Legal advice on the formation of lists of medicines

Amendments to the registration documents of medical devices

BRACE Law Firm, within the framework of the “Healthcare and Pharmaceuticals” practice, provides legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law. We provide legal assistance in the areas of business support, dispute resolution and litigation, government and corporate procurement, antitrust law, international trade law, regulatory issues, and compliance.

One of the important areas of legal services in the framework of the practice “Health and Pharmaceuticals” are the services in the field of forming lists of medicines.

Formation of lists of medicines

Decree of the Government of the Russian Federation of August 28, 2014 No. 871 approved the rules for the formation of the List of Vital and Essential Drugs Use and the List of Medicines designed to provide people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissue, multiple sclerosis, hemolytic-uremic syndrome, juvenile arthritis with a systemic onset, mucopolysaccharidosis I, II and VI types and those after transplantation of organs and (or) tissues. The List of Vital and Essential Drugs is compiled according to international nonproprietary names of drugs for medical use that meet the following criteria:

• the drug is registered in the prescribed manner in the Russian Federation;

• the drug is used for the diagnosis, prevention, treatment and rehabilitation in the provision of medical care in case of diseases and conditions, including those prevailing in the structure of morbidity in the Russian Federation;

• a drug has an advantage over other drugs in treating a particular disease or condition.

The list of expensive drugs is compiled according to the international non-proprietary names of these drugs from drugs that meet the following criteria:

• the drug is registered in the prescribed manner in the Russian Federation;

• the drug is included in the List of Vital and Essential Drugs;

• the drug has an advantage over other drugs in the treatment of people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, hemolytic uremic syndrome, juvenile arthritis with systemic onset, mucopolysaccharidosis of types I, II and VI, as well as individuals after transplantation of organs and (or) tissues.

The specifics of their treatment and the possibility of providing some advantages in the circulation of such drugs will depend on which particular drugs will be included in the above lists.

To consider the possibility of including drugs in one of the above lists, it is necessary to submit an appropriate application with a set of documents established by the Government of the Russian Federation. However, to achieve the result of including the drug in the lists, it is necessary to comply with the requirements for the application and documents.

Legal services

    1. Consulting support when the client independently forms an application and a set of documents for inclusion in the lists of medicines
    2. Provision of services for the preparation of legal opinions on the appropriateness/inappropriateness of inclusion in the lists of medicines
    3. Assistance in the preparation and submission of an application for inclusion in the lists of medicines with the formation of a complete package of necessary documents and its submission.
    4. Representation of interests when submitting and considering the relevant application for inclusion in the lists of medicines
    5. Legal support for the exclusion of a drug from the lists of medicines, including legal analysis of the grounds for such exclusion. Legal assistance in appealing against the illegal compulsory exclusion of their lists of medicines.

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