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PHARMACEUTICAL INDUSTRY PRACTICE GROUP |
The CLS pharmaceutical industry practice group advises pharmaceutical companies and companies engaged in diagnostics, clinical trials and operating drug stores. Representative matters include advising on the construction of new manufacturing facilities in several alternative regions in Russia, price regulation, interaction with government regulatory bodies and other issues of importance to the pharmaceutical industry. Our attorneys have extensive experience working in-house in major pharmaceutical companies and know the industry well.
Our projects for pharmaceutical companies have included:
- Assistance to international drug companies incorporating and developing business in Russia, organization of Representative Offices, negotiation of office leases, tax planning, and comprehensive legal support for business startups;
- Assistance in organizing the manufacture of pharmaceutical products, including participation in pharmaceutical clusters being developed in Leningrad, Yaroslavl, Kaluga Regions and other regions of the Russian Federation;
- Legal support for contracts with distributors and drug store networks, subject to restrictions imposed by the industry-specific and antitrust legislation, including drafting and enforcing distribution agreements, advising on marketing and discounting policies, and agreements with pharmaceutical institutions;
- Advising on the circulation of vital and essential drugs including price control issues;
- Legal support for promotion and advertising of drugs and medical goods;
- Assistance in interaction with the Federal Antitrust Service (the "FAS"), assistance in the course of FAS inspections, staff training, legal recourse against competitors’ unlawful actions and responses to competitors’ claims, and advice on state and municipal tenders;
- Legal support for drug clinical trials, agreements for holding clinical trials, assistance in arranging document flow, including informed consents by patients, and control over compliance with legislation on personal data
- Consulting on issues concerning medical equipment and medical goods;
- Assistance in obtaining licenses for pharmaceutical activity, the manufacture of drugs and medical equipment, the maintenance of medical equipment, and activity related to the circulation of illicit and psychotropic drugs;
- Interaction with the government authorities that regulate the pharmaceutical industry, including Roszdravnadzor and Minzdravsotzrazvitiya, as well as customs bodies, and currency control bodies; drafting requests, official correspondence, representation in proceedings related to administrative offences;
- Advising on relations with medical representatives and arranging their interaction with doctors and pharmacy institutions;
- Advising on the packaging, storage and transportation of drugs, including thermolabile preparations;
- Tax advice on various aspects of the pharmaceutical industry, including issues concerning the discounted value added tax ("VAT") rate for medical devices, and planning and recordkeeping for drug advertising expenses;
- IP issues, including consulting protection of rights to results of a drug company’s intellectual activity, trademarks, patents; and protection of manufacturers of drugs from unlawful manufacture of generics;
- Legal support for the import of drugs to the Russian Federation, and advice on customs issues;
- Representation before commercial arbitration courts, courts of general jurisdiction, and in arbitration proceedings on any issues arising in a medical company’s business.
We are glad to be useful to you in any legal aspect of your business related to pharmaceuticals, diagnostics, clinical trials and the pharmacy business. To discuss legal issues with our drug work group, please contact Vladislav Zabrodin or Derek Bloom.
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