Legal support of medicines, medical devices, and dietary supplements manufacture
Legal services (legal assistance) on manufacture of medicines, medical devices, and dietary supplements
An important area of practice of BRACE Law Firm is the provision of legal services to support of medicines, medical devices, and dietary supplements manufacture.
Healthcare and pharmaceuticals are key areas of industry specialization for lawyers at BRACE Law Firm, in which we provide legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law.
Manufacture of medicines, medical products, and dietary supplements
For the production of medicines and medical products, a license is required. It is important to follow the correct procedures for conducting preclinical and clinical studies with subsequent state registration of medicines and medical devices. Besides, it is important to choose a land plot for the production premises, to comply with all requirements for industrial premises and production technology, as well as to carry out subsequent deliveries of manufactured medicines, medical products, and dietary supplements to the pharmaceutical market.
Each of these stages is subject to separate legal regulations and has its characteristics concerning each of the types of production facilities. This requires close monitoring of fairly frequent changes to the legislation governing each of the issues that manufacturers of medicines, medical devices, and dietary supplements have to deal with. Besides, in addition to knowing the requirements of current legislation, timely monitoring of law enforcement practice is required, as well as knowledge of the basics of the functioning of the market in the field of circulation of medicines, medical devices, and dietary supplements.
Localization of the production of medicines, medical products, and dietary supplements
With the introduction of a trend towards a decrease in the share of imported goods in the Russian market, the trend towards localization of production becomes particularly relevant. This is due both to the need for Russian manufacturers to start independent production of medicines, medical products, dietary supplements while maintaining the quality of foreign analogs and to the fact that foreign investors also remain interested in introducing their products on the Russian market, which helps to create a production on their part full cycle in Russia and other countries of the Eurasian Economic Union.
Localization of production may include the conclusion of investment agreements, determining the procedure for registration of drugs and medical devices, passing all necessary preclinical and clinical studies, resolving issues with the acquisition of assets necessary for localizing production. As a rule, the decision to localize production requires the adoption of quick and correct decisions aimed at the implementation of a comprehensive project. Localization of production requires not only one-time legal support but also legal assistance from lawyers with the skills to plan all stages of the project with the assessment of promising risks and the skills to resolve potential disputes.
Contract manufacturing of medicines, medical devices, and dietary supplements
Due to the emergence of additional requirements for the production of medicines, medical products, and dietary supplements, as well as the need for pharmaceutical products to meet GMP standards, situations arise when not all manufacturers can meet changing modern requirements. Nevertheless, the withdrawal from the market of small enterprises cannot be considered a positive trend for the economy. One way to avoid such adverse effects is the possibility of a partnership between various organizations in the pharmaceutical and healthcare sectors to create a product that meets all the requirements for production technology and product quality.
Contract manufacturing can be considered on the example of creating medicines, medical devices and dietary supplements developed by one manufacturer based on production capacities (based on the factory) of another manufacturer.
The organization of contract manufacturing requires legal support for such aspects of the project as agreeing with partners, adhering to the requirements for technological processes to maintain the quality of the production facility, calculating possible tax risks, preventing inspections of control bodies or protecting interests during inspections, etc.
- Legal advice at all stages of the manufacturing of medicines, medical devices, and dietary supplements
- Legal support of the manufacturing of medicines, medical devices, and dietary supplements
- Legal support on issues related to the localization of production
- Development and legal examination of contracts aimed at the interaction of partners in the production of medicines, medical devices, and dietary supplements
- Preparation of draft documentation necessary for the production of medicines, medical devices, and dietary supplements following the requirements of applicable law