Please use this identifier to cite or link to this item: https://www.um.edu.mt/library/oar/handle/123456789/117295
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

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