chains.
The document proposes to extend the list of medicinal products liable for simplified state registration, in particular to simplify the procedure for those medicinal products that have already been registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union.
The Parliament Health Care Committee did not support this Draft Law and submitted it for further improvement. The Regulation proposes to establish the selection procedures (development of the first draft Essential Medicines List by the Expert Committee) and yearly revision of the National Essential Medicines List. Further, upon the approval of the first Draft National Essential Medicines List the Expert Committee shall revise the existing taking into account the abovementioned factors and sources. The Draft Regulation also established the schedule of revision of the National Essential Medicines List.
Please note that the Order of the Ministry of Health of Ukraine as of February 11, 2016, a„– 84 approved the Regulation on the National Essential Medicines List and the Regulation on the Expert Committee on the selection and usage of essential medicinal products. For 28 years, The Legal 500 has been analyzing the capabilities of law firms across the world, with a comprehensive research programme revised and updated every year to bring the most up-to-date vision of the global legal market. The Concept suggests the implementation of activities aimed at solving the issues of timely patients support with qualitative, safe and efficient medicinal products, immunobiological products and medical evices, and activities aimed at the prevention of corruption and limited competition that lead to medicinal products and medical devices procurement at an over-inflated price.
The document authors note that the Concept designates the directions, mechanisms and terms for public procurements system transformation in healthcare sector of Ukraine through the development of modern convenient system aimed at the establishment of competitive environment and further development of fair competition in this sector. The Concept shall be implemented with the assistance of international organizations and donors in three stages during 2016—2018.
Stage 1 (2016) – establishment of institutional and legal basis for the reformation of public procurements in healthcare sector.
CPO shall fulfill the procurements at local and foreign levels, and if required shall maintain the procurement from international suppliers — import of medicinal products, immunobiological products and medical devices, involve other organizations into customs clearance, storage and distribution, conduct other business activities based on long-term plan principles. The procedure for insulin products reimbursement foresees that the pharmacy warehouse should file monthly report on the medicinal products sold. Moreover, the document amends the CMU Resolution as of March 5, 2014, a„– 73 "On the Implementation of Pilot Project on State Regulation of Insulin Products Prices" regarding the definition of the unified mechanism of the state regulation of insulin products prices. These medical devices are allowed for market distribution before their expiry date and not later than 5 years from the date of their sales start without the compliance assessment and national quality standard mark. Based on the abovementioned, the compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date. Another significant change introduces the opportunities to conduct the compliance assessment procedures during the period of validity of medical devices registration certificate.
Moreover, certain changes have been introduced into the registration of the officials responsible for putting medical devices into operation. In case such entity is not a resident of Ukraine, the authorized representative should be assigned with the responsibility to introduce such medical devices into Ukrainian market.
State Administration of Ukraine on Medicinal Products should maintain a Register of entities responsible for the introduction of medical devices into the market. The legal support of the development and adoption of the abovementioned Order of Cabinet of Ministers, as well as the above-mentioned order of the Ministry of Health of Ukraine was provided by the Legal Alliance Company in cooperation with the SIAPS project. The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards  in terms of health and level of funding for health care.
The Expert Committee will consist of 12-18 people, it will be composed of specialists with higher medical, pharmaceutical and economic education.
Once an expert committee under the Ministry of Health of Ukraine is established, work concerning the selection of drugs to be included in the National List will be conducted by them. Interested individuals and legal entities can apply with a package of necessary documents  for inclusion of drugs in the National List of Medicines. Notice of tax assessment is developed for each separate tax due together with the penalties, as well as for each penalty and poena for the violation of other legislation being under supervision of regulatory authorities. Notice of tax assessment is considered to be submitted to the taxpayer – legal entity if such assessment notice is delivered by hand to the official employee of such taxpayer against acknowledgement or forwarded in a letter with notification of the delivery. Notice of tax assessment is considered to be submitted to the taxpayer – individual if such assessment notice is delivered by hand to such individual or his authorized representative or forwarded in a letter with notification of the delivery to the address of residence or of the latest known location of such individual. The new Law provides for the implementation of public procurement with the use of two competitive regulatory procedures: open tendering and competitive dialogue, as well as a non-competitive procedure - negotiating the purchase procedure. An important innovation of the Law is the introduction of electronic procurement (e-auction), the electronic review system, as well as the implementation of the exchange of information, documents, to provide clarifications in the e-procurement system.
Moreover, for the conduct of unauthorized concentration, which did not lead to monopolization and significant impediment of competition on Ukrainian market , the AMCU recommends to calculate the basic penalty in accordance with the total revenue (income) received from the sales of products (goods, services) at all commodity markets of Ukraine. The AMCU made the greatest specification regarding the calculation of the basic penalties in the cases of the infringements of informational character. Moreover, the AMCU believes that if the incorrect information has been provided several times during the consideration of the case regarding the violation of informational character, the total penalty charges shall amount to the penalty for one relevant violation. It is worth to mention that the AMCU established the reduced penalty, which may be imposed on the respondent during the investigation of the case of informational character and on the applicant in the case regarding the concentration and the concurrent actions if they provided incomplete case information. Correction of previously determined penalty taking into consideration the aggravating and mitigating circumstances. Declarations with violation of the deadlines for submission for the reporting period in case the application is submitted within its contents. The registers are published at the official State Fiscal Service’s web-site on a daily basis.
