Import and export of medicines, medical devices, dietary supplements
Legal services (legal assistance) on the import and export of medicines, medical devices, dietary supplements
An important area of practice of BRACE Law Firm is the provision of legal advice on legal advice on the import and export of medicines, medical devices, dietary supplements.
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.
Legal regulation of the import/export of medicines, medical devices, dietary supplements
Legal regulation of the import/export of medicines, medical products, and dietary supplements has its own characteristics.
Decree of the Government of the Russian Federation “On the Procedure for the Importation of Medicines for Medical Use into the Territory of the Russian Federation” established a certain subject composition of persons who can import medicines into the territory of the Russian Federation, which includes the following legal entities:
- manufacturers of medicines for the purposes of own production;
- organization of wholesale trade in medicines; foreign drug developers and foreign manufacturers;
- scientific organizations, educational organizations of higher education and manufacturers of medicines with the permission of the Ministry of Health of Russia;
- medical organizations for providing medical care according to the vital indications of a particular patient.
For the importation of drugs into the territory of Russia, it is necessary to obtain an appropriate permit from the Ministry of Health of Russia.
As a general rule, the circulation of medical devices in the Russian Federation is permitted only after their state registration. Thus, the import into the Russian territory of unregistered medical devices is possible only after issuing a permit for a single import into the territory of Russia of medical devices for state registration within 6 months from the date of issue. The registration term after a single import is 6 months.
In accordance with the legislation of the Eurasian Economic Union, the treatment of dietary supplements is possible only provided that they have passed the necessary conformity assessment procedures established by the technical regulations of the Customs Union.
In general, the procedures for importing and exporting from the territory of the Russian Federation medicines, medical devices and dietary supplements differ in their specificity and require interaction with regulatory authorities, as well as a quality approach to the preparation of all necessary documents.
Thus, due to the multidimensional nature of the actions required to be carried out for the import and export to/from the territory of the Russian Federation of medicines, medical devices, and dietary supplements, as well as high material risks if import/export is found to violate the requirements of the legislation of the Russian Federation or legislation of the Eurasian Economic Union, high-quality and timely legal support in the framework of the support of these legal relations is especially important.
- Legal analysis of documents submitted by the client
- Consultation of lawyers and lawyers of BRACE Law Firm
- Legal advice on issues related to the import/export of medicines, medical devices, dietary supplements
- Legal support of the import/export of medicines, devices, dietary supplements
- Legal support on issues related to the emergence, amendment or termination of legal relations in the process of import/export of medicines, medical devices, dietary supplements
- Development and legal examination of the documentation necessary for the legal support of the import and export of medicines, medical devices, dietary supplements
- Preparation of legal opinions on the importation and exportation of medicines, medical products, dietary supplements