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https://www.um.edu.mt/library/oar/handle/123456789/51115| Title: | A simplified approach for the registration of medicines in small European countries |
| Authors: | Cilia, Francesca Wirth, Francesca Serracino-Inglott, Anthony Azzopardi, Lilian M. |
| Keywords: | Drug registration -- European Union countries Drug registration -- Handbooks, manual, etc. Drug registration -- Malta Drug accessibility -- Malta Pharmaceutical policy Pharmaceutical industry -- Malta -- Management States, Small |
| Issue Date: | 2018-11 |
| Publisher: | University of Malta. Department of Pharmacy |
| Citation: | Cilia, 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. |
| Abstract: | A 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. |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/51115 |
| Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| A_simplified_approach_for_the_registration_of_medicines_in_small_European_countries_2018.pdf | 383.71 kB | Adobe PDF | View/Open |
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