In case the Main Directorates of the State Fiscal Service in regions, or in the city of Kyiv send to the appellant the decision on final or partial denial of the appeal, the appellant has a right to file the subsequent appeal within 10 calendar days upon the receipt of such decision. The document in its new edition, updated and improved in line with the requirements of the Law of Ukraine "On Prevention of Corruption", was recently approved by the  Management Board of AIPM Ukraine. The project was conducted by Oleksii Bezhevets, partner with Legal Alliance Company and senior associate Lidiya Sangarovskaya-Gurlach. The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree a„– 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure).
Thus, the new procedure determines that the applicant may have more than one system of pharmacovigilance, for example, specific systems for different types of medicines (vaccines, OTC drugs, etc.). With regards to the authorized person, the new order establishes that in the case of the applicant, who is located in Ukraine, the authorized person must be part of the applicant's personnel. The new procedure defines the document with a detailed description of the pharmacovigilance system as a Pharmacovigilance System Master File (PSMF). An important achievement of the new procedure is to establish the requirements for the system of risk management in pharmacovigilance. In contrast to the existing rules, the new procedure provides for the obligation of creating a risk management plan.
In concern with medicinal products that do not require the creation of risk management plans, the applicant must support the specification file of important identified risks and important potential risks with the aim of preparing regular reports.
In terms of other amendments foreseen by the new procedure, emphasis should be given to the advanced categorical apparatus and a new player in the field of pharmacovigilance - rapid response groups of relevant departments of Health, which are responsible for investigating all serious adverse events after immunization and some others.
Therefore, the adoption of the new order will contribute to the harmonization of national legislation with the European legislation.in the field of pharmacovigilance.
It is to be recalled that  in their time some of the provisions were "the bone of contention" between the regulator and the subjects of the pharmaceutical market. Therefore a situation may arise where the abovementioned provisions will be in force before the relevant decision of the Cabinet of Ministers' of Ukraine albeit with the edition of order a„– 143. The abovementioned draft legislation proposes the disclosure of information contained in the materials of the pre clinical studies and the clinical trials that are attached to the application for the registration of the medicinal product. In the opinion of the legislation draft's initiators, the closed nature of such data results in the circulation of drugs, whose effectiveness and safety have not been proved. The Project aims to supporting of Ukrainian government in issue of improvement of effectiveness and transparence in public purchasing system for medicinal products, in particular, by complying of National list of main medicinal products and medical devices with international standards. This year the event attended 130 representatives of the pharmaceutical sector, specialized media, non-governmental organizations, professional associations, and state regulatory authorities. In the beginning of the session Dmytro Aleshko presented a report on the regulation of the medicinal products and medical devices market.
Taking into consideration the composition of the event members many of whom represented the medical devices market, the regulation of the medical devices circulation in 2016 was discussed during a separate interactive session involving Pavel Harchyk, President of the Association of market operators of medical devices, Natalia Serhienko, Health Care Committee Executive Director, European Business Association, and Darya Bondarenko, CEO of Association of market operators of medical devices. The next session of the conference touched the most current issues of the organization of corporative ethics and anticorruption compliance system in the pharmaceutical business.
Following the traditions of the summery conferences the session on taxation of pharmbusiness was held. The highly topical conference programme did not let the participants to relax and loose focus, just as the regulatory and law-enforcement authorities does not let the sector representatives to relax in the course of the year.
Hygiene requirements  exclusively concern dietary suppements and do not apply to medicinal products, functional foods and special dietary foods. Hygienic requirements set requirements for the content of dietary supplements, in particular, the latter indicate that for the production of dietary supplements  vitamins and minerals listed in Annex 1 of the hygiene requirements may be used, in the form specified in Annex 2 to the hygienic requirements.
Therefore  amendments are provided to the Law of Ukraine "On Insurance" , namely by defining sponsor liability insurance a mandatory type of insurance .
The document designates the mechanism for taxpayers’ appeals against tax assessment notices or any other decisions made by the regulatory authorities in the course of administrative procedure. This Procedure shall not be applied to the appeals against the regulatory authorities’ decisions, actions or inactions of their officers or other employees if the special law establishes other procedures for appeals. Complaints about the decisions of state tax inspection offices are filed to regulatory authorities in Kyiv and regions, to inter-regional territorial agencies. Complaints about the decisions of regulatory authorities of Kyiv and regions, of inter-regional territorial agencies, and of customs offices are submitted to the State Fiscal Service of Ukraine. The decisions of State Fiscal Service of Ukraine made upon the consideration of taxpayers’ complaints are final and without any further administrative appeal, however may be appealed to court. The complaint should be submitted in writing to the higher regulatory authority within 10 calendar days following the taxpayer’s receipt of the respective decision made by the regulatory authority.
The complaints for the regulatory authorities’ decisions and actions should be cited and submitted separately. The taxpayers may attach to their complaints all calculations and evidence, which they deem appropriate. Certified copies of quality certificates (certificates of analysis, test reports, etc.) issued by the manufacturer for the series of medicinal products to be imported.
