Differentiation of the production of medicines and pharmaceutical activities
https://doi.org/10.17803/1994-1471.2019.100.3.134-141
Abstract
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.
About the Author
K. S. Soloviev
Kutafin Moscow State Law University (MSAL)
Russian Federation
Russian Federation
Postgraduate of the Department of Entrepreneurial and Company Law,
125993, Moscow, ul. Sadovaya-Kudrinskaya, d. 9
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Review
For citations:
Soloviev K.S. Differentiation of the production of medicines and pharmaceutical activities. Actual Problems of Russian Law. 2019;(3):134-141. (In Russ.) https://doi.org/10.17803/1994-1471.2019.100.3.134-141
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