Medicine and Pharmaceuticals

It is a well-known fact, that an economy distinguishes a few irreplaceable needs of human being. Food, clothing, house, communication, ecclesiastical sphere and etc. are included in this section. Maybe, these statements cannot be named undisputable, but we will not question them. Instead, we’ll add medical treatment to the list based on the opinion of some authorities.   Medicine existed since the emergence of mankind and is one of the most important and demanded areas of social life. Of course, medicine and pharmaceuticals are interrelated, as without pharmaceuticals it is not possible to talk about qualified, comprehensive healing.

As with any activity, medicine and pharmaceuticals are regulated by the statute. However, lawmaker, understanding the importance of medicine and pharmaceuticals, appointed special legal status for this area of law. First of all, Federal Law from 04.05.2011 N 99-FL “On licensing of certain activities” establishes the necessity for the licensing of medical operation.  Secondly, the decree of Russian Government from 16.04.2012 N 291 “On licensing of medical operation (excluding activities carried out by medical and other organizations enrolled in the private system of healthcare in Skolkovo)” clarifies the actions and activities which should be licensed and also the order of licensing and the requirements for the licensee.

Similar norms may be found in respect of pharmaceutical activity (s.12 (1) (47) of Federal Law N99-FL and Decree of the Government of the Russian Federation from 22.12.2011 N 1081 “On licensing of pharmaceutical activity”). Adding to these, there are a lot of legal acts, containing requirements for conducting a medical and pharmaceutical activity. If we look at sections of the Administrative Misconduct Act of the Russian Federation or Criminal Law Act, we can surely say that non-compliance with requirements in this area of law leads to serious liability. For example, s.235 of the Criminal Law Act establishes criminal liability which involves up to 5 years of imprisonment. Everything mentioned above, points out a special attitude of the lawmaker to medical and pharmaceutical activity. Therefore, any organization, operating or planning to operate in this field, should be very careful.

First of all, it is necessary to study the legal basis of licensing of given activity and requirements for the licensees. After, it will be helpful to identify the main priorities in complying with these requirements, as compliance with all of them is not always possible. Of course, it is an immense volume of work, which can be handled only by the legal department. Also, considering the specific nature of the area of law, the work of the department does not exclude mistakes.

Mistakes in operation may lead to different legal consequences, from fines to revocation of the license, not to mention criminal liability. That is why it is important to pay close attention to the compliance with those requirements, noncompliance with which may lead to the most negative legal consequences.

Most certainly not every firm is prepared to maintain the whole legal department and vouch for the quality of their work. Usually, at the moment of employment, it is not possible to establish the size of knowledge, personal and legal qualities of the lawyer.

The only rational way out of this is attracting lawyers, who are well known for the quality of their qualified lawyers in this area.

Prime Legal LLC offers its service to support medical and pharmaceutical activities. We are prepared to provide a high level of quality of legal service and guarantee a conscientious attitude to the work. Prime Legal LLC always pays close attention to details, which allows ensuring the high level of quality of service. Our services are used by many large medical firms and organizations in Russia.

Our services include in medicine and pharmaceuticals include:

• Consultancy in the area of medical law and pharmaceuticals
• Analysis and development of the contracts
• Corporate issues
• Resolution of disputes with supervisory authorities
• Court representation
• Assistance in getting the license
• Other services of legal nature.

If you want to provide reliable legal protection, minimize risks in business operation, avoid negative legal consequence, you should turn to us.

Call to the Prime Legal LLC and we will assist you to provide effective legal protection of interests in almost any field of law.