The Ministry of Health shall within five working days from documents delivery shall issue for the importer a certificate of import confirmation or send a written refusal notice indicating the reasons for refusal.
The Ministry of Health shall issue within five working days from documents delivery the certificate of confirmation for the medicines payment under the agreements or send a written refusal notice indicating the reasons for refusal. The supplier shall submit the confirmation certificate to the revenues and duties authority, where it is registered as a tax payer, not later than 10 working days after the deadline for submission of VAT declaration for the relevant reporting (tax) period.
The intended use of the medicinal products and medical devices exempt from VAT shall be fulfilled in accordance with corresponding legislation. Nevertheless, the tax payers are still obliged to pay advanced corporate profit tax payments for the first three quarters of 2016.
The failure to make this payment shall result in imposing on such tax payer the penalty in the amount provided in Article 123 of the Tax Code of Ukraine. In such a way, the National List of Essential Medicinal Products and Medical Devices has been renamed into the National Essential Medicines List. Since CMU Resolution a„– 333 as of March 25, 2009 adoption, the list has not been amended with any medical device. National Essential Medicines List should be formed with due consideration of world-wide practices of rational pharmacotherapy and pharmacotherapeutic approach to primary health care of patients with priority pathologic conditions taking into consideration disease burden and mortality rate, and health care sector standards. In the majority of countries this function is fulfilled by the WOH Model List of Essential Medicines, which has been elaborated as a core document for ensuring public health care at government expense. The designated authority, on the basis of a document of compliance issued by a foreign authority, shall apply the conformity assessment procedure or part of it and issue the relevant document under this procedure under its responsibility. This Regulation shall enter into force six months after the date of publication and will be valid until 31st March 2019. It is to be noted that these legislative changes are due to the implementation of public procurement procedures of medical devices involving specialized international organizations that provide states and other entities with related services.
Dmytro Aleshko, Legal Alliances' Partner, became a member of the working group on essential medicines selection within the implementation of the project for National Medicinal Products Policy development. Kindergarten to College has achieved its goal of reaching all elementary schools in the San Francisco Unified School District.
This year, Citi Microfinance and the Citi Foundation partnered to drive a discussion on agricultural value chain finance through a panel titled "From Farm to Plate" (check out this blog post for one attendee's take). Citi Community Development was proud to support the 38th Annual Lunar New Year Banquet of its long-time community partner, Asian Americans for Equality (AAFE.) Citi Foundation has supported the work of AAFE's affiliate, Renaissance Economic Development Corporation, a CDFI and technical assistance provider focused on low-income, minority and women-owned businesses in low-income immigrant neighborhoods.
CurrenC SF is a partnership between the San Francisco Office of Financial Empowerment, the San Francisco Chamber of Commerce, and the United Way of the Bay Area, with generous support from Citi Community Development, Visa and the Levi Strauss Foundation. For employers, moving to direct deposit and paperless pay can lower payroll processing costs by up to 90 percent, and eliminates the headache of lost and stolen checks.
CurrenC SF is an extension of the City's pioneering program Bank on San Francisco, which has provided over 72,000 bank accounts to low-income San Franciscans and spread to more than 100 cities across the country. More than 67,000 households in San Francisco are paid with paper checks, including 68 percent of low-income workers.
Several CurrenC SF Employer Champions including Recology, Blue Shield of California, William Watlington Foods, Walgreens, Rickshaw Bagworks, Bi-Rite Market and Goodwill Industries were recognized for their leadership in financial empowerment efforts and participated in the launch.
The CurrenC SF website provides resources to help employers initiate or expand direct deposit in their organizations. As Black History Month draws to a close, I am mindful of how fortunate I am to work for two organizations that are strongly committed to the twin, complementary goals of diversity and empowerment.


Similarly, New York City Mission Society, for which I am Chair of the Board of Directors, promotes the positive development of underserved young people and families in order to strengthen communities and, as a consequence, our city's diversity. As it turns out, both Citi and New York City Mission Society are celebrating 200 years of service in 2012. Citi's commitment to diversity spans the organization a€” particularly through the activities of Citi's Employee Networks a€” and the calendar, with events and activities highlighting the months that have been formally designated to celebrate the culture, history and contributions of various communities.
Across the country, Citi's African Heritage Networks (AHN) provide a wide range of educational, cultural and fellowship-building opportunities during African American History Month. Ellen Stafford, who has been with Citi in Irving, Texas for a little over four years, got involved with the Dallas-Fort Worth AHN as Communications Chair this year. As Executive Recruiter for North America, Ellen is very aware that Citi provides an even playing field on which qualified applicants, both within and outside Citi, can compete.
Ellen is shifting her recruiting focus from IT to sustaining Citi's overall culture of diversity. More broadly, Ellen would like to see an increase in positive, healthy messages in popular culture, particularly for children, and a continued and strong policy focus on education. Annette Griffin of Baltimore agrees about the importance of education and how helpful it can be to have a mentor, as she did. Annette is a Senior HR Generalist and supports employees in Maryland, Virginia, West Virginia, Ohio and Pennsylvania. In Columbus, Ohio, Jenine Johnson of Securities Processing notes that Citi has had a major impact on diversity in her metropolitan area, thanks in particular to the leadership of the Columbus Office Director Mark Bjorstrom. Jenine has taken an active role herself in expanding diversity, including introducing Citi's African Heritage Network in Columbus. Jenine strongly values African American History Month and all the diversity months that Citi celebrates.
