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dc.identifier.citationCilia, F., Wirth, F., Serracino-Inglott, A., & Azzopardi, L. M. (2018, November). A simplified approach for the registration of medicines in small European countries. Poster session presented at the X Malta Medical School Conference, St Julian's, Malta.en_GB
dc.description.abstractA poster presentation regarding a simplified approach for the registration of medicines in small European countries. Introduction: A medicine requires a Marketing Authorisation (MA) before it could be made available on the EU market (Directive 2001/83/EC) to ensure its safety, quality and efficacy. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The problem of accessibility to medicines is of particular interest to small countries such as Malta. The research question of this study was: Can registration of medicines in small EU countries such as Malta be simplified? Aims: • To review the processes by which medicines are registered in the EU, with particular interest to small countries such as Malta. • To analyse the strengths and weaknesses of these registration processes and identify problems in the registration process in Malta. • To compile a guide intended to simplify the process for the registration of medicines in Malta and in small EU countries.en_GB
dc.publisherUniversity of Malta. Department of Pharmacyen_GB
dc.subjectDrug registration -- European Union countriesen_GB
dc.subjectDrug registration -- Handbooks, manual, etc.en_GB
dc.subjectDrug registration -- Maltaen_GB
dc.subjectDrug accessibility -- Maltaen_GB
dc.subjectPharmaceutical policyen_GB
dc.subjectPharmaceutical industry -- Malta -- Managementen_GB
dc.subjectStates, Smallen_GB
dc.titleA simplified approach for the registration of medicines in small European countriesen_GB
dc.rights.holderThe 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.contributor.creatorCilia, Francesca-
dc.contributor.creatorWirth, Francesca-
dc.contributor.creatorSerracino-Inglott, Anthony-
dc.contributor.creatorAzzopardi, Lilian M.-
Appears in Collections:Scholarly Works - FacM&SPha

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