Journal article
The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists
- Abstract:
- By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure that no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law and whether or not these actions are sufficient. We found that Poland is only partially compliant with the FMD and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland about the prevalence of falsified medication and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 557.4KB, Terms of use)
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- Publisher copy:
- 10.1136/ejhpharm-2016-000970
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- European Journal of Hospital Pharmacy More from this journal
- Volume:
- 25
- Issue:
- 1
- Pages:
- 10-15
- Publication date:
- 2016-07-27
- Acceptance date:
- 2016-07-05
- DOI:
- EISSN:
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2047-9964
- ISSN:
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2047-9956
- Keywords:
- Pubs id:
-
pubs:641549
- UUID:
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uuid:6135a8d2-92a3-4307-a86b-79b7406e0cbd
- Local pid:
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pubs:641549
- Source identifiers:
-
641549
- Deposit date:
-
2016-09-05
Terms of use
- Copyright holder:
- Merks et al
- Copyright date:
- 2016
- Notes:
- © 2016 Merks et al. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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