Willie Henry Jr., of Citi's Graduate Recruitment Team in Jacksonville, Florida, is co-chair of the AHN there. Willie draws inspiration from football legend Jerry Rice a€” "who showed that, with the right tools and hard work, you can compete with anyone even without traditional stamps of status" a€” and from his own brother-in-law, who moved up the ranks at one of the country's largest retailers. On July 17, 2009, a national consortium of non-profit affordable housing developers submitted an application to the U.S. CPLC has organized this coalition in partnership with National Association for Latino Community Asset Builders (NALCAB).
Listen to Jason Ott's experiences with the San Miguel Cristo Rey Corporate Internship Program.
Citi volunteers will contribute about 150 service hours at local VITA sites this tax season. Volunteers also will be out in force at Tucson's 2011 Money Faire on April 2 to help the United Way of Tuscon and Southern Arizona's mobile VITA team prepare tax returns for free. Citi has partnered with United Way of Tucson and Southern Arizona to transform and expand a successful, six-year financial education program called Citi Youth into a dynamic and holistic family financial capability center, called the Prosperity Center. Imagine teaching a young person about how to find available college scholarships and then helping his parents complete the standard financial education application form.
With the Prosperity Center, Citi has partnered with United Way (UW) of Tucson and Southern Arizona to transform and expand a successful, six-year financial education program called Citi Youth into a dynamic and holistic family financial capability center.
The Prosperity Center offers financial education classes from 3-6pm, when students typically participate in after-school programs, and will remain open until at least 7pm so that adults (including those who don't have children at the host school) also can participate in workshops and avail themselves of the Center's other asset-building services.
The Citi Youth financial education program, now in its sixth year, teaches basic financial concepts to youth aged 5-16 and also offers "train-the-trainer" sessions for financial education teachers. Citi Community Development has partnered with the USC-operated MBDA Business Center in Los Angeles, the City of Los Angeles Mayor's Office of Economic & Business Policy, the Southern California Minority Business Development Council, SBA SCORE, and three ethnic minority chambers to launch the Bridges to Business Success (B2BS) Program to provide an advanced business training program focused on building the capacity of minority small business owners in Southern California.
With a lending commitment of more than $100 million, Citi is helping to revitalize the Bayview district of San Francisco. AnewAmerica Community Corporation's Green Business Certificate program" part of its comprehensive, three-year Virtual Business Incubator model" educates and encourages budding, low-income entrepreneurs to adopt green, sustainable business practices. Since the Green Business Certificate program began in 2008, 270 people have received intensive training in green business practices and 80 have achieved green business certification. In California's Central Valley, Citi has invested more than $28,000 to support four EITC sites. In 2010, with Citi's support, local VITA sites helped bring over $14.9 million in tax refunds back to more than 11,000 low- and moderate-income clients and their local communities.
The Citi Foundation supports the Financial Literacy and Asset Development Program, a ten-week course that teaches concepts and skills for saving money, using credit and practicing sound money management. Participants spend twenty hours in classroom sessions and receive individualized guidance in creating personalized money management plans and analyzing their credit scores with the goal of repairing damaged credit.
In California, Cabrillo Economic Development Corporation is making affordable housing available and sustainable. In 2009, the Citi Foundation provided a grant to Cal State University Northridge (CSUN) Student Outreach and Recruitment Services to support its College Can Happen Initiative (CCHI), a strategic and comprehensive program to improve enrollment at the university.
CCHI provides information and encouragement to middle and high school students and their parents, in low to moderate-income (LMI) communities in San Fernando Valley and Los Angeles, to help them prepare for entrance into a four-year college.
Many of the students reached by CCHI would be first-generation college students, and the program aims to foster a college-going culture. As part of the CCHI program, Citi volunteers have taught financial education workshops at CSUN on how to manage finances on a student budget, credit, savings and investing.
Citi is working with Self-Help to expand financial inclusion for thousands of Californians. A supportive and welcoming environment, achieved through staff preparation and branch design. Additionally, through financial education that is provided, innovatively, to customers waiting in line, the Micro Branch encourages individuals who use only its check cashing services to expand their relationship by becoming savings account holders and credit union members.
To enable replication of the Micro Branch model, the CCD grant also supports analysis of the operating model and customer outcomes. Jose came regularly to the Micro Branch, every Friday, to cash his check and send money to his family. Read the latest announcement from the City and County of San Francisco about the Kindergarten to College program. Kindergarten to College is an easy-to-use savings platform that will help more families start saving earlier for college.
The program will continue to motivate college savings through additional matches and incentives. An important part of the Kindergarten to College program is its financial education component. In a recent USA Today supplement on Financial Literacy, Citi's collaboration with the City and County of San Francisco is featured prominently in the article "Milk money, crayons, bank account," and Bob Annibale, Global Director of Citi Microfinance and Community Development, is among the Panel of Experts weighing in on Youth Financial Literacy.
