Regulation of drug circulation. Major terms and concepts in the field of drug circulation

For the first time, the term "sphere of appeal of the HP" was introduced into pharmaceutical practice with the publication of the Federal FZ RF No. 86-FZ "On medicinesah "(1998), which is represented legal basis Activities of Subjects pharmaceutical market (physical I. legal entitiesexercising pharmaceutical activity).

Appeal of the LS-generalized concept of activities, including development, research, production, manufacture, storage, packaging, transportation, state registration, standardization and quality control, sale, labeling, advertising, the use of drugs, the destruction of drugs that have come into disrepair, or LANs with an expired expiration date and other actions in the field of HPP.

Aspects of storage, packaging, sales, marking, advertising are important for goods analyzing from the sphere of circulation of drugs.

In this regard, it is advisable to consider the basic concepts and terms used in these activities of the FD.

Drugs - Substances used for prevention, diagnosis, treatment of disease, prevention of pregnancy, obtained from blood, blood plasma, attacks of organs, human or animal, plants, minerals, synthesis methods or using biological technologies. The LAN also includes

substances of vegetable, animal or synthetic origin, which have pharmacological activity and intended for the production and manufacture of drugs.

Medications - Dosage LS, ready for use.

Immunobiological LS are intended for immunological prevention and immunological therapy.

Narcotic drugs are LS included in the list of narcotic drugs, compiled and updated in accordance with the Unified Convention on narcotic drugs 1961 and legislation Russian Federation.

Psychotropic substances - substances included in the list, compiled and updated in accordance with the Convention on psychotropic substances 1971 and legislation of the Russian Federation.

Patented LS are medicinal products, the right to the production and sale of which is protected by the patent legislation of the Russian Federation.

Illegal copies of drugs - drugs enrolled in violation of the patent legislation of the Russian Federation.

Original drugs - drugs enrolled in circulation of registered own names.

Reproduced LS (generics) - drugs received in appeal after the expiration of exceptional patent rights to the original LS.

• Instructions for the use of norms of natural loss of medicines and medical products in pharmacy organizations, regardless of the organizational and legal form and form of ownership
• Norms of natural decrease in the storage of medicines in pharmacy institutions (organizations), organizations of wholesale trade in medicines and healthcare facilities
• Order of the Ministry of Health and Social Development of the Russian Federation of January 9, 2007 N 2 "On approval of the norms of natural loss during the storage of medicines in pharmacy institutions (organizations), organizations of wholesale trade in medicines and healthcare facilities"
• Normal loss of medicines and medical products in pharmacy organizations regardless of the organizational and legal form and form of ownership
• Order of the Ministry of Health of the Russian Federation of July 20, 2001 N 284 "On approval of norms of natural loss of medicines and medical products in pharmacy organizations, regardless of the organizational and legal form and form of ownership"
• Instructions on the application of marginal norms of natural loss (production waste) of decisions of drugs on pharmacy warehouses