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LEGAL ALLIANCE, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries.

OUR CLIENTS represent the following industries: pharmaceuticals, medical devices, consumer goods, medicine, cosmetics, para-pharmaceuticals, chemistry, biotechnology, agriculture and food products.

LEADING ASSOCIATIONS — AIPM Ukraine, APRaD as well as the EBA Healthcare Committee have chosen Legal Alliance as their legal advisor.

Policy Making

Legal Alliance Company possesses a significant experience in policy making, mainly in the area of pharmaceutical regulation, as well as in counseling regarding their legal support and coordination with central executive authorities.

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OUR EXPERIENCE

1. Legal Alliance team drafts the package of documents aimed at adoption of National Essential Medicines List being elaborated on the basis of legal regulation of World Health Organization.

The developed concept stipulates that National Essential Medicines List shall comply with the latest version of Basic Essential Medicines List of World Health Organization. This list is to be adapted to the needs of Ukrainian patients taking into consideration the capabilities of public funding.

The work included drafting and approval of the following legal regulations:

At the moment, the Draft Resolution of the Cabinet of Ministers "On Amendments to Decree of the Cabinet of Ministers of Ukraine No. 333 dated March 25, 2009", developed with the participation of the Legal Alliance, is being submitted for public consideration. By this document the National List of Essential Medicines must be approved.

2. The Company’s associates supported the elaboration of Draft Law of Ukraine “On Medicinal Products” №2162, registered in the Parliament on 17.02.2015.

European model of operation with medicinal products stipulated by EU Directive 2001/83 formed the basis the Draft Law. As this regulation does not cover the full spectrum of required issues, certain chapters of the Draft Law have been developed in accordance with European countries’ experience. The peculiarities of Ukrainian pharmaceutical market were absolutely taken into account.

The Draft Law was highly appreciated by the experts of World Health Organization.

3. In 2013 the Company elaborated certain Draft Resolutions of the Cabinet of Ministers of Ukraine aimed at adaptation of Ukrainian legislation to the requirement of the Global Fund to Fight AIDS, Tuberculosis and Malaria, in particular:

4. Dmytro Aleshko, partner, as well as Alexander Bondar, senior associate, acts as a Consultant to United Nations Development Program in Ukraine regarding policy making in the area of public procurements of medicinal products and medical devices conducted by the Ministry of Health of Ukraine with the involvement of international specialized organizations (UNDP, UNICEF, WHO and Crown Agents).

In particular Legal Alliance team extended its legal support regarding the following legal regulation:

5. In 2012-2014 Mr. Aleshko acted as a Vice-President of Association “Market Operators of Medical Devices”. In cooperation with the Association he participated in the drafting of changes to the Laws of Ukraine, Resolutions of the Cabinet of Ministers of Ukraine, Orders of the Ministry of Health of Ukraine that regulate the activity of medical devices market operators, in particular:

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