On October 5, 2010, the City and County of San Francisco and Citi announced the launch of the Kindergarten to College partnership, the nation's first city-wide, universal college savings program for children. Citi's commitment and success in developing innovative, collaborative and impactful solutions to critical community needs was recognized on November 8, 2011, when Citi Community Development received the Community Impact Award at the 15th Annual CRA & Fair Lending Colloquium. Jenny Flores, Senior Vice President for Citi Community Development in California, receives the Community Impact Award on behalf of Citi from Edward B.
The Community Impact Award is bestowed each year "to dedicated compliance professionals and their institutions," to honor "outstanding and innovative efforts in furtherance of the goals of the Community Reinvestment Act." The Award also is intended to encourage innovative community lending and to provide the financial industry with examples of superb programs that have made a large impact on underserved communities. K2C was developed with participation across Citi's businesses and with leadership by Citi Microfinance and Citi Community Development.
The award was accepted on behalf of Citi by Jenny Flores, Senior Vice President for Citi Community Development in California. Citi is a longtime supporter of the FRC's Family Economic Success Program, which includes free tax preparation services for low-income individuals and families through VITA. In Oakland, California, the East Bay Asian Local Development Corporation (EBALDC) is ensuring that students in elementary school learn good money management habits. Students who complete the program are provided with a popular board game that involves purchasing and money management issues or a $50 savings bond that's intended to jump-start their good savings habits. Citi Community Development is providing a $150,000 grant to enable Enterprise Community Partners and Waypoint Homes to provide a financial capability program coupled with the purchase, renovation and rental of "real estate owned" (REO) properties. Meet the participants in Bridges to Business Success, a pioneering, multi-stakeholder program that enables the City of Los Angeles to leverage its allocation from the Federal Neighborhood Stabilization Program to provide contracting opportunities to local, minority-owned small businesses. Entrepreneurs in the food service industry face sizeable start-up and operational costs, among other challenges. The Chef's Center of California is run by the Episcopal Housing Alliance and Economic Development (EHAED), which also provides business training courses for aspiring chefs and food entrepreneurs. Part of the facility, the Citi Small Business Technology Center, offers training and technical assistance to incubator participants. A variety of food-related business have been launched through the Chef's Center, including popular food trucks, gourmet bakeries, farmers market vendors and restaurants.
Victor Ramirez of Citi Community Development serves as vice-chair of the Center's Board of Directors.
Microloans that enable people to start small businesses and lift themselves out of poverty have proven their effectiveness in developing countries. The program makes loans of $250, $500 and $1000 to women with very low incomes to empower them to start small businesses in their communities. With Citi's support, FFW has been able to expand its impact by opening new loan centers in the poorest communities of San Diego County.
The program benefits primarily Latin American and African immigrant women, specifically those who have no banking or credit history and lack access to capital. Choose your subscription package Individual Enterprise Subscribe to MEED today for unlimited access to our content platforms anytime, anywhere.
Offshore operations require ongoing maintenance programmes to ensure public and environmental safety. Exceeding recommended serving will not improve results and may cause serious adverse health effects. Discontinue use and call a health professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms. In particular, the team made a comprehensive research on medicinal product markets, which may be affected by the concluded marketing agreement, conducted social and marketing studies, analyzed the experience of GlaxoSmithKline group of companies regarding the relevant agreements in other countries, developed internal standard operating procedures for the Client with regard to pharmacies and pharmacy chains cooperation. We would also like to express our gratitude to the project team members representing GlaxoSmithKline Ukraine for the fruitful collaboration. The Draft Law was initiated by the Cabinet of Ministers of Ukraine and presented the same say at the Government session.
This Regulation belongs to the package of documents drafted in order to implement the new model of Essential Medicines List.
The difference lies in the fact that all individuals intending to include a particular medicinal product into the List shall have an opportunity to submit a corresponding application including the documents confirming the comparative efficiency, safety and cost-effectiveness of the product.
The Regulation Annexes formalize the application execution Instruction for amending the National Essential Medicines List. The adoption of the Draft Resolution shall promote the establishment of professional centralized procurement organizations (hereinafter - CPO) in Ukraine, which requires some time and incremental actions. CPOs shall be established under the Health Ministry decision and shall operate under its supervision. During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration. Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market. The structure and contents of national lists will be based on the latest edition of the Basic List of Essential Medicines recommended by WHO.
An important step forward is the need to study whether or not such persons present a conflict of interest, as well as the possibility of participation of foreign specialists with the necessary knowledge and experience in the selection process in the national list,"- said Dmytro Aleshko, who heads the team of experts developing a normative - regulatory package  on this matter. Such persons shall not present a real conflict of interest, in particular,  they should not be in an employment or any other contractual relationships with producers and holders of certificates of registration of drugs or associated persons. At the same time, the Law provides a number of cases to which the provisions of the latter do not apply.
In addition, the AMCU has specified the meaning of such aggravating circumstances as the obstruction of case investigation.
