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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. The sub-working group members are responsible for the implementation of essential medicines concept, establishment of the state priorities for participation in the pharmaceutical sector according to national morbidity rate. The Order provides for a simplified assessment procedure of the registration materials for the medicinal products that are purchased on budgetary funds via specialized international organizations.
Therefore, as opposed to the general procedure, the assessment does not provide for the conduct of a preliminary or specialized examination of registered materials for the validation of quality, safety and effectiveness of the medicinal product. It is to be noted that in order to conduct the assessment for the authentication of materials, a batch of documents is submitted, which differs from the one required for the general assessment. The materials from the register dossier, which were submitted to the state authority at the place where the product has been registered for the registration of the medicinal product or for the reclassification of this medicinal product by the WHO.
It is to be noted that unlike the general procedure, the applicant submits all of the documents to the Ministry of Health, which in turn forwards on its' own within one working day the documents required for the assessment to the State Expert Centre. It should also be noted that the deadline for the conduct of the assessment is five working days. In accordance with the results of the authentication expertise, the SEC  compiles a conclusion, which is forwarded to the Ministry of Health within one working day. It is to be reminded that under current legislation the Ministry of Health has 7 working days (as opposed to 1 month for the general procedure) to make a decision concerning the state registration of a medicinal product, which is procured by international organizations. The first session of the meeting was devoted to the development of a strategic approach to ensure access to better medicines for the population as well as specific issues of concern, which is likely to face in the background of medication for the population and also to more specific issues with will possibly be met against the background of changes in the demographic, economic conditions and modalities of the pharmaceutical market.
Moreover, the provisions of the Draft Law specify the AMCU decision making procedure for the concerted actions and concentration permission. The Draft Law specifies in details the AMCU actions when there are sufficient grounds for the concerted actions and concentration prohibition.
With that, in order to reject the information provision it is unnecessary for the agency that received the data to be the same agency that requested it.
In case of the corresponding inquiry the responsible for information provision authority should submit the written rejection to the AMCU department, which requested the information, together with the indication of the reference data of the letter that previously revealed the requested information.
Therefore, the Draft Order proposes to include the new provision into the List of Medicinal Products Data, which is submitted for the Register. The same information should be indicated in the Extract form the Register according to the Annex 2 of the Rules of Procedure of the Register. Therefore, the updated List provides the new version of the paragraphs, which contained the list of medicinal products and medical devices for children with oncology and oncohematology diseases available for centralized procurements in 2015. One of the positive aspects of Licensing Requirements is the implementation of the comprehensive list of requirements compulsory for the licensee, and the complete list of documents attached to the license application for license acquisition for manufacturing, wholesale and retail trade, and import of medicinal products. Licensing Requirements approved the list of necessary documents or their copies, which the licensee should store during the whole term of license for the purpose of accuracy confirmation of the data provided by the licensee. The Licensing Requirements also provide for the clarification of qualification requirements to the personnel of license holders. The participants of the meeting discussed the completion status of the legal regulations for the implementation of European approaches to the abovementioned list development. The Draft Resolution also entrenches the provisions for medical practice licensing of the individuals entrepreneurs, who do not have a special education and do not satisfy the unified qualification requirements approved by the Ministry of Health of Ukraine. Moreover, the Draft Resolution provides a range of requirements to the development of unified management and quality control system for medical services rendered by the business entity.

