In the EU, a medicinal product needs a marketing authorization (MA) to be placed on the market. The EU's medicinal products'legislative framework allows for a reduced application for medicines outside their data exclusivity. One such type of application is the well-established use (WEU) medicinal product application. Recently, these MA applications have been subject to arbitration procedures at the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) because of disagreements between member states during the authorisation process. This paper reflects on these cases and highlights their potential impact on future WEU applications.
In the EU, a medicinal product needs a marketing authorization (MA) to be placed on the market. The EU's medicinal products'legislative framework allows for a reduced application for medicines outside their data exclusivity. One such type of application is the well-established use (WEU) medicinal product application. Recently, these MA applications have been subject to arbitration procedures at the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) because of disagreements between member states during the authorisation process. This paper reflects on these cases and highlights their potential impact on future WEU applications.
Reflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJ / Borg, Jj; Laslop, A; Pani, L; Maciulaitis, R; Melchiorri, Daniela. - In: SCIENTIA PHARMACEUTICA. - ISSN 2218-0532. - ELETTRONICO. - 82:(2014), pp. 541-554. [10.3797/scipharm.1402-14]
Reflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJ.
MELCHIORRI, Daniela
2014
Abstract
In the EU, a medicinal product needs a marketing authorization (MA) to be placed on the market. The EU's medicinal products'legislative framework allows for a reduced application for medicines outside their data exclusivity. One such type of application is the well-established use (WEU) medicinal product application. Recently, these MA applications have been subject to arbitration procedures at the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) because of disagreements between member states during the authorisation process. This paper reflects on these cases and highlights their potential impact on future WEU applications.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
