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Title: | Requirements for the good distribution practice of medicinal products |
Authors: | von Brockdorff, Bettina Azzopardi, Lilian M. |
Keywords: | Pharmacists -- Practice -- European Union countries Vocational guidance -- Handbooks, manuals, etc. Pharmaceutical industry -- Standards -- European Union countries Pharmaceutical industry -- Quality control Drugs -- Law and legislation -- European Union countries Drugs -- Administration -- European Union countries -- Safety measures Wholesale trade |
Issue Date: | 2021 |
Publisher: | The Organisation for Professionals in Regulatory Affairs |
Citation: | von Brockdorff, B., & Azzopardi, L. M. (2021). Requirements for the good distribution practice of medicinal products. Regulatory Rapporteur, 18, 1-4. |
Abstract: | In the EU, good distribution practice (GDP) in the wholesale distribution of medicinal products is governed by EU-GDP guidelines. As yet, a standardised and formal educational framework with defined competencies and skills is not established to practice as a responsible person (RP) in the EU. It establishes that variability exists in both the educational requirements and the number of years of experience necessary for the RP role across EU states. The lack of both a defined educational framework and defined requirements poses limitations in terms of smooth mobility of RPs in Europe. (Note that the study was conducted before the UK left the EU, so it is included here among the EU member states.) |
URI: | https://www.um.edu.mt/library/oar/handle/123456789/117295 |
ISSN: | 17428955 |
Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
File | Description | Size | Format | |
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Requirements_for_the_good_distribution_practice_of_medicinal_products(2021).pdf Restricted Access | 81.05 kB | Adobe PDF | View/Open Request a copy |
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