This method is recommended in case the respondent did not provide any information on the total revenue at the market where the concentration took place and at adjacent markets. Thus, previously the basic penalty equaled up to 5% of the revenue from the sales of the products (goods, works, services) of economic entity in the last reporting year prior to the year the penalty was charged, and if there was no revenue or the respondent did not provide any information on the total revenue – the penalty equaled to 10 000 of non-taxable incomes of the residents.
The written appeal should contain all data outlined in the Procedure, it should be signed by the appellant-physical entity or by the authorized person, for other appellants – the appeal should be signed by the director or a legally authorized representative and sealed (if available).
Thus, the new procedure provides a number of new features, the most interesting of which relate to the applicant.
At the same time, each applicant's pharmacovigilance system can have only one authorized person responsible for the pharmacovigilance (hereinafter – authorized person). Should the applicant not be located in Ukraine, then a contact person for pharmacovigilance in Ukraine, who is a subordinate of the applicant's authorized person, must be assigned on the territory of Ukraine. In comparison with the current procedure, the new procedure establishes simultaneously a clear framework for such PSMFs with the requirements for information that must be contained in it.
It should be noted that the current procedure contains a provision, according to which the applicant creates a pharmacovigilance risk management plan, i.e. The draft resolution prepared by the Ministry of Health of Ukraine , does not contain any significant differences , except for some editorial amendments.
The matter concerns a three-way contract, the requirement for the conclusion of which seems by importers to not be feasible. Therefore the draft legislation at hand is aimed at initiating access to such information, which will enable all interested citizens, their associations and professionals to decide on the selection  for the appointment and the medical use of the medicinal products on the basis of objective data concerning the level of proof on their safety and effectiveness.


Being an annual event for the pharmaceutical sector representatives, the Conference focuses on the regulatory aspects of the pharmbusiness and other legal tendencies of the pharmaceutical market.
Krzysztof Siedlecki, European Business Association President, Astellas Pharma Europe BV Country Manager Ukraine, Dr.
The discussion was held around the current status, potential problems and roadmaps in this sphere. The session was opened by Legal Alliance Partner Oleksii Bezhevets, who informed the participants on the main changes in anticorruption requirements.
Legal Alliance Associate Partner Andrii Gorbatenko, who leads the antimonopoly and competition law practice, acted as a moderator of this session.
Nevertheless, all the attendees remained satisfied with a quantity and quality of the information received at the event and expressed a desire to meet in such a format at least twice a year.
Quality criteria for nutrients used for the production of dietary supplements must comply with the requirements of Ukrainian legislation and in their absence - standards established by the Codex Alimentarius Commission.
The opportunity to track  dietary supplements and any substance intended to be administered in dietary supplements should be ensured at all stages of production and circulation. According to the proposed changes , the relevant contract may be concluded not only by the sponsor of the clinical trial , but also by their  authorized representative. In addition the mentioned procedures shall not be applied to the appeals against decisions made in the course of administrative violations proceedings. Prior to this Resolution adoption the list approved by the CMU Resolution a„– 400 March 29, 2006 was in force containing 783 products among which only 1 product was a medical device – test system. The essential medicines are selected with regard to the morbidity rate, comparative effectiveness and safety evidence, economic efficiency. The Skoll World Forum, viewed by many as the social impact sector's version of the World Economic Forum meetings in Davos, Switzerland, brought together 900 highly-selected attendees from leading organizations to explore new ways for civil society, often in partnership with business and government, to address global challenges like financial inclusion. Bob Annibale, Global Director of Citi Microfinance and Community Development, led a conversation with representatives from Nestle, Green Mountain Coffee Roasters, the Bill and Melinda Gates Foundation, and Root Capital (a Citi Foundation grantee) about how to bring additional value to smallholder farmers that grow staples like coffee and cocoa that many multinational buyers in turn sell to consumers. Employees who receive paper checks often turn to check cashers and other fringe financial services, costing the average worker $1,000 per year in fees. The CurrenC SF website offers how-to guides, marketing materials, best practices, and expert advice to employers, and connects employees to low-cost checking accounts and other healthy financial products. Department of Housing and Urban Development in response to the Neighborhood Stabilization Program Round II (NSP II) Notice of Funding Availability released on May 4, 2009.
The Prosperity Center is strategically located in a local middle school for convenient access by low- and moderate-income families and offers a wide range of free financial education workshops and services, including Earned Income Tax Credit (EITC) knowledge and free tax preparation that translates into recovered earnings and increased assets. This program targets communities of people who often are underbanked or unfamiliar with available financial services, including immigrants from Southeast Asia who live in the Sacramento area. Learn about their impact in the community and meet someone who has a decent, affordable place to live thanks to Cabrillo. In December, after being a customer for eight months, he declared he was ready to open an account. E-FILE web-based program developed by the Legal Aid Society of Orange County to help people file their taxes at no charge. Kramer, Executive Vice President for Regulatory Programs at Wolters Kluwer Financial Services. Kramer, Executive VP for Regulatory Programs at Wolters Kluwer Financial Services (sixth from right).
A Citi Foundation grant supports FRCs free volunteer income tax assistance (VITA) program, which helps low-and moderate-income (LMI) individuals and families claim the Earned Income Tax Credit (EITC), enabling them to save up to $360 by avoiding costly commercial tax services. Citi employees will donate their time through the entire tax season, providing onsite banking services at VITA sites in the Bay Area including at the FRC to help low-income families. Citi also has supported FRC's offering of Money$mart, a 10-module financial education program created by the FDIC, as well as financial counseling and coaching. Through its Money Savvy Youth program, which is supported by Citi, EBALDC teaches financial education to fourth and fifth graders in the Oakland public school district. With Citi's help, EBALDC was able to expand its Money Savvy Youth Program in 2011 to serve 20 out of 60 public schools in Oakland, reaching 750 students a€” almost double the number from the year before. Minority-owned businesses are extremely effective at driving economic growth and and the 'Bridges' program will create more than 200 jobs by the end of 2012.
The Center offers a ten-week series of small business seminars, taught by Citi volunteers, on entrepreneurial skills including developing a business plan, strategic marketing, product presentation, food-handling requirements, licenses and certification requirements. To date, 107 businesses have utilized Chef Center's community kitchen and their business training programs. For the best experience of this website, please upgrade to a newer version or another browser.
This is forcing the region’s oil producers to shift their focus to offshore opportunities in the Gulf, the Mediterranean and the Red Sea, all of which offer different challenges. Producing oil and gas offshore is recognised as one of the most challenging tasks in the hydrocarbons industry, with added costs and risks compared with operations onshore. The consequences of an incident in an offshore operation can often be far more catastrophic and far-reaching than a similar incident in an onshore setting, as was the case in the 2010 Gulf of Mexico oil disaster.  With most of the Gulf’s hydrocarbons already discovered … oil and gas companies are looking further afieldWithin this context, the Gulf provides one of the best offshore environments in the world for oil and gas production, offering shallow, warm and relatively calm waters.
Subscribe today and support your strategic planning with the MENA region’s best source of business information. In addition, we would like to mention a substantial expertise and due attention to this issue expressed by Antimonopoly Committee specialists.
The reimbursement of insulin products costs shall be fulfilled at the rate of reference price for the medicinal product approved by the Ministry of Health of Ukraine. The patients shall receive their medication for a lowered price or for free in accordance with these categories.
Business entity should submit the relevant report not later than the 5th day of the month following the reporting month, and in December — not later than the 24th day of the reporting month.
An important selection criterion is the presence of experience of the evaluation of the comparative efficacy (effectiveness), safety and cost-effectiveness of drugs.
This Order updates the mailing procedures for tax assessment notices to be sent to taxpayers by regulatory authorities. Today the AMCU increased the penalty up to 30% of the revenue from the sales of the products (goods, works, services) that violated the legislation on the protection against unfair competition. In the end of the session the Legal Alliance senior associate Alexander Bondar presented a report on the new public procurements law, which practically implements the electronic procurements (electronic auction), electronic system of appeal, and the exchange of information, documents, submission of explanations in the electronic procurements system.
In the course of his report the delegated had an opportunity to discuss the plans and implementations of 2015 and to share their expectations and forecasts for the coming year. After he passed the floor to the special guests of the conference - Aliona Kushnova, Judge at the regional Kiev administrative court, and Jonas Triggvason, Managing Partner, UPharma Consulting. The session was traditionally opened with an analytical report on the status of the pharmaceutical market in 2015 presented by Irina Gorlova, General Director, SMD.
Vitalii Savchuk, Senior Associate, Legal Alliance, presented a report on the most high-profile cases, investigations and court practices regarding the pharmaceutical industry. Before 2006 the list approved by the CMU Resolution a„– 1482 as of November 16, 2001 was acting. With a dramatically growing demand for sustainable and certified products (fair trade, organic, etc.), multinationals such as Nestle are developing shared value approaches to their sourcing and supply chain to ensure a higher quality and quantity with greater consistency. CurrenC SF empowers San Francisco's businesses and workers by helping them adopt modern, innovative payroll solutions. In addition, the San Francisco Office of Financial Empowerment has worked with payroll companies, payroll card providers, banks, and other financial institutions to develop a list of healthy alternatives for businesses to consider when moving to direct deposit. Citi volunteers will participate as financial education teachers, tax preparation guides and mentors for the students. Since its inception, the Financial Literacy and Asset Development Program has helped hundreds of individuals to understand the financial services available to them and to acquire the knowledge needed to build assets. He had heard the tellers talk about the accounts for months, but needed time to build his trust. Since 2004, more than 14,000 filers have taken advantage of this program, resulting in the return of more than $21 million in federal refunds, including $12 million through the EITC. In addition, Citi has provided Individual Development Accounts (IDAs), which are matched saving accounts, through FRC.
As an added benefit, the participating small businesses will renovate foreclosed properties and increase the supply of affordable housing. This allows seismic surveys to be carried out easily and has other advantages, including the relative ease with which oil and gas rigs can be constructed, pipelines laid and other facilities installed.Major oil and gas producersThe Gulf holds some of the world’s largest oil and gas reserves, and is home to the biggest offshore oil and gas fields.
