Group names for herbal medicines: the need for introduction and rationale for establishing
Abstract
The article considers the importance of International Nonproprietary Names (INNs) and group names in the development of common information standards for the industry in the light of creation of the EurAsEC market and shared information space. The necessity to define the rules for assigning group names to herbal drugs results from the requirement introduced to Federal Law No. 61-FZ «On circulation of medicines», making it obligatory to specify group names on drug labels in the absence of INNs in the State Register of pharmaceutical products. The article covers the development of the methodological approach to establishing group names for the mentioned group of medicinal products.
About the Authors
M. N. Lyakina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. L. Kovaleva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
O. B. Nikolaeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. M. Krutikova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. G. Olenina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
L. A. Kolganov
Centre for Expert Evaluation and Quality Control of Medical Care
Russian Federation
Russian Federation
References
1. WHO Drug Information. WHO. Geneva.
2. International Nonproprietary Names for Pharmaceutical Substance. Cumulative List 2007; 12. WHO. Geneva.
3. Loshakov LA. The system of national and international nonproprietary names of medicines. Vestnik Roszdravnadzora 2008; (6): 31–3 (in Russian).
4. On approval of the appointment and prescribing drugs, as well as forms of prescription for drugs, procedures for obtaining these forms, their recording and storage. Order of the Ministry of Health of the Russian Federation¹ 1175n, 20.12.2012 (in Russian).
5. Guidelines on the Use of International Nonproprietary Names (INNs) for Pharmaceutical Substances. 1997. WHO/PHARM S/NOM 1570.
6. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJL 311, 28.11.2001, p. 67).
7. Available from: https://yadi.sk/d/euzr-wosnqEcw.
Review
For citations:
Lyakina M.N., Kovaleva E.L., Nikolaeva O.B., Krutikova N.M., Olenina N.G., Kolganov L.A. Group names for herbal medicines: the need for introduction and rationale for establishing. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2016;(3):9-11. (In Russ.)
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