The European Union’s current regulations for the licensing of generic and hybrid medications
1 Department of Pharmaceutical Regulatory Affairs, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116, India.
2 Assistant Professor, Department of Pharmaceutics, Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116, India.
Review
World Journal of Biology Pharmacy and Health Sciences, 2023, 13(02), 105-110
Article DOI: 10.30574/wjbphs.2023.13.2.0233
Publication history:
Received on 01 December 2022; revised on 04 February 2023; accepted on 07 February 2023
Abstract:
In the European Union, the applicant must specify the legal justification for the application in any Marketing Authorization Application (MAA) for a pharmaceutical product. The dossier's content and the market exclusivity are significantly influenced by this legal foundation, which is outlined in Directive 2001/83/EC as modified. The right legal foundation must be chosen carefully for new development projects involving active chemicals that are already known, including novel strengths, dosage forms, administration methods, and indications. In accordance with Article 10 and the so-called "hybrid" and "generic" applications, this article describes the registration criteria and the procedure for obtaining a marketing authorization for applicants utilizing the Article 8(3) legal foundation.
Keywords:
Hybrid medication; Generic medication; License of medications; European union regulations; European Medicine Agency
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