Group names for herbal medicines: the need for introduction and rationale for establishing

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 nam...

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Opis bibliograficzny
Główni autorzy: M. N. Lyakina, E. L. Kovaleva, O. B. Nikolaeva, N. M. Krutikova, N. G. Olenina, L. A. Kolganov
Format: Artykuł
Język:Russian
Wydane: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Seria:Регуляторные исследования и экспертиза лекарственных средств
Hasła przedmiotowe:
Dostęp online:https://www.vedomostincesmp.ru/jour/article/view/84
Opis
Streszczenie: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.
ISSN:3034-3062
3034-3453