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LIFE SCIENCES LAWYERS | UKRAINE & CIS
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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.

Pharmaceutical Regulatory

The practice of pharmaceutical regulatory is one of the priority practices of Legal Alliance Company

Due to the long-term collaboration of the Company with representatives of national regulatory bodies, active membership in professional associations and public councils at the public authorities, special education of our lawyers and their experience in the healthcare system of Ukraine, as well as a unique expertise in law-making, today we are offering our clients a unique set of legal services to address issues related to the pharmaceutical regulatory.

Within this practice, we provide legal advise on the regulation of industries (pharmaceuticals, medical products, hygienic products, cosmetics, etc.) and certain activities (public procurement, pricing, clinical trials, etc.).


OUR SERVICES

Law-making

  • Development of draft regulatory acts in the field of healthcare and accompanying documents thereto.
  • Legal support for the process of approval of the mentioned documents with the executive authorities and their units.

Licensing and certification of production, control over quality and safety of medicines:

  • Consulting on licensing issues.
  • Legal support in obtaining a license.
  • Conducting legal examination for compliance with the licensing conditions.
  • Legal support during pre- and post-licensing inspections.
  • Consulting on compliance with Good Manufacturing Practices (GMP) and Good Clinical Laboratory Practice (GCLP).
  • Legal support for the receipt of the Certificate / Opinion of the State Drug Service on compliance with GMP.

Clinical trials and post-marketing research:

Consulting on procedure and requirements to the subjects.

  • Development of a financing scheme.
  • Development of draft agreements with contractor research organizations, clinical bases, researchers and insurance companies.

Issues of export and import of medicines:

  • Development of schemes for the supply of medicines to Ukraine, development of draft agreements accompanying the supply of medicines.
  • Legal advising and support for obtaining a license to import medicines.
  • Conducting due diligence for compliance with import licensing conditions.
  • Legal support during pre- and post-licensing inspections of business entities.
  • Advising on compliance with the Customs Code of Ukraine.
  • Obtaining the status of a customs warehouse.
  • Settlement of disputes with customs authorities, including the determination of customs value and the reclassification of medicines and medical products based on the Ukrainian Classification of Products in Foreign Economic Activities.

Wholesale and retail trade in medicines:

  • Advising on obtaining a license.
  • Legal support in obtaining a license.
  • Conducting legal examination for compliance with the licensing conditions.
  • Legal support during pre- and post-licensing inspections.
  • Legal support for the accreditation of pharmacy institutions.
  • Contractual registration of procurement of medicines.
  • Advice on compliance with Good Distributory Practices (GDP), Good Pharmacy Practice (GPP), Good Storage Practices (GSP).

State price regulation

  • Advising on the setting of wholesale and retail mark-ups and other issues of pricing for medicines.
  • Advising on the declaration of ex-factory prices. Legal support for the declaration process.

Public procurement:

  • Advising on procurement issues.
  • Providing legal support in the procurement process to its participants.
  • Accompanying appeals against procurement procedures in the Antimonopoly Committee of Ukraine and the courts.

Turnover of medical products:

  • Advising on the quality and safety of medical products.
  • Legal support for obtaining the certificate of compliance of medical products with the technical regulations.
  • Advising and providing legal support for the implementation of Technical Regulations.
  • Legal support for certification / declaration of medical products.
  • Advising on national standards on medical products, classes and compliance assessment modules.

OUR EXPERIENCE

  • Legal support for the development and approval of by-laws with a view to introducing an updated National List of Essential Medicines based on the WHO model in Ukraine.
  • Legal support for the development and approval of the National Drug Policy based on international experience with the aim of harmonizing Ukrainian legislation with the EU legislation.
  • Legal support for the implementation of the medicines and medicinal products procurement mechanism with the involvement of international specialized organizations.
  • Providing legal advice to an international specialized organization in the field of procurement of medicines and medical devices.
  • Providing legal assistance in the process of reforming the mechanisms of public procurement of medicines and medical products.
  • Representation of the clients' interests in the Antimonopoly Committee of Ukraine in connection with the consideration of complaints regarding violations of legislation in the field of public procurement.
  • Legal support for the preparation of a new edition of the Law of Ukraine “On Medicines”
  • Providing legal support to the Ministry of Health of Ukraine on introduction and implementation of the reimbursement system “Affordable Medicines”, pricing in connection with currency fluctuations, improvement of the procedure for declaring ex-factory prices for medicines.
  • Providing legal support to the Ministry of Health of Ukraine on preferential and free dispensing of medicines through pharmacies.
  • Advising pharmaceutical market entities in the sphere of price regulation on medicines and medical products, in particular, those procured for budgetary funds.
  • Legal support for the development and approval of by-laws in the sphere of medical products turnover, in particular regarding the implementation of compliance assessment and taxation of operations with medical products.
  • Development of regulatory acts in the field of control over observance of rights and ensuring the safety of patients in the provision of medical services, regarding the competition for positions of heads of state and municipal healthcare institutions and concluding contracts with them, and supporting the approval process thereof.
  • Advising an international organization in the field of combating the spread of tuberculosis, HIV / AIDS.
  • Advising a number of pharmaceutical companies on licensing of the import of medicines, registration of drugs, in particular examination of registration materials, labelling of packages.
  • Accompanying the process of obtaining a license for the retail sale of medicines, as well as a license for medical practice.
  • Accompanying projects for the declaration of prices for a total of more than 100 names of medical products and medicines.
  • Development of pharmacovigilance agreements, model provisions for pharmacovigilance for the implementation in the pharmaceutical companies contracts.
  • Representation of the pharmaceutical company in a case of the ban on its drug turnover on the territory of Ukraine.
  • Other projects.

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