Consulting during audits of healthcare organizations

Amendments to the registration documents of medical devices

BRACE Law Firm provides advice on the conduct of inspections of pharmaceutical organizations and companies in the field of circulation of medical devices.

Any inspection requires careful preparation by the inspected entity. To avoid illegal actions of inspection bodies, it is important to know the procedural features of inspections and the authority of inspection organizations.

The activities of pharmaceutical companies and organizations in the field of the circulation of medical devices are controlled by many state bodies. In particular, inspections can be carried out by the Federal Antimonopoly Service, the Federal Service for Supervision of Healthcare, the Federal Service for the Protection of Consumer Rights, the Federal Service for the Protection of Consumer Rights and Human Well-being, the prosecutor's office, and law enforcement agencies, etc.

A special place in control over the activities of pharmaceutical companies is licensed control over the circulation of medicines and medical devices. As a general rule, the subject of an unscheduled on-site inspection in accordance with the procedure of licensing control may be the condition of premises, buildings, structures, technical equipment, equipment, other objects that are supposed to be used by the license applicant or licensee in carrying out the licensed type of activity, and the availability of employees necessary for carrying out such activities complying with licensing requirements.

The subject of federal-state supervision in the field of the circulation of medicines may be the verification of compliance by the subjects of the circulation of medicines established by the Federal Law April 12, 2010 N 61-FZ “On the Circulation of Medicines” with the requirements for preclinical studies of medicines, clinical trials of medicines, storage, transportation, import into the Russian Federation, dispensing, sale of medicines, use of medicines, destruction of medicines funds, as well as the conformity of medicines in civilian circulation with the established mandatory requirements for their quality.

Persons in respect of whom the audit is carried out must submit to the antimonopoly authority (its officials), at its motivated request, the required documents, explanations, information, respectively, in written and oral form (including information constituting commercial, official, other protected by law, within the established deadline secrecy), including acts, contracts, certificates, business correspondence, other documents and materials made in the form of a digital record or in the form of a record on electronic media. It is quite common for Federal Antimonopoly Service of Russia to check pharmaceutical companies for cartel conspiracies.

The prosecutor's office of the Russian Federation is endowed with fairly broad powers to oversee compliance with the law (including in the field of pharmaceutical medical law).

Legal services

    1. Advice on the conduct of all types of inspections
    2. A steam analysis of the legality of the grounds for initiating an audit.
    3. Analysis of documents and materials requested to conduct an audit with the determination of the validity of the request and the legitimacy of the requirements of the inspection authority
    4. Informing the client about the risks of prosecution based on the results of inspections and developing proposals to minimize such risks to relieve liability or mitigate liability measures
    5. Representation of client interests in inspection bodies
    6. Legal support in contesting decisions and actions (inaction) of the checking authorities in higher authorities
    7. Representation of interests in judicial instances when contesting unlawful actions of authorities during inspections, as well as contesting unlawful prosecution based on the results of such inspections

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