It is to be noted, that at the end of October The Ministry of Health signed an agreement with the U.N Development Program (UNDP) concerning the provision of services for the purchase of medicinal products on the sum of 620 million hryvnas. It is to be noted that the pharmaceutical legislation team of Legal Alliance Company, under the management of Dmytro Aleshko contributed to the facilitated the finalization of a number of legal acts aimed at the implementation of public procurement with the assistance of specialized international organizations, which were adopted by the Cabinet of Ministers of Ukraine as of November, 2015. In general, the draft decree, like its predecessor, regulates the procedure for providing access to the Patients’ Registrar doctors of health facilities authorized to have information about patients by employees of the Ministry of Health of Ukraine, responsible for the review and analysis of impersonal information, as well as pharmacies, which are entitled to perform supply of medicines on prescriptions with access to the patients registrar. Another common feature is the establishment of a comprehensive list of information about the patient included in the Patients’ Registrar and the procedure for its formation and maintenance. It is required to adhere to 2 conditions simultaneously when determining the excess sum of dividends available for distribution for which the income tax advance installment is calculated over the tax object value during the relevant fiscal (reporting) year. Tax liabilities payment procedures for the income tax during dividends distribution is designated in the paragraph 57.11 article 57 of the Tax Code. If the dividends are distributed for an incomplete calendar year, the tax object value shall be used for the amount calculation of the mentioned excess sum. State Fiscal Service made it clear that the cost of unsuitable for selling and submitted for reprocessing goods shall be included into the cost of new products increasing VAT charges accordingly. In view of the abovementioned, within the framework of legal support of the case Legal Alliance associates analyzed in detail all information components being published by pharmaceutical company for the compliance with applicable competition laws. The Draft provides, in particular, the procedure for labor contract conclusion, its terms and termination, the specification of labor payments in different conditions, the responsibility of the employer for untimely salary payment to the employees, etc.
Currently it is foreseen that the Labor Code upon approval shall come into effect on January 1, 2016. On the whole, great changes are expected for all labor market participants, which by no means shall have an impact on HR-departments and on every aspect of the relationship between the employers and the employees.
Nevertheless, today we believe that it is too early to give legal opinions for the new Draft of Labor Code is, as its provisions may significantly change and be amended in the nearest future. As a result of fruitful discussion between the working group members AMCU announced the decision to provide additional amendments to its Recommendations for pharmaceutical market players on the contents of marketing agreements and cost calculation of marketing services being rendered to the pharmacies. Moreover, the order provides for the application form on adjustment of registration materials. The approval of application forms with the fixed content shall minimize on the whole the risks of illegal refusal to business entities for state registration of the products due to formal issues. In accordance with the Order within the two month upon its approval, the Working Group shall develop the Draft Act of the Cabinet of Ministers of Ukraine regarding the Concept for Reformation of state procurement system for medicinal products and medical devices and publish it on official website of the Ministry of Health for public consideration. Important changes were introduced to the general procedures for state control of the quality.
Moreover, the Procedures foresee the possibility to issue a conclusion for the same series of medicinal products imported by different business entities according to the results of in-vitro analysis of the samples selected from one of them. As previously, the Procedures designate that medicinal product may not be recommended for state registration provided that the results of specialized expertize have not confirmed the conclusions on its efficiency, safety and quality, i.e. As opposed to the last Expertize Procedures drafts the new version foresee that in case of the applicants failure to submit registration materials after application filing for medicinal product registration such application shall be withdrawn within 3 business days and not within 10 days.
In particular, the State Expert Centre (SEC) examines only the authentication of the registration materials for the mentioned product category. However, the expertise of the materials of the medication, which is submitted for the State registration with a full dossier can continue for up to 210 working days. During the second session, the special place that pricing policies have in the wide spectrum of medicinal products was examines alongside the opportunities for the restrictions of various pricing mechanisms.

We express our gratitude to all the colleagues for such a high appreciation of our niche expertize.
In particular, it was proposed to bind the AMCU to provide the permission for the concerted actions and concentration if there are no grounds for their prohibition.
In such cases AMCU shall notify the participants and designate the term for participants’ proposals on their liabilities to eliminate the negative impact of the concerted actions on the competition.
Therefore, the commercial court should also use the abovementioned Methodology when considering such kind of cases. Consequently, this information shall be included into the Extract form the Register, which is provided upon legal and physical entities request. Therefore, the business entity should ensure the quality control for medical services; provide for in vitro and in vivo control of the laboratory studies quality (if there is a laboratory), etc.
The UNDP has intended to purchase medicinal products and medical devices for the treatment and diagnosis of tuberculosis, HIV- infections, treatment of children suffering from type A or B hemophilia, Villebrand disease, chronic viral hepatitis B and C and orphan diseases. Our associates still have a critical position according this draft law, as there is no place for the employees’ protection norms of the soviet times in a concurrent society. We are proud of the self-consciousness revealed by each community member for the common cause. In its turn, State Administration on Medicinal Products and Drugs Control had to be established as a merger of State Administration on Medicinal Products and State Administration on Drugs Control in view of implementation of the state course  on optimization of central executive authorities system.
Subject matter experts  and representatives from other Ministries, state authorities, non-governmental and international organizations, upon their consent in accordance with the law, shall be involved into this work, if required. Therefore, the Procedures provide that the copy of quality certificate issued by the manufacturer for each series of medicinal products and its translation being submitted by the applicant should be signed by the director or other authorized person, but sealed with a stamp only upon stamp availability. The basis for such actions is an application by the owner of marketing authorization or his official representative with additional documents confirming the fact of medicinal products delivery of the same series and their storage at the same customs licensed warehouse. Therefore, the Procedures have been published in the new version which currently provides for a number of different changes.
Yesterday, it was decided to start work on a national strategy for the pharmaceutical sector. Upon fulfillment of these liabilities the AMCU will be able to provide the permission for the concerted actions and concentration.
The information provider should also justify the non-disclosure status of the information, and submit to the AMCU the non-confidential version of the documents with removed, crossed out, or otherwise modified information, which may harm this provider if being disclosed. It is worth to mention that Legal Alliance Company participates in SIAPS project and is responsible for regulatory development within the framework of the project aimed at drafting of the new version of National Essential Medicines List. In case of the existence of unsettled bill of debts, the advance installment shall be calculated from the whole sum of dividends available for distribution.
With that the draft left the obligation for such entities to conduct quality control of the imported products on their own and to report on a monthly basis to the State Administration on Medicinal Products the results of such control. Herewith, these proposals should be negotiated between the participants and the AMCU in the course of joint consultations. Nevertheless, the issued permission for the construction stipulated the destruction of the entire recreation site of Bereznyaky residential area in Kyiv.

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