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Abstract

This paper gives an overview of some regulatory requirements for the labeling of clinical trial samples. The regulatory requirements of the following countries were investigated: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, The Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom, and the United States. It can be concluded that, due to the different requirements in regulation, the manufacture of standard international labels is not feasible. To reduce the diversity in labeling requirements, a common attitude — at least within the European Economic Community (EEC) — towards the nature of the information on a clinical trial label is needed

Keywords

Clinical trial samples Labeling Regulatory requirements

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References

Nordic Guidelines. Clinical trial of drugs. NLN Publication No. 11, 1983.

Swedish Clinical Trial Guidelines, 1984, p. 9.

German Drug Act, §10AMG, Kennzeichnung der Fertigarzneimittel, p. 19–22.

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Code of Federal Regulations, Title 21, Part 211, Section 211.130.

Labeling of Clinical Trial Samples: An Overview of Some Regulatory Requirements

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