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DC Field | Value | Language |
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dc.contributor.author | Borg, John Joseph | - |
dc.contributor.author | Laslop, Andrea | - |
dc.contributor.author | Pani, Luca | - |
dc.contributor.author | Maciulaitis, Romaldas | - |
dc.contributor.author | Melchiorri, Daniela | - |
dc.date.accessioned | 2020-08-17T10:30:47Z | - |
dc.date.available | 2020-08-17T10:30:47Z | - |
dc.date.issued | 2014 | - |
dc.identifier.citation | Borg, J. J., Laslop, A., Pani, L., Maciulaitis, R., & Melchiorri, D. (2014). Reflections on decisions made on the well-established use of medicinal products by EU Regulators and the ECJ. Scientia Pharmaceutica, 82(3), 655-664. | en_GB |
dc.identifier.uri | https://www.um.edu.mt/library/oar/handle/123456789/59519 | - |
dc.description.abstract | Background: In the European Union (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 (i.e. bibliographic applications). 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. Methods: Decisions adopted by the European Commission on WEU applications between 2009 and 2012 were identified from the EU Community Register on medicinal products for human use. Subsequently, decisions were reviewed to understand the potential serious risk to public health (PSRPH) that EU regulators raised during MA application procedures. Results: Four decisions were adopted by the EU commission between 2009 and 2012. Three followed disagreements between member states on PSRPH grounds. One decision was the outcome of a centralised marketing authorisation application. Six key messages were identified from the four cases reviewed and presented. Conclusion: A guideline on WEU to implement the technical specifications to fulfil Annex I of Directive 2001/83/EC for MA applications is not available. Thus, reflections on recent decisions on WEU applications provide scientific direction to the industry as well as the medicinal product regulators on the documentation required to successfully file and obtain a WEU MA. | en_GB |
dc.language.iso | en | en_GB |
dc.publisher | Osterreichische Apotheker-Verlagsgesellschaft m.b.H. | en_GB |
dc.rights | info:eu-repo/semantics/openAccess | en_GB |
dc.subject | Medicine -- Europe | en_GB |
dc.subject | Administrative agencies -- Europe | en_GB |
dc.subject | Public health -- Europe | en_GB |
dc.subject | Drug utilization – Europe | en_GB |
dc.subject | Generic drugs | en_GB |
dc.subject | Medical audit | en_GB |
dc.subject | Risk communication | en_GB |
dc.title | Reflections on decisions made on the well-established use of medicinal products by EU regulators and the ECJ | en_GB |
dc.type | article | en_GB |
dc.rights.holder | The copyright of this work belongs to the author(s)/publisher. The rights of this work are as defined by the appropriate Copyright Legislation or as modified by any successive legislation. Users may access this work and can make use of the information contained in accordance with the Copyright Legislation provided that the author must be properly acknowledged. Further distribution or reproduction in any format is prohibited without the prior permission of the copyright holder | en_GB |
dc.description.reviewed | peer-reviewed | en_GB |
dc.identifier.doi | 10.3797/scipharm.1402-14 | - |
dc.publication.title | Scientia Pharmaceutica | en_GB |
Appears in Collections: | Scholarly Works - ERCMedGen |
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