It is well understood that sometimes there is a definite need for relaxation and recuperation. SleepWalker was designed for multi-purpose use 2 pills to boost your mood, 4 pills for the maximum euphoric pleasure. Our joint efforts led us to the implementation of the project that only yesterday seemed to be almost impossible”. The reports should be submitted to local budgets holders who have been legitimately assigned for the execution of operating expenses of local budgets for preferential provision of insulin products to diabetic patients defined by the decisions on such expenditures in accordance with the legislation for the reimbursement to business entity of the amount stated in the register within 15 days upon the report receipt.
In addition to a lot of interesting facts the reporter highlighted that the total volume of the medicinal products market in Ukraine amounted to 2.1 billion USD in 2015. The goal of this initiative is to achieve a fully electronic, paperless payday, helping to bring thousands of San Francisco households into the financial mainstream and reducing reliance on high-cost check cashing services. Motivated by a desire to build his savings so that he could return home to visit his family, he decided that a 'My Piggy Bank' account would work well for him. Households that earned less than $49,000 in 2010 are eligible for free tax preparation at VITA sites. This unique public-private collaboration, designed and supported by Citi Community Development, provides a blueprint for other local governments to put minority-owned small businesses at the center of neighborhood revitalization. After the courses, many of the students took the next steps in starting food service enterprises, and many have continued to use Chef's Center's kitchen services.
With that in mind, Red Dawn created the finest blend of ingredients to make your worries disappear.
Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development APRaD. Saudi Arabia is the biggest offshore oil producer, while Qatar and Iran are the largest in the gas sector.All major oil producers in the Middle East, with the exception of Iran, are supported by several international oil companies (IOCs), as well as engineering consultancies and specialised offshore engineering, procurement and construction contractors. In the framework of this session the participants discussed the adjustments in the personal data protection, as well as promotional activities and programs of the pharmaceutical companies. Therefore, the National Essential Medicines List did not function properly from the very beginning of its development.
This support is either in the form of production-sharing agreements for the fields or specialist long-term agreements for maintenance programmes. Many new offshore projects in the Gulf are executed by building man-made islands with a pipeline back to the mainland. This means most new drilling rigs are unmanned and are controlled from the shore using computerised operation equipment.Saudi Arabia controls the world’s largest offshore oil field and has also started operations on its first offshore non-associated gas field. The best retail figures are shown by dietary supplements, patients care items and medicinal products, the worst figures – personal care products and cosmetics. He casually mentioned that he had thought about buying a house one day but knew it would be difficult since he did not have any credit history. Session speakers - Zoya Zamikhovska, Junior associate, Lidiya Sangarovskaya-Gulach, Senior associate, and Andrii Gorbatenko, Associate partner, who presented to the audience their reports on medicinal products advertising, marketing agreements in the pharmacy sector, and distribution contracts. The teller described our 'My Fresh Start' loan, a product she was very familiar with since she had recently completed her own loan. Andrii Gorbatenko emphasized the types of law infringements foreseen by the competition law, and paid the attendees attention to the provisions of distribution contracts, which are attracting a close attention of the Antimonopoly Committee of Ukraine, in particular the provisions regulating the reports, discounts and bonus payments. She mentioned the benefits of the loan: in addition to building credit history it is structured so the member amasses $500 in savings when the loan is paid off. This figure does not include its share of the oil and gas produced in the Divided Zone between Kuwait and Saudi Arabia.The kingdom is increasing its gas operations, but the Gulf’s major producers are Qatar and Iran. Gas production has increased over the past 10 years as Qatar ramped up its operations in line with huge onshore infrastructure investment. In the span of 12 months, Jose went from being a repeat check-cashing client to an account-holder with a 'My Piggy Bank' account and, now, a borrower.
Qatar is now the largest exporter of liquefied natural gas in the world, with a capacity of 77 million tonnes a year.  Most of this gas comes from the world’s largest non-associated gas field, located in the territorial waters of Qatar and Iran. Called the North Field by Qatar and South Pars by Iran, the field covers a total area of 9,700 square kilometres, with 6,000 sq km in Qatari waters and 3,700 sq km in Iran. The field has estimated gas reserves of 1,800 trillion cubic feet and an additional 50 billion barrels of condensate.Iran is struggling to maintain production at its offshore operations due to sanctions imposed by the international community. This means that much of the technology and services available to its neighbours from IOCs and engineering consultancies is not available to Tehran.The vast majority of the UAE’s offshore operations are carried out by Abu Dhabi.
Abu Dhabi is currently initiating a spending programme aimed at expanding its offshore operations.With most of the Gulf’s hydrocarbons already discovered and being exploited or under development, oil and gas companies are looking further afield. If the 100-billion-barrel figure is correct, the first phase of development is expected to be worth at least $25bn. If enough hydrocarbons reserves are discovered, this figure could rise fourfold. Deep sea challengeBut the Red Sea presents a very different challenge to the Gulf. The Red Sea is deep water and the conditions are similar to the North Sea in Europe or the Gulf of Mexico in the US.
A major new hub will also have to be built, with oil industry executives discussing the port city of Dhuba as the likeliest location.  In the Mediterranean, IOCs working off the coast of Libya are now restarting exploration activities.



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