vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-469Research ArticleОБЗОРЫREVIEWSСТАТЬЯ ОТОЗВАНА: Международный опыт экспертизы наименований лекарственных препаратов: Европейское агентство по лекарственным средствамRETRACTED: International experience in drug names assessment: European Medicines AgencyМироновА. Н.MironovA. N.СакаеваИ. В.SakaevaI. V.ДудченкоВ. В.DudchenkoV. V.КорнееваЛ. В.KorneevaL. V.ЯворскийА. Н.YavorskyA. N.201316062022023842Copyright © Миронов А.Н., Сакаева И.В., Дудченко В.В., Корнеева Л.В., Яворский А.Н., 20182018Миронов А.Н., Сакаева И.В., Дудченко В.В., Корнеева Л.В., Яворский А.Н.Mironov A.N., Sakaeva I.V., Dudchenko V.V., Korneeva L.V., Yavorsky A.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/469

СТАТЬЯ ОТОЗВАНА

Рассмотрен опыт работы единого экспертно-контрольного органа по регулированию обращения лекарств в странах Европейского Союза (ЕС) – Европейского агентства по лекарственным средствам. Представлено основное содержание действующей в странах ЕС нормативной документации, посвященной критериям приемлемости новообразованных наименований для лекарственных препаратов. Эти критерии направлены на защиту прав потребителя и позволяют не допустить негативных последствий для здоровья и жизни человека вследствие регистрации новых лекарственных препаратов, наименования которых идентичны или сходны до степени смешения с наименованиями ранее зарегистрированных препаратов, различных по составу и действию.

RETRACTED ARTICLE

The present article considers the experience of a unitary expert and control authority regulating the circulation of medicines in the European Union (EU) – the European Medicines Agency. It also describes the main contents of the current EU regulatory documentation on the newly formed drug names eligibility criteria. These criteria are directed to protect consumer's rights and allow to prevent adverse effects on human health and life caused by the marketing authorization of new drugs, which names are identical or confusingly similar with the names of previously authorized products, but different in composition and effects.

лекарственный препаратЕвропейское агентство по контролю лекарственных средствнаименование лекарственного препаратаэкспертизаdrugthe European Medicines Agencydrug nameassessmentReferencesGuideline on the acceptability of names for human medicinal products processed through the centralised procedure - London, 5 February 2007 CPMP/328/98, Revision 5.Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - London, 5 February 2007 CPMP/328/98, Revision 5.Council Regulation (EEC) No 2309/93 laying down Community procedures for he authorization/and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal products.Council Regulation (EEC) No 2309/93 laying down Community procedures for he authorization/and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal products.Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.Directive 2001/83/EC, as amended of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.Directive 2001/83/EC, as amended of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.Directive 2003/63/EC of the European Commission of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.Directive 2003/63/EC of the European Commission of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.Communication on the Community marketing authorisation procedures for medicinal products (OJ C 229/4 of 22.07.1998).Communication on the Community marketing authorisation procedures for medicinal products (OJ C 229/4 of 22.07.1998).

The authors declare that there are no conflicts of interest present.