Open AccessDifferentiation of the production of medicines and pharmaceutical activities
Author(s) -
K. S. Soloviev
Publication year - 2019
Publication title -
aktualʹnye problemy rossijskogo prava
Language(s) - English
Resource type - Journals
eISSN - 2782-1862
pISSN - 1994-1471
DOI - 10.17803/1994-1471.2019.100.3.134-141
Subject(s) - legislator , license , legislation , production (economics) , business , circulation (fluid dynamics) , law and economics , set (abstract data type) , law , public economics , computer science , political science , economics , engineering , microeconomics , programming language , aerospace engineering
On the basis of the concepts used in the legislation on the circulation of medicines (including the relevant provisions on licensing) the paper distinguishes between two licensed activities: drug production and pharmaceutical activities. The concepts of “manufacturing” and “production”, “vacation” and “sale” are related within the framework of the norms of the Federal Law dated April 12, 2010 No. 61-FZ “On Circulation of Medicines”, taking into account the need to separate economic activities according to the Russian Standard Industrial Classification of Economic Activities (OKVED 2) OK 029-2014. There are examples from judicial practice that consider cases when obtaining a license for pharmaceutical activity is not required (taking into account the objectives of the activity, as well as the list of entities established in the law that need to obtain a license for pharmaceutical activity). The problem of a significantly wider use of the concept of “pharmaceutical activity” in various special and scientific literature as compared with the definition set by the legislator is touched upon.