Abstract
Aim
To report a case in France where the application of the French regulation on drug imports blocked the use of a French registered drug.
Case report
The authors were not allowed by the French Drug Agency (AFSSaPS) to use a French registered drug that was no longer available in France, but in Sweden.
Discussion
The authors emphasize the inconsistencies of the regulations on drug imports and on their application by the French Drug Agency.
Conclusion
Clarification of European regulations regarding drug circulation within Europe is awaited.
References
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French Public Health Code: Art L.5121-12, Art R.5121-68 to R.5121-76, Art R.5121-108 to R.5121-136. http://www.legifrance.gouv.fr (10 September 2007)
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The authors disclose any relevant associations that might pose a conflict of interest.
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Edouard, B., Parquin, F. & Fadel, E. Inconsistencies in the application of regulations about drug imports: A case report. J Public Health 16, 375–376 (2008). https://doi.org/10.1007/s10389-007-0175-4
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DOI: https://doi.org/10.1007/s10389